the effectiveness of static hand and wrist splints …...the effectiveness of static hand and wrist...
TRANSCRIPT
The Effectiveness of Static Hand and Wrist Splints for
People with Rheumatoid Arthritis:
A Systematic Literature Review
Gemma Mottern
A research project submitted in partial fulfillment of the requirements of the degree
Master of Occupational Therapy at Otago Polytechnic, Dunedin, New Zealand
29 July, 2013
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Abstract
Occupational therapists commonly use static hand splints for patients with rheumatoid
arthritis to improve hand function, prevent deformity, increase grip strength and
relieve joint pain (Henderson & McMillan, 2002), yet the evidence to support this
intervention is limited. A systematic review was conducted to assess the effectiveness
of five different types of static hand and wrist splints for adults with rheumatoid
arthritis. Articles were identified through a computerized search of seven
bibliographic databases from their inception to June 2012. The literature search
procedure was complimented by manually scanning the reference lists of retrieved
articles, searching for grey literature and checking personal reference collections.
Articles were evaluated according to predetermined criteria for inclusion at each of
the title, abstract, and article levels. Included studies were independently scored using
the Structured Effectiveness Quality Evaluation Scale (SEQES) and also graded
according to Sackett’s Levels of Evidence. Fifty-one studies were identified as
potentially relevant. After assessment of relevance and quality, only 18 articles
fulfilled the inclusion criteria. Quality scores on the SEQES ranged from 14 to 46 out
of a possible 48. The current evidence provided varied support for all five types of
static splints. There is strong evidence that wearing a prefabricated wrist extension
splint during certain functional tasks significantly relieves wrist pain after one month
and does not compromise dexterity and grip strength. There was insufficient evidence
to support or refute the role of static resting splints to reduce pain, grip strength or
improve upper limb function. However, participants who wore these splints for one
month preferred to wear soft splints to rigid ones. The one study of thumb splints
provided evidence of statistically significant benefit in pain reduction wearing the
splint for 12 weeks. Indicative findings for evidence that swan neck splints,
boutonnière splints and metacarpal ulnar deviation splints improve hand function were
found. In overview, until more evidence becomes available, an evidence-informed
approach in which occupational therapists use their clinical experience while
integrating all available levels of evidence to meet the patients’ needs and goals is
recommended.
Key words: rheumatoid arthritis, occupational therapy, splinting, hand function
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Acknowledgments
Firstly, I would like to take this opportunity to express my deepest gratitude to
the most important person in my studies, Sian Griffin, supervisor of my master’s
research project, who provided me with all the necessary support, guidance, patience,
constructive feedback and encouragement which are indispensable to the success of
my postgraduate studies.
I would like to extend my sincere thanks to my family members for their
loving support during my study. I must also express my gratitude to my husband,
Michael Mottern, for his continuing encouragement, support and understanding.
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Table of Contents
List of Tables ................................................................................................................... vi
List of Figures ................................................................................................................. vii
Chapter One: Introduction to the Study ............................................................................ 1
Need for a Systematic Literature Review .................................................................. 4
Aims of the Systematic Review ................................................................................. 5
Chapter Two: Pathomechanics of Rheumatoid Deformities in the Hand and Wrist ........ 6
Wrist Deformities ...................................................................................................... 7
Metacarpophalangeal Joint Deformities .................................................................... 8
Swan Neck Deformity ............................................................................................... 9
Boutonniere Deformity ............................................................................................ 10
Deformities of the Rheumatoid Thumb ................................................................... 11
Chapter Three: Static Splints for the Hand and Wrist .................................................... 12
Static Resting Splints ............................................................................................... 12
Wrist Extension Splints ........................................................................................... 13
Finger Splints ........................................................................................................... 13
(1) Splinting for swan neck deformity ........................................................... 13-14
(2) Splinting for boutonniere deformity .............................................................. 15
Metacarpal Ulnar Deviation Splints ................................................................... 16-17
Splinting for the Rheumatoid Thumb ...................................................................... 18
Static Splints and their Principles of Action ............................................................ 19
Chapter Four: Methodology ............................................................................................ 20
What is a Systematic Literature Review? ................................................................ 20
Why is a Systematic Literature Review Needed? .................................................... 21
The Process of a Systematic Review ....................................................................... 22
Framing the research question ............................................................................ 22
Search strategy ............................................................................................... 23-26
Inclusion and exclusion criteria ..................................................................... 26-27
Critical Appraisal/Quality Assessment ............................................................... 29-30
Levels of Evidence................................................................................................... 32
Grades of Recommendation..................................................................................... 33
Chapter Five: Results ...................................................................................................... 34
Search and Selection of Studies .......................................................................... 34-35
v
Methodological Quality of the Included Studies ..................................................... 36
Static Resting Splints .......................................................................................... 38-40
Wrist Extension Splints ...................................................................................... 43-47
Finger Splints ........................................................................................................... 52
splinting for swan neck deformity.................................................................. 52-55
splinting for boutonniere deformity .................................................................... 58
Metacarpal Ulnar Deviation Splints ................................................................... 60-61
Thumb Splints ..................................................................................................... 64-65
Chapter Six: Discussion .................................................................................................. 67
Static Resting Splints .......................................................................................... 67-69
Wrist Extension Splints ...................................................................................... 69-70
Finger Splints ........................................................................................................... 71
(1) Swan neck splints ..................................................................................... 71-72
(2) Boutonniere splints ................................................................................... 72-73
Metacarpal Ulnar Deviation Splints ........................................................................ 73
Thumb Splints .......................................................................................................... 74
Limitations of the Study ..................................................................................... 74-75
Limitations of the Current Evidence ................................................................... 75-76
Chapter Seven: Conclusion ............................................................................................. 77
Implications for Practice ..................................................................................... 77-78
Recommendations for Future Research .............................................................. 78-79
References .................................................................................................................. 80-93
Appendix A: Anatomical Structure of the Hand and Wrist ...................................... 94-95
Appendix B: Search Strategies from the Different Databases ........................................ 96
Appendix C: SEQES interpretation guide ............................................................... 97-101
Appendix D: Characteristics of Excluded Studies ........................................................ 102
vi
List of Tables
Table 1. Rheumatoid Thumb Deformities .................................................................... 11
Table 2. Study Inclusion and Exclusion Criteria .......................................................... 28
Table 3. Structured Effectiveness of Quality Evaluation Scale ................................... 31
Table 4. Sackett’s Level of Evidence Model................................................................ 32
Table 5. Grades of Recommendations and Definitions ................................................ 33
Table 6. Methodological Quality of the 18 Splinting Studies ...................................... 37
Table 7. Summary of Evidence for Static Resting Splints ...................................... 41-42
Table 8. Summary of Evidence for Wrist Extension Splints................................... 48-51
Table 9. Summary of Evidence for Swan Neck Splints .......................................... 56-57
Table 10. Summary of Evidence for Boutonniere Deformity......................................... 59
Table 11. Summary of Evidence for Metacarpal Ulnar Deviation Splints ..................... 63
Table 12. Summary of Evidence for Thumb Splints ...................................................... 66
vii
List of Figures
Figure 1. Caput ulnar syndrome ....................................................................................... 7
Figure 2. Radiograph of a typical wrist deformity ........................................................... 7
Figure 3. Clinical appearance of ulnar drift deformity .................................................... 8
Figure 4. Radiograph of a classic metacarpal ulnar deviation deformity ........................ 8
Figure 5. Swan neck deformity ........................................................................................ 9
Figure 6. Boutonniere deformity .................................................................................... 10
Figure 7. Static resting splint ......................................................................................... 12
Figure 8. Commercial wrist extension splint ................................................................. 13
Figure 9. Prefabricated thermoplastic splint, Oval-8 design .......................................... 14
Figure 10. Silver ring splint ........................................................................................... 14
Figure 11. Custom thermoplastic splint for swan neck deformity .................................. 14
Figure 12. DS anti-boutonniere splint ............................................................................ 15
Figure 13. Boutonniere prefabricated thermoplastic splint ............................................. 15
Figure 14. Volar based custom boutonniere splint ......................................................... 15
Figure 15. Modified MUD splint, described by Rennie (1996) ...................................... 16
Figure 16. LMB splint, volar hand based design ............................................................ 16
Figure 17. Ulnar drift splint, neoprene (3.2mm) ............................................................. 16
Figure 18. Norco Fabrifoam soft MCP ulnar drift splint ................................................ 17
Figure 19. Wrist-hand-based splint – palmer view ......................................................... 17
Figure 20. Wrist-hand-based splint – dorsal view .......................................................... 17
Figure 21. Thermoplastic short opponens splint ............................................................. 18
Figure 22. Neoprene CMC joint thumb splint ............................................................... 18
Figure 23. Flowchart of the five essential steps in a systematic review ......................... 23
Figure 24. Flowchart of the study selection process in the systematic review ............... 35
Figure 25. MCP-blocking splint, palmer view................................................................ 62
Figure 26. MCP- blocking splint, dorsal view ................................................................ 62
Figure 27. Innovative thumb splint, dorsal view ........................................................... 65
1
Chapter One:
Introduction
Hand function disability is common in patients with rheumatoid arthritis (RA)
(Maini & Feldman, 1998). Local inflammation initially causes pain, swelling and a
limited range of movement. Within one year of diagnosis, 50% of individuals with RA
have difficulty with impaired hand function; in particular, finger flexion and pincer
grip (Eberhardt & Fex, 1995). As the disease progresses, approximately, 90% of those
individuals develop specific hand and wrist deformities (Horsten, Ursman, Roorda, van
Schaardenburg, Dekker, & Hoeksma, 2010), and the resultant damage can lead to long
term disability. Static hand and wrist splints have been used in rheumatology for many
years (Rotstein, 1965). They are recommended for helping individuals manage their
arthritis (Adams, 1996), and are a commonly used intervention in occupational
therapy (Henderson & McMillan, 2002). Despite splinting’s widespread use, evidence
in the form of published clinical studies is limited. The aim of this systematic review
was to determine the effectiveness of five types of static hand splints for persons with
RA. This review focuses on the use of splinting for non-surgical treatment, not on the
efficacy of post-operative splinting.
The most prevalent recognizable hand deformities in RA include ulnar
deviation of the metacarpophalangeal joints, the boutonniere deformity, and the swan-
neck deformity. Most individuals will also develop thumb involvement (Terrono,
2001). These deformities can cause significant functional consequences and impact
quality of life (Madenci & Gursoy, 2003). There is also the potential loss of social and
financial independence (Young et al., 1998) and the burden of care on direct (e.g.,
medical care) and indirect costs (e.g., effects on the individual’s ability to work)
(Jantti, Aho, Kaarela, & Kautiainen, 1999; Cooper, 2000). Given the major impact RA
deformities can have on hand function and quality of life (Johnsson & Eberhardt,
2009); occupational therapists are frequently looking for the most effective splints to
alleviate pain, increase joint stability, prevent joint deformity and improve function.
Rheumatoid arthritis is a chronic, systemic, inflammatory condition that
affects approximately 1% of the population worldwide (Taylor, 2007). It occurs twice
as often in woman as in men (Uhlig & Kvien, 2005), with a peak incidence between
45 and 65 years (Lee & Weinblatt, 2001). The course of RA is variable and
unpredictable but for a significant number of patients it is a severe disease resulting in
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persistent joint pain, progressive joint destruction and long-standing disability
(Tehlirian & Bathon, 2008; Wolfe & Zwillich, 1998). The etiology is still not fully
understood but involves a complex interplay of environmental and genetic factors
(Uhlig & Kvien, 2005).
The disease is characterized by symmetrical involvement of the peripheral
joints, in particular, the small joints of the hands and wrists (Scott & Kingsley, 2008).
In a recent study of RA patients attending a rheumatology clinic, hand involvement
occurred in approximately 75% of participants (Oldfield & Felson, 2008). This
finding is supported by Dellhag and Bjelle (1995) who found that 90% of all patients
had wrist, metacarpophalangeal (MCP) joints, and/or proximal phalangeal (PIP) joint
involvement, causing significant pain and impaired hand function.
In the early stages of RA, involvement of the hand and wrist is frequently
described, causing pain and limited range of motion. McQueen and colleagues (1998)
performed a longitudinal, prospective study to investigate the progression of joint
damage in early RA using magnetic resonance imaging (MRI).The results
demonstrated that 40% of people first develop inflammatory symptoms in their finger
joints, then hand and wrist erosions within four months of disease onset. In long-
standing RA the hand joints are involved in up to 85% of patients (Eberhardt,
Rydgren, Pettersson, & Wollheim, 1990) and these deformities can lead to severe
limitations in activities of daily living (e.g., in family life, in working life, and in other
social situations) (Johnson & Eberhardt, 2009).
Rheumatoid arthritis causes synovitis and joint erosions, leading to capsular
distention, ligament laxity, loss of joint motion and imbalance of muscle function
(Boutry et al., 2003). When combined with external forces on the joints (Flatt, 1996),
three hand deformities commonly develop, ulnar drift deformity of the metacarpals,
swan neck deformity and boutonnière deformity (Madenci & Gursoy, 2003). These
deformities develop early in the disease process and their presence is a predictor of
disease severity (Johnsson & Eberhardt, 2009). In a recent study of RA patients
attending a rheumatology clinic, 59% of patients developed one or more hand
deformities after 10 years, with MCP joint deformity the most prevalent (Johnsson &
Eberhardt, 2009). Development of these deformities is correlated with a positive
rheumatoid factor (Johnsson & Eberhardt, 2009), active synovitis, and disease
duration (Madenci & Gursoy, 2003). There is no association with hand dominance
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and more than one deformity can develop in the same hand (Eberhardt, Malcus-
Johnson & Rydgren, 1991).
Splinting
Hand and wrist splints are a common component of occupational therapy
programs for persons with rheumatoid arthritis. Recent literature suggests splinting
has the potential to improve hand function, by attempting to support the proximal
joints, applying counterbalanced force to deforming joints and improving
biomechanical advantage (Prosser & Connolly, 2003). Hand splints have both
biomechanical and biological rationales for their use and action (McClure, Blackburn,
& Dusold, 1994), however evidence to support the clinical effectiveness is still
emerging (Adams, Hammond, & Burridge, 2005). The rationale for the use of wrist
and hand splints in rheumatology has included:
To decrease soft tissue and joint pain (Pagnotta, Korner-Bitensky,
Mazer, Baron, & Wood-Dauphinee, 2005).
To rest/immobilize weakened joint structures and decrease local
inflammation (Jansen, Phiferons, van de velde, & Dijkmans, 1990).
To correctly position joints (Ouellette, 1991).
To increase joint stability (Kjeken, Moller, & Kvien, 1995).
To increase hand function (e.g., grasping or pinching) (Pagnotta et al.,
2005).
To contribute towards self-management strategies in long-term disease
management (Hammond, 1998).
To minimize joint contractures and hand deformities (McClure et al.,
1994).
4
Need for a Systematic Literature Review
Despite substantial progress in medical management over the last decade, hand
deformities remain prevalent in RA. These deformities have substantial functional
consequences and negative burden on health-related quality of life (Luqmani et al.,
2006). They can impair hand strength; range of motion, dexterity, and ability to use
hands efficiently for activities of daily living (Johnsson & Eberhardt, 2009; Vliet
Vlieland, van der Wijk, Jolie, Zwinderman, & Hazes, 1996). Regardless of the relative
frequency with which hand deformities are encountered, there is no current consensus
on the use of splinting for this condition. Treatment may vary from one facility to
another.
A systematic review published in the last decade (Steultjents et al., 2004)
reported indicative findings that splints are effective in reducing pain, but did not
distinguish between hand resting splints, wrist splints or finger splints. This study
concluded that there was a lack of scientific evidence to draw conclusions about
optimal occupational therapy (OT) interventions for RA affecting the hand. One
Cochrane review by Egan et al. (2003) addressing the efficacy of orthoses for RA
patients, evaluated only a small part of OT interventions. Egan et al. (2003) concluded
that there is no evidence, as yet, if splinting can help reduce or prevent hand
deformity, or maintain function in the longer term. Furthermore, the extent to which
splinting prevents the relentless transition from mild to marked instability, and then to
a fixed deformity, is difficult to determine with absolute certainty.
To date, no clinical guidelines on the management of adults with RA affecting
the hands and wrists have been produced by the Accident Compensation Corporation
(ACC), or the New Zealand Guidelines Group (NZGG). Recent UK guidelines
recommend that skilled rheumatology occupational therapists should be available to
people with RA to assess the impact and treat the consequences of the condition
(Luqmani et al., 2006; NICE, 2009; SIGN, 2011). Treatment provided can involve a
variety of modalities. These include instruction on joint protection; training in the use
of assistive devices, provision of splinting, hand exercise, energy conservation and
fatigue management. Hence, current treatment is a balance between the provision of
strategies to support and protect joints and exercise to improve strength, maintain
flexibility and increase functional ability.
With the current emphasis on evidence based practice, it is essential that
occupational therapists working in New Zealand are aware of both the rationale and
5
research findings on which their treatments are based. A systematic literature review
is required to determine the efficacy or otherwise of the use of static hand and wrist
splints, in the treatment of people with rheumatoid arthritis. This allows therapists to
select appropriate splints that are based on the best available evidence and to ensure
that scarce resources are being use in the most cost-effective way. Until now, the use
of static hand and wrist splints in the non-surgical management of RA has not been
exclusively investigated.
Aim of the Systematic Review
The aim of this systematic review was to appraise, interpret and summarize the
literature relating to static splinting in the nonsurgical management of persons with
RA. This included a review of all the available evidence on the effectiveness of five
types of static hand and wrist splints.
The following research question was posed to guide the selection of research studies
for this systematic review:
“Does the published evidence demonstrate that static splinting for the hand and
wrist of people with Rheumatoid Arthritis is effective in augmenting hand
function, preventing deformity, increasing grip strength, and reducing their
pain?”
6
Chapter Two:
Pathomechanics of Deformities in the Rheumatoid Hand and Wrist
The hand is capable of both great strength and precise manipulation. Joints,
tendons and nerves are dependent on each other’s integrity to achieve this level of
complex activity. Destruction of a joint and/or invasion of soft tissue structures by
proliferative synovitis can have a devastating effect on the ability of the hand to carry
out its multiplicity of functions (Adams et al., 2005). It is important to reflect on why
specific deformities in the wrist and hand develop with RA because this can help us to
understand how splinting may contribute to preserving joint integrity.
The development of deformities in the wrist and hand is a very complex
process. Since the joints are so intimately related in both structure and function,
destruction and deformity in one will inevitably affect the others. See Appendix A for
examples of the anatomical structure of the wrist and hand. A modern view of RA
regards the pathology of the synovium in two slightly separate but related
components: inflammation and proliferation (Beasley, 2012). Inflammation, the initial
process, is demonstrated by inflammatory joint effusion, which raises articular
pressure, stretches and weakens joint-supporting structures, and causes pain. To
reduce pain, the inflamed joint assumes a position whereby it is anatomically
positioned to provide the greatest volume of fluid, intra-articular pressure is lowest,
and the joint capsule and other soft tissues are slack (Firestein et al., 1997).
As the disease progresses, the synovium remains inflamed, proliferates, and
becomes destructive to articular cartilage, the subchondral bone, and surrounding soft
tissues. The synovial pannus, further increases intra-articular pressure, stretches and
weaken the already lax joint supporting structures, and can lead to eventual
subluxation and collapse (Muller-Ladner, Gay, & Gay, 1998). The joint in this state
loses the ability to withstand internal and external forces acting on it, thus causing
secondary biomechanical and primary pathophysiological imbalance of the joint. In
theory, if a static hand or wrist splint disrupts this process, then it may help to relieve
symptoms and to maintain structural and functional integrity of the hand.
7
Wrist Deformities in Rheumatoid Arthritis
The wrist is the most commonly involved joint in the upper extremity of
patients with rheumatoid arthritis. Approximately 70-80% of patients will develop
wrist symptoms during the course of the disease (Lee & Hausman, 2005). The
disability associated with progressive rheumatoid arthritis is significant. According to
Swanson (1995) the wrist is the key joint for proper hand function, and instability of
the wrist can affect grip and pinch activities. The wrist involves three joints
(radiocarpal, midcarpal and distal radioulnar joint) which have relatively low bony
instability. Much of the stability and balance of the wrist is due to the soft tissues
including the radiocarpal, intercarpal, triangular fibrocartilage complex, and crossing
tendons. Since RA is a disease of the synovium, many of these stabilizing structures
are affected. The ligaments are attenuated and become lax, the triangular
fibrocartilage complex is progressively destroyed and the tendons are surrounded and
infiltrated by hyperplastic synovium. Imbalance of the wrist then occurs causing
deformity. The anatomical effects of rheumatoid synovitis in the wrist follow
predictable patterns. Typical deformity includes shortening of the wrist, scapho-lunate
dissociation, translocation of the carpus in an ulna and volar direction, radial deviation
of the carpus and dorsal subluxation of the ulna. (See Figure 1 & Figure 2). The
extensor carpi ulnaris tendon often subluxes volarly, further contributing to the
deforming forces. The clinical result of these deformities includes pain, decreased grip
and pinch strength and loss of hand function (Shapiro, 1996).
Figure 2 .Radiograph of a typical deformity of the wrist. Photograph from my personal file. Permission given for use.
Figure 1. A patient with dorsal prominence of the distal ulna. This condition is called caput ulna syndrome, as described by Backdahl (1963).
8
Metacarpophalangeal Joint Deformities
The metacarpophalangeal (MCP) joint is possibly the most important joint in
the digit for function of the fingers (Bielefeld & Neumann, 2005). The MCP joints are
condylar, permitting active motion in two separate planes. As a result of this anatomic
formation, their inherent strength is less than that of the interphalangeal joints;
therefore, they are more susceptible to the deforming forces that occur in RA. The two
most common deformities of the of the MCP joints associated with RA and instability
are palmar subluxation and ulnar drift deformity (Figure 3 & Figure 4).
Ulnar drift deformity is characterized by ulnar deviation and palmar
subluxation often MCP joints with a reported prevalence of 44% after 10 years of
disease duration (Johnsson & Ebherhardt, 2009). According to Bielefeld and
Neumann (2005) this deformity occurs when persistent synovitis of the MCP joints
weakens the periarticular structures, creating an imbalance of passive and active
forces, leading to joint instability and eventual deformity. Capsular distention and
attenuation of the collateral ligaments and volar plate allow the flexor digitorum
profundus and flexor digitorum superficialis tendons to bowstring, promoting volar
subluxation of the proximal phalanx on the metacarpal. The extensor digitorum
communis tendon slips ulnarly if the radial sagittal band is compromised; creating
flexion and ulnar deviation forces (Flatt, 1996). Instability created by ulnar drift
deformity has an intense effect on grip and pinch (Vliet Vlieland et al., 1996).
Furthermore, the inability to extend at the MCP joints impairs the ability to open the
hand to grasp large items (Johnsson & Eberhardt, 2009), which further compromises
hand function.
Figure 3.Clinical appearance of ulnar drift deformity. Photograph from my personal file. Permission was given to use image.
Figure 4. In this X-ray the radiographic changes correlate with the clinical deformities of ulnar drift deformity of the MCP joints. Photograph from my personal file. Permission was given to use image.
9
Swan Neck Deformity
The swan neck deformity (SND) is common in RA, and is characterized by a
zigzag collapse of the interphalangeal (IP) joints with proximal interphalangeal (PIP)
joint hyperextension and distal interphalangeal (DIP) joint flexion (Figure 5). One
study by Johnson and Eberhardt (2009) found that prevalence of SND in RA patients
is 24% after 10 years of disease duration. The pathomechanics of SND are complex
and any anatomical susceptibility to hyperextension can expedite the deformity
process (Dreyfus & Schnitzer, 1983). In RA, this deformity can originate from
primary involvement at the metacarpophalangeal (MCP), PIP or DIP joints (Alter,
Feldon, & Terrono, 2002). Initial involvement at the MCP joint is considered the most
common cause in RA (Melvin, 1989).
At the MCP joint, synovitis weakens periarticular and muscular structures that
usually provide dynamic stability to the joint. As the proximal phalanx volarly
subluxes on the metacarpal bone, contractures of the intrinsic muscles create
extension force at the PIP joint, leading to a SND. As the MCP joint deviates ulnarly,
a nasty cycle develops - the ulnar intrinsic muscles contract even more, increasing the
swan neck deformity (Feldon, Terrono, Nalebuff, & Millender, 2005). At the PIP
joint, flexor synovitis stretches out the volar plate and allows the PIP joint to
hyperextend. With the PIP joint in hyperextension, the lateral bands displace dorsally.
This relaxes the tension on the terminal extensor tendon. Consequently, the DIP joint
falls into flexion. DIP joint flexion is secondary, a consequence of PIP joint
hyperextension. This is the least common cause of SND in adult RA patients because
PIP joint synovitis most frequently causes a boutonniere deformity (Melvin, 1989).
Swan neck deformity contributes to the limitations in hand related everyday
activities. Van der Giesen and associates (2010) found seven hand function specific
problems experienced by RA patients with swan neck deformity - flexion initiation;
pain with PIP joint hyperextension; appearance; tasks requiring small grip; activities
requiring large grip; application of pressure at fingertips; and comprehensive hand
related tasks.
Figure 5. Clinical appearance of a Swan Neck Deformity (SND). Photograph from my personal file. Permission was granted to use image.
10
Boutonnière Deformity
The boutonniere deformity is another zigzag collapse that frequently occurs in
patients with RA. Like the swan neck deformity, this deformity is the result of
muscle-tendon imbalance and/or joint laxity. It is characterized by proximal
interphalangeal (PIP) joint flexion, hyperextension of the distal interphalangeal (DIP)
joint, and hyperextension of the metacarpophalangeal (MCP) joint (Figure 6). While
the swan neck deformity may originate from any of the finger joints, the boutonniere
deformity only begins with flexion of the PIP joint. The changes to adjacent joints are
secondary.
Boutonniere deformity occurs when synovial proliferation disrupts the
extensor mechanism at the level of the PIP joint. As a result, the central slip is unable
to maintain full extension of the joint, and PIP joint flexion develops (Tubiana,
Thomine, & Mackin, 1998). Transverse fibers connecting lateral tendons to the central
slip are further lengthened by synovitis, causing the lateral bands to displace volarly.
This increases the tension on the distal phalanx, causing DIP joint hyperextension.
This deformity is initially flexible but eventually becomes fixed as a result of
secondary contractures of the extensor mechanism (Coons & Green, 1995).
Boutonniere deformities are common in patients with RA and can lead to substantial
finger and hand function impairment (Chung & Pushman, 2011). Activities that use
forceful PIP joint flexion, for example, using a tripod pinch when handwriting or
holding a vegetable peeler should be avoided.
Figure 6. Boutonniere deformity, showing flexion of the PIP joint, hyperextension of the DIP joint, and hyperextension of the MCP joint. Photograph adapted from my personal file. Permission was given to use image.
11
Deformities of the Rheumatoid Thumb
Thumb involvement in RA is a common and important source of functional
loss and disability (Chacko & Rozental, 2008). Fortunately, it is possible to
understand the various deformities and apply nonsurgical interventions to prevent
deformity and restore function. Disruption of the thumb biomechanics regularly leads
to substantial loss of a person’s ability to perform daily activities. Activities like
buttoning clothing or manipulating small objects are difficult to achieve if the person
lacks either control or stability of the thumb joint.
There are a variety of thumb deformities encountered in RA, and these are due
to changes taking place intrinsic and extrinsic to the thumb. Synovial proliferation
within the thumb joints can destroy the articular cartilage and also stretch the
supporting collateral ligaments and joint capsules. Consequently, each joint can
become unstable and react to the stresses applied to it (Chacko & Rozental, 2008). In
1968, Nalebuff devised a classification system for thumb deformities in RA. This
classification system takes into account the degree of severity of the imbalance and
the involvement of adjacent structures. Thumb deformities are now classified from
Type I to Type VI, as shown in Table 1.
Table 1 Rheumatoid Thumb Deformities
Type CMC Joint MCP Joint IP Joint I (boutonnière) Not involved Flexed Hyperextended II (uncommon) CMC flexed and
adducted Flexed Hyperextended
III (swan neck) CMC subluxed, flexed, and adducted
Hyperextended Flexed
IV (gamekeeper's) CMC not subluxed; flexed, and adducted
1°, hyperextended, ulnar collateral ligament unstable
Not involved
V May or may not be involved
1°, volar plate unstable Not involved
VI (arthritis mutilans) Bone loss at any level Bone loss at any level Bone loss at any level
Note. Adapted from Nalebuff (1968) classification system of the rheumatoid thumb deformities.
12
Chapter Three:
Static Splints for the Hand and Wrist Static hand splints have been routinely prescribed for individuals with RA for
the past 30 years (Fess & Phillips, 2002). They are recommended for helping patients
support and protect joints, minimize pain, and enhance function (Akil & Amos, 1995).
They may also provide localized rest to reduce inflammation, enhance joint stability
and align joints in a stable anatomical position to minimize deformity. This chapter
will explore the five types of static hand and wrist splints used in rheumatology: static
resting splints, wrist extension splints, metacarpal ulnar deviation splints, finger
splints and thumb splints.
Static Resting Splints
Static resting splints are external devices applied to a body segment, whose aim
is to decrease localized pain and inflammation by resting the joint in a correct
anatomical position, and realigning drifting metacarpophalangeal (MCP) joints by
providing an ulnar border to the splint and restricting carpal movement (Biese, 2002)
(Figure 7). The splint should also provide volar support for the carpus and proximal
phalangeals to prevent subluxation (Bielefeld & Neumann, 2005), thereby maintaining
a biomechanically functional hand unit (Fess & Phillips, 1987). These splints do not
permit wrist and hand movement and are recommended to be worn whilst resting
and/or during the night.
The rationale that correct joint positioning at rest can influence joint integrity
has been challenged. Adams et al. (2005) argue that the forces contributing towards
joint deformity are present when the hand is used functionally, thus correct
positioning at rest is unlikely to address or correct these. Nevertheless, static resting
splints are the most commonly utilized splint in the treatment of RA and the most
frequently used to relieve wrist and hand pain (Henderson & McMillan, 2002).
Figure 7. A static resting splint. The wrist is positioned in neutral to slight extension; MCP joints 30-40° flexion; PIP joints in 20-30° flexion; DIP joints in 10° flexion, and thumb in palmer abduction as recommended by Fess and Philips (1987). Photograph was taken from my personal file. Permission granted to use image.
13
Wrist Extension Splints
Wrist extension splints may be custom-made using either thermoplastic or
neoprene material or commercially manufactured from a soft or reinforced fabric with
a possible addition of a volar metal support that needs to be adapted for each
individual (Figure 8). Ideally, the splint should conform to the transverse arch of the
hand and not impede MCP joint or thumb movement. They are prescribed for
reducing wrist and hand pain during functional activities (Adams et al., 2005), and can
stabilize the wrist in a functionally effective wrist position (10-15 degrees), while
facilitating the action of the extrinsic finger flexors to improve grip strength (Stern,
Ytterberg, Krug, Mullin, & Mahowald, 1996a). They may be also be used to limit
wrist circumduction and decrease torque during heavy tasks involving the wrist
(Cordery & Rocchi, 1998).
Finger Splints
(1) Splinting for swan neck deformity Finger swan neck splints apply a three-point force around the PIP joint to
prevent hyperextension and subsequent distal interphalangeal (DIP) joint flexion
present in swan necking of the fingers. They are small functional splints that permit
full proximal interphalangeal (PIP) flexion but prevent hyperextension. The aim of
these splints is to decrease finger pain, prevent or correct swan necking in the digits
and improve hand function (Zijlstra, Heijnsdijk-Rouwenhorst, & Rasker, 2004).
Currently, various types of finger splints are available, including silver ring splints
(SRS), commercial prefabricated thermoplastic splints (PTS) and custom-made
Figure 8. A commercially manufactured wrist extension splint. Photograph taken from my personal file. Permission granted for its use.
14
thermoplastic splints (CTS). See Figures 9-11 below for examples of the different
splint designs.
Silver ring splints are made of sterling silver and manufactured according to
the patients ring size. The maximum allowed extension of the PIP joint can be
individually adjusted by bending the splint within material limits. Custom
thermoplastic splints are individually fabricated. Their cost depends on the time
needed for fabrication, usually ranging from 21 to 44 minutes (Ter Scheggart &
Knipping, 2000). Prefabricated thermoplastic splints are available in kits containing
numerous sizes, with minimal time required for individual adjustments. They are
made of less material than custom thermoplastic splints and their price is
approximately NZD 30.00, exclusive of the therapist time (van der Giesen et al.,
2009).
Figure 9. A prefabricated thermoplastic splint (PTS) such as the Oval-8 splint allows PIP joint flexion during daily living tasks. This photograph was taken from my personal file. Permission granted for its use.
Figure 10. The custom sized silver ring splint (SRS) prevents PIP joint hyperextension and allows PIP flexion. This photograph was taken from my personal file. Permission granted for its use.
Figure 11. Custom made thermoplastic splint (CTS) used in the treatment of swan neck deformity. This photograph was taken from my personal file. Permission granted for its use.
15
(2) Splinting for boutonniere deformity
The Boutonniere deformity is the most challenging of the RA deformities to
splint and is characterized by a posture of proximal interphalangeal (PIP) joint flexion
and distal interphalangeal (DIP) joint hyperextension (Williams & Terrono, 2011).
Anti-boutonniere splints are designed to reduce a flexion deformity of the PIP joint
and preserve the length of the oblique retinaculum ligament (Biese, 2002).
In patients demonstrating a flexible boutonniere deformity, a three-point splint
can be employed. The aim of this splint is to minimize the risk of PIP joint contracture
by placing the PIP joint in zero degrees extension. This position reduces the stress on
the central slip and prevents tightening of the lateral bands and retinacular ligaments
(Mary Pack Arthritis Program, 2011). According to Beasley (2011) several patients
discard this splint during daily activities because it limits the ability to flex the PIP
joint and can put pressure over the joint. It is suggested that night splinting may be
more acceptable by these patients.
There are three designs of three-point finger splints available, a silver ring
splint, a prefabricated thermoplastic splint, or a thermoplastic volar gutter splint
(Figure 12-14). The volar based splint is an inexpensive option, however, it can be
bulky, and may splay fingers. It holds the PIP joint in its extended position and is
adjusted to improve extension by increasing tension on the dorsum of the digit. The
splints are initially worn for half an hour and increased gradually as tolerated. Skin
checks must be done frequently.
Figure 14. A volar based custom thermoplastic splint. Photograph taken from my personal file. Permission granted for its use.
Figure 13. A prefabricated thermoplastic splint, called an Oval-8 splint. Photograph taken from my personal file. Permission granted for its use.
Figure 12. The DS anti-boutonniere splint. It keeps the joint in an extended position by positioning the spacer on the dorsal side of the joint. Photograph adapted from http://www.digisplint.ca/wp-content/uploads/2013/08/page-45-Boutonnniere-Splint-measuring.pdf.Retrieved 8 June, 2013.
16
Metacarpal Ulnar Deviation Splints
Metacarpal ulnar deviation (MUD) splints are used to correct and prevent
further ulnar deviation occurring at the metacarpophalangeal (MCP) joints. There are
a variety of hand-based static metacarpal ulnar deviation splints (Figures 15-18), with
or without hinges and strapping for each proximal phalanx. The hand-based splint
aims to realign the metacarpals and phalanges during use to improve functional ability
of the hand and to prevent further ulnar drift and volar subluxation of the MCP joints
(Adams et al., 2005). These splints are ideal for use during the day, especially for
relatively active, high functioning persons.
Figure 15. Modified MUD splint described by Rennie (1996). Dorsal based with a molded palmer bar supporting the MCP heads and palmer arch. A proximal phalangeal component is hinged to the dorsal base at the joint axes on the radial and ulnar sides. This photograph was taken from my personal file. Permission granted for its use.
Figure 17. Manufactured from 3.2mm neoprene to provide warmth and stronger support. Designed to help support the MCP joint and reduce ulnar drift whilst allowing functional use of fingers. This photograph was taken from my personal file. Permission granted for its use.
Figure 16. The hand-based LMB splint. Photograph adapted from http://www.assistireland.ie/eng/Products_Directory/Orthoses/Hand_Wrist_Splints_and_Braces/Progressive_Hand_Splints/LMB_Soft_Core_Wire-Foam_Ulnar_Deviation_Splint.html. Retrieved 8 June 2013.
17
In comparison, the wrist-hand-based static MUD splint has the therapeutic
benefit of providing a rigid support across painful and inflamed joints throughout the
entire wrist and hand (Figure 19 and Figure 20). Furthermore, by blocking radial
deviation of the wrist, wrist-hand-based splints can, in theory, limit the zigzag
pathomechanics (Boozer, 1993). It is however, a challenge to design a splint that
simultaneously blocks radial deviation of the wrist while not compromising the
effectiveness of blocking ulnar drift at the MCP joints, and vice versa (Biese, 2002).
Figure 18. Norco Fabrifoam soft MCP ulnar drift splint. This splint supports the MCP joints while allowing fingers to move for functional use. Fabrifoam provides thinner, comfortable support that won’t slip. This photograph taken from my personal file. Permission granted for its use.
Figure 19. Wrist-hand-based splint. Palmar view showing the soft foam-padded flannel. Retrieved from http://www.pattersonmedical.com/app.aspx?cmd=get_subsections&id=57961.
Figure 20. Wrist-hand-based splint. Dorsal view showing flexible stiffener along ulnar border which assists in maintaining wrist alignment. http://www.pattersonmedical.com/app.aspx?cmd=get_subsections&id=57961
18
Splinting for the Rheumatoid Thumb
When the carpal metacarpal (CMC) joint of the thumb is involved, the
synovitis stretches the joint capsule. This stretching can lead to joint subluxation or
dislocation, with the metacarpal assuming an adducted position (Beasley, 2011). The
goal of splint positioning for this condition is to gently place the thumb opposite that
of the developing deformity to help prevent the adduction contracture and to maintain
a functional ROM (Weiss, LaStayo, Mills, & Bramlet, 2004). To accomplish this
objective, a CMC joint splint can be used to maintain the web space and stabilize and
protect the CMC joint. The thumb interphalangeal (IP) joint is often left free to allow
activities in the splint.
There are two types of splints commonly utilized for this deformity. A short
opponens splint made of lightweight thermoplastics (Figure 21) or a soft neoprene
CMC joint splint (Figure 22). The wrist is not included in the splint; so it is more
easily tolerated by the patient while performing daily tasks (Terrono, Nalebuff, &
Phillips, 2011). To be effective, the splint must extend far enough into the web space
to maintain thumb abduction. This allows the thumb metacarpal to be stabilized
against the index metacarpal.
Figure 21. A short opponens thermoplastic splint. The first metacarpal is placed in gentle palmer abduction and the MCP joint in slight flexion. The CMC joint is stabilized with the base of the splint and a strap. This photograph was taken from my personal file. Permission granted for its use.
Figure 22. A soft neoprene CMC joint thumb splint. This photograph was taken from my personal file. Permission granted for its use.
19
Static Splints and their Principles of Action
The rationale for splinting the acutely inflamed rheumatoid joint is both
biomechanical and physiological. By externally supporting, positioning and restricting
motion of the inflamed joint, the splint may reduce the pain, stress, and deformity
caused by abnormal muscle action, positional factors and external loads. For example,
the static resting splint, immobilizes the hand and wrist in order to counter balance
deforming forces. During periods of acute synovitis, resting the affected joint and its
capsule in a biomechanically sound position may also reduce joint friction and
temperature (Fess & Philips, 1987). Theoretically, decreasing joint movement and
activity helps to decrease friction and temperature within the synovial joint, which in
turn may also reduce localized inflammation and the pro-inflammatory chemical
environment within the joint (Hendiani et al., 2003).
Static splints also aim to support vulnerable structures within the hand and
wrist to correctly position joints, minimize deformities and increase joint stability. In
theory, by realigning and redistributing the damaging internal and external forces
acting on the joint, the splint may help prevent or correct deformity. The radio-carpal
joint, carpal metacarpal (CMC) joint, metacarpophalangeal (MCP) joint, and proximal
interphalangeal (PIP) joints and the thumb web space are key areas for consideration
when splinting the hand. Where inflammation causes the potential for muscle
imbalance, for example in swan neck and boutonnière deformities, static finger splints
can provide a counterbalance force to prevent or correct extensor tendons slipping
across the normal joint fulcrums.
Lastly, static splints aim to improve hand function by adding support to the
proximal joints, applying counterbalanced force to deforming joints, and in turn
improving the biomechanical advantage. For example, the static wrist extension splint,
this splint stabilizes the wrist in slight extension and allows full opposition of the
thumb with the digits. The splint is designed to facilitate the patient’s use of the joint
for specific hand functions (e.g., grasp or pinch) or tasks (e.g., handwriting or lifting).
Thus, static hand and wrist splints have some biological and biomechanical
underlying principles for their mode of action (McClure et al, 1994), however recent
scientific evidence to support this theory is limited (Adams et al., 2005).
20
Chapter Four:
Methodology
What is a Systematic Literature Review?
Systematic literature reviews attempt to gather all empirical evidence that fits
pre-specified eligibility criteria to answer a specific research question. It uses explicit,
systematic methods that are selected with a view to minimizing bias, thus providing
more reliable findings from which conclusions can be drawn and decisions made
(Antman, Lau, Kupelnick, Mosteller, & Chalmers, 1992). In this way, they differ from
traditional narrative reviews and off-the-cuff commentaries produced by experts.
More importantly, the recommendations from systematic reviews are, instead of
reflecting personal views of ‘experts’ based on balanced inferences generated from the
collated evidence. The key characteristics of systematic reviews are:
A clearly stated set of objectives with pre-defined eligibility.
An explicit, reproducible methodology.
A systematic search that attempts to identify all studies that would meet the
eligibility criteria.
An assessment of the validity of the findings of the included studies.
A systematic presentation, and synthesis, of the characteristics of the
included studies (Oxman & Guyatt, 1993).
A systematic review may, or may not, include a meta-analysis. Meta-analysis
is the use of statistical methods, used predominantly in systematic reviews, to
summarize the results of independent studies (Glass, 1976). By combining
information from all relevant studies, meta-analyses can provide more precise
estimates of the effects of health care than those derived from individual studies
included within a review (Higgins & Green, 2008). The distinction between the
systematic review and meta-analysis is important because it is always appropriate and
desirable to systematically review a body of data, but it may sometimes be
inappropriate or misleading, to statistically pool results from separate studies
(Eysenck, 1995).
21
Why is a Systematic Literature Review Needed?
The vast volume of healthcare research that needs to be considered by
occupational therapists is constantly expanding. In the last ten years, healthcare
professional publishing has seen between 20,000 and upwards of two million articles
per year (Mulrow & Cook, 1998), and these numbers are estimated to increase (Bjork,
Roos, & Lauri, 2009). In many areas it has become simply impossible for the busy
occupational therapist to read, critically evaluate and synthesise all of this material, let
alone keep updating this on a regular basis. Equally there may be a number of studies
on the same topic that appear to contradict each other or produce inconclusive
findings.
Furthermore, since Mulrow (1994) drew attention to the poor quality of
narrative reviews it has become clear that traditional reviews are an unreliable source
of information. Traditional reviews do not routinely use systematic Methods to
identify, assess and synthesise information. Often there is no Methods section for the
actual conduct of the review. The reader has no way of knowing whether the review is
based on a systematic review of the evidence, or on a collection of papers, which the
author has found in a less systematic way, and thus the evidence presented may not be
complete. A further limitation of a narrative review is that there is often subjectivity
involved in the selection of articles for inclusion or exclusion from the review
(Cusick, 1986). Whilst traditional reviews may provide very useful background
reading, they rarely provide high quality evidence.
Conventionally, systematic reviews were needed to establish the clinical and
cost effectiveness of a particular intervention. They are increasingly used to identify
areas where the available evidence is insufficient and future research is required. For
the occupational therapy profession, they have become increasingly valuable to help
establish clinical practice guidelines (Cook, Mulrow, & Haynes, 1997), and justify
reimbursement for services (Murphy, Robinson, & Lin, 2009).
With the increasing demands placed on occupational therapists to ensure their
practice is based on sound evidence (Taylor, 2003), systematic reviews have become
essential tools for keeping up with current research that is accumulating in their field
of interest. In the current healthcare climate, occupational therapists must be able to
demonstrate that their interventions are clinically and economically effective. This
ensures that limited resources are best used to deliver the best outcomes for the
population served (World Health Organization, 2004).
22
The Process of a Systematic Review
Framing a relevant research question
As with all research, systematic reviews follow a clear process (Khan, Kunz,
Kliejnen, & Antes, 2003), as shown by flowchart diagram (Figure 23). The first and
most important decision in preparing this review was to determine its focus. This was
done by clearly framing the research question the researcher wanted to answer. For
example, “Is splinting for the hand and wrist effective in helping adults with
rheumatoid arthritis improve their hand function, decrease deformity, increase grip
strength, and reduce their pain?” According to Hedges (1994) well formulated
questions will guide the many aspects of the review process, including determining
eligibility criteria, searching for studies, collecting data from included studies and
presenting findings.
Figure 23. Flowchart of the Five Essential Steps in a Systematic Review. Adapted from “Systematic Reviews to Support Evidence Based Medicine. How to Review and Apply Findings of Healthcare Research by K. S. Khan, R. Kunz, J. Kliejnen and G. Antes, 2003. p. 2.
The researcher devoted a substantial amount of time and effort ensuring that
the clinical question was not too broad because too much research can become
overwhelming and is difficult to synthesize and interpret. Furthermore, writing may
require more resources (Sackett, Richardson, Rosenberg, & Haynes, 1997).
Conversely, if the topic was too narrow it may result in sparse evidence, and findings
may not be generalizable to other settings or populations.
step 1 11 • Framing the research question
step 2 22 • Identify appropriate literature
step 3 33 • Assess the quality of the literature
step 4 44 • Summarizing the literature
step 5 55 • Interpreting the findings
23
To help formulate a high-quality research question for this systematic review,
the clinical question required consideration of four key components, the types of
population (or participants) studied, the interventions (and comparisons), and the
outcomes that were of interest (Richardson, Wilson, Nishikawa, & Hayward, 1997).
The acronym PICO (Participants, Interventions, Comparisons and Outcomes)
(Institute of Medicine [IOM], 2008) helped to serve as a reminder of these. For
example, “Do adult patients with rheumatoid arthritis (P) receiving splinting for the
hand and wrist (I) have improved hand function, increased grip strength, reduced pain
or decreased deformity (O) compared with rheumatoid arthritis patients not receiving
hand splints (C)?” Explicitly framing the research question using these four specific
components not only helped to clarify the question, but also improve the quality of
each of the remaining steps in this systematic review.
Search Strategy
Having defined the research question, the second step was to perform a
thorough, objective and reproducible search of all potentially relevant sources of
information. The search was conducted by one researcher, and eligibility screening
occurred by scrutinizing the title, abstracts and key words of all the studies, based on
pre-determined inclusion and exclusion criteria presented in Table 2 at the end of this
chapter. All abstracts identified as pertinent to the review, including those abstracts
that did not provide enough information, were ordered in full text to make certain that
no study was excluded because of poor citation detail. The full articles retrieved were
reviewed by the researcher using the eligibility criteria. The researcher is aware that
the overall process should, ideally, be directed by a peer reviewed protocol to help to
control investigator bias during the search (Meade & Richardson, 1998). Since this
review was part of a post graduate research project, it was not possible to have two
independent reviewers. Despite this, in cases of doubt regarding whether a particular
article met the inclusion criteria, the article was discussed with the student’s
supervisor until a consensus was reached.
A comprehensive search of published and unpublished literature ensured that
all relevant research studies were located and included in the review. This is a major
factor in distinguishing systematic reviews from traditional narrative reviews and
helps to minimize bias and therefore help in achieving reliable estimates of effects
(Hemingway & Brereton, 2009). A search of MEDLINE alone is not adequate. A
24
previous systematic review (Dickersin, Scherere, & Lefebvre, 1994) found that only
30-60% of all known published randomized control studies were identifiable using
MEDLINE. Even if relevant articles can be found in MEDLINE, it can be difficult to
retrieve them (Whiting, Westwood, Burke, Sterne, & Glanville 2008). Going beyond
MEDLINE is important not only for ensuring that as many relevant studies are located
but to also minimize selection bias for those that are found (Altman, 1991).
The electronic search in this review covered seven bibliographic databases
from their inception to June 2012. The databases were MEDLINE, EMBASE, and
CENTRAL (The Cochrane Central Register of Controlled Trials), as well as, selected
databases with a subject-specific focus including DARE (Database of Abstracts of
Reviews of Effectiveness, CINAHL (the Cumulative Index to Nursing and Allied
Health Literature), PEDro (a physiotherapy evidence database) and OT Seeker. There
is substantial evidence that limiting the search to only a few databases tends to bias
the review. Therefore, a broader based search was employed, in hope of producing a
more precise and valid answer. The search strategy that was used is presented in
Appendix B.
Grey literature (material that is not formally published, such as technical reports,
discussion papers, and dissertations) was searched through the new database called
OpenSIGLE, which provides access to all the former SIGLE records. Only one thesis,
by Hammond (1994), was found relating to the research question, but it could not be
accessed. Collecting unpublished material is a real challenge for the librarian and the
researcher. Grey items such as reports, proceedings, or working papers cannot be
purchased or bought like journals and books since there is no special agency or
supplier for grey materials (Egger, Juni, Bartlett, Holestein, & Sterne, 2003). For this
reason, it was not included in the review. The researcher is aware that failure to
include this unpublished thesis might affect the results due to publication bias. The
inclusion of data from grey literature can itself introduce bias (Sterne, Egger &
Moher, 2008). Unpublished studies may be of lower methodological quality than
published studies, and the studies that can be purchased may be an unrepresentative
sample of all the unpublished studies.
English language-only key word searches were used with a combination of
terms including, rheumatoid arthritis, hand, wrist, occupational therapy, hand therapy,
conservative treatments, and interventions (splinting, orthotics, joint protection,
patient education, adherence, hand deformities). The nature of the key words chosen
25
was important because it not only represented the various components of the research
question, but also provided a way of retrieving articles that may use different words to
describe the same concept (O’Connor, Green, & Higgins, 2008). To begin to identify
appropriate search terms for a particular database, articles were retrieved that met the
inclusion criteria, and common text words and subject terms that indexers had applied
to the articles were examined, and used for a full search. After identifying a key
article, additional articles were located, for example by using the ‘find similar’ option
in Ovid or the ‘related articles’ in PubMed.
A search strategy should build on the key words, synonyms and related terms
for each concept at a time, joining together each concept with the Boolean ‘AND/OR’
operator (Lefebvre, Manheimer, & Glanville, 2008). For example, combining
rheumatoid arthritis AND splinting retrieved citations where both of these terms are
found. On the other hand, combining rheumatology OR splinting retrieved all the
citations where either one or both of these terms are found. This ensured that the
various components of the research question were captured (Chalmers & Altman,
1995). Whenever possible review authors should attempt to identify and assess for
eligibility of all possibly relevant reports of trials irrespective of language of
publication (Moher, Pham, Lawson, & Klassen, 2003). The decision to exclude
studies reported in languages other than English was due to the lack of resources
available to translate. Therefore, language bias may be increased in this systematic
review (Gregoire, Derderian, & Lelrier, 1995), although the research examining this
issue is conflicting (Juni, Holenstein, Sterne, Bartlett, & Egger, 2002; Moher et al.,
1996).
The literature search procedure was complemented by manually searching the
reference lists of retrieved articles for potential studies on the topic of hand splinting
for adults with rheumatoid arthritis. Hand searching healthcare journals is considered
a useful adjunct to searching electronic databases because not all trial reports are
included in electronic bibliographic databases, and even when they are included, they
may not contain relevant search terms in the titles or abstracts (Dickersin et al., 1994).
A Cochrane methodology review has found that a combination of hand searching and
electronic searching is necessary for full identification of relevant reports published in
journals, even for those that are indexed in MEDLINE (Hopewell, Clarke, Lefebvre,
& Scherer, 2007a).
26
A personal collection of references was available; these consisted of
occupational therapy, rheumatology, and hand therapy textbooks, which were also
hand searched. A panel of subject matter experts was also consulted to identify studies
not captured by the searches.
Inclusion and Exclusion criteria
One of the features that distinguish a systematic review from a narrative
review is the pre-specification of criteria for including and excluding studies in the
review (eligibility criteria) (Hemingway & Brereton, 2009). Eligibility criteria are a
combination of aspects of the clinical questions plus specifications of the types of
studies that have addressed the question (Montori, Swiontkowsky, & Cook, 2003). An
inclusion and exclusion criteria checklist was created for this systematic review, based
on the characteristic of participants, the types of interventions (and comparisons),
outcome measures utilized, and the study design, as shown in Table 2 (page 28).
The criteria for considering the types of participants to be included in this
review was sufficiently broad to encompass the likely diversity of studies (Wright,
Brand, Dunn, & Spindler, 2007), but adequately narrow to ensure that a meaningful
answer can be obtained when studies are considered in aggregate (Counsell, 1997).
The types of participants of interest were considered in two steps. First, the condition
of interest was defined using explicit criteria for establishing their presence or not. For
example, patients who fulfilled the American College of Rheumatology criteria for
rheumatoid arthritis (Arnett et al, 1988). Second, the broad population was
specifically defined by age, for example, adult’s ≥ 18 years. Studies with participants
under the age of 18 years were not included because the primary diagnosis would no-
longer be rheumatoid arthritis; it would be classified as Juvenile Rheumatoid arthritis
(JVR) (The Michigan Juvenile Arthritis Initiative Expert Panel, 2002).
A hierarchy of evidence provides a way to help interpret study rigor and reduce
bias (Sackett, Rosenberg, Gray, Haynes, & Richardson, 1996). The type of question
being asked will determine which research methodology can provide the best
evidence, and hence which type of studies to search for (Bennett & Glaszious, 1997).
Hierarchies of evidence are commonly presented for questions concerning treatment
effectiveness (Sackett, Richardson, Rosenberg, & Hayes, 1997); however different
hierarchies of evidence exist for answering other types of clinical questions (Bury,
1998). Randomized controlled trials are the preferred design for studying the effects
27
of healthcare interventions because, in most circumstances, the randomized trial is the
study design that is the least likely to be biased (Hill & Spittlehouse, 2003). Sackett
and colleagues (1996) recommend that in situations where no randomized studies
have been performed, it is reasonable to use the next level of methodological evidence
(e.g., non-randomized experimental designs).
The researcher acknowledges that selection bias may be increased by
introducing non-randomized studies (Helfand, 2005). Due to the paucity of RCTs
relating to static splinting for the rheumatoid hand and wrist, the following types of
studies were included, non-randomized controlled trials; controlled before-and-after
studies; cohort studies; case-control studies; and cross-sectional studies.
28
Table 2 Study Inclusion and Exclusion Criteria
CRITERIA Yes/No
Research population (all of the criteria needs to be met for inclusion)
Diagnosis of Rheumatoid Arthritis according to the ACR*
Age ≥ 18 years, male, female or combined
Study design (one of these criteria must be met for inclusion)
Randomized control trials
Controlled clinical trials
Non-randomized clinical trials
Cohort studies
Cross-sectional studies
Case control studies
Interventions (one of these criteria needs to be met for inclusion)
1. Splints
-All rigid splints, semi-rigid splints, wrist extension splints,
metacarpal ulnar deviation splints, static resting splints, finger swan
neck and boutonniere
-Studies comparing the use of splints against control, placebo or
active interventions (including alternative splinting designs)
Outcome (must have at least one of the following to be used for
inclusion)
Pain
Stiffness
Range of motion
Endurance
Strength
Dexterity
Quality of life
Self- reported
measure of function
Exclusion (exclude if any of these are met)
Studies published in languages other than English
Studies conducted solely on persons with other forms of arthritis
Studies which referred exclusively to the surgical management of the
condition
Studies on individuals that were receiving splinting as part of
rehabilitation after hand surgery
Studies conducted specially on the use of compression gloves
Literature reviews, qualitative studies, expert opinions, non-controlled
observational studies and individual case studies
* ACR= American College of Rheumatology
29
Critical Appraisal/Quality Assessment
Once relevant articles were retrieved, information needed to be critically
appraised to extract the clinical information of value. Moher and colleagues (1996)
describe critical appraisal as the process of judging the quality of a piece of
information and determining its applicability to clinical practice. It involves carefully
reading and evaluating the reliability, validity and overall quality of the source of the
data that was located. Critical appraisal checklists provide a series of key questions
that can help the therapist establish the validity and clinical usefulness of research
results. Occupational therapists can select different critical appraisal instruments
depending on their study design, their familiarity with critical appraisal, personal
preference and the appropriate balance between time commitment and depth of the
analysis to be carried out (Coomarasamy, Taylor, & Khan, 2003).
For this review, the researcher conducted a quality assessment using the
Structured Effectiveness Quality Evaluation Scale (SEQES), as shown in Table 3. The
SEQES, was developed by MacDermid (2004) at McMaster University, in response to
the need for a rating scale that could quantify the important elements of design for a
spectrum of clinical research designs (on effectiveness). Formerly, most quantitative
critical appraisal tools used in systematic reviews were designed to evaluate only
RCTs. Unfortunately, in occupational therapy, few randomized control trials exist
(Murphy et al., 2009). Many questions concerning the effectiveness of occupational
therapy treatments are more suited to quasi experimental or single case experimental
designs (Johnson, Ottenbacher, & Reichardt, 1995). As a result, the SEQES was
developed, to critically appraise the lower levels of evidence for the effectiveness of
interventions in rehabilitation (Sackett et al., 1996).
Determining the validity of the findings in an article requires consideration of
many aspects of a study (Bennett & Bennett, 2000). The SEQES is a standardized 24-
item critical appraisal tool used to evaluate the quality of a study, including, but not
limited to randomized control trials. It is a reliable and valid tool (MacDermid, 2004),
which rates the quality of a study based on the categories of study design, subjects,
intervention, outcomes, analysis, and recommendations.
Specific scoring criteria for each item in the SEQES are provided in an
accompanying interpretation guide, as shown in Appendix C. Each category has
several criteria and each criterion was scored 0-2, where 0 indicates either poor
quality or incomplete fulfillment of the criterion, a score of 1 represents that the
30
criterion has been partially met, and a score of 2 indicates that the criterion has been
fully met according to guidelines connected to the SEQES. Each study was ranked as
low, moderate, or high quality based on the cumulative score out of a total of 48.
Studies were considered to be of moderate quality if the scores ranged from 17-32. If
the studies score fell below 17, it was considered to be of low quality. The studies that
scored above 32 were considered to be of high quality (Berger Stanton, Lazaro, &
MacDermid, 2009).
31
Table 3 Structured Effectiveness Quality Evaluation Scale (SEQES) Evaluation Criteria Score Study question 2 1 0
1. Was the relevant background work cited to establish a foundation for the research question?
Study design 2. Was a comparison group used? 3. Was patient status at more than one time point considered? 4. Was data collection performed prospectively? 5. Were patients randomized to groups? 6. Were patients blinded to the extent possible? 7. Were treatment providers blinded to the extent possible? 8. Was an independent evaluator used to administer outcome measures?
Subjects 9. Did sampling procedures minimize sample/selection biases?
10. Were inclusion/exclusion criteria defined? 11. Was an appropriate enrollment contained? 12. Was appropriate retention/follow-up obtained? Interventions 13. Was the intervention applied according to established principles? 14. Were biases due to the treatment provider minimized (i.e., attention,
training)?
15. Was the intervention compared to appropriate comparator? Outcomes 16. Was an appropriate primary outcome defined? 17. Were appropriate secondary outcomes considered? 18. Was an appropriate follow-up period incorporated? Analysis 19. Was an appropriate statistical test(s) performed to indicate differences
related to the intervention?
20. Was it established that the study had significant power to identify treatment effects?
21. Was the size and significance of the effects reported? 22. Were missing data accounted for and considered in analyses? 23. Were clinical and practical significance considered in interpreting
results?
Recommendations 24. Were the conclusions/clinical recommendations supported by the study
objectives, analysis, and results?
Total quality score (sum of above) = Note. Adapted from Evidence-Based Rehabilitation: A Guide to Practice (2nd ed.) by M. Law, and J MacDermid, 2008. Thorofare, NJ: Slack Publishing Incorporated.
32
Level of Evidence
After critically appraising the quality of each article, it is recommended to give
the material an overall rating, as this indicates the quality the literature offers (Law,
2002). The concept of ranking the levels of evidence is based on the principle that
certain study types have more rigor and the higher quality study designs provide more
confidence to associated clinical decision making (Sackett et al., 1997). As previously
discussed, considerable emphasis has been placed on randomized controlled trials
(RCTs) as they can minimize the likelihood of bias in the conduct of studies
addressing treatment effectiveness. Randomized controlled trials are not always
feasible or best for answering all clinical questions, and other research methods may
need to be considered, depending on the questions concerned (Sackett & Weinberg,
1997).
In this review, the level of evidence of each article was determined using
Sackett’s Levels of Evidence Model (Table 4). This model, developed by Sackett
Straus, Richardson, Rosenberg and Haynes (2000) stratifies study designs based on
the level of confidence that a therapists can have in applying a study's results to an
individual patient. The study designs described in Sackett’s Levels of Evidence Model
for intervention range from level 1 (i.e., systematic reviews of randomized, controlled
trial) to level 5 (i.e., expert opinion). Table 4 Sackett’s Levels of Evidence Model for Interventions
Level of Evidence and Definitions Level of Evidence General Criteria for Level of Evidence
1a Systematic review of homogeneous RCT 1b Single high-quality RCT 1c All or none study 2a Systematic review of homogeneous cohort studies 2b Single cohort study (including low-quality RCT; i.e., less than 80%
follow-up) 2c ‘‘Outcomes’’ research; ecological studies 3a Systematic review of homogeneous case–control studies 3b Single case–control study 4 Case-series, low-quality cohort and case–control studies 5 Expert opinion without explicit critical appraisal, or based on
physiology or ‘‘first principles’’ Note. RCT= randomized controlled trials. Adapted from “Evidence-based Medicine: How to Practice and Teach EBM, (2nd Ed) by D. Sackett, S. Straus, S. Richardson, W. Rosenberg, and R. Haynes. 2000. New York: Churchill Livingstone.
33
Grades of Recommendation
The usefulness of a systematic literature review can be greatly enhanced by
providing evidence-based recommendations to occupational therapists. Generating
graded practice recommendations from the findings of the studies may help achieve
this objective and is a frequently used approach used in clinical practice guidelines
(Sackett et al., 1997). Grading recommendations are important even when reviews are
rigorously conducted. According to Sackett et al. (2000) it is important to differentiate
between recommendations that are based on strong versus weak evidence, which in
turn depends on a number of factors including study design and quality.
Proponents of evidence based practice have long emphasized the need to assess
the strength of recommendations according to levels or hierarchies of evidence, which
are based primarily on individual study designs. Using this approach evidence may
now be now classified as high (Levels 1), moderate (Level II), Fair (Level III) or low
(Level IV and V). For the purpose of grading recommendations generated from the
evidence, the levels can be converted from roman numerals into alphabetical (A, B, C
and D) grades, as shown in Table 5. Grade ‘A’ and ‘B’ recommendations are
generally based on a body of evidence which can be trusted to guide clinical practice,
whereas Grade ‘C’ and D’ recommendations must be applied carefully to individual
clinical and organizational circumstances and should be followed with care. Table 5 Grades of Recommendations and Definitions
Note. Adapted from “Evidence-based Medicine: How to Practice and Teach EBM, (2nd Ed) by D. Sackett, S. Straus, S. Richardson, W. Rosenberg, and R. Haynes. 2000. New York: Churchill Livingstone.
Level of Evidence and Definitions Grade of Recommendation General Criteria for Grade of Recommendation
A Consistent level 1 studies B Consistent level 2 or 3 studies (or extrapolations from level 1
studies) C Level 4 studies (or extrapolations from level 2 or 3 studies) D Level 5 evidence(or inconsistent or inconclusive studies of
any level)
34
Chapter 5:
Results
Search and Selection of Studies
In this review, the initial literature search yielded 1,038 articles from the
computerized database search, with an additional two identified through manual
searching. After removal of duplicate records, the researcher reviewed the title and
abstracts of 728 articles to further exclude descriptive studies in the form of case
reports and opinion pieces, review papers, clinical practice guidelines, and studies not
published in the English language. The remaining 51 were selected as “potentially
relevant” to this study based on abstract review (Figure 24).
The researcher read the full text of the remaining studies and applied the
inclusion-exclusion criteria presented in chapter 4, on page 28. After this process, 33
studies were excluded. See Appendix D for characteristics of excluded studies. The
primary reasons for exclusion from the study were: 1) the study design did not meet
the inclusion criteria, 2) the study population did not focus specifically on hand
rheumatoid arthritis, 3) the study included participants less than 18 years of age, 4) the
intervention referred exclusively to the post-surgical management of rheumatoid
arthritis and, 5) the studies did not specifically focus on the effects of static splinting
for the hand and/or wrist. Thus, 18 studies were included in this systematic review
(Table 6) and were appraised for quality using the Structure Effectiveness Quality
Evaluation Scale (SEQES). Recommendations were based on the results of these
studies.
Due to the high level of study heterogeneity it was not possible to undertake a
meta-analysis to calculate an average estimate of effectiveness for this specific group
of data. The studies included were not all conducted in the same way and to the same
experimental protocols. Therefore, a quantitative analysis was not suitable, and a
narrative review was required. Examples of heterogeneity included differences in
treatment modalities, variable lengths of interventions (from one week to one year),
different splint designs (ranging from resting splints for the entire hand to splints that
immobilize only the fingers), the use of multiple outcomes measures, differences in
follow-up times and the application of different inclusion and exclusion criteria.
35
The narrative synthesis provided an opportunity to pull the review together and
comment on the quality of the evidence that had been reviewed. It includes a
discussion of the methodological quality and a comparison of the various studies. This
must be remembered when interpreting the results.
Figure 24. Flowchart of study selection process in the systematic review
Articles identified through database searching
(n=1038)
Iden
tific
atio
n Additional articles identified through other sources
(n=2)
Scre
enin
g
Articles excluded on the bases of title and abstract
(n= 677)
Articles excluded with reasons (n=33)
Full-text articles assessed for eligibility
(n=51)
Elig
ibili
ty
Incl
uded
Articles screened (n=728)
Articles after duplicates removed (n=728)
Articles included in this systematic literature review
(n=18)
36
Methodological Quality for Included Studies
Overall, the levels of evidence of the reviewed studies ranged from 1b to 4
using Sackett’s Level of Evidence model, and the SEQES scores for the quality of
these studies ranged from 14 to 46, out of a possible 48. The quality evaluation of
each study is presented in Table 6. The reported effectiveness of static hand and wrist
splints varied considerably across studies.
A number of different outcome measures were used in the studies. The
primary outcome measures included pain, grip strength, pinch strength, range of
motion (ROM), quality of life, and various functional abilities (including dexterity).
The more recent studies received higher SEQES scores because the authors were more
likely to use standardized outcome measures (Adams, Burridge, Mullee, Hammond, &
Cooper, 2008; Haskett, Backman, Porter, Goyert, & Palenjko, 2004; Silva, Jones,
Silva, & Natour, 2008) and reported findings in terms of clinical significance (Silvia
et al., 2008; Veehoff, Taal, Heijnsdijk-Rouwenhorst, & van de Laar, 2008).
After critical appraisal of all the reviewed studies (n=18), each of the 24 items
on the SEQES was examined independently. Scores from all studies were summed for
each of the 24 evaluation criteria. Total scores were used to determine common
strengths and methodological shortcomings of the reviewed studies. Four strengths
(defined as SEQES items with total scores of 32 or more) were identified. These
included:
1. Thorough background information cited to establish rationale for the
research question
2. Consideration of patient status at more than one time points
3. Prospective data collection, and
4. Support of conclusion by study results
Common study flaws (defined as SEQES items with total item scores of 16 or
less) were also identified. These comprised:
1. Insufficient blinding of treatment providers
2. Lack of independent evaluators used to deliver outcome measures
3. Inadequate sample size/enrollment or lack of sample size calculation
4. Potential for treatment provider biases, and
5. Lack of consideration of clinical and/or practical significance of results
37
Tab
le 6
Met
hodo
logi
cal Q
ualit
y of
the
18 sp
lintin
g st
udie
s (SE
QES
scor
es a
nd S
acke
tt’s L
evel
of E
vide
nce)
SEQ
ES E
valu
atio
n cr
iteria
St
udy
1 2
3 4
5 6
7 8
9 10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
T
otal
L
OE
sc
ore
ratin
g A
dam
s et a
l. (2
008)
2
2 2
2 2
2 2
2 2
2 2
2 1
2 2
2 2
1 2
2 2
2 1
2 46
1b
H
igh
Cal
linan
et
al. (
1995
) 2
0 2
2 1
1 1
0 1
2 0
1 1
1 1
2 1
1 1
1 1
0 1
2 26
2b
M
oder
ate
Form
sa &
D
ikjs
tra
(200
8)
2 0
2 2
0 1
1 0
1 2
1 1
1 0
0 2
1 2
2 0
1 1
2 2
27
3b
Fair
Has
ket e
t al.
(200
4)
2 0
2 2
2 1
1 2
1 2
1 2
2 1
1 2
2 2
1 1
2 1
2 2
37
1b
Hig
h K
jeke
n et
al
(199
5)
1 2
1 2
1 1
1 0
1 1
1 1
1 1
2 1
1 1
1 1
1 1
1 1
27
2b
Mod
erat
e Li
-Tsa
ng e
t al
. (20
02)
2 2
2 1
1 1
0 2
1 1
0 1
1 1
2 2
0 1
1 0
1 1
1 2
27
2b
Mod
erat
e N
orde
nski
old
(199
0)
1 1
1 1
1 1
0 0
0 1
0 0
1 0
1 1
0 0
1 0
0 1
1 1
14
4 Lo
w
Pagn
otta
et
al. (
1998
) 2
2 2
2 1
1 1
0 1
2 2
2 1
1 1
2 1
1 2
2 2
1 1
2 35
1b
H
igh
Ren
nie
(1
996)
2
1 2
2 0
1 1
0 1
1 1
1 1
0 0
1 1
1 1
1 1
1 1
2 23
2b
M
oder
ate
Silv
a et
al.
(2
008)
2
2 2
2 2
2 1
1 2
2 1
2 2
1 2
2 1
2 2
1 2
1 1
2 39
1b
H
igh
Silv
a et
al.
(200
8)
2 2
2 2
2 2
1 2
2 2
2 1
2 2
2 2
2 2
2 2
2 1
2 2
45
1b
Hig
h Sp
ika
et a
l (2
009)
1
1 2
2 1
1 1
0 0
1 0
1 1
1 1
1 1
2 1
0 1
0 1
1 22
2b
M
oder
ate
Ster
n et
al
(199
6)
2 1
2 1
1 1
0 0
1 1
0 0
1 1
1 2
1 1
1 1
1 1
1 1
23
2b
Mod
erat
e Te
r Sch
egge
r et
al
(200
0)
2 1
2 2
1 1
1 0
1 1
0 2
1 0
2 0
1 1
1 0
2 1
1 2
26
2b
Mod
erat
e Ti
jhui
s et a
l. (1
998)
2
1 2
2 1
1 1
1 1
1 0
2 1
1 2
1 0
1 1
0 1
1 1
2 27
2b
M
oder
ate
Van
der
G
iese
n et
al.
(200
9)
2 2
1 2
2 1
1 0
2 2
1 2
1 2
2 2
2 1
2 2
2 2
2 2
40
1b
Hig
h
Vee
hoff
et
al. (
2008
) 2
2 2
2 2
1 0
0 2
2 2
2 2
1 2
2 2
2 2
1 2
1 2
2 40
1b
H
igh
Zijls
tra e
t al.
(200
4)
1 0
1 1
0 0
1 0
1 1
0 1
1 0
0 2
1 1
1 0
1 0
1 2
17
4 Lo
w
Tot
als
32
22
32
32
21
20
15
10
21
27
14
24
2
2 1
6 2
4
29
20
23
25
15
25
1
7 2
3 3
2
37
38
Static Resting Splints
Three studies were evaluated that examined the effectiveness of static resting
splints in the treatment of adult patients with hand RA. Two 1b studies (Adams et al.,
2008; Silvia et al., 2008) and one 2b study (Callinan & Mathiowetz’s, 1996) using a
total of 215 subjects. The quality scores of these three studies ranged from 26 to 46.
The main features and findings are summarised in Table 7, pages 41-42.
Adams and colleagues (2008) performed a one year, randomized controlled
trial (n = 116) to compare the effects of static resting splints plus standard
occupational therapy versus standard occupational therapy alone, with people with
early RA. The primary outcome measure was hand pain (Visual Analogue Scale 0-
10). Secondary outcome measures included grip strength, pinch strength, hand
function (measured with the Health Assessment Questionnaire), upper limb disability
and symptoms (measured with the Disability of the Arm, Shoulder and Hand
questionnaire); and patient satisfaction with treatment (Likert scale).
The main findings included no significant difference between groups for grip
strength, metacarpophalangeal (MCP) ulnar deviation, dexterity, hand function or
pain. For a small subgroup of participants in the splint group, there was a significant
decrease (p = 0.021) in early morning stiffness at the end of the trial. However, the
duration was significantly lower in the control group over the 12 months, indicating
stiffness was greater with splint wear. Adams et al. (2008) concluded that static
resting splints used with people with early RA provided no advantage over standard
occupational therapy alone at 1 year and continuing use of static resting splints as a
routine treatment should be carefully considered.
Adams et al. (2008) study is a well-designed and adequately powered
multicenter trial, attaining a quality score of 46/48 on the SEQES. Nevertheless, the
study had a number of limitations. First, despite measuring a variety of outcomes, the
inclusion criteria did not specify that patients needed to exhibit problems in these
specific areas. The baseline data demonstrate that patients had a modest degree of
symptomology (pain, morning stiffness and Health Assessment Questionnaire scores),
thereby restricting their potential for significant improvement. Second, omitted from
the report were a description of the frequency and intensity of intervention and a
comparison of these factors between groups. Thirdly, it is difficult to standardize
splint wearing in research trials. As in this study, participants are instructed to wear
39
the splint during ‘rest’. However, as daily living patterns are extremely individual,
prescribed regimes for ‘rest’ can vary significantly.
Adherence to prescribed regimes is also an acknowledged problem (Adams et
al., 2005) as are subjective estimates of splint wearing. In this study, approximately 50
% of participants only wore the splint for less than 5 hours/week. Adams et al. (2008)
suggest that splints were potentially being provided too early, with non-adherers
considering splints unnecessary, and the impact of disease-modifying drugs at this
early stage leads to difficulty in distinguishing splint effects. Prior success or failure
may also influence compliance and perceived benefit. Despite the common belief that
increased wearing of the splint should result in better outcomes, this study found no
correlation between wearing time and perceived effectiveness.
Silva and associates (2008) performed a randomized control trial (n=50)
comparing the effectiveness of night-time static resting splints over 3 months to no
treatment at all. This study scored highly on the SEQES (45/48), suggesting high
methodological quality. A positioning splint was fabricated for the participants in the
experimental group with directions to wear it while sleeping. The splint placed the
hand in 10° wrist extension, 25-30° metacarpophalangeal (MCP) joint flexion, 30°
proximal interphalangeal (PIP) joint flexion and thumb abduction. The average
wearing time of the splint per night was 8 hours (range 4.5-11 hours). People in the
control group were not provided with a splint. At 12 weeks the mean visual analogue
scale hand pain for the control group was 5.79 (standard deviation (SD) 2.14) versus
3.4 (SD 2.08) in the splint group. The mean difference between groups in hand pain at
3 months was 2.39, with a 95% confidence interval (CI) of [1.15, 3.36]. Statistically
significant differences were also found between groups of Health Assessment
Questionnaire scores (p ≤ 0.05), Disability of Arm, Shoulder and Hand Q2 scores (p ≤
0.011), Disability of Arm, Shoulder and Hand Q3 scores (p ≤ 0.010), and palmer
pinch (p ≤ 0.002). The authors conclude that the use of a night time hand positioning
splint statistically reduced pain, improved grip and pinch strength, and upper limb
function in patients with RA.
Silva et al. (2008) study was entirely powered on the determination of a
clinically important difference in improvement between groups of 3 points on a 10-
point Visual Analogue Hand Pain Scale. The results showed that the group that wore
splints reported statistically significantly improved scores for reported hand pain,
40
general functional ability; self-reported upper limb disability and grip strength,
compared with the group that received no splint and no treatment.
There are several possible explanations for these results. Firstly, the
randomization of individuals formed groups that appear balanced at baseline.
However, it is not clear if disease activity changed throughout the trial and whether
this was different between groups. The Health Assessment Questionnaire that
improved in the splint group but not in the control group has been shown to be a
sound indicator of disease activity (Smolen et al., 2003) but is reported as less
effective in accurately reporting change in hand functional ability (Nordh &
Nordenskiold, 2001). Lastly, disease activity is a strong predictor of function and pain
in RA. It may be difficult to interpret the true impact of these splints without reporting
or controlling for disease activity in the analysis.
The effects of comfort and personal preference on compliance were considered
in a study by Callinan and Mathiowetz (1995). They demonstrated that for two types
of static resting splints (soft fabric and hard thermoplastic) there were significant
reductions in overall pain levels when these splints are worn at night time for 1 month,
and that individuals complied more with wearing the soft splint, although this finding
was not statistically significant. This study scored 26/48 on the SEQES, suggesting
moderate methodological quality. However, with such a small sample size (n = 39),
caution is needed in interpreting results, when changes in disease activity and
progression from baseline to follow-up had not been taken into account. Thus, it is
difficult to extrapolate the positive benefits (if they exist) from the disease process
itself. Like Silva et al. (2008) study, without including analysis of co-variance of
disease activity in splinting trials the potential benefits of splints will be inextricably
linked with levels of disease activity.
41
Tab
le 7
Su
mm
ary
of E
vide
nce
for S
tatic
Res
ting
Splin
ts
St
udy
Met
hods
Pa
rtici
pant
s In
terv
entio
n O
utco
mes
C
oncl
usio
ns
Com
men
ts LO
E &
QS
Ada
ms,
Bur
ridg
e,
Mul
lee,
H
amm
ond,
& C
oope
r (2
008)
Pros
pect
ive,
m
ulti-
site,
sing
le
blin
ded
desi
gn
Ran
dom
izat
ion:
ye
s In
tent
ion
to tr
eat:
ye
s Lo
st to
follo
w-
up: 0
A
sses
sor
blin
ding
: yes
Eigh
t clin
ical
site
s in
the
UK
N
= 12
0 (9
7% c
ompl
eted
the
stud
y)
Incl
usio
n cr
iteria
: ≥18
yea
rs,
diag
nosi
s of R
A a
ccor
ding
to
the
AC
R
Excl
usio
n cr
iteria
: Se
x: 8
4 fe
mal
es; 3
6 m
ales
A
ge: 2
3-82
yea
rs
(mea
n =
57.4
yea
rs)
Dur
atio
n of
sym
ptom
s: <
5 ye
ars
Bot
h gr
oups
rece
ived
st
anda
rd O
T incl
udin
g jo
int
prot
ectio
n, A
DL as
sess
men
t, ha
nd e
xerc
i se,
ass
istiv
e de
vice
s, an
d ot
her w
rist/h
and
splin
ts a
s nec
essa
ry.
Expe
rimen
tal g
roup
als
o re
ceiv
ed a
ther
mop
lasti
c sta
tic
rest
ing
splin
t: W
rist –
neu
tral
MC
PJ -
60° f
lexi
on
PIP
J - 3
0° fl
exio
n T
hum
b –
in o
ppos
ition
leng
th o
f fol
low
-up:
12
mon
ths
Prim
ary
outc
ome:
G
rip st
reng
th (M
IE
digi
tal g
rip a
naly
zer)
Se
cond
ary
outc
ome:
R
ange
of m
otio
n (g
onio
met
ry)
Han
d fu
nctio
n:
(Arth
ritis
han
d fu
nctio
n te
st)
Self-
repo
rted
hand
fu
nctio
n (M
HQ
, 5-p
oint
sc
ale)
No
sign
ifica
nt
diffe
renc
e be
twee
n th
e 2
inte
rven
tions
on
grip
st
reng
th, d
efor
mity
, ha
nd fu
nctio
n an
d pa
in.
RC
T W
ell d
esig
ned
and
adeq
uate
ly
pow
ered
N
o de
scrip
tion
of
the
frequ
ency
and
in
tens
ity o
f th
e in
terv
entio
n P
robl
ems
asso
ciat
ed w
ith
adhe
renc
e to
pr
escr
ibed
sp
lintin
g re
gim
es
1b
46/4
8
Cal
linan
&
Mat
hiow
etz
(199
5)
Cro
ss-o
ver
desi
gn, h
ead
to
head
stud
y R
ando
miz
atio
n:
yes
Ass
esso
r bl
indi
ng: u
ncle
ar
Inte
ntio
n to
trea
t:
Not
repo
rted
Lost
to fo
llow
-up
: 5
N=
45
Incl
usio
n cr
iteria
: dia
gnos
is of
R
A, p
rese
nce
of h
and
pain
, m
orni
ng st
iffne
ss o
r bot
h Ex
clus
ion
crite
ria: c
oexi
stin
g co
nditi
on o
f fib
rom
yalg
ia,
carp
al tu
nnel
synd
rom
e or
ot
her n
euro
logi
cal o
r or
thop
edic
con
ditio
n Se
x: 3
6 fe
mal
es, 3
mal
es
Age
: mea
n 51
yea
rs (r
ange
: 19-
76 y
ears
) D
urat
ion
of sy
mpt
oms:
14.
5 ye
ars
Han
d/w
rist e
xten
sion
splin
ts:
1. R
igid
ther
mop
last
ic sp
lint,
circ
umfe
rent
ial d
esig
n, lo
w
tem
pera
ture
ther
mop
lasti
c sp
lint
2. C
onve
ntio
nal r
estin
g m
itt-
type
soft
splin
t (pa
dded
m
ediu
m te
mpe
ratu
re
ther
mop
last
ic sp
lint).
Splin
ting
regi
me:
28
days
at
nigh
t tim
e on
ly
leng
th o
f fol
low
-up:
28
day
s H
and
Func
tion(
D-
AIM
S-2)
G
rip st
reng
th (J
amar
dy
nam
omet
er)
Com
plia
nce
(dai
ly
diar
y)
Splin
ting
pref
eren
ce
(ratin
g qu
estio
nnai
re)
Res
ting
hand
splin
ts ar
e ef
fect
ive
for p
ain
relie
f in
pat
ient
s with
RA
Pa
tient
s pre
fer w
earin
g a
soft
splin
t to
hard
sp
lints
N
o si
gnifi
cant
di
ffere
nce
in h
and
func
tion
RC
T S
ubje
cts s
erve
d as
th
eir o
wn
cont
rols
G
ood
desc
riptio
n of
han
d an
d w
rist
posi
tion
in sp
lints
R
elat
ivel
y sh
ort
wea
ring
time
No
com
plia
nce
enha
ncin
g st
rate
gies
incl
uded
in
pro
gram
2b
26/4
8
Not
e. L
OE=
leve
l of e
vide
nce,
QS=
qua
lity
scor
e (S
EQES
), O
T= O
ccup
atio
nal T
hera
py, A
DL=
Act
ivity
of D
aily
Liv
ing,
MC
PJ =
met
acar
poph
alan
geal
join
t, PI
PJ =
pro
xim
al in
terp
hala
ngea
l joi
nt, A
CR
= A
mer
ican
Col
lege
of R
heum
atol
ogy,
MH
Q=
Mic
higa
n H
and
Out
com
es Q
uest
ionn
aire
, D-A
IMS-
2=Th
e D
utch
Arth
ritis
Impa
ct M
easu
rem
ent S
cale
2.
41
42
Tab
le 7
S
umm
ary
of E
vide
nce
for S
tatic
Res
ting
Splin
ts
St
udy
Met
hods
Pa
rtici
pant
s In
terv
entio
n O
utco
mes
C
oncl
usio
ns
Com
men
ts
LOE
& Q
S
Silv
a,
Jone
s, Si
lva,
&
Nat
our
(200
8)
Ran
dom
izat
ion:
ye
s, op
aque
en
velo
pes w
ith
conc
eale
d al
loca
tion
Ass
esso
r blin
ding
: ye
s In
tent
ion
to tr
eat:
yes
Lost
to fo
llow
-up:
3
Out
patie
nt c
linic
s, R
heum
atol
ogy
Div
isio
n, F
eder
al U
nive
rsity
of S
ao
Paul
o, B
razi
l N
= 50
In
clus
ion
crite
ria:
RA
acc
ordi
ng to
the
AC
R c
riter
ia,
mal
e &
fem
ale
18-6
5 ye
ars.
Excl
usio
n cr
iteria
: Se
vere
han
d de
form
ities
, tho
se
alre
ady
usin
g an
y ot
her t
ype
of
uppe
r lim
b sp
lint,
surg
ery
sche
dule
≤
6 m
onth
s fol
low
ing
stud
y, a
llerg
ic to
sp
lintin
g m
ater
ial,
livin
g in
in
acce
ssib
le a
reas
with
diff
icul
t ac
cess
to tr
ansp
orta
tion.
Se
x: 4
1 fe
mal
e, 9
mal
es
Age
51
year
s (av
erag
e ag
e)
Dur
atio
n of
sym
ptom
s: 9
.5 y
ears
A p
ositi
onin
g sp
lint w
as
mad
e fo
r par
ticip
ants
in
the
expe
rimen
tal g
roup
w
ith in
stru
ctio
ns to
w
ear i
t whi
le sl
eepi
ng.
The
splin
t pla
ced
hand
in
: 10°
wris
t ext
ensi
on
25
-30°
of M
CPJ
fle
xion
30° P
IP jo
int a
nd
thum
b ab
duct
ion.
Mea
n tim
e sp
lint u
se
per n
ight
8 h
ours
(ran
ge
4.5-
11 h
ours
) C
ontro
l gro
up w
ere
not
prov
ided
with
a sp
lint
leng
th o
f fol
low
-up:
45
/7 &
90/
7 Pr
imar
y ou
tcom
e :
Han
d pa
in (V
AS)
Seco
ndar
y ou
tcom
e :
Grip
stre
ngth
(Jam
ar
dyna
mom
eter
) Pi
nch
stre
ngth
(pin
ch
gaug
e)
Func
tion
(HA
Q)
Upp
er li
mb
disa
bilit
y an
d sy
mpt
oms (
DA
SH-
ques
tionn
aire
) Pa
tient
satis
fact
ion
(Lik
ert s
cale
0-4
)
The
use
of a
nig
ht-
time
hand
pos
ition
ing
splin
t red
uces
pai
n,
impr
oves
grip
and
pi
nch
stren
gth,
upp
er
limb
func
tion
and
func
tiona
l sta
tus i
n pa
tient
s with
rh
eum
atoi
d ar
thrit
is
• R
ando
miz
ed
• A
dequ
atel
y po
wer
ed
• V
alid
and
relia
ble
outc
ome
mea
sure
s •
Exce
llent
adh
eren
ce
to sp
lintin
g re
porte
d
1b
45/4
8
Con
tinue
d N
ote.
LO
E= L
evel
of E
vide
nce,
QS=
Qua
lity
scor
e (S
EQES
), M
CPJ
= m
etac
arpo
phal
ange
al jo
int,
PIPJ
= p
roxi
mal
inte
rpha
lang
eal j
oint
, AC
R=
Am
eric
an C
olle
ge o
f Rhe
umat
olog
y, H
AQ
= H
ealth
Ass
essm
ent Q
uest
ionn
aire
, DA
SH=
Dis
abili
ties o
f the
Arm
, Sho
ulde
r and
Han
d, V
AS=
Visu
al A
nalo
gue
Scal
e.
42
43
Wrist Extension Splints
Seven studies were included that examined the effect of wrist extension splints
in adults with hand RA. Three 1b studies (Haskettet al., 2004; Pagnotta et al.,1998;
Veehoff et al., 2008), three 2b studies (Kjeken et al., 1995; Stern, Ytterberg, Krug,
Mullin, & Mahowald, 1996a; Tijhuis, Theodora, Vliet Vlieland, Zwinderman, &
Hazes, 1998) and one level 4 study (Nordenskiold, 1990) using a total of 255 subjects.
The quality scores of these seven studies ranged from 14-40. The main features and
findings are shown in Table 8, pages 48-51.
In Nordenskjold’s (1990) study twenty-two participants selected one of two
designs of elasticised prefabricated wrist extension splints, and were splinted
bilaterally with their choice (i.e., the Camp or the Rehband). The results were
combined and the grouped splinting effects were examined on maximum pain-free
grip strength and on self-reported pain during three daily living tasks including,
setting the table, vacuum cleaning for 3 minutes and pouring milk out of the carton.
Nordenskjold (1990) reported that the application of wrist splints significantly
increased pain-free grip strength across both left and right hands (22-29%) and
decreased pain during daily living tasks by as much as 52%. While the results of this
study are promising, this study was considered to be of low quality, scoring only
13/48 on the SEQES. A number of flaws were identified in the study design and need
to be highlighted. Firstly, 20 out of the 22 participants regularly used the same splint
prior to the trial. Therefore, it is hard to categorize this study in terms of duration or
splint exposure. The participants histories with, and prolonged use of the splint
outside of the study may have influenced both the pain-free grip strength and their
pain during the investigated activities of daily living (ADL). Furthermore, order of
testing (splinting versus not splinting) was not counterbalanced and may have
influenced the results.
A randomized controlled trial by Kjeken et al. (1995) analyzed splint wear
versus non-splint wear over 6 months (n=69). In addition to several measures of
disease activity, the trial evaluated wrist pain on motion, wrist pain during two simple
tasks, and maximum grip and pinch strength. The authors found no significant
difference between the splinted and the control groups in disease activity. Joint motion
improved slightly in the control group and remained unchanged in the splinting group.
Therefore, it is possible that the use of wrist splints over time may be associated with
some reduced motion, although this theory is unproven. Interestingly, after 6 months,
44
patients in the splinting group had a 25% improvement in grip strength (measured by
a 20mmHg inflated, standardized bag connected to a sphygmomanometer) and 50%
reduction in pain while using the wrist splint. In clinical trials, this improvement (20-
30%) is considered to be significant for a therapeutic effect (Goldsmith, Boers,
Bombardier, & Tugwell, 1993).
Kjeken et al. (1995) study scored 27/48 on the SEQES, suggesting moderate
methodological quality. The main criticisms of this study are that the article did not
specify if test order (e.g., splinted versus non-splinted) was counterbalanced across
participants, as this may have influenced the results (Stern, 1991), nor, do they address
whether similar differences were seen initially on the first day of the study. In
addition, it appeared that the treating therapist and the outcome assessor were the
same person. This was a potential source of bias in two ways. Firstly, a patient may be
more likely to report successful outcomes to their treating therapist than to an
independent assessor and, secondly, the therapist desiring good outcomes may be
more likely to overestimate the effects of treatment (Polit, Beck, & Hunglar, 2001).
Kjeken et al. (1995) acknowledge that there is a possibility that the expectation of an
effect may have influenced the results especially with subjective measures as pain, but
it is less likely for assessment of grip and pinch strength.
Haskett and colleagues (2004) compared the effect of three wrist splints (two
prefabricated commercial splints and one custom made) on perceived wrist pain and
upper extremity hand function in adults with RA. After one month of splint use, all
wrist splints were associated with improved grip and pinch strength, consistent with
two previous studies (Kjeken et al., 1995; Nordenskiold, 1990), but the Roylan splint
provided significantly stronger grip then the Anatech commercial splint (p = 0.004).
Haskett et al. (2004) concluded that the magnitude of the difference was small and the
practical significance of these changes is difficult to assess. Nonetheless, even a small
improvement may enable a person to complete a task, especially if the person is near
the threshold for the strength required to do it.
Haskett et al. (2004) study is a well-designed, prospective, single-center trial,
scoring 37/48 on the SEQES, indicating high methodological quality. A strength of
this study was the length of wear time for each splint, which improved upon prior
studies concerning the immediate and short-term effects of wrist splints (Anderson &
Mass, 1987; Stern et al., 1996). It was limited, however, by one of the measures used
to capture the effect of wrist splints. The McMaster-Toronto Arthritis Patient Function
45
Preference (MACTAR) outcome tool did not seem to show changes in functional
activities. Given the highly localized nature of the intervention, perhaps, an alternative
functional measure may have been more appropriate to capture changes in function
reported by patients, such as the Disabilities of the Arm, Shoulder and Hand
questionnaire (Beaton et al., 2001).
Tijhuis et al. (1998) performed a small randomized crossover trial (n=10) to
compare the clinical effectiveness of commercially made Futuro wrist supports with a
newly developed, custom made ThermoLyn wrist splint. The results indicated that
there was no difference, after two weeks of wear, on grip strength with or without the
splint. The results of this study are in partial agreement with the study by Stern et al.
(1996). In this prospective, randomized, cross-over trial the immediate and short-term
effects of 3 commercial wrist splints were investigated. After 1 week of using these
splints, 2 of the 3 splints (including the Futuro design) were associated with reduced
grip strength. Both studies, by Tijhuis et al. (1998) and Stern et al. (1996), scored
above 17/48 on the SEQES, indicating moderate methodological quality. However,
the results are in conflict with Kjeken et al. (1995) findings concerning splinted and
non-splinted grip strengths. The possible reasons for these contrasting findings may be
ascribed to differences between the studies outcomes tools (e.g., modified
sphymomomanometer versus Jamar dynamometer) or duration of exposure (6 months
versus 1 week).
Veehoff and colleagues (2008) performed a randomized controlled trial (n=33)
to investigate the efficacy of wrist splints after splinting for a period of time in
patients with RA. Patients were randomly allocated using block randomization, with a
block size of four, to the splinting or control group. Veehoff et al. (2008) found that
patients in the splinting group had a 32% pain reduction after 4 weeks, while the
control group showed an average pain increase of 17%. This difference in change
scores between the groups was statistically significant (p <0.002) and indicated a large
and clinically meaningful treatment effect (Tubach, et al., 2005). The authors
concluded that prefabricated wrist splints are extremely effective in reducing wrist
pain after 4 weeks of splinting in adults with RA affecting the wrists.
Despite scoring highly on the SEQES (40/48), Veehoff et al. (2008) study had
several limitations. The first potential drawback concerns the small sample size. Data
from a previous trial on wrist extension splints (Tijhuis et al., 1998) were used to
develop power analysis and determine the number needed to treat. The minimal
46
sample size to give a definitive answer about clinical significance (detect a difference
of 15mm on Visual Analogue Scale for wrist pain with 80% power and a one-sided
significance level of (p = 0.05) was calculated to be 54 patients (27 in each group).
From previous studies (Salaffi, Stancati, Silvestri, Ciapetti, & Grassi, 2004; Tubach et
al., 2005), they found that a difference of Visual Analogue Scale pain score of 155mm
corresponds to an improvement of approximately 30% which is the level of
improvement considered to be clinically significant. It would have been preferable if
this study met that group size. Although the effect of wrist splints on Visual Analogue
Scale-pain scores was discovered to be clinically significant (exceeded minimal
improvement factor of 30% to be clinical significant), this randomized control trial
was ‘underpowered’ as the minimum sample size of (n=54) was not recruited.
Therefore, although the effect of splinting significantly reduced Visual Analogue
Scale pain scores, it is not possible to conclusively state that the results of this study
were clinically significant.
Another limitation in Veehoff et al. (2008) study concerns the possibility of
expectation bias. Neither the participants nor the evaluator were blinded to the
treatment allocation. The results might therefore have been influenced by the
expectation of a treatment effect. The investigators attempted to take into
consideration a feature common to many splinting studies - the amount of time the
splint was actually worn, by using self-reporting. However, due to the lack of blinding
of assessors and the participants, possible bias due to self-reporting may have
influenced the results. In addition, all participants in the experimental group wore
wrist splints in the week preceding the final assessments; therefore, this treatment
effect might be attributed to both the immediate effect of wrist splints and to reduced
inflammation.
Studies examining hand function have demonstrated that wrist splints are
particularly task specific, e.g. they may be able to assist in one particular hand skill
but reduce another (Pagnotta et al., 1998; Stern et al., 1996). Stern et al. (1996) found
that patients reported using their splints for everyday activities like vacuuming, lawn
raking, and lifting moderately heavy objects, but that they removed the splint for tasks
such as equipment repair because it seemed to ‘get in the way’ or reduced any
required mobility or flexibility of the hand and wrist. This study scored 23 out of 48
on the SEQES, indicating moderate methodological quality.
47
Stern et al. (1996) findings are supported by a more recent study by Pagnotta et
al. (2005), showing splinting to be most beneficial for household chores that
incorporated the metal insert into the task action, e.g. using a knife to chop vegetables.
Conversely, splint wear was perceived as offering minimal benefit in tasks requiring a
secure grip of an object in the hand such as lifting a pot or turning a jar lid. It is
conceivable that the splint may also contribute to increased discomfort in other joints.
For example, wrist splints are known to place added stress on the proximal joints
(Collier & Thomas, 2002), and this has important implications particularly for people
who have several compromised joints. If there is task specificity in relation to work
performance it may explain why patients show variable adherence to wearing the
splint (Agnew & Mass, 1995).
Pagnotta et al. (2005) study is a well-designed, cross-over trial, scoring 35/48
on the SEQES. Despite the high methodological quality, there are a couple of
limitations. Firstly, the small sample size (n=30) and the patient variability may have
limited the power of the study to detect a significant effect of splint use. Secondly,
only individuals who were wearing a commercially available, circumferential fabric
type wrist splint with a palmar metal insert met the inclusion criterion. Thus, the
findings cannot be inferred to the general population.
48
Tab
le 8
Su
mm
ary
of E
vide
nce
for W
rist
Ext
ensi
on S
plin
ts
St
udy
Met
hods
Pa
rtici
pant
s In
terv
entio
n O
utco
mes
C
oncl
usio
ns
Com
men
ts LO
E &
QS
Has
ket,
Bac
kman
, Po
rter
, G
oyer
t, &
Pa
lejk
o (2
004)
Ran
dom
izat
ion:
yes
A
sses
sor b
lindi
ng: y
es
Inte
ntio
n to
trea
t: no
t re
porte
d
Lost
to fo
llow
-up:
2
3-ph
ase
cros
s ove
r de
sign
Pr
ospe
ctiv
e tri
al
Out
patie
nt o
ccup
atio
nal t
hera
py
depa
rtmen
t, N
= 45
In
clus
ion
crite
ria: d
iagn
osis
of R
A,
pres
ents
with
any
2 o
f the
se
sym
ptom
s: pa
lpab
le sw
ellin
g, p
ain
on m
otio
n or
with
dire
ct p
ress
ure,
w
rist R
OM
rest
ricte
d by
≥20
°, ab
le
to sp
eak,
read
and
writ
e En
glish
, ≥2
0 ye
ars.
Excl
usio
n cr
iteria
: obt
aini
ng a
re
plac
emen
t wris
t spl
int,
not w
illin
g to
par
ticip
ate
in th
e 2/
52 w
asho
ut
perio
d w
ith n
o sp
lint u
se, r
equi
red
an a
ltern
ativ
e cu
stom
splin
t Se
x: 3
9 fe
mal
e, 6
mal
e A
ge: m
ean
=49
year
s D
urat
ion
of sy
mpt
oms:
mea
n=8.
6 ye
ars
Type
s of s
plin
t(s):
1. C
usto
m-m
ade
leat
her
wris
t spl
int (
LWS)
2.
Roy
lan
wris
t ext
enso
r sp
lint (
RW
S)
3. A
nato
mic
al
Tech
nolo
gies
ela
stic
w
rist s
uppo
rt (A
WS)
4/
52 p
erio
d of
eac
h sp
lint,
with
a 1
/52
was
hout
per
iod
betw
een
splin
ts.
Wea
ring
regi
me:
D
urin
g ac
tiviti
es th
at
caus
ed p
ain
or d
iscom
fort
durin
g th
e da
y.
Dur
atio
n: 1
0 ho
urs/
wee
k fo
r 1 m
onth
.
leng
th o
f fol
low
-up:
4/
52, 8
/52,
12/
52, 6
/12
Perc
eive
d Pa
in:
(10c
m-h
oriz
onta
l V
AS)
H
and
func
tion:
AH
FT,
MA
CTA
R
ques
tionn
aire
Afte
r 4/5
2 w
rist
splin
ts
sign
ifica
ntly
re
duce
pai
n,
impr
ove
stre
ngth
an
d do
not
co
mpr
omis
e de
xter
ity.
The
cust
om-m
ade
LWS
and
com
mer
cial
ly
avai
labl
e R
WS
had
simila
r effe
ct
and
both
wer
e su
perio
r to
the
AW
S.
Ran
dom
ized
A
sses
sor b
linde
d
Sub
ject
s not
blin
ded
Clin
ical
sign
ifica
nce
repo
rted
Rel
iabi
lity
and
valid
ity o
f out
com
es
repo
rted
Goo
d de
scrip
tion
of
treat
men
t pro
toco
ls
Not
all
OT
depa
rtmen
ts w
ill b
e ab
le to
pro
vide
cu
stom
fabr
icat
ion
serv
ices
S
ubje
cts a
ct a
s ow
n co
ntro
ls
1b
37/4
8
Kje
ken,
M
olle
r, &
K
vien
, (19
95)
Ran
dom
izat
ion:
yes
A
sses
sor b
lindi
ng: n
o In
tent
ion
to tr
eat:
not
repo
rted
Lost
to fo
llow
-up:
14
The
reas
ons i
nclu
ded
deat
h, a
ltere
d di
agno
sis,
conc
urre
nt
dise
ase,
exa
cerb
atio
n of
dis
ease
and
no
ncom
plia
nce
Pros
pect
ive
desi
gn
Sing
le-c
ente
r tria
l
Occ
upat
iona
l The
rapy
Dep
artm
ent,
N
orw
egia
n Lu
ther
an H
ospi
tal
Osl
o, N
orw
ay
N=6
9
36 in
the
splin
ting
grou
p 33
in th
e co
ntro
l gro
up
Incl
usio
n cr
iteria
: Adu
lts w
ith e
ither
R
A o
r per
sist
ent s
eron
egat
ive
arth
ritid
es, a
nd in
volv
emen
t of t
he
dom
inan
t wris
t joi
nt in
clud
ing
at
leas
t 2 o
f the
follo
win
g si
gns:
sw
ellin
g, p
ain
on m
otio
n, a
nd/o
r lim
ited
mot
ion.
Ex
clus
ion
crite
ria: s
urge
ry o
f the
do
min
ant h
and
durin
g th
e pr
eced
ing
6mon
ths a
nd u
se o
f wris
t spl
ints
an
y tim
e du
ring
the
prev
ious
yea
r.
Sex:
52
fem
ale,
17
mal
e A
ge:6
4 ye
ars
Dur
atio
n of
sym
ptom
s: 3
Trea
tmen
t gro
up: R
ehba
nd
elas
tic w
rist o
rthos
is, w
rist
held
in 1
0-15
° of
exte
nsio
n.
Con
trol g
roup
: no
splin
t fo
r the
sam
e pe
riod
Wea
ring
regi
me:
trea
tmen
t gr
oup
used
the
splin
t whe
n pe
rform
ing
pain
ful
activ
ities
, as w
ell a
s in
term
itten
tly in
rest
ing
posi
tion
durin
g pe
riods
of
seve
re p
ain,
for 6
mon
ths.
Bot
h gr
oups
wer
e in
struc
ted
verb
ally
and
in
writ
ing
on h
and
exer
cise
s an
d jo
int p
rote
ctio
n an
d ap
prop
riate
tech
nica
l de
vice
s.
leng
th o
f fol
low
-up:
6/
12 w
ith a
nd w
ithou
t sp
lints
Act
ivity
Pai
n (V
AS)
G
rip st
reng
th: u
sing
a (s
phyg
mom
anom
eter
Pi
nch
stre
ngth
(pin
ch
met
er)
Ran
ge o
f mot
ion
(gon
iom
eter
)
Wris
t spl
ints
im
prov
e fu
nctio
n an
d re
duce
d pa
in
but h
ad n
o ef
fect
s >
6/12
com
pare
d to
a c
ontro
l gro
up
on m
easu
res o
f lo
cal o
r gen
eral
di
seas
e ac
tivity
.
Ran
dom
ized
A
sses
sor n
ot
blin
ded
Pat
ient
s not
blin
ded
Mod
erat
e re
liabi
lity
and
valid
ity o
f ou
tcom
e to
ols
Poo
r ran
dom
izat
ion
proc
ess.
2b
27/4
8
Not
e. L
OE=
Lev
el o
f Evi
denc
e, Q
S= Q
ualit
y sc
ore
(SEQ
ES),
VA
S: V
isua
l Ana
logu
e Sc
ale,
AH
FT=A
rthrit
is H
and
Func
tion
Test
, MA
CTA
R=
McM
aste
r-To
ront
o A
rthrit
is P
atie
nt F
unct
ion
Pref
eren
ce
ques
tionn
aire
, RO
M=R
ange
of M
otio
n.
48
49
Tab
le 8
Su
mm
ary
of E
vide
nce
for W
rist
Ext
ensi
on S
plin
ts
St
udy
Met
hods
Pa
rtici
pant
s In
terv
entio
n O
utco
mes
C
oncl
usio
ns
Com
men
ts LO
E &
QS
Nor
dens
kiol
d (1
990)
R
ando
miz
atio
n:
yes
Ass
esso
r blin
ding
: no
t rep
orte
d In
tent
ion
to tr
eat:
no
t rep
orte
d
Lost
to fo
llow
-up:
0 C
ross
sect
iona
l de
sign
Rhe
umat
olog
ic O
utpa
tient
C
linic
at S
ahlg
rens
ka H
ospi
tal,
Got
ebor
g, S
wed
en
N=
22
Incl
usio
n cr
iteria
: ser
opos
itive
R
A, t
akin
g on
ly N
SAID
Ex
clus
ion
crite
ria:
Pts.
rece
ivin
g lo
cal s
tero
ids i
n th
e pa
st 14
day
s Se
x: w
oman
onl
y M
ean
age:
53
year
s (ra
nge
30-
65 y
ears
) D
urat
ion
of sy
mpt
oms:
11
yea
rs (r
ange
1-3
3 ye
ars)
Expe
rimen
tal G
roup
: ha
d th
e ch
oice
of
2 ty
pes o
f sof
t vol
ar w
rist
splin
ts to
wea
r C
ontro
l gro
up:
82 w
oman
with
out R
A
(age
rang
e 23
-65
year
s)
Leng
th o
f fol
low
-up:
N
one .
Eva
luat
ion
is pe
rform
ed a
t one
tim
e.
Pai
n us
ing
a10c
m
VA
S.
Grip
stre
ngth
: new
el
ectro
nic
inst
rum
ent
calle
d th
e ‘G
rippi
t’
Fun
ctio
nal
asse
ssm
ent
ques
tionn
aire
The
appl
icat
ion
of
wris
t spl
ints
si
gnifi
cant
ly re
duce
s pa
in d
urin
g th
ree
AD
Ls fo
r wom
an w
ith
RA
.
Wris
t spl
ints
si
gnifi
cant
ly im
prov
e gr
ip fo
rce
at o
nset
of
pain
Que
stio
nabl
e va
lidity
an
d re
liabi
lity
of
outc
ome
tool
S
mal
l sam
ple
size
, po
wer
not
est
ablis
hed
Pot
entia
l exp
ecta
tion
bias
A
sses
smen
t pr
oced
ures
not
cle
ar
Ran
dom
izat
ion
of ta
sk
orde
r
4 14
/48
Pagn
otta
et
al.
(199
8)
Ran
dom
izat
ion:
ye
s A
sses
sor b
lindi
ng:
not r
epor
ted
Inte
ntio
n to
trea
t:
not r
epor
ted
Lo
st to
follo
w-u
p:
0 2 pe
riod
cros
sove
r de
sign
Pr
ospe
ctiv
e de
sign
Rhe
umat
ic D
isea
se U
nit
Jew
ish
Reh
abili
tatio
n H
ospi
tal
Mon
treal
, Can
ada
N=4
0 In
clus
ion
crite
ria: d
iagn
osis
of
RA
, pai
nful
dom
inan
t han
d du
e to
syno
vitis
or d
amag
e to
the
radi
ocar
pal j
oint
, Ex
clus
ion
crite
ria: u
nabl
e to
w
ear a
splin
t due
to ra
sh, s
kin
brea
kdow
n, a
llerg
y or
alte
red
sens
atio
n, p
revi
ous
corti
cost
eroi
d in
ject
ion
last
2/12
, CTS
, sev
ere
finge
r de
form
ity, f
usio
n of
the
radi
ocar
pal j
oint
, pre
viou
s use
a
sim
ilar s
plin
t prio
r to
adm
issi
on.
Sex:
33f
emal
e, 7
mal
e M
ean
age:
52.
4 ye
ars (
rang
e 25
-81
year
s)
Dur
atio
n of
sym
ptom
s:9.
2 ye
ars a
vera
ge
Com
mer
cial
wris
t spl
int
(Fut
uro)
In
terv
entio
n ra
ndom
ly
assi
gned
Leng
th o
f fol
low
-up:
1/
52
Wor
k pe
rform
ance
: as
sess
ed u
sing
a w
ork
sim
ulat
or, w
ith a
nd
with
out s
plin
t D
exte
rity:
mea
sure
d us
ing
the
JHFT
, with
an
d w
ithou
t spl
int.
Pai
n (1
0 cm
VA
S)
Splin
t wea
r on
wor
k pe
rform
ance
is h
ighl
y ta
sk sp
ecifi
c.
The
ergo
nom
ic
dem
ands
of a
n in
divi
dual
’s d
aily
life
m
ust b
e co
nsid
ered
if
a sp
lint i
s pre
scrib
ed
to g
ive
max
imal
ef
fect
iven
ess.
Wel
l des
crib
ed
treat
men
t int
erve
ntio
n P
ower
cal
cula
tions
co
mpl
eted
V
alid
and
relia
ble
me a
sure
men
t too
ls
1b
35/4
8
Con
tinue
d
Not
e. L
OE=
Lev
el o
f Evi
denc
e, Q
S=Q
ualit
y sc
ore
(SEQ
ES),
NSA
ID=N
onst
eroi
dal A
nti-I
nfla
mm
ator
y D
rugs
, VA
S=V
isua
l Ana
logu
e Sc
ale,
JHFT
=Jeb
sen
Han
d Fu
nctio
n Te
st, C
TS=
Carp
al T
unne
l Sy
ndro
me,
AD
L=A
ctiv
ities
of D
aily
Liv
ing.
49
50
Tab
le 8
Su
mm
ary
of E
vide
nce
for W
rist
Ext
ensi
on S
plin
ts
St
udy
Met
hods
Pa
rtici
pant
s In
terv
entio
n O
utco
mes
C
oncl
usio
ns
Com
men
ts LO
E &
QS
Ster
n,
Ytte
rber
g,
Kru
g,
Mul
lin, &
M
ahow
ald
(199
6)
Ran
dom
izat
ion:
yes
A
sses
sor b
lindi
ng:
not r
epor
ted
Inte
ntio
n to
trea
t:
not r
epor
ted
Lo
st to
follo
w-u
p:
not r
epor
ted
cros
sove
r des
ign
Vol
unte
er su
bjec
ts. R
ecru
itmen
t st
rate
gy is
unc
lear
. N
= 36
In
clus
ion
crite
ria: d
iagn
osis
of R
A
(per
the
AC
R),
func
tiona
l cla
ss II
or
III,
dom
inan
t wris
t act
ive
exte
nsio
n ≥2
0°
Excl
usio
n cr
iteria
: wris
t su
blux
atio
n, ra
dial
dev
iatio
n>15
°, M
CPJ
uln
ar d
evia
tion ≥3
0°,
histo
ry o
f wris
t sur
gery
, dia
gnos
ed
neur
olog
ical
dis
orde
r affe
ctin
g ha
nd u
se.
Se
x: 1
8 fe
mal
e, 0
mal
e M
ean
age:
49.
44 y
ears
D
urat
ion
of sy
mpt
oms:
12 y
ears
av
erag
e
3 ph
ases
of 1
wee
k w
ith
each
of 3
splin
ts,
sepa
rate
d by
1-w
eek
was
hout
per
iods
. In
stru
ctio
ns to
wea
r the
sp
lint f
or a
t lea
st 4
ho
urs d
aily
for 5
of t
he
7 da
ys.
Onl
y do
min
ant h
and
splin
ted
Splin
t des
igns
: F
utur
o R
oyla
n D
-ring
A
liMed
free
dom
lo
ng
Leng
th o
f fol
low
-up:
1/
52
Grip
stre
ngth
: usin
g th
e Ja
mar
dy
nam
omet
er.
Mea
sure
d w
earin
g th
e sp
lint
Pain
(VA
S)
Com
mer
cial
wris
t sp
lints
do
not i
ncre
ase
grip
stre
ngth
, eith
er
imm
edia
tely
or a
fter 1
w
eek.
D
iffer
ent s
plin
t de
sign
s may
hav
e di
fferin
g in
fluen
ce o
n sp
linte
d gr
ip st
reng
th?
Sub
ject
s ser
ved
as
thei
r ow
n co
ntro
ls
Ran
dom
ized
splin
t us
e G
rip st
reng
th te
st
orde
r was
co
unte
rbal
ance
ac
ross
subj
ects
2b
23/4
8
Tijh
uis,
Vlie
t V
liela
nd,
Zwin
derm
, &
Haz
es
(199
8)
Ran
dom
izat
ion:
yes
A
sses
sor b
lindi
ng:
no
Inte
ntio
n to
trea
t:
no
Lost
to fo
llow
-up:
0
Ran
dom
ized
cr
osso
ver d
esig
n
Dep
artm
ent o
f Rhe
umat
olog
y Le
iden
Uni
vers
ity H
ospi
tal
The
Net
herla
nds
N=1
0 In
clus
ion
crite
ria: d
iagn
osis
of R
A
acco
rdin
g to
the
AC
R, s
wol
len
and
pain
ful w
rist o
f the
dom
inan
t ha
nd, f
unct
iona
l cla
ss II
or I
II,
disp
laye
d do
min
ant w
rist a
ctiv
e ex
tens
ion
of ≥
20°
Excl
usio
n cr
iteria
: his
tory
of w
rist
surg
ery
in th
e pa
st y
ear,
splin
t use
3/
12 p
rior t
o th
e stu
dy
Sex:
8 w
oman
, 2 m
en
Age
: mea
n ag
e of
47.
3 ye
ars
(rang
e 28
-71)
D
urat
ion
of sy
mpt
oms:
6.4
yea
rs
(rang
e 1-
15)
Splin
t des
igns
: 1.
Com
mer
cial
ly m
ade
Futu
ro w
rist s
plin
t 2.
Cus
tom
-mad
e Th
erm
oLyn
wris
t sp
lint
Wea
ring
regi
me:
2
wee
ks e
ach
with
a 1
-w
eek
w
ash-
out p
erio
d be
twee
n sp
lints
leng
th o
f fol
low
-up:
2/
52
Patie
nts s
atis
fact
ion
ques
tionn
aire
Te
nder
join
t cou
nt,
Wris
t ran
ge o
f mot
ion
(Ger
hadt
& R
ipps
tein
m
etho
d)
Grip
stre
ngth
(Mar
tin
Vig
orim
eter
)
Bot
h sp
lint d
esig
ns
wer
e eq
ually
eff
ectiv
e in
with
resp
ect t
o sh
ort-t
erm
util
ity a
nd
clin
ical
effe
ctiv
enes
s.
Sm
all s
ampl
e si
ze,
pow
er n
ot
esta
blish
ed
Non
-val
idat
ed a
nd
relia
ble
mea
surin
g to
ols
Sam
plin
g bi
as
2b
27/4
8
Con
tinue
d
Not
e. L
OE=
Lev
el o
f Evi
denc
e, Q
S=Q
ualit
y Sc
ore
(SEQ
ES),
VA
S= V
isua
l Ana
logu
e Sc
ale,
MC
PJ =
Met
acar
poph
alan
geal
Join
t, A
CR
= A
mer
ican
Col
lege
of R
heum
atol
ogy
.
50
51
Tab
le 8
Su
mm
ary
of E
vide
nce
for W
rist
Ext
ensi
on S
plin
ts
St
udy
Met
hods
Pa
rtici
pant
s In
terv
entio
n O
utco
mes
C
oncl
usio
ns
Com
men
ts LO
E &
QS
Vee
hof,
Taal
, H
eijn
sdik
-R
ouw
ensh
orst
, &
van
de
Laa
r (2
008)
Ran
dom
izat
ion:
ye
s A
sses
sor
blin
ding
: no
Subj
ect
blin
ding
: no
Inte
ntio
n to
tre
at:
Not
repo
rted
Lost
to fo
llow
-up
: 0
Rhe
umat
olog
y ou
tpat
ient
clin
ic
Med
isch
Spec
trum
Tw
ente
Hos
pita
l,
Ensc
hede
Th
e N
ethe
rland
s N
=33
• Pa
rtici
pant
s wer
e ch
osen
by
the
rheu
mat
olog
ist
In
clus
ion
crite
ria:
RA
, clin
ical
sign
s of a
ctiv
e ar
thrit
is o
f th
e w
rist d
ue to
RA
, pai
nful
wris
ts (a
s as
sess
ed b
y th
e V
AS)
, sta
ble
DM
AR
D w
ithin
the
prec
edin
g th
ree
wee
ks p
rior t
o ba
selin
e m
easu
rem
ent
with
no
expe
cted
cha
nges
for t
he n
ext
four
wee
ks, s
tabl
e sy
mpt
omat
ic
ther
apy
(NSA
IDs o
r cor
ticos
tero
ids)
, ag
e ≥1
8 ye
ars
Excl
usio
n cr
iteria
: inj
ectio
n of
co
rtico
ster
oid
in w
rist o
r han
d w
ithin
pr
eced
ing
mon
th, s
ever
e de
form
ities
of
the
wris
t and
/or f
inge
rs a
ffect
ing
hand
func
tion
or re
quiri
ng a
n al
tern
ativ
e sp
lint,
had
a h
isto
ry o
f w
rist s
urge
ry, h
ad a
dia
gnos
is o
f CTS
or
neu
rolo
gica
l dis
orde
rs a
ffect
ing
hand
func
tion,
use
d a
wris
t spl
int f
or
two
wee
ks p
rior t
o th
e stu
dy.
Sex:
gr
oup
1, 7
1% fe
mal
es
g
roup
2, 6
9% fe
mal
e
A
ge: g
roup
1(m
ean
age
60.3
yea
rs);
gr
oup
2 (m
ean
age
55.
1 ye
ars)
D
urat
ion
of sy
mpt
oms:
not
repo
rted
Splin
ting
grou
p (n
=17)
C
ontro
l gro
up (n
=16)
U
sual
car
e fo
r fou
r w
eeks
by
the
occu
patio
nal t
hera
pist
Ty
pes o
f spl
int:
com
mer
cial
ly
avai
labl
e w
rist s
plin
t (1
0-20
° wris
t ex
tens
ion)
. The
pat
ient
co
uld
choo
se th
e R
oyla
n D
-ring
, the
G
M00
5H, G
M00
8 or
G
M00
9.
W
earin
g re
gim
e:
durin
g th
e da
y, a
s m
uch
as p
ossib
le,
espe
cial
ly d
urin
g ac
tiviti
es fo
r 4/5
2 Pa
tient
s wer
e al
so
give
n ed
ucat
iona
l and
be
havi
oral
stra
tegi
es to
in
crea
se sp
lint u
se.
leng
th o
f fol
low
-up:
m
easu
rem
ents
wer
e pe
rform
ed a
t ba
selin
e an
d fo
ur
wee
ks a
fter t
he st
art
of tr
eatm
ent
Prim
ary
outc
ome:
W
rist p
ain
(100
mm
-pa
in V
AS)
Se
cond
ary
outc
ome:
G
rip st
reng
th
(Mar
tin
Vig
orim
eter
, dy
nam
omet
er w
ith
an a
ir-fil
led
rubb
er
ballo
on.
Func
tiona
l abi
lity:
D
ASH
, sho
rt ve
rsio
n of
the
SOD
A
Wor
king
wris
t spl
ints
sign
ifica
ntly
redu
ce
wris
t pai
n in
pat
ient
s w
ith R
A w
ho h
ave
wris
t arth
ritis
.
Sm
all s
ampl
e si
ze,
did
not m
eet t
he
inte
nded
pow
er
calc
ulat
ion
P
oten
tial e
xpec
tatio
n bi
as
Sub
ject
s and
as
sess
ors n
ot b
linde
d
Gro
up a
lloca
tion
was
co
ncea
led
via
a pa
tient
sele
ctio
n of
se
aled
env
elop
es
Goo
d de
scrip
tion
of
the
treat
men
t and
sp
lintin
g re
gim
es
1b
40/4
8
Con
tinue
d N
ote.
LO
E= L
evel
of E
vide
nce,
QS=
Qua
lity
Scor
e (S
EQES
), N
SAID
=Non
ster
oida
l ant
i-inf
lam
mat
ory
drug
s, D
MA
RD
s= D
isea
se -m
odify
ing
Ant
i-Rhe
umat
ic D
rug
s, D
ASH
=Dis
abili
ties o
f the
Arm
, Sh
ould
er, a
nd H
and
ques
tionn
aire
, VA
S: V
isua
l Ana
logu
e Sc
ale,
SO
DA
= S
eque
ntia
l Occ
upat
iona
l Im
pact
Dex
terit
y A
sses
smen
t, C
TS=C
arpa
l Tun
nel S
yndr
ome.
51
52
Finger Splints
Splinting for swan neck deformity
Four studies were included that evaluated the clinical effectiveness of splinting
for swan neck deformities (SND) in adults with RA. One 1b study (Van der Giesen et
al., 2009), two 2b studies (Spika, Macleod, Adams, & Metcalf, 2009; Ter Schegget &
Knipping, 2000) and one level 4 study (Zijlstra et al., 2004) involving a total of 93
participants. The quality of scores of these four studies ranged from 16 to 39. The
main features and findings are summarised in Table 9, pages 56-57.
Van der Giesen et al. (2009) compared the effectiveness of silver ring splints
and prefabricated thermoplastic finger splints (Oval-8 splint) for the treatment of
swan neck deformity. Patients with RA and a mobile swan-neck condition of the
index and/or middle finger were recruited (n =50). According to a randomized cross-
over design patients wore both the silver ring splints and the prefabricated
thermoplastic splints for 4 weeks, with a wash out period of 2 weeks in between.
Afterward, patients used the preferred splint for another 12 weeks. Outcome
assessments included the Sequential Occupational Dexterity Assessment (SODA),
hyperextension of the proximal interphalangeal (PIP) joint (goniometer), grip strength
(Jamar dynamometer), pinch strength (North Coast pinch gauge) and general hand
function measured by the Dutch Arthritis Impact Measurement Scales 2 (D-AIMS2)
and the Michigan Hand Outcomes Questionnaire (MHQ).
With both splints, a significant increase in hand function was seen according to
the SODA total and pain scores (p = <0.5). Moreover, hyperextension of the PIP joint
decreased significantly with the silver ring splints. There were no significant
differences between the change scores of the two splints for any other clinical
outcome measure. At the end of the study 24 patients preferred the silver ring splints,
21 preferred the prefabricated thermoplastic finger splints and 2 patients did not want
to use any of the splints. In the follow-up period, with the patients wearing the splint
of choice, 2 aesthetics-related items of satisfaction were valued higher in the silver
ring splint than in the prefabricated thermoplastic splint: however, the absolute
difference was small, so its clinical significance is questionable. Van der Giesen et al.
(2009) concluded that there were no significant differences in clinical effectiveness
between silver ring splints and prefabricated thermoplastic finger splints in patients
with RA and a mobile swan neck deformity.
53
Despite scoring highly on the SEQES (40/48), Van der Giesen et al. (2009)
study had a number of limitations. The study used a cross over design, where despite
statistical testing, carryover or period effects cannot be completely ruled out. Due to
the nature of the intervention, the assessors and patients were not blinded to the
treatment allocation. Thus, the findings may have been influenced by the expectation
of a treatment effect relating to finger splinting. In addition, the outcome assessors and
authors appear to be the same people. This was another potential source of bias since
the author hoping for a good outcome may be more likely to overestimate the
treatment effects.
Ter Schegget and Knipping (2000) performed a randomized crossover trial to
compare the effectiveness of custom made thermoplastic splints versus silver ring
splints for swan neck deformity. The splints were compared on the variables of
cosmesis, comfort, functional use and wearing time per 24 hours. In this study, 18
subjects were randomly assigned to two groups. Group 1 participants were given
custom thermoplastic splints for all involved digits, while those in Group 2 were also
provided with silver ring splints for all involved digits. Both groups wore the splints
for 6 months continuously. With respect to the comparison of the effectiveness of
prefabricated thermoplastic finger splints with silver ring splints, the results from Van
der Giesen et al. (2009) study parallel those by Ter Schegget and Knipping (2000),
where custom thermoplastic splints were found to be equally effective as silver ring
splints (p = 0.05) in improving dexterity and reducing dexterity related pain
(p = 0.05). Although, in Ter Schegget and Knipping (2000) study, custom
thermoplastic splints were found to be far less acceptable than silver ring splints,
primarily due to their less attractive appearance and their bulk, which made the
fingers spread. Furthermore, custom thermoplastic splints start to lose their form in
hot water and cannot be worn during activities such as showering or dish washing
(Ter Schegget & Knipping, 2000).
Ter Scheggart and Knipping (2000) demonstrated a significant improvement
(p = 0.01) in digital stability and distal interphalangeal (DIP) joint extension when the
anti-swan neck splint is worn. Ter Scheggart and Knipping (2000) suggest that the
positive changes of the DIP joint in the splint may possibly be explained by the
dynamics of the finger within the three-point splint. This finding is supported by
Zijlstra et al. (2002) showing that when the proximal interphalangeal (PIP) joint is
54
correctible to zero degrees, positioning the PIP joint in 10 degrees flexion can prevent
tightening of the intrinsic muscles and prevent stretching of the PIP joint volar plate,
joint capsule and flexor digitorum superficialis (FDS) tendon. Zijlstra et al. (2004)
also reported a significant improvement in dexterity (p = 0.026) with a silver ring
splint. This result was similar to those found by Van der Giesen et al. (2009), except
the SODA results were larger. In addition, the SODA-pain score improved (p = 0.05),
whereas in the study by Zijlstra et al. (2004) no improvement was seen.
Although the results of Zijlstra et al. (2004) study appear promising, the study
was considered to be of low quality, scoring only 16/48 on the SEQES. The greater
improvement in dexterity may be explained by the fact that Zijlstra and associates
included patients with longstanding disease (average 21 years) and worse hand
function, which is revealed by lower baseline SODA scores (median 71). As
suggested by Zijlstra et al. (2004) it could be hypothesized that finger splints for swan
neck deformity are more effective in earlier stages of the disease, when correction is
relatively easy. To date, there are no known studies available with respect to clinical
significance of the observed changes of the SODA score.
A recent observational pilot study by Spicka et al. (2009) investigated the
immediate impact of silver ring splints on dexterity and grip strength. Outcome
measures included the Nine Hole Peg Test and the Medical Informatics Engineering
(MIE) digital handgrip analyzer. Eight participants, who routinely wore individually
customized silver ring splints were divided into two groups of four people, and were
tested with and without the splints in situ. Although no statistically significant
differences were found in bilateral dexterity and handgrip strength (p > 0.05), there
was a trend for dexterity and grip strength to improve when the finger splints were
worn. The results of this study concur with findings reported in Zijlstra et al. (2004)
and Ter Schegget and Knipping (2000) who also showed no statistically significant
difference when individuals were measured with and without splints for grip strength.
Spicka et al. (2009) concluded that further research is indicated to evaluate the effect
of silver ring splints on hand function especially the long-term effect on finger
deformities.
The Spicka et al. (2009) study scored 20/48 on the SEQES, suggesting
moderate methodological quality. However, with such small sample size no
generalization about the study results can be made to the wider RA population. The
55
poor response rate is another limitation of this study. More participants might have
been recruited if non-respondents had been followed up. Finally, it should be
acknowledged that the three studies mentioned above (Ter Schegget & Knipping,
2000; Van der Giesen et al., 2009; Zijlstra et al., 2004) and the study by Spicka et al.
(2009) did not employ power calculations required to ensure an adequate sample size
to detect true clinical differences if these exist. Thus, a Type II error cannot be totally
ruled out.
56
Tab
le 9
Su
mm
ary
of E
vide
nce
for F
inge
r Spl
ints
use
d in
the
Trea
tmen
t of S
wan
Nec
k D
efor
mity
Stud
y M
etho
ds
Parti
cipa
nts
Inte
rven
tion
Out
com
es
Con
clus
ions
C
omm
ents
LOE
& Q
S T
er
Sche
gget
&
K
nipp
ing
(200
0)
Ran
dom
izat
ion:
Yes
, bu
t pro
cess
not
re
porte
d A
sses
sor b
lindi
ng:
yes
Inte
ntio
n to
trea
t: ye
s Lo
st to
follo
w u
p: 0
M
ulti-
cent
er
cros
sove
r des
ign
Pr
ospe
ctiv
e st
udy
Uni
vers
ity H
ospi
tal,
Gro
ning
en, T
he
Net
herla
nds
n=18
In
clus
ion
crite
ria:
diag
nosi
s RA
, SN
D 1
or
mor
e di
gits
Ex
clus
ion
crite
ria:
Prio
r sur
gica
l int
erve
ntio
n fo
r SN
D. N
o So
uter
cla
ss 4
de
form
ity’s
(FFD
PIP
J)
Sex:
2 m
ale,
16
fem
ale
Age
: 39
year
s D
urat
ion
of sy
mpt
oms:
not
st
ated
9pts
: Pre
fabr
icat
ed
splin
ts (S
RS)
wor
n ea
ch d
ay fo
r 3
mon
ths v
ersu
s 9
pts.:
cus
tom
-mad
e sp
lints
wor
n fo
r 3
mon
ths e
ach
day
Splin
ts c
ompa
red
varia
bles
of
cosm
esis
, com
fort,
fu
nctio
nal u
se a
nd
wea
ring
time
per 2
4 ho
ur
leng
th o
f fol
low
-up:
3/1
2,
6/12
Su
bjec
tive:
Pai
n, c
omfo
rt of
sp
lint,
cosm
esis
, sat
isfa
ctio
n w
ith sp
lint a
nd h
and
func
tion
whi
le w
earin
g sp
lint (
VA
S)
splin
ting
adhe
renc
e: se
lf-re
porte
d w
earin
g tim
e in
ho
urs o
ver e
very
four
hou
r pe
riod
Grip
stre
ngth
: “m
y gr
ippe
r st
reng
th m
easu
rem
ent t
ool”
pi
nch
stren
gth
usin
g Pr
esto
n pi
nch
met
er
Ran
ge o
f mot
ion:
gon
iom
etry
Cus
tom
mad
e sp
lints
are
co
mpa
rabl
e to
SR
S sp
lints
whe
n co
nsid
erin
g th
e m
echa
nics
and
ef
fect
iven
ess.
Com
fort
and
cosm
esis
ra
ted
high
er fo
r the
SR
S sp
lint
Bot
h sp
lint d
esig
ns
impr
ove
stab
ility
and
m
obili
ty to
the
DIP
join
t B
oth
splin
ts d
id n
ot
impe
de to
tal g
rip
stre
ngth
Ran
dom
izat
ion
used
A
sses
sor b
linde
d M
oder
ate
relia
bilit
y &
va
lidity
of o
utco
mes
to
ols
Sm
all s
ampl
e si
ze
No
was
hout
per
iod
2b
29/4
8
Van
der
G
iese
n et
al
. (20
09)
Ran
dom
izat
ion:
yes
, w
ith ra
ndom
dig
it ge
nera
tor
Ass
esso
r blin
ding
: No
In
tent
ion
to tr
eat:
not
repo
rted
Lost
to fo
llow
up:
3
Mul
ti-ce
nter
cr
osso
ver d
esig
n, 2
w
eek
was
hout
per
iod
Pr
ospe
ctiv
e st
udy
3 ou
tpat
ient
rheu
mat
olog
y cl
inic
s in
the
Net
herla
nds
n =
50
Incl
usio
n cr
iteria
: di
agno
sis o
f RA
, SN
D o
n on
e or
mor
e di
gits
, m
anua
lly c
orre
ctab
le to
≥4
5° P
IPJ f
lexi
on, s
tabl
e di
seas
e ac
tivity
Ex
clus
ion
crite
ria: m
edic
al
cond
ition
s oth
er th
an R
A,
seve
re fi
nger
def
orm
ity,
use
of fi
nger
splin
ts
Sex:
41
fem
ale,
9 m
ale
Age
: 53.
8 yr
s D
urat
ion
of sy
mpt
oms:
21
.6 y
ears
SRS>
PTS,
n=
26
PTS>
SRS,
n=2
4 In
2 d
iffer
ent
sequ
ence
s (SR
S-PT
S or
PTS
-SR
S),
subj
ects
used
bot
h sp
lints
for 4
wee
ks,
with
was
hout
per
iod
of 2
wee
ks.
Afte
rwar
ds p
atie
nts
used
pre
ferr
ed sp
lint
for f
urth
er 1
2 w
eeks
. Pt
s. as
ked
to w
ear
splin
ts a
s muc
h as
po
ssib
le, r
emov
e on
ly fo
r cle
anin
g
leng
th o
f fol
low
-up:
4/5
2,
6/52
, 10/
52 &
furth
er 1
2/52
Pr
imar
y ou
tcom
e:
Dex
terit
y: u
sing
SO
DA
Se
cond
ary
outc
ome:
H
and
func
tion
(D-A
IMS2
) &
the
(MH
Q)
patie
nt sa
tisfa
ctio
n an
d pr
efer
ence
(13-
item
qu
estio
nnai
re)
Splin
ting
adhe
renc
e: se
lf -re
porte
d in
dia
ry th
e nu
mbe
r of
hou
rs p
er d
ay
SRS
and
PTS
are
equa
lly
effe
ctiv
e an
d ac
cept
able
. B
oth
splin
ts im
prov
e de
xter
ity a
s mea
sure
d by
th
e S
OD
A a
nd d
ecre
ase
de
xter
ity re
late
d pa
in
Nei
ther
splin
t si
gnifi
cant
ly im
prov
ed o
r in
terfe
red
with
han
d fu
nctio
n, g
rip o
r pin
ch
stre
ngth
Ran
dom
izat
ion
used
G
ood
desc
riptio
n of
tre
atm
ent
Goo
d in
tern
al v
alid
ity
Sam
ple
size
cal
cula
ted
No
valid
ated
qu
estio
nnai
re to
m
easu
re R
A p
atie
nts
satis
fact
ion
with
han
d or
fing
er sp
lints
– th
e on
e us
ed w
as
prev
ious
ly d
evel
oped
by
one
of t
he a
utho
rs
Wea
ring
the
splin
ts a
s m
uch
as p
ossib
le
varie
s in
inte
nsity
and
fre
quen
cy o
f pat
ient
s
1b
39/
48
Not
e. LO
E= L
evel
of E
vide
nce,
QS=
Qua
lity
scor
e (S
EQES
); SN
D=
Swan
Nec
k D
defo
rmity
; SR
S= S
ilver
Rin
g Sp
lint;
PTS=
Pre
fabr
icat
ed th
erm
opla
stic
splin
t; V
AS
= V
isual
Ana
logu
e Sc
ale;
SO
DA
=S
eque
ntia
l Occ
upat
iona
l Dex
terit
y A
sses
smen
t; D
-AIM
S2 =
Dut
ch A
rthrit
is Im
pact
Mea
sure
men
t Sca
les 2
; PIP
J=Pr
oxim
al In
terp
hala
ngea
l Joi
nt; F
FD=F
ixed
Fle
xion
Def
orm
ity; M
HQ
=Mic
higa
n H
and
Out
com
es Q
uest
ionn
aire
.
56
57
Tab
le 9
Su
mm
ary
of E
vide
nce
for F
inge
r Spl
ints
use
d in
the
Trea
tmen
t of S
wan
Nec
k D
efor
mity
Stud
y M
etho
ds
Parti
cipa
nts
Inte
rven
tion
Out
com
es
Con
clus
ions
C
omm
ents
LOE
& Q
S Z
ijlst
ra,
Hei
jnsd
ijk-
Rou
wen
hors
t, R
aske
r (2
004)
Ran
dom
izat
ion:
No
Ass
esso
r blin
ding
: N
o In
tent
ion
to tr
eat:
not
repo
rted
Lost
to fo
llow
-up:
2
Pilo
t obs
erva
tiona
l si
ngle
cas
e se
ries
desi
gn
Pros
pect
ive
trial
Med
isch
Spec
trum
Tw
ente
H
ospi
tal,
Ensc
hede
, The
N
ethe
rland
s N
=17
Incl
usio
n cr
iteria
: dia
gnos
is of
R
A, s
tabl
e di
seas
e, fi
nger
de
form
ities
app
ropr
iate
for S
RSs
Ex
clus
ion
crite
ria:
Not
stat
ed
Sex:
14
fem
ale,
3 m
en
Age
: 65
year
s med
ian
age
(3
7-74
) D
urat
ion
of sy
mpt
oms:
ave
rage
21
yea
rs
72 S
RSs
O
bser
ved
over
tim
e an
d ev
alua
ted
on
outc
omes
of
inte
rest
leng
th o
f fol
low
-up:
1/
12,3
/12
and
1 ye
ar
Prim
ary
outc
ome:
D
exte
rity
(SO
DA
) Se
cond
ary
outc
omes
: G
rip st
reng
th (h
and-
size
d pr
essu
re b
allo
on)
Pinc
h st
reng
th (p
inch
ga
uge
PG-6
0, B
NL
Engi
neer
ing)
H
and
func
tion:
(D-
AIM
S2)
SRSs
can
sign
ifica
ntly
im
prov
e de
xter
ity e
ven
in p
atie
nts w
ith
long
stan
ding
RA
de
form
ities
. R
elat
ivel
y in
expe
nsiv
e op
tion
vers
us su
rger
y.
Sim
ple,
non
inva
sive
de
sign
N
o po
wer
cal
cula
tions
fo
r sam
ple
size
R
elia
bilit
y an
d va
lidity
of
out
com
es n
ot
avai
labl
e N
o co
ntro
l gro
up
incl
uded
, ind
ivid
ual
serv
es a
s the
ir ow
n co
ntro
l T
hera
pist
s cho
ose
the
finge
r def
orm
ities
to
splin
t
4 16
/48
Spik
a,
Mac
leod
, A
dam
s, &
M
etca
lf (2
009)
Ran
dom
izat
ion:
yes
A
sses
sor b
lindi
ng:
no
Inte
ntio
n to
trea
t: no
t sta
ted
Lost
to fo
llow
-up:
0
Pilo
t obs
erva
tiona
l
trial
Uni
vers
ity o
f Sou
tham
pton
, UK
N
= 8
In
clus
ion
crite
ria: R
A, O
T re
ferra
l by
rheu
mat
olog
y co
nsul
tant
, pt
. ass
esse
d fo
r or
purc
hase
d a
SRS
Excl
usio
n cr
iteria
: dee
med
from
a
vuln
erab
le g
roup
, una
ble
to
unde
rsta
nd E
nglis
h Se
x: 7
fem
ale,
1 m
ale
Age
: 63
year
s (av
erag
e)
Dur
atio
n of
sym
ptom
s: n
ot
repo
rted
Sam
ple
was
di
vide
d in
to 2
gr
oups
. One
gr
oup
was
as
sess
ed
wea
ring
the
splin
ts fi
rst.
The
othe
r gro
up w
as
asse
ssed
w
ithou
t the
sp
lints
in p
lace
.
leng
th o
f fol
low
-up:
N
one
Dex
terit
y: T
he N
ine
Hol
e Pe
g Te
st,
Grip
stre
ngth
: MIE
di
gita
l grip
ana
lyze
r
Furth
er st
udie
s are
re
quire
d to
eva
luat
e th
e fu
ll ef
fect
of S
RS
on h
and
func
tion
espe
cial
ly it
s lon
g-te
rm e
ffect
on
defo
rmiti
es.
Ran
dom
izat
ion
used
S
tand
ardi
zed
tool
s use
d A
sses
sor a
nd p
atie
nts
not
blin
ded
Sm
all s
ampl
e si
ze
Eva
luat
ion
take
s pla
ce a
t sa
me
time
Diff
icul
t to
draw
cau
se-
effe
ct c
oncl
usio
ns fr
om
the
resu
lts b
eyon
d th
e gr
oup
bein
g stu
died
S
ubje
cts v
olun
teer
ed
2b
20/4
8
Con
tinue
d N
ote.
LO
E= L
evel
of E
vide
nce;
QS=
Qua
lity
scor
e (S
EQES
); SR
S= S
ilver
Rin
g Sp
lint,
SOD
A =
Seq
uent
ial O
ccup
atio
nal I
mpa
ct D
exte
rity
Ass
essm
ent;
D-A
IMS2
= D
utch
Arth
ritis
Impa
ct
Mea
sure
men
t Sca
le 2
.
57
58
Splinting for boutonniere deformity
Only one 2b study was found, by Li-Tsang, Hung, and Mak (2002) which
compared the effect of corrective splinting on flexion contracture of rheumatoid
fingers. The SEQES score of this prospective study was 25/48, indicating moderate
methodological quality. The main features and findings of the study are shown in
Table 10, page 59.
In this small (n=24) matched-pair experimental study, a baseline comparison
was completed at the initial assessment and at 6 weeks when all patients received their
regular medication. Dosage and types of medication remained the same throughout
the 12-week period of the study. After the baseline period of 6 weeks, the participants
were randomly divided into two groups, and each followed a different splinting
protocol. Twelve patients were treated with dynamic finger extension (Capener)
splints for 6 weeks, while another 12 patients were treated with static finger extension
(belly gutter) splints. The outcome measures included grip strength, joint range of
motion and the Jebsen Hand Function Test (JHFT). The results showed significant
improvement in both groups, not only in the correction of the finger flexion
contracture at the proximal interphalangeal (PIP) joint (p < 0.0005) but also in grip
strength (p = 0.001) and hand function (p < 0.0005). Patients with dynamic finger
extension splints did not differ from those with static splints in extension gains
(p =0.631), but they did have better flexion than patients with static splints.
This result may be explained by the fact that the Capener splint encourages
both active flexion and extension while worn during the splinting program, whereas
the static thermoplastic splint was unable to perform both functions. The major
consideration in prescribing dynamic splints for patients with RA is fear that the
stretching force might create further damage to the joints and therefore cause
discomfort and pain (Hittle, Pedretti, & Kasch, 1996). The dynamic finger splint used
in this study was not associated with negative or adverse effects as noted in other
reports (Palchik, et al., 1990; Rennie, 1996). Participants did not complain of pain,
tiredness, or over stretching after wearing the dynamic Capener splint. Therefore, the
author concluded that both types of splints can be recommended for flexion
contracture of rheumatoid fingers, depending on patients' preferences and comfort.
59
Tab
le 1
0 Su
mm
ary
of E
vide
nce
of F
inge
r Spl
intin
g us
ed in
the
Trea
tmen
t for
Bou
tonn
iere
Def
orm
ity
St
udy
Met
hods
Pa
rtici
pant
s In
terv
entio
n O
utco
mes
C
oncl
usio
ns
Com
men
ts LO
E &
QS
Li-T
sang
, H
ung,
&
Mak
(2
002)
Ran
dom
izat
ion:
ye
s A
sses
sor
blin
ding
: yes
In
tent
ion
to tr
eat:
not r
epor
ted
Lost
to fo
llow
-up
: 6
Pros
pect
ive
stud
y
3 O
utpa
tient
R
heum
atol
ogy
clin
ics,
Hon
g K
ong
n=30
G
roup
1 (n
=12)
G
roup
2 (n
=12
Incl
usio
n cr
iteria
: 15-
65 y
ears
of a
ge,
diag
nosi
s of R
A w
ith
finge
r fle
xion
co
ntra
ctur
e ≤4
5°
Excl
usio
n cr
iteria
: FF
C ,
artic
ular
da
mag
e on
the
PIP
join
t, PI
PJ’s
with
di
ffere
nce
in P
RO
M
≤10°
Se
x: 2
mal
e, 2
2 fe
mal
e M
ean
Age
: 35.
71
year
s D
urat
ion
of
sym
ptom
s: 6
yea
rs
Reg
ular
med
icat
ion
and
ther
apy
serv
ices
, exc
ept
splin
ting,
on
both
han
ds.
Gro
up 1
: dyn
amic
cap
ner
splin
t. D
urat
ion
of sp
lint
depe
nded
on
the
patie
nt’s
to
lera
nce,
min
imum
6
hour
s per
day
. Als
o in
struc
ted
to e
xerc
ise
the
join
t dur
ing
perio
d w
earin
g th
e sp
lint
Gro
up 2
: cus
tom
-mad
e st
atic
fing
er e
xten
sion
sp
lint.
Wor
n at
rest
, m
inim
um 6
hou
rs p
er
day.
Exe
rcis
e an
d m
obili
ze th
e PI
P jo
int
durin
g th
e da
y w
hile
sp
lint w
as re
mov
ed.
leng
th o
f fol
low
-up:
ba
selin
e co
mpa
rison
an
d ag
ain
at 6
/52
Grip
stre
ngth
: (Ja
mar
dy
nam
omet
er)
Han
d Fu
nctio
n A
sses
smen
t: Je
bsen
H
and
Func
tion
Test
(J
HFT
) R
ange
of m
otio
n:
goni
omet
ry
Bot
h ty
pes o
f spl
ints
can
be
reco
mm
ende
d fo
r co
rrect
ing
flexi
on
cont
ract
ure
of th
e jo
int
and
impr
ovin
g gr
ip
stre
ngth
and
han
d fu
nctio
n.
Sm
all s
ampl
e si
ze
Ran
dom
izat
ion
used
A
sses
sor b
linde
d S
ubje
cts u
nabl
e to
be
blin
ded
Rel
iabl
e &
val
id
outc
omes
tool
s P
oor m
onito
ring
of a
ctua
l sp
lint t
ime
No
pow
er c
alcu
latio
ns fo
r sa
mpl
e si
ze
2b
25/4
8
Not
e. L
OE=
Lev
el o
f Evi
denc
e; Q
S= Q
ualit
y sc
ore
(SEQ
ES);
JHFT
=Jeb
sen
Han
d Fu
nctio
n Te
st; P
IPJ=
Prox
imal
Inte
rpha
lang
eal J
oint
; PR
OM
=Pas
sive
Ran
ge o
f Mot
ion.
59
60
Metacarpal Ulnar Deviation Splints
Two studies were included that investigated the effect of functional metacarpal
ulnar deviation (MUD) splints in adults with hand RA. One 2b study (Rennie, 1996)
and one 3b study (Formsa & Dijkstra, 2008) using a total of 43 patients. The quality
scores of these two studies ranged from 22 to 26, indicating moderate methodological
quality. The main features and findings are shown in Table 11, page 63.
Rennie (1996) conducted a small (n=26) repeated measures study on the
effectiveness of MUD splints on hand function, grip strength, pain and
metacarpophalangeal (MCP) joint alignment. The results at the end of the 6 month
trial demonstrated that the splints were highly accepted (95.8%) and were rated well
on scales of acceptability and satisfaction recorded by a study specific questionnaire.
The author reported that wearing the splint significantly reduced ulnar drift in the
middle (p = 0.0002), ring (p < 0.0001) and little (p < 0.0001) fingers, as assessed by
radiography and goniometry. They also significantly improved three-point pinch
strength as measured by a calibrated B and L Engineering Pinch Gauge. However,
there was no significant improvement in scores on the Sollerman Test of Hand
Function, reduced visual analogue pain levels or gross power grip strength measured
by the Jamar dynamometer. There was no evidence to suggest that metacarpal ulnar
deviation splints had any long-term effect on correcting MCP joint alignment or
delayed the progression of ulnar deviation. When the splints were removed the fingers
returned to their original deviated position.
A descriptive pilot study by Formsma and Dijkstra (2008) evaluated the
effectiveness of an innovative MCP-blocking splint (Figure 25 and Figure 26)
combined with hand exercises in 23 patients with RA. The MCP-blocking splint was
designed to inhibit the activity of the intrinsic muscles and to facilitate the activity of
the extrinsic muscles. The splint allows undisturbed movement of the wrist and
interphalangeal (IP) joints. Since the tendency of the MCP joints is to sublux volarly
in RA (Bielefeld & Neumann, 2005), these joints are held close to full extension to
provide volar support. To stabilize the MCP joints in this position, a strap with foam
was used on the dorsal side on the hand. Because of the multidimensional impact of
RA, the outcome measures included grip and pinch strength, joint range of motion,
dexterity and hand function.
61
The results included a significant improvement in both dexterity (p = 0.046)
and pain (p = 0.043), measured by the SODA. Patients also reported improvements in
handwriting, playing the guitar, tying shoe laces and closing buttons, but no
significant changes were found on grip and pinch strength, ROM or perception of
disability. Reasons for lack of significant changes may be due to the small sample size
and variation in age and duration of RA. Formsma and Dijkstra (2008) concluded that
this new splint design combined with hand exercise improves the dexterity of RA
patients with an intrinsic-plus posture and movement pattern in one or more hands.
While the results of these two studies were promising, a number of
methodological flaws were identified in the study designs; namely the lack of control
group and the fact that a number of treatments were used simultaneously. The lack of
a control group means there was no baseline against which the effects of the
intervention could be measured. Without this baseline for comparison there is a
possibility that the improvements reported may have been simply due to chance, or to
placebo effect (Polit et al., 2001).
The use of two or more treatments may have also had an effect on the reported
outcomes. Both studies did not control for simultaneous treatments such as disease
modifying anti-rheumatic drugs. Only by measuring the effect of one variable at a
time can cause and effect be proven (Polit et al., 2001). Therefore, it is difficult to
conclude that the treatment alone resulted in any differences as other factors may
change over time, for example the disease severity may change.
62
Figure 25 Design of the blocking splint proposed by Formsa and Dijkstra (2008). This photograph is taken from my personal file. Permission granted for its use.
Figure 26 Dorsal view of MCP-block splint. This photograph is taken from my personal file. Permission granted for its use.
63
Tab
le 1
1 Ev
iden
ce fo
r Met
acar
pal U
lnar
Dev
iatio
n Sp
lints
Not
e. L
OE=
Leve
l Of E
vide
nce;
QS=
Qua
lity
Scal
e (S
EQES
); M
CPJ
=m
etac
arpo
phal
ange
al jo
int;
EDC
= Ex
tens
or D
igito
rum
Pro
fund
us; M
CPJ
=Met
acar
palp
hala
ngea
l Joi
nt; P
IPJ=
Pro
xim
al
inte
rpha
lang
eal J
oint
.
Stud
y M
etho
ds
Parti
cipa
nts
Inte
rven
tion
Out
com
es
Con
clus
ions
C
omm
ents
LOE
& Q
S R
enni
e (1
996)
St
udy
desi
gn: R
epea
ted
mea
sure
s, on
e gr
oup
over
tim
e
Ran
dom
izat
ion:
unc
lear
A
sses
sor b
lindi
ng:
No
Inte
ntio
n to
trea
t: no
t re
porte
d
Lost
to fo
llow
-up:
0
Out
patie
nts
N=
26 (r
ecru
itmen
t of p
atie
nts
not d
escr
ibed
) In
clus
ion
crite
ria: d
iagn
osis
of
RA
Ex
clus
ion
crite
ria: n
ot re
porte
d
Sex:
15
fem
ales
; 11
mal
es
Age
: 36-
84 y
ears
(m
ean
= 64
yea
rs)
Dur
atio
n of
sym
ptom
s: n
ot
prov
ided
Uln
ar D
evia
tion
finge
r spl
int
who
le d
ay fo
r 3
mon
ths
Wea
ring
regi
me
of sp
lints
not
de
scrib
ed
Leng
th o
f fol
low
-up:
4/
52, 8
/52,
12/
52
Han
d fu
nctio
n (s
olle
rman
test
of
hand
func
tion)
G
rip st
reng
th (j
amar
dy
nom
eter
) Pi
nch
stre
ngth
(p
inch
gau
ge)
Pain
(VA
S)
Patie
nt sa
tisfa
ctio
n (L
iker
t sca
le)
Uln
ar d
rift a
ngle
im
prov
ed.
No
sign
ifica
nt
impr
ovem
ent i
n ha
nd fu
nctio
n, p
ain,
gr
ip st
reng
th a
nd
late
ral p
inch
.
N
o co
ntro
l gro
up
G
ood
valid
ated
and
re
liabl
e ou
tcom
e m
easu
res e
xcl.
the
patie
nt sa
tisfa
ctio
n qu
estio
nnai
re
N
o de
scrip
tion
of
the
frequ
ency
and
in
tens
ity o
f th
e sp
lintin
g in
terv
entio
n
2b
26
/48
Form
sa &
D
ijkst
ra
(200
8)
Stud
y de
sign
: D
escr
iptiv
e pi
lot s
tudy
w
ith p
re-te
st/p
ost-t
est
desi
gn
Con
veni
ence
sam
plin
g,
all i
ndiv
idua
ls m
eetin
g th
e in
clus
ion
crite
ria
ente
red
stud
y un
til th
e de
sire
d sa
mpl
e si
ze w
as
reac
hed.
R
ando
miz
atio
n: N
o A
sses
sor b
lindi
ng: N
o In
tent
ion
to tr
eat:
Not
re
porte
d Lo
st to
follo
w-u
p: 0
Out
patie
nts ,
Uni
vers
ity
Med
ical
Cen
tre, G
roni
ngen
, Th
e N
ethe
rland
s N
= 17
, 19
hand
s tre
ated
In
clus
ion
crite
ria: R
A, n
o re
d,
swol
len,
or p
ainf
ul M
P or
IP
join
ts, i
ntrin
sic p
lus p
ostu
re in
ha
nd(s
), ab
le to
spea
k an
d un
ders
tand
s Dut
ch la
ngua
ge
Excl
usio
n cr
iteria
: fix
ed
cont
ract
ures
of M
CP
or P
IP
join
ts, t
endo
n ru
ptur
es, E
DC
slipp
age,
or s
agitt
al b
and
atte
nuat
ion,
cog
nitiv
e or
ps
ycho
logi
cal p
robl
ems
Sex:
9 fe
mal
es; 8
mal
es
Age
: ran
ge 3
5-74
yea
rs
(mea
n =
56.5
year
s)
Dur
atio
n of
sym
ptom
s: m
ean
= 17
.6 y
ears
, age
rang
e 5-
34
year
s.
MC
PJ b
lock
ing
splin
t com
bine
d w
ith st
anda
rdiz
ed
exer
cise
pro
gram
Sp
lint d
esig
n:
Palm
-bas
ed, M
CP
join
ts h
eld
clos
e to
full
exte
nsio
n (1
0-25
° fle
xion
.
M
P-bl
ocki
ng sp
lint
com
bine
d w
ith
exer
cise
s, sh
ows
impr
ovem
ent o
f the
de
xter
ity o
f RA
pa
tient
s with
an
intri
nsic
-plu
s po
sture
. Fu
rther
rese
arch
is
need
ed to
supp
ort
thes
e fin
ding
s
N
o ra
ndom
izat
ion
R
elia
ble
and
valid
ou
tcom
e to
ols
La
ck o
f con
trol
Sm
all s
ampl
e si
ze
3b
22
/48
63
64
Thumb Splints
Only one study was included that examined the effectiveness of thumb splints
for boutonniere deformity in patients with RA (Silva, Lombardi, Breitschwerdt,
Araujo, & Nztour, 2008). The SEQES score for this study was 39/48, signifying high
methodological quality. The main features and findings of the study are shown in
Table 12, page 66.
In this study, 40 participants with RA and a boutonniere deformity on the
dominant hand were randomly assigned into two groups of 20. The treatment group
used the splint at home during activities of daily living, bringing it back to the clinic
for the evaluation sessions. While the control group only used the splint during the
evaluation. A new thermoplastic thumb splint was designed for this study that
provided immobilization while allowing functionality required for the thumb. The
splint provides stabilization of the 1st metacarpophalangeal (MCP) joint, with volar
support to the MCP joint and restricted hyperextension of the proximal
interphalangeal (PIP) joint, with support on the dorsum of the distal phalanx. This
position allows the tip of the thumb to be placed in the pinch position with the other
digits (Figure 27).
The outcome measures included dexterity (using the O’Connor Dexterity
Test), grip strength (Jamar dynamometer), pinch strength (Smith & Nephew pinch
gauge), pain (using a visual analogue scale with range 0-10 cm), and functional ability
using the Health Assessment Questionnaire (HAQ). The results indicated a
statistically significant reduction in pain over the control group (p=0.003). The thumb
splint did not negatively affect grip and pinch strength, function or dexterity in either
group. At the end of the trial, participants in the intervention group reported a 75
percent improvement in hand function associated with the use of the splint. The
authors concluded that the use of a thumb splint for either type I or II boutonniere
deformities is effective in relieving pain in adults with RA.
This study had a number of strengths including adequate handling of dropouts
to prevent bias in data analysis and the outcome measures were described well in
terms of validity and reliability. The investigator randomly allocated patients to the
experimental/control groups. This ensured that there was no selection bias and that the
two groups were as comparable as possible at baseline (Helfand, 2005). Allocation
was adequately concealed by sealed envelopes.
65
However, there are some points regarding quality that need to be highlighted. The
HAQ detected no significant differences during the trial. This outcome tool is a global
questionnaire relating to daily living tasks involving and not limited to the upper
limbs. Perhaps a more specific questionnaire to evaluate hand function would have
been appropriate (Ferraz, Olivereira, Araujo, Atra, & Tugwell, 1990). As to the
sample, only 4 males participated in this study. Although females are more vulnerable
to RA, it would be helpful in comparing gender differences in adherence to thumb
splints if more male subjects were recruited in future studies. Regarding the research
setting, the participants of this study were recruited only from one teaching hospital in
Brazil and limited to the patients in the outpatient clinic. Therefore, inferences drawn
from results may be of limited application.
Figure 27 Innovative functional splint designed by Silva et al. (2008) for boutonniere deformities of the thumb. This photograph was taken from my personal file. Permission granted for its use.
66
Tab
le 1
2 Su
mm
ary
of E
vide
nce
for T
hum
b Sp
lint
St
udy
Parti
cipa
nts
Met
hods
In
terv
entio
n O
utco
mes
C
oncl
usio
ns
Com
men
ts LO
E &
QS
Silv
a,
Lom
bard
i, B
reits
chw
erd
t, A
rauj
o &
N
ztou
r (2
008)
Out
patie
nts C
linic
s of t
he
Rhe
umat
olog
y D
ivis
ion
Uni
vers
ity F
eder
al d
e Sa
o Pa
ulo
Sao
Paul
o,
Bra
zil
n=40
G
roup
1 (n
=20)
G
roup
2 (n
=20)
In
clus
ion
crite
ria:
Type
I or
II b
outo
nnie
re
defo
rmity
of t
he d
omin
ant h
and,
m
ale
and
fem
ale
acce
pted
. Ex
clus
ion
crite
ria:
≤18
year
s, do
min
ant h
and
defo
rmity
’s th
at d
id n
ot a
llow
th
e tip
of t
he in
dex
finge
r to
touc
h th
e tip
of t
he th
umb,
VA
S sc
ores
low
er th
an 3
or g
reat
er
than
7 fo
r the
dom
inan
t han
d,
curre
nt u
se o
f a th
umb
splin
t, ha
nd su
rger
y pl
anne
d w
ithin
6
mon
ths,
alle
rgy
to o
rthos
is
mat
eria
l, m
enta
l disa
bilit
y,
geog
raph
ical
inac
cess
ibili
ty.
Sex:
4 m
ale,
36
fem
ale
Mea
n A
ge:
54.5
yea
rs in
the
inte
rven
tion
grou
p 57
.10
year
s in
the
cont
rol g
roup
D
urat
ion
of sy
mpt
oms:
9.3
5 ye
ars i
n th
e in
terv
entio
n gr
oup
and
13.6
5 in
the
cont
rol g
roup
.
Ran
dom
izat
ion:
yes
A
sses
sor b
lindi
ng:
yes
Inte
ntio
n to
trea
t: ye
s Lo
st to
follo
w-u
p: 2
• Th
e in
terv
entio
n gr
oup
used
the
thum
b sp
lint d
aily
•
The
cont
rol g
roup
us
ed th
e sp
lint
only
dur
ing
the
eval
uatio
n
Thum
b sp
lint d
esig
n M
CPJ
im
mob
iliza
tion,
PIP
J ex
tens
ion
rest
rictio
n sp
lint.
Mad
e fro
m
3.2m
m E
zefo
rm
ther
mop
last
ic
mat
eria
l.
leng
th o
f fol
low
-up:
b
asel
ine
eval
uatio
n,
45 d
ays a
nd 9
0 da
ys
Grip
stre
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: (Ja
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er)
Pinc
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Smith
& N
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Ass
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r Dex
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st
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us
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man
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Pain
in th
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CP
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t: V
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(0-1
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) Fu
nctio
nal A
bilit
y:
Hea
lth A
sses
smen
t Q
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(HA
Q)
The
use
of th
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splin
ts fo
r typ
e I a
nd
type
II b
outo
nnie
re
defo
rmiti
es w
as
effe
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e in
relie
ving
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g an
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que
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with
co
ncea
led
allo
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ols
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er
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ions
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ple
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mpl
eted
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8
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; MC
PJ=m
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phal
ange
al Jo
int;
PIPJ
= Pr
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terp
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nt.
66
67
Chapter Six:
Discussion
In the present review, 18 studies were qualitatively analyzed to investigate the
evidence for the effects of static hand and wrist splints in the non-surgical treatment
for people with rheumatoid arthritis (RA). The evidence was considered in regard to
five different static splint categories; static resting splints; wrist extension splints;
finger splints; metacarpal ulnar deviation splints and thumb splints.
Static Resting Splints
Studies investigating the effectiveness of hand and wrist splints in the
management of people with rheumatoid arthritis are undeniably complex. For
instance, static resting splints are recommended to reduce the pain and swelling by
resting the joint in an anatomically sound position and restricting joint motion. These
splints are recommended to be worn while resting/and or during the night. Given the
fluctuating course of the disease, it is difficult to know what the length of follow-up
should be when pain relief is only likely to be evident during times of active joint
inflammation. Without including an analysis of co-variance of the disease activity in
splinting trials, the potential benefits of splints will be inextricably linked with levels
of disease activity. Regrettably none of the studies to date have controlled or analyzed
disease activity at trial baseline and follow-up. This must be considered as being one
of the contributing factors for the differing outcomes in the literature reviewed.
Although static resting splints continue to be enthusiastically endorsed for
individuals with rheumatoid arthritis (Henderson & McMillan, 2002), this review
found little evidence to support or refute this intervention. In 2008, two studies
reported conflicting results on the effectiveness of static resting splints in rheumatoid
arthritis. Both papers scored highly on the Structured Effectiveness Quality Evaluation
scale (SEQES) (Adams et al., 2008; Silvia et al., 2008) suggesting good
methodological quality and strong internal validity. However, one study reports no
effect of splinting while the other concludes that splinting is effective on several
outcomes. The results of Adams et al. (2008) study concluded that static resting
splints used with individuals with early RA had no advantage over standard
occupational therapy. Also, the splints positioned the metacarpophalangeal (MCP)
68
joints in up to 60 degrees flexion which is not recommended in RA (Fess, 1987), as it
may contribute to intrinsic shortening.
In contrast, the findings from Silvia et al. (2008) study recommend the use of
night time positioning splints to reduce pain, increase grip strength and improve upper
limb function in persons with RA. The remaining study, demonstrated significant
reductions in overall pain levels when the splint was worn at night time for one
month, but like Silvia et al (2008) study, it did not report or control for disease
activity.
It is difficult to give credit to the results of one study over another. Adams et
al. (2008) studied 116 individuals over 12 months, and showed no additional benefits
in improving grip strength and pain between the splinting and the control group. In
comparison, Silvia et al. (2008) study showed significant reduction in hand pain over
3 months. Unfortunately, this latter study included a control group that had no
intervention at all and a small sample size (n=50). Although such regimes may not
reflect current practice of all occupational therapists, the study design offers insight
into the possible differences static resting splints may add over no treatment at all if
disease activity is constant.
Occupational therapists should also acknowledge that patients recently
diagnosed with rheumatoid arthritis are often bombarded with medical assessments,
interventions and referrals to other health professionals. A client centered approach
that allows patients to identify their own information and functional needs, may be the
most effective way. In addition, early-stage rheumatoid arthritis could be ‘too early’
for splinting intervention. Hammond (2004) advises that the success of occupational
therapy requires people to participate in positive changes to their health behaviors.
During the early stages of the disease patients may not be ready to change behavior
(e.g., wearing splints), and may not perceive the potential threats of the disease as
serious.
Currently, there is no evidence to suggest that wearing static resting splints at
night time help prevent deformity from occurring, or correct established deformity.
Arguably, if the factors that produce rheumatoid deformities are dynamically
produced when the hand is moving and working it is difficult to extrapolate how much
of any improvement may be attributable to correct positioning at rest. There is
insufficient evidence to suggest that hand pain may be improved wearing a static
resting splint in early RA, nor which design of splint may be most effective. No
69
evidence was found regarding the mechanism by which splinting may work: a number
of rationales have been proposed but none proven. This review adds further evidence
to the current body of knowledge, that the current evidence to support static resting
splints in early rheumatoid arthritis is lacking.
Wrist Extension Splints
People with rheumatoid arthritis are commonly prescribed and provided with
wrist extension splints. In contrast with static resting splints, wrist splints are designed
to enable the user to continue to function, while reducing pain and providing support
for the wrist (Adams et al., 1996; Cordery & Rocchi, 1998). The difficulty in studying
wrist and hand splints is further illustrated by static wrist extension splints. Typically,
patients are instructed to wear the splints during heavy tasks. However, it is
acknowledged that wrist splints may increase the time taken to complete dexterous
tasks, or the splints might become too unclean to be practical (Stern et al., 1996a).
Thus, both the wearing time and the amount and type of stress on the joints would
vary considerably among study participants, depending on the types of activities
which they ordinarily perform.
While efforts to standardize wearing times has been attempted in some studies
(Hasket et al., 2004; Kjeken et al., 1995; Veehoff et al., 2008), it is more challenging
to standardize the amount of stress participants put through the joints. To assume that
joint stress will balance out between the treatment and control groups may not be
realistic. If patients in the splinting group feel safer completing strenuous activities
without wearing the splint, they will then be exposed to more joint stress.
The findings from this review are largely in line with the results of previous
studies on the effects of wrist extension splints after a period of splinting. When
prefabricated wrist extension splints are first worn there is good evidence that they
have an immediate effect on perceived wrist pain and a statistically significant effect
on pain reduction with certain functional tasks (Hasket et al., 2004; Kjeken et al.,
1995; Nordenskiold, 1990; Pagnotta et al., 2005; Tijjhuis et al., 1998; Veehoff et al.,
2008). The 36 participants in Kjeken et al. (1995) study using wrist splints for 6
months sustained statistically significant improvements in wrist pain during certain
activity. However, the control group (n=33) without splints showed statistically
significant improvements in wrist range of motion that was not evident in the splinted
70
group. It has been suggested that prefabricated wrist splints can reduce wrist
movement when worn over a number of months, although, this theory is not proven.
In two small scale studies, commercial wrist extension splints have been
shown to improve power grip strength for individuals with moderate to severe
rheumatoid arthritis (Haskett et al., 2004; Nordenskiold, 1990), although, only Haskett
et al.s (2004) study reached statistical significance. In contrast, the remaining two
studies (Stern et al., 1996a; Veehoff et al., 2008) found transiently reduced grip
strength when first worn and no improvement in dominant grip strength after one
month. It has been established that the optimal wrist position for maximum grip
strength is thirty-five degrees extension in normal subjects (O’Driscoll, Horii, & Ness,
1992). The splints used in Stern et al. (1996a) and Veehoff et al. (2008) studies held
the wrist in 10-20 degrees of extension, which may explain the observed loss of grip
strength during use of the splint. Until now, the relationship between wrist position
and grip strength in adults with rheumatoid arthritis has not been exclusively
investigated.
Wrist extension splints have traditionally been prescribed for patients with
wrist involvement for symptom control and hand function. The findings of this review
suggest that the prescription of wrist extension splints is not a simple process. The
occupational therapist and patient need to work together to determine the daily
wearing schedule. The impact of a wrist extension splint on work performance and
dexterity is likely to be task specific and patients should be made aware of this
information.
It is recommended that the spectrum of daily activities carried out by patients
be considered, and that a variety of patients’ routine tasks be practiced with and
without the splint to allow an individualized prescribed wrist splint protocol. This
should help promote realistic expectations regarding the value of using a wrist splint,
which maximizes its benefits and minimizes its inconvenience according the patients
personal needs.
In summary, static wrist extension splints have been shown to increase hand
grip strength, hand function and provided immediate hand pain relief in some patients.
Nevertheless they may also contribute to a less dexterous and less mobile hand. There
is little evidence to demonstrate the long-term effectiveness of wrist extension splints
and the quality of evidence available indicates the clinical effectiveness of these
splints is moderate.
71
Finger Splints
(1) Swan neck splints
Swan neck splints are frequently used in the non-surgical management of
flexible swan neck deformities to correct hyperextension deformities at the proximal
interphalangeal (PIP) joint (Porter & Brittain, 2012). These splints aim to ease joint
pain, improve hand function and prevent the swan neck position of the finger (Zijlstra
et al., 2002). The pathomechanics of swan neck deformity are complex and any
anatomical susceptibly to hyperextension can expedite the deformity process
(Johnsson & Eberhardt, 2009).
To date, studies on the effectiveness of swan neck deformity is sparse. The
results of the available evidence suggest that finger splints can enhance hand function
in individuals with RA and swan neck deformities (Spicka et al., 2009; Ter Schegget
& Knipping, 2000; van der Giesen et al., 2009; Zijlsra et al., 2004).
Currently, various types of finger splints are available, including silver ring
splints (SRS), prefabricated thermoplastic splints (PTS), and custom-made
thermoplastic splints (CTS). Studies comparing silver ring splints with custom
thermoplastic splints (Ter Schegget & Knipping, 2000) or prefabricated thermoplastic
splints (van der Giesen et al., 2009) have demonstrated similar effectiveness relating
to digital strength, grip strength and mobility. However, custom thermoplastic splints
were considered less comfortable and less attractive due to their thickness making the
fingers spread (Ter Schegget & Knipping, 2000). In contrast, no difference in
satisfaction was reported between silver ring splints and prefabricated thermoplastic
splints (van der Giesen et al., 2009). Two of the studies (van der Giesen, 2009; Zijlstra
et al., 2004) reported intermittent paraesthesia, pressure on bony edges and skin
abrasions in some patients wearing splints. Therefore, frequent evaluation of skin
integrity is recommended.
Although cost was not the focus in this review, it should also be considered in
the prescription process. The available evidence points to similar clinical effectiveness
of silver ring splints and prefabricated thermoplastic splints, and that the positive and
negative appreciations are seen with both types of splints. Thus, it seems sensible that
occupational therapists inform patients about the characteristics of both splints and
advise them to try the prefabricated thermoplastic splint first. This is especially the
case since prefabricated thermoplastic finger splints are less expensive than silver ring
72
splints, with similar time needed for the therapist to measure and adjust the splint to
obtain optimal fit and allowed extension.
If prefabricated thermoplastic splints are found to be effective, patients can
decide at a later stage whether or not to continue with the prefabricated thermoplastic
splint or switch to silver ring splint, especially since silver ring splints are a relatively
inexpensive alternative to hand surgery for finger deformities.
(2) Boutonniere deformity splints
There is very limited evidence on the effectiveness of splinting for boutonniere
deformity. Only one study compared a dynamic splint to a static splint for the
correction of flexion contractures in patients with rheumatoid arthritis (Li –Tsang et
al., 2002). The findings demonstrated that both splints achieved similar extension
gains, but the dynamic splint attained superior flexion at the proximal interphalangeal
(PIP) joint.
Most occupational therapists are reluctant to prescribe corrective or dynamic
splints for patients with RA, for fear they might create additional damage to the joints
and thus cause more pain. The findings from this study conflicted with previous
biomechanical analysis (Li, 1999). In Li-Tsang et al. (2002) study participants did not
complain of pain, fatigue, or over-stretching after wearing the dynamic or static splint.
Furthermore, there was also no evidence of either splinting regimes leading to
detrimental consequences.
Therefore, it is recommended in clinical practice that splinting for 6 weeks
may be worth trying on patients with RA, with a view of reducing the flexion
contracture. The rationale for this recommendation is that the proximal
interphalangeal (PIP) joint is responsible for 85% of total encompassment in the
grasping of an object (Prosser, 1996). If a PIP joint is limited in active movement,
then activities involving handling and maintaining grip on medium to small objects
becomes difficult. Thus, even a small improvement in range of motion might enable a
person with RA to independently complete a task.
The major consideration in the application of corrective splints is whether
there are signs of active synovitis. Occupational therapists need to seriously consider
the methods of splint fabrication and ensure not to overstretch the delicate tissues
around the joints. If dynamic splinting is to be considered, the elasticity of the coils
should be checked frequently, since it is important to control the amount of corrective
73
force on the joint generated by the coil spring. This small clinical study adds further
knowledge and understanding of the biomechanical and clinical aspects of splint
intervention for patients with rheumatoid arthritis and a PIP joint flexion contracture.
Further studies are required to examine the effect of splinting and the generation of
corrective force in more depth.
Metacarpal Ulnar Deviation Splints
Metacarpophalangeal (MCP) ulnar drift is one of the most frequently seen
deformities in adults with rheumatoid arthritis (Stirrat, 1996). This deformity is
progressive and known to have a multifactorial cause. There are a variety of volar-
based static metacarpal ulnar deviation (MUD) splints, with or without hinges and
strapping for each proximal phalanx, designed to correct MCP alignment and improve
finger dexterity and grip strength. Some of the splints also have wrist and forearm
components.
Despite the wide range of designs available, there is little evidence to support
MUD splints as an intervention in adults with rheumatoid arthritis. Of the two studies
(Formsa & Dijkstra, 2008; Rennie, 1996), that had no control groups, one study found
increased finger alignment during function, tripod pinch strength and performance
satisfaction (Rennie, 1996), but no significant improvements with respect to hand
function test scores, pain or grip strength. Anatomical alignment was improved
significantly in all except the index fingers. In comparison, Formsa and Dijkstra
(2008) found significant improvements in dexterity and pain. It is not clear if there
was any effect on the ulnar drift angle of the MCP joints wearing this innovative
splint.
Overall, the findings from this review suggest that MUD splints may assist
function in those with existing correctable deformities while worn. However, it should
be emphasized that splinting the MCP joints does have its practical limitations. While
immobilization has been shown to reduce synovitis (Adams et al., 2008), restricting
movement of the MCP joints can impede the functional use of the hand. All of these
factors influence patient’s acceptance and compliance with splint wear. The benefits
of splinting are ultimately dependent on the patient’s willingness to wear a splint. It
would seem that patients are more likely to agree to wearing a splint if pain relief is
obtained with its use, or the benefits outweigh the restrictions.
74
Thumb Splints
Thumb deformity is one of the most frequent conditions that affect individuals
with rheumatoid arthritis (RA), occurring in 60-80% of cases. Thumb deformity and
pain affects functional ability, independence and quality of life among patients with
RA (Vliet, et al., 1996), yet there is scarce literature on the conservative treatment of
CMC joint rheumatoid arthritis using splints.
The aims of splinting the carpometacarpal (CMC) joint of the thumb are to
increase stability, reduce pain, improve hand function and decrease the mechanical
stress that may be causing the instability. Only one study was found that met the
inclusion criteria for this review (Silvia et al., 2008). Although the study size was
small, the findings suggest that splinting for type I and type II thumb deformities
significantly decrease joint pain, and have no adverse effect on function, grip strength
and dexterity. At the end of the study, patients in the treatment group reported 75
percent improvement in hand function associated with use of the splint.
Pain is usually the primary factor that directs the course of splinting for the
unstable CMC joint of the thumb. The patient may complain of pain even in the
absence of typical pain-related symptoms such as warmth or swelling. A painful
thumb can dramatically limit the performance of activities of daily living. Pain
typically increases following activities such as repetitive pinching, grasping (i.e.,
holding a book) and twisting (i.e., holding a key). Therefore, it is recommended that
occupational therapists trial 3 months of thumb splinting, as per this study, with a
view of reducing joint pain and improving hand function. The rationale for this
recommendation is that pain free stability at the basal joint of the thumb is essential
for normal hand function, and though splinting will not cure the pathology (Firestein
et al., 1997), it may provide sufficient relief to avoid or at least postpone surgical
reconstruction in a number of patients.
Limitations of the Study
Despite a wide range search strategy, only one piece of grey literature was
identified for consideration in this systematic review, and this could not be included
because of difficulty accessing it. The researcher acknowledges that failure to include
this unpublished thesis might affect the results due to publication bias (Bowling,
2002). However, since only one unpublished study was identified from the literature
75
search, this suggests that no large volume of unpublished data has been missed and so
is unlikely to have biased this systematic review.
Another potential source of bias was the exclusion of non-English language
studies; two studies published in a language other than English were identified but
excluded because of the lack of time and financial resources to fund translation. It is
unknown what these studies would have contributed to the review findings.
It is also acknowledged that the use of only one researcher to screen titles and
abstracts may have introduced bias. Ideally, the process should have been directed by
a peer reviewed protocol to help to control investigator bias during the search (Meade
& Richardson, 1998). Since this review was part of a post graduate research project, it
was not possible to have two independent reviewers. Despite this, in cases of
uncertainty regarding whether a particular study met the inclusion criteria, the study
was discussed with the student’s supervisor until an agreement was reached.
Limitations of the Current Evidence
Even though the quality of the studies appraised was generally moderate to
high, there were methodological concerns common to all of the studies that could
have had an impact on the results. The limitations in the studies included in this
review can be summarized as follows:
A shortage of well powered, longitudinal, controlled studies investigating
homogenous groups of adults with rheumatoid arthritis at similar stages of
disease duration.
The variability of the disease course between and within study participants
makes it difficult to detect the true impact of wearing static splints over
time, partly because very few studies have included any indicators of
disease activity.
In several studies, neither the patients nor the assessor were blinded to the
treatment allocation. The results might therefore have been influenced by
the expectation of a treatment effect. However, it should be noted that
strict blinding of subjects and therapists is almost impossible with
splinting interventions. Splints are external devices that provide support
for a body part. How can this appear to be done without the patient
knowing that no support is being provided? Conversely, issues related to
76
blinding of evaluators are not as hard to manage, since in most
circumstances, the splint can be removed before the evaluation.
Although standardized measures were occasionally used, investigator
measures designed especially for the study, or rating scales with no report
of reliability and validity, were commonly employed.
Only one study with a comparison group reported a power calculation,
making it impossible to estimate the probability of a Type II error (i.e.
reporting a non-significant difference when a true difference is present).
The other problem with most studies reviewed was the small sample size
(15 out of the 18 studies included had numbers less than 50). While the
small sample sizes reduced the power of the studies to find significant
treatment effects, it is too early to conclude that the non-significant
findings prove a lack of effectiveness of the splints assessed.
Considering the above, caution needs to be exercised in acknowledging that
the absence of clear evidence for the effectiveness of static hand and wrist splints does
not equate to evidence of absence of the effectiveness.
77
Chapter Seven:
Conclusion
Implications for Practice
The effectiveness of hand and wrist splints in persons with rheumatoid arthritis
is exceptionally complex to study. Consequently, no single approach can be directly
applied to all patients. The recommended wearing time varies between each individual
and with the changing course of the disease. Given the paucity of well-designed
studies, it is difficult to draw firm conclusions regarding the efficacy of static splinting
in the non-surgical treatment of adults with rheumatoid arthritis. However, this review
can be applied in respect to how occupational therapists can recommend static hand
and wrist splints to future patients with rheumatoid arthritis, by taking into
consideration the findings of each high quality study.
It appears that that there is moderate quality evidence that prefabricated wrist
extension splints provide short term pain relief when worn, and may help with some
functional tasks that place large demands on the wrist (i.e., vacuuming or chopping
vegetables). Given that these splints did not provide any harmful effect on grip
strength or range of movement, and may provide pain relief while performing various
upper limb activities, it seems reasonable to try these splints with patients that have
localized wrist pain, until additional evidence is presented.
The efficacy of static resting splints for night time use in reducing pain and
increasing grip strength was only evaluated in two studies. In the remaining study that
examined patient preference after one month of splint use, subjects preferred wearing
a soft splint than a hard splint for pain relief. Based on these findings, there is an
indication for the effectiveness of static resting splints, but insufficient evidence to
make practice recommendations. Occupational therapists are encouraged to provide
options to their patients with rheumatoid arthritis, with attention to comfort and
preference to ensure satisfaction and to enhance compliance with treatment.
There is preliminary evidence to support the use of prefabricated thermoplastic
finger splints and silver ring splints to improve dexterity in swan neck deformity.
Custom thermoplastic splints are more bulky and less preferred by patients.
Boutonnière splints were only assessed in one small study involving participants with
early, reducible deformities. Although further studies are required, the initial findings
78
suggest that boutonnière splints may be helpful in reducing correctable proximal
interphalangeal joint flexion deformity less than 40 degrees.
To date, there is scarce evidence to make strong conclusions about the
effectiveness of metacarpal ulnar deviation splints in decreasing pain or improving
grip strength. They appear to realign correctable ulnar deviation deformities and may
assist with hand function while worn, although the long-term benefits have not been
evaluated. During a flare up, static thumb splints may be indicated to decrease joint
pain in treating Type I and II boutonnière deformity. When the splints were worn,
individuals reported an improvement in performing daily tasks as well as pain relief.
What's more, it appears that these splints do not have any short term negative effects
on pinch strength, grip strength, or dexterity. Since thumb splints are relatively
inexpensive, and may have the potential to decrease pain, it appears reasonable to try
patients with these splints until further studies become available.
This systematic literature review sought to determine the effectiveness of five
types of static hand and wrist splints to ameliorate the following four issues:
augmenting hand function, preventing deformity, increasing grip strength, and
reducing their pain. While these aims can be achieved surgically, this review has
highlighted that static splinting in the non-surgical management of rheumatoid
arthritis also has a role to play, with current research indicating that they can be
effective in many cases. These findings are encouraging for occupational therapy
practice as splinting is one of the most commonly used interventions (Adams et al.,
2005), and an important part of the treatment for persons with rheumatoid arthritis
affecting the hand and wrist.
Recommendations for Future Research
Although the findings from this systematic literature review are promising,
research in this area is still in its early stages. More high quality research is needed
into the underlying mechanism of deformity formation in the acute inflamed and the
chronic rheumatoid joint. Currently, there is debate regarding the cause of rheumatoid
hand and wrist deformity. The effectiveness of static splinting depends on how it
affects the symptomatic presentation of the rheumatoid disease and whether it has a
role in preventing local joint inflammation.
During a time when drug developments continue to assist with more effective
control of disease activity and synovitis, continued research is needed on the most
79
commonly prescribed static hand and wrist splints. More rigorous, adequately
powered studies examining the different types of splints and splinting regimes should
help to determine the short and long-term effectiveness in treating the progressive
signs and symptoms of rheumatoid arthritis. Greater insight into these factors may
also help occupational therapists develop appropriate non-surgical splinting protocols.
To date, evidence is still required to support the most appropriate design of splint and
the best stage of the disease process to prescribe them.
Rheumatoid arthritis and the use of static splinting as an intervention for this
condition present some unique issues around research design. The disease has a
variable course of exacerbations and remissions with a gradual decline in function.
Medications may change, and goals of treatment could be to improve impairment and
function, or to prevent further decline. Therefore, study samples must be chosen very
carefully to ensure similar objectives for all participants, but also to enable some
generalizability of results. Repeated measures at baseline and at various time points
through the study might help establish more stable estimates of effect. Preliminary
power calculations would help to minimize the possibility of Type II statistical errors
and collection of disease activity markers would be required to try and extrapolate the
effects of splinting as distinct from disease activity changes.
Providing “blinded” treatment will always be difficult with splinting studies,
but “placebo” or alternate interventions should be applied to the control group to
minimize effects due to attention or education from the occupational therapist. The
use of clearly defined standardized and validated outcome measures is of paramount
importance to ensure that the research is of clinical benefit. Additionally, the use of
well validated self-report measures and other qualitative reports of hand function may
be beneficial adjuncts alongside sensitive, standardized assessments to incorporating
individuals own perspectives on whether these splints are worthwhile over time.
80
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reviews of test accuracy should search a range of databases to identify primary
studies. Journal of Clinical Epidemiology, 61, 357-357.
Williams, K., & Terrono, A. L. (2011). Treatment of boutonniere finger deformity in
rheumatoid arthritis. Journal of Hand Surgery, 36(A), 1388-1393.
doi:10.1016/j.jhsa.2011.05.029
Wolfe, F., & Zwillich, S.H. (1998). The long-term outcomes of rheumatoid arthritis: a
23-year prospective, longitudinal study of total joint replacement and its
predictors in 1,600 patients with rheumatoid arthritis. Arthritis & Rheumatism,
41(6), 1072-1082.
World Health Organization. (2004). World report on knowledge for better health
summary. Geneva: Author.
Wright, R. W., Brand, R. A., Dunn, W., & Spindler, K. P. (2007). How to write a
systematic review. Clinical Orthopedics and related Research, 455, 23-29.
doi: 10.1097/BLO.0b013e31802c9098
Young, A., Dixey, J., Cox, N., Davies, P., Devlin, J., Emery, P., …Winfield, J. (2000).
How does functional disability in early rheumatoid arthritis (RA) affect
93
patients and their lives? results of 5 years of follow-up in 732 patients from the
early RA study (ERAS). Rheumatology, 39(6), 603-611.
Zijlstra, T. R., Heijnsdijk-Rouwenhorst, L., & Rasker, J. J. (2004). Silver ring splints
improve dexterity in patients with rheumatoid arthritis. Arthritis &
Rheumatism, 51(6), 947-951.
94
Appendix A: Anatomical Structures of the Wrist and Hand
Bones of the Right Hand and Wrist (Palmer view)
Dorsal view of the middle finger. Note the distal, proximal and metacarpophalangeal joints
95
Appendix A: Anatomical Structures of the Wrist and Hand
Note. Adapted from Rehabilitation of the Hand and Upper Extremity, 2-Volume Set, 6th Edition by Terri M. Skirven, A. Lee Osterman, Jane Fedorczyk, and Peter C. Amadio.
Volar view of the superficial muscles of the hand
View of the tendons of the extrinsic extensor muscles on the dorsum of the hand and wrist
96
Appendix B: Search Strategies from the Different Databases
Note. CINAHL= Cumulative Index to Nursing and Allied Health Literature; Limiters - English Language; Research Article; Human; Expanders - Apply related words, Search modes - Boolean/Phrase; PEDro=Physiotherapy evidence based; All Evidence Based Medical Reviews including: EBM Reviews - Cochrane Database of Systematic Reviews 2005 to July 2012, EBM Reviews - ACP Journal Club 1991 to July 2012, EBM Reviews - Database of Abstracts of Reviews of Effects 3rd Quarter 2012, EBM Reviews - Cochrane Central Register of Controlled Trials July 2012, EBM Reviews - Cochrane Methodology Register 3rd Quarter 2012, EBM Reviews - Health Technology Assessment 3rd Quarter 2012, EBM Reviews - NHS Economic Evaluation Database 3rd Quarter 2012.
Database Keywords
CINAHL
1. TX Splinting 2. TX Rheumatoid Arthritis 3. (Splinting) AND (S1 and S2) (266) 4. TX Hand 5. (hand) AND (S1 and S2 and S4) 6. TX Joint protection (265) 7. (joint protection) AND (S2 and S6) 8. TX Hand exercise 9. (hand exercise) AND (S2 and S8)
Ovid MEDLINE
1. exp Splints 2. exp Arthritis, Rheumatoid 3. 1 and 2 4. Joint protection.mp. 5. 2 and 4 6. Hand exercise.mp. 7. 2 and 6
Academic Search Premier
1. Rheumatoid arthritis 2. Splinting 3. ((S1 and S2)) AND (S1 and S2) 4. Hand splints 5. (hand splints) AND (S1 and S4) 6. Joint protection 7. (joint protection) AND (S1 and S8) 8. Hand 9. (hand) AND (S9 and S10)
PubMed
1. "Arthritis, Rheumatoid"[Mesh] 2. Hand splints 3. (("Arthritis, Rheumatoid"[Mesh])) AND (splints) AND (hand) 4. ("joints"[MeSH Terms] OR "joints"[All Fields] OR "joint"[All Fields]) AND
protection[All Fields] 5. (#1) AND (#5) 6. (#1) AND (hand exercises)
PEDro
1. Rheumatoid Arthritis AND splinting 2. Rheumatoid Arthritis AND joint protection 3. Rheumatoid Arthritis AND hand exercise
OTseeker
1. Rheumatoid arthritis AND hand splints OR wrist splints 2. Rheumatoid Arthritis AND Joint Protection 3. 3. Rheumatoid Arthritis AND Hand Exercise
All Evidence
Based Medical Reviews
Cochrane DSR, ACP
Journal Club, DARE, and
CCTR*
1. Rheumatoid arthritis.mp. [mp= ti,ot,ab,tx,ct,sh,hw]
2. Splinting.mp. [mp= ti,ot,ab,tx,ct,sh,hw] 3. Splints.mp. [mp=ti,ot,ab,tx,ct,sh,hw] 4. 1 and 3 5. Joint protection.mp. [mp= ti,ot,ab,tx,ct,sh,hw] 6. 1 and 5 7. Orthotics.mp mp=ti,ot,ab,tx,ct,sh,hw] 8. 1 and 7 9. Hand exercise.mp. [mp=ti,ot,ab,tx,ct,sh,hw]) 10. 1 and 9 11. Adherence to joint protection.mp. [mp=ti,ot,ab,tx,ct,sh,hw] 12. Compliance with splinting.mp. [mp=ti,ot,ab,tx,ct,sh,hw]
97
Appendix C: Structured Effectiveness Quality Evaluation Scale (SEQES) Interpretation Guide
Question
Descriptors
1 2 The authors performed a thorough literature review indicating what is currently known about the problem and the intervention at present
presented a critical, but unbiased, view of the current state of knowledge indicated how the current research question evolves from the current knowledge base
established a clear research question(s) based on the above 1 All of these above were not fulfilled, but a clear rationale was proved for the
research question 0 A foundation for the current research question was not developed
Study design 2 2 Two or more contemporary (same point in time) groups of similar patients were
compared crossover trials which include randomization/blinding of intervention order and complete wash-out effects can be considered equivalent.
1 A comparator group was present, but did not fulfill the above criteria 0 No comparator group was included
3 2 Patients were evaluated prior to the intervention, and at one or more clinically relevant time points, following the intervention using the same evaluation criteria.
1 Patients were evaluated at more than one point in time (including case control studies); but the above criteria were not fulfilled
0 Patients were evaluated at only one point in time 4 2 A standardized set of (prospective) data were collected at specific pre-set intervals
according to a preplanned study protocol. 1 A core set of prospective data were collected from patients or obtained from
database retrieval. This data was collected across multiple intervals, but the actual data collection strategy was not determined specifically for this study
0 Data were based on retrospective records/interpretations or recall of past events 5 2 An appropriate randomization strategy was used to allocate patients to interventions
and the specifics of randomization were described 1 Randomization was used, but information describing the randomization process was
not included or did not confirm a truly random process 0 Randomization was not used
6 2 Patients were blinded as to the intervention that was provided and either a post-hoc analyses indicated that blinding procedures were effective or it was evident that patients would be unable to distinguish which intervention they received.
1 Blinding patients was not possible or it was unclear whether an effective blinding strategy was used
0 Blinding was possible, but was not utilized
98
Appendix C: Continued
Question
Descriptors
7 2 Treatment providers were blinded to the intervention they were administrating and this blinding was substantiated either through audits or other post-hoc analyses indicated that the blinding procedure was effective
1 Blinding was not possible or it was unclear whether an effective blinding strategy was used
0 Blinding was possible, but was not utilized 8 2 Outcome measures were administered by an evaluator who was blind to the treatment
provided and/or the purpose of the study. Self-report can be considered as equivalent if provided by an independent person
1 Evaluators were not blinded, but were not involved in treatment of patients (were independent) or Self-report administered by treatment provider
0 Outcome measures were obtained by unblended treatment providers Subjects 9 2 The authors documented a specific recruitment strategy that was intended to
maximize the representation of subjects in relation to specific target population and sampling procedures were applied equally across comparison groups
1 The study sample appears representative of the population of clinical interest, but adequate information on sampling procedures or description of the reference population is not provided.
0 Sampling biases are evident; systematic differences occurred between the comparison groups; and/or selection procedures used make it impossible to determine what types of patients were included
10 2 Specific inclusion and exclusion criteria for the study were defined and designed to yield a study group generalizable to clinical situations
1 Some information on the type of patients included in the study and excluded are defined, but the information is insufficient to allow the reader to generalize the study results to a specific clinical population
0 No information on inclusion and exclusion criteria and limited patient’s descriptors are provided.
11 2 Authors performed a sample size calculation upon which their recruitment targets were defined, described the target population from which subjects were drawn, and the response from the target population in terms of participation in the study
1 The authors performed a sample size calculation and/or provided a satisfactory rationale for the number of subjects included in the study
0 The size of the sample or its relationship to target population were not rationalized
12 2 90% or more of the patients enrolled or eligible for study 1 More than 70% of the patients eligible for study or enrolled were evaluated for
outcomes 0 Less than 70 % of patients eligible for study or enrolled were evaluated
99
Appendix C: Continued
Question
Descriptors
Intervention 13 2 The parameters of the treatment (provider/equipment, frequency, duration,
application process, progression and other technical components) and compliance/monitoring were sufficiently described that they could be replicated. The specific parameters used were based on published basic science or clinical evidence documenting that the specific treatment effects intended are achievable given the treatment parameters used.
1 A sound rationale OR adequate description was provided for the treatment intervention, but the above level of documentation was not cited.
0 A rationale for the treatment intervention was not provided AND an adequate description of the intervention was not included OR the application of the intervention did not conform to present knowledge on potentially effective parameters.
14 2 The study was designed to minimize biases due to the treatment provider. Treatment provider biases can be minimized if the treatment provider is blinded to which treatment they provide. In cases where this is impossible, methods such as equalize attention to groups, selecting treatment providers without vested interests in a specific intervention, training treatment providers according to a standardized process or assuring a specific level of training when recruiting providers can be used to assure sufficient equipoise.
1 Minimal attention was directed either in methods or discussion to the potential for treatment provider biases, but no inherent opportunity for bias was apparent.
0 No attention was directed at the potential for treatment provider bias and the opportunity for bias is evident, given the nature in which interventions were applied.
15 2 A rationale was provided for the comparison group selected. Where no specific intervention has previously been demonstrated to be effective, placebo is an appropriate comparator. A comparator group that has previously been shown to be effective or is commonly considered as acceptable standard of care is also appropriate.
1 A rationale for the comparison group was not established 0 No comparison group was included
Outcome 16 2 A primary outcome measure which represented important clinical outcomes was
selected and supported by evidence of appropriate psychometric properties (reliability, validity, responsiveness).
1 A relevant primary outcome measure was evident, but was insufficient in either its clinical relevance or its psychometric properties.
0 A primary outcome was not evident or was inappropriate, because it was irrelevant or methodologically unsupported.
17 2 Appropriate secondary outcome measures were identified that augmented the perspective provided by the primary outcome measure, ensuring a comprehensive view of outcomes was obtained; and these secondary outcome measures had sound psychometric properties.
1 Secondary outcomes were considered, but were not identified as being secondary or were deficient either in terms of their relevance or methodological properties
100
Appendix C: Continued
Question Descriptors
17 0 Appropriate secondary outcomes were not considered 18 2 Patients were followed at important time points that provided an indication as to the
early response and longer-term outcomes achieved. These time points were sufficient to support a clear definition of the relative value of the intervention, over a clinically meaningful time period. A rationale and/or discussion of the appropriateness of these follow-up periods was included
1 At least one relevant follow-up evaluation was incorporated, but the study did include other important clinical time points or a rationale for the specific follow-up time.
0 The follow-up period was insufficient to establish the true outcome of the intervention Analysis 19 2 The statistical tests utilized to determine whether differences existed due to the
intervention were appropriate and specifically related to their stated research objectives. The authors documented important elements on the statistical tests (software used, that statistical assumptions underlying tests were met, Alpha levels).
1 Tests(s) of statistical difference was used, but were insufficient to describe whether statistical differences occurred because of treatment; there was insufficient documentation of the specifics of the analyses performed
0 Statistical tests were not performed or those selected were not appropriate to the research question or data collected
20 2 Power was established. A justified sample with significant statistical difference is one indication of this. If statistical differences were not obtained, a post-hoc power analysis was conducted and identified that the study was appropriately powered.
1 The sample size was substantial, but post-hoc power analyses were not conducted in response to non-significant results.
0 The sample size was small and post-hoc power analyses were not in response to non-significant results.
21 2 The authors appropriately conveyed both the statistical significance and size of the treatment effect when reporting the results. This could be indicated by the inclusion of p-values and the associated confidence intervals; effect sizes, number-needed-to-treat; or other similar statistical methods.
1 Statistical significance of the outcomes achieved by the intervention group were described 9means and p-values), but no quantitative description of the confidence intervals/effect sizes of these differences was presented
0 Descriptive, statistical information on the size of the treatment effects was not reported 22 2 1) Complete data collection was achieved on all subjects or
2) A specific described strategy for handling missing data was documented and where missing data occurred in more than 10 percent of cases a specific analysis was conducted to determine the impact of missing data management.
1 Missing data was not an apparent issue, but the exact protocol for handling missing data was not adequately described.
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Appendix C: Continued
Question
Descriptors
Intervention 22 0 Missing data may have been an issue and the protocol for handling missing data was
not adequately described. 23 2 The authors fully addressed clinical significance by relating the observed differences
to that required for clinically important change (or minimally important significant differences) and described practical issues such as specific training or equipment required to achieve the effects described in the study.
1 The relevant issues on the clinical and practical significance were addressed in the discussion of the study results, but not documented in relation to specifically established criteria (certifications of treatment providers or established minimally/clinically important differences.)
0 Clinical and practical significance were not considered when interpreting the results Recommendations 24 2 Specific conclusions and clinical recommendation made by the authors directly
related to the objectives of the study, the specific analyses conducted and results of those analyses. Recommendations neither 1. ignored observed results 2. overstated their generalizability/clinical application or 3. stated that the treatment is ineffective when there was insufficient power to establish this was the case.
1 Conclusions and clinical recommendations are either incomplete, or generalize beyond the domain of the study or the results actually obtained.
0 Conclusions and clinical recommendations were not founded on the results of the study or contradict findings of the study
102
Appendix D: Characteristics of Excluded Studies Author Year Reasons for exclusion Ayling & Marks 2000 Looks only at efficacy of paraffin wax baths Backman 1988 Case study Barbarioli 2001 Case study Bishop, Hench, Lacroix, Millender, & Opitz
1991 Expert opinion piece
Burtner, Anderson, Marcum, Poole, Qualls, & Picchiarini,
2003 This article looks at use of dynamic splinting
Byron 1994 Practice forum/case study Celerier 2004 Non-English [French] Chacko & Rozental 2008 Not a clinical trial Chinchalkar & Pitts 2006 Review article on dynamic splinting Codish, Shakra, Flusser, Friger, & Sukenik
2005 Efficacy of mud compress therapy only
Culic, Battaglia, Wichman, & Schmid,
1979 Only looks at the effect of compression gloves
De Boer, Peeters, Ronday, Mertens, Breedveld & Vliet Vlieland
2008 Does not investigate treatment effects of splinting
Dell & Dell 1996 Not a clinical trial Eberhardt, Malcus-Johnson & Rydgren
1991 Prospective study on occurrence of hand deformities
Fess 2002 Literature review Helders, Van der Net, & Nieuwenhuis
2002 Splinting for Juvenile rheumatoid Arthritis
Keilani, Paternostro-Sluga, Crevenna, Zauner-Dungl, & Fialka-Moser
2003 Non-English [German]
King 1992 Case study Lee & Hausman 2005 Literature review Malcus-Johnson, Carlqvist, Sturesson, & Eberhardt
2005 Does not assess treatment effectiveness
McKnight & Kwoh 1992 Compression gloves only, plus no control period Murphy 1996 Not a clinical trial Neumann & Bielefeld 2003 Clinical commentary Nicholas, Gruen, Weiner, Crawshaw, & Taylor
1982 No mention at all of types of splints patients were wearing
O’Carroll & Hendriks 1989 Study of splinting compliance Palchik, Mitchell, Gilbert, Schulz, Dedrick, & Palella
1991 No information provided on statistic tests done
Schroder, Crabtree, & Lyall-Watson
2002 Subjects with other pathologies
Stewart & Maas 1989 Qualitative study design Van der Giesen, Nelissen, van Lankveld, Kremers-Selten, Peeters, Stern, et al.
2010 Qualitative study design
Wajon & Ada 2005 Splinting for OA not RA Weiss, LaStayo, Mills, & Bralmet
2000 Splinting for OA not RA
Williams & Terrono 2011 Surgical management of RA deformities Woodruff Thomforde 2005 Case study