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1 THE EFFECTIVENESS OF MECHANICAL CERVICAL TRACTION COMBINED WITH CONVENTIONAL THERAPY ON PATIENTS WITH UNILATERAL MECHANICAL NECK PAIN A research project submitted by Bhatt Jahnvi Ashokkumar Rathod Prerna Naranbhai Tandel Krupali Vinodbhai Tandel Soniya Sumanbhai Under the Guidance of Dr. DIBYENDUNARAYAN BID [PT] MPT (Ortho), PGDSPT SENIOR LECTURER The Sarvajanik College of Physiotherapy, Rampura, Surat.

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Page 1: The effectiveness of mechanical cervical traction combined with conventional therapy on patients with unilateral mechanical neck pain

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THE EFFECTIVENESS OF MECHANICAL CERVICAL TRACTION COMBINED WITH

CONVENTIONAL THERAPY ON PATIENTS WITH UNILATERAL MECHANICAL NECK PAIN

A research project submitted by

Bhatt Jahnvi Ashokkumar

Rathod Prerna Naranbhai

Tandel Krupali Vinodbhai

Tandel Soniya Sumanbhai

Under the Guidance of

Dr. DIBYENDUNARAYAN BID [PT]

MPT (Ortho), PGDSPT

SENIOR LECTURER

The Sarvajanik College of Physiotherapy,

Rampura, Surat.

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Declaration

This is to certify that Project entitled ‘THE EFFECTIVENESS OF MECHANICAL

CERVICAL TRACTION COMBINED WITH CONVENTIONAL THERAPY ON PATIENTS

WITH UNILATERAL MECHANICAL NECK PAIN’ is submitted by us in Bachelor of

Physiotherapy to ‘The Sarvajanik College of Physiotherapy, Surat’ comprises

only our original work and due acknowledgement has been made in the text to all

other material used.

Date: 18th June, 2013 Bhatt Jahnvi Ashokkumar

Rathod Prerna Naranbhai

Tandel Krupali Vinodbhai

Tandel Soniya Sumanbhai

Approved by: Dr. Dibyendunarayan Bid [PT]

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CERTIFICATE

This is to certify that Project entitled ‘THE EFFECTIVENESS OF MECHANICAL

CERVICAL TRACTION COMBINED WITH CONVENTIONAL THERAPY ON PATIENTS

WITH UNILATERAL MECHANICAL NECK PAIN’ which is submitted by Bhatt Jahnvi

Ashokkumar, Rathod Prerna Naranbhai, Tandel Krupali Vinodbhai and Tandel

Soniya Sumanbhai, is a record of the candidates’ work carried out by them under

my guidance and supervision.

The concept, design and review for this project were provided by the guide.

The data analysis and interpretation were provided by Dr. Thangamani

Ramalingam A.

The matter embodied in this project work is original.

Date: 18th June, 2013 Dr. Dibyendunarayan Bid [PT]

Guide’s signature

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ACKNOWLEDGEMENT

We owe our sincere thanks to Dr. Dibyendunarayan Bid [PT] for his constant guidance

and suggestions.

We sincerely thank to Dr. Thangamani Ramalingam A. [PT] for helping us in data

analyses and interpretation.

We sincerely thank all our teachers who taught us the finesse of physiotherapy.

It is indeed a matter of deep satisfaction to acknowledge our gratitude towards

Almighty.

We want to thank our respective dear parents who always held us high throughout

our study.

Bhatt Jahnvi Ashokkumar

Rathod Prerna Naranbhai

Tandel Krupali Vinodbhai

Tandel Soniya Sumanbhai

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Contents CHAPTER 1 - INTRODUCTION ........................................................................................................................ 9

1.1 The Problem and its Setting .................................................................................................................. 9

1.2 Aim of the Study ................................................................................................................................. 11

1.3 Hypothesis ........................................................................................................................................... 11

1.3.1 Null Hypothesis .......................................................................................................................... 11

1.3.2 Alternate Hypothesis ................................................................................................................. 11

1.4 Benefits of the Study .......................................................................................................................... 12

CHAPTER 2 – REVIEW OF THE RELATED LITERATURE ................................................................................. 13

2.1 Incidence and Prevalence of Neck Pain .............................................................................................. 13

2.2 Mechanical Neck Pain ........................................................................................................................ 14

2.2.1 Definition, etiology, risk factors and diagnosis of mechanical neck pain .................................. 14

2.2.2 Clinical Presentation .................................................................................................................. 16

2.3 Basic Normal Anatomy of Cervical spine ............................................................................................ 16

2.4 Functional Biomechanics of Cervical Spine (Levangie & Norkin, 2005) ............................................ 18

2.4.1 Kinematics .................................................................................................................................. 18

2.4.2 Kinetics ....................................................................................................................................... 23

2.5 Cervical Spine Traction ...................................................................................................................... 25

2.5.1 Introduction ............................................................................................................................... 25

2.5.2 Indication for Cervical Spine Traction ........................................................................................ 26

2.5.3 Types of Cervical spine Traction ................................................................................................ 26

2.5.4 Most effective positions for applying cervical traction ............................................................. 27

2.5.5 Force to be used in cervical spine traction ................................................................................ 27

2.5.6 Optimum angle for cervical spine traction ................................................................................ 27

2.5.7 Effects of Cervical spine Traction ............................................................................................... 28

CHAPTER 3 – METHODOLOGY .................................................................................................................... 29

3.1 Introduction ......................................................................................................................................... 29

3.2 Aim of Study ...................................................................................................................................... 29

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3.3 STUDY DESIGN ................................................................................................................................ 29

3.4 SUBJECT RECRUITMENT ................................................................................................................. 29

3.4.1 Sample and Selection Criteria .................................................................................................... 30

3.5 INCLUSION AND EXCLUSION CRITERIA ......................................................................................... 30

3.5.1 Inclusion criteria ......................................................................................................................... 30

3.5.2 Exclusion criteria ........................................................................................................................ 32

3.6 RESEARCH METHODOLOGY/PROCEDURE .................................................................................... 32

3.6.1 Treatment Group A – Mechanical cervical traction with conventional therapy. ...................... 33

3.6.2 Treatment Group B – Conventional therapy alone. .................................................................. 33

3.7 MEASUREMENTS .............................................................................................................................. 34

3.7.1 Objective measurements ........................................................................................................... 34

3.7.1.1 Universal Goniometer ............................................................................................................. 34

3.7.2 Subjective measurements .......................................................................................................... 35

3.7.2.1 Neck Disability Index (NDI) ...................................................................................................... 35

3.7.2.2 Numerical Pain Rating Scale .................................................................................................... 35

CHAPTER 4 – DATA ANALYSES AND INTERPRETATION ............................................................................... 36

4.1 Statistical analyses ............................................................................................................................. 36

4.2 Results ............................................................................................................................................... 36

4.2.1 One way repeated measure ANOVA for within group difference ............................................. 37

4.2.2 Independent t-test for between groups difference ................................................................... 46

4.2.3 NDI within Groups ...................................................................................................................... 48

4.2.4 NDI between Groups .................................................................................................................. 48

4.2.5 Correlation analysis for both the groups at week 2 ................................................................... 50

4.3 Limitations of Study ............................................................................................................................ 51

4.4 Discussion .......................................................................................................................................... 51

4.5 Conclusion ......................................................................................................................................... 52

CHAPTER 5 – RECOMMENDATIONS ............................................................................................................ 54

5.1 Recommendations............................................................................................................................... 54

Bibliography ................................................................................................................................................ 56

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Appendices .................................................................................................................................................. 60

Appendix-I: Neck Disability Index - Gujarati Version ................................................................................. 60

Appendix-II: Numerical Pain Rating Scale (NPRS). .................................................................................. 62

Appendix –III: Consent Letter ................................................................................................................... 63

Appendix-IV: Raw Data ............................................................................................................................ 64

List of Tables

Table 1 : Demographical characteristics ..................................................................................................... 36

Table 2 : Demographic & clinical characteristics ........................................................................................ 37

Table 3 : Measure- Flexion- Traction Group ............................................................................................... 38

Table 4 : Measure- Flexion- Conventional Group ....................................................................................... 39

Table 5 : Measure- Extension – Traction Group ......................................................................................... 40

Table 6 : Measure- Extension – Conventional Group ................................................................................. 40

Table 7 : Measure- Side Flexion – Traction Group ...................................................................................... 41

Table 8 : Measure- Side Flexion – Conventional Group .............................................................................. 42

Table 9 : Measure- Rotation – Traction Group ........................................................................................... 43

Table 10 : Measure- Rotation – Conventional Group ................................................................................. 43

Table 11 : Measure- NPRS- Traction Group ................................................................................................ 44

Table 12 : Measure- NPRS – Conventional Group ...................................................................................... 45

Table 13 : Between Groups differences independent t-test ...................................................................... 46

Table 14 : Paired Sample t-test ................................................................................................................... 48

Table 15 : Independent Sample t-Test ........................................................................................................ 49

Table 16 : Correlations (N=40) .................................................................................................................... 50

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List of Figures

Figure 1 Nodding motions of the atlanto-occipital joints. A. Flexion. B. Extension.................................... 20

Figure 2 Superior view of rotation at the atlantoaxial joints: The occiput and atlas pivot as one unit

around the dens of the axis. ....................................................................................................................... 21

Figure 3 A. Flexion of the lower cervical spinecombines anterior translation and sagittal plane rotation

of the superior vertebra. B. Extension combines posterior translation with sagittal plane rotation. ...... 22

Figure 4 Motion at the lower cervical interbody joints occurs in the plane of the zygapophyseal joints

about an axis perpendicular to the plane. .................................................................................................. 23

List of Graphs

Graph 1: Comparison of NPRS between groups ......................................................................................... 45

Graph 2: Comparison of NDI between groups ............................................................................................ 49

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CHAPTER 1 - INTRODUCTION

1.1 The Problem and its Setting

The average amount of productive time lost due to individuals suffering from

neck pain ranges from 2.8-11.3%, with the annual incidence of neck pain among

the working population ranging from 6-23 per 10,000 people (Côté et al., 2008). It

is found that 34% of the population suffers from neck pain, and 26-65% of those

suffer from mechanical neck pain.

Mechanical neck pain (MNP) is the most common type of cervical spine pain

encountered. It is also referred to as simple or non-specific neck pain, and is

common in all groups of people. Often the exact cause of pain is unknown. It may

include discogenic pain, myofascial trigger points, ligaments in the cervical spine;

cervical facet syndrome or poor posture may also contribute to this pain.

The etiology of neck pain multifactorial and poorly understood (Binder, 2007)

(Bergman & Peterson, 2002). The common factors include poor posture,

depression, anxiety, aging, acute injury and occupational or sporting activities.

This leads to altered joint mechanics, muscle structure or function and can result

in mechanical neck pain. Gatterman; and Peterson & Bergman stated that the

most common cause of MNP is zygapophyseal joint locking and muscle strain

(Gatterman, 1998) (Bergman & Peterson, 2002).

According to Peloza, neck pain can be either intrinsic or extrinsic in nature.

Intrinsic pain is broken down into mechanical neck pain, this type of neck pain is

any neck pain which originates from the joints or intervertebral discs, whereas

extrinsic conditions are conditions which cause pain in the cervical spine; they

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include nerve root irritation, compression neuropathies, shoulder pathologies and

cardiovascular condition (Peloza, May 02, 2007).

An inflammatory reaction is initiated by musculoskeletal dysfunction; this is

identical to that for an infection. Pain accompanying inflammation may initiate a

local reflex muscle contraction, which over time may lead to ischemia and

therefore more pain (Bergman & Peterson, 2002).

Cervical traction consists of administering a distracting force to the neck in order

to separate the cervical segments and relieve compression of nerve root by

intervertebral discs. Several techniques and different durations have been

recommended in the literature (Colachis & Strohm, 1965). However, due to poor

methodological quality of the available data, there is currently little evidence to

suggest that individuals with MNP may benefit from physiotherapy combined

with traction aimed at improving hand strength, neck discomfort and to

decompress nerve impingement (Joghataei et al., 2004) (Jellad et al., 2009)

(Young et al., 2009).

In a similar type of study Joghataei et al. randomly assigned 30 patients with C7

radiculopathy due to disc herniation and/or cervical spondylosis to take part in a

treatment programme consisting of regular physiotherapy and exercises either

with or without intermittent cervical traction for 10 sessions. The group who

received intermittent cervical traction exhibited better improvements in grip

strength after 5 sessions, but not statistically significant differences were

observed between the two groups after 10 treatment sessions. Since, the authors

did not interpret the patients according to their etiology; the real benefits of the

cervical traction could not be ascertained (Joghataei et al., 2004).

With the above consideration, the present study was performed to compare the

clinical parameters of cervical traction with conventional physiotherapy and

conventional physiotherapy alone in the treatment of MNP.

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1.2 Aim of the Study

The aim of the study is to compare the efficacy of ‘mechanical cervical traction

with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in

mechanical neck pain. Here efficacy is measured on the basis of following

outcome measures: Neck Disability Index (NDI), Numerical Pain Rating Scale

(NPRS), and Goniometry for cervical range of motion.

1.3 Hypothesis

1.3.1 Null Hypothesis

H1: There will be no difference in pain relief due to ‘mechanical cervical traction with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in mechanical neck pain.

H2: There will be no difference in improvement of ROM of cervical spine i.e. flexion, extension, side flexion (affected side), rotation (affected side) due to the ‘mechanical cervical traction with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in mechanical neck pain.

H3: There will be no difference in Neck Disability Index outcome measure of the ‘mechanical cervical traction with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in mechanical neck pain.

H4: There will be no difference in Grip Strength improvement of the ‘mechanical cervical traction with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in mechanical neck pain.

1.3.2 Alternate Hypothesis

A1: There will be difference in pain relief of the ‘mechanical cervical traction with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in mechanical neck pain.

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A2: There will be difference in improvement of ROM of cervical spine i.e. flexion, extension, side flexion (affected side), rotation (affected side) due to the ‘mechanical cervical traction with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in mechanical neck pain.

A3: There will be difference in Neck Disability Index outcome measure of the ‘mechanical cervical traction with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in mechanical neck pain.

A4: There will be difference in Grip Strength improvement of the ‘mechanical cervical traction with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in mechanical neck pain.

1.4 Benefits of the Study

This study will add to the growing body of knowledge regarding the benefit of

combining the cervical traction with conventional physiotherapy in the treatment

of MNP.

The expected outcome of this study was to show if these two therapy techniques

yield comparable outcomes and if one technique is superior to the next which

should be the alternate choice of therapy.

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CHAPTER 2 – REVIEW OF THE RELATED LITERATURE

2.1 Incidence and Prevalence of Neck Pain

The prevalence of neck pain in musculoskeletal practice is second only to that of

low back pain (Vernon et al., 2007). In a cross-sectional survey on neck pain

within the general Norwegian population, Bovim et al. found that 34.4% of the

9918 responders had experienced neck pain within the last year and 13.8%

reported neck pain lasting more than six months (Bovim et al., 1994). In a

Canadian epidemiological neck pain study (n = 1133), Côte et al. found that

the six month prevalence of neck pain was 54.2% (Côte et al., 2003).

Guez et al. did a population-based study on the prevalence of neck pain in

northern Sweden (n = 6000) and found that 43% of the population reported

neck pain (48% woman and 38% men) and 18% of the population (19%

woman and 13% men) had chronic neck pain (lasting longer than six months).

Thirteen percent of these cases were of a non-traumatic origin and only 5% were

traumatic (Guez et al., 2002).

In South Africa, Ndlovu did a survey (n = 1000) of the indigenous African

population within the greater Durban area and found that individuals between

the ages of 21 – 30 years of age had a 50% incidence of neck pain and individuals

between the ages of 31 – 60 years of age had a 46.7% - 54.5% incidence of neck

pain (Ndlovu, 2006).

Due to the high incidence and prevalence of neck pain, internationally it is very

important to further evaluate efficacy of treatment techniques in the form of

clinical trials to improve the prognosis of mechanical neck pain.

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2.2 Mechanical Neck Pain

There has been a slow but constant increase in the amount of attention

paid to neck pain due to its escalating costs and burden on society (Côte et

al., 2003). Twenty-six to 71% of the adult population can recall experiencing an

episode of neck pain or stiffness in their life time. Neck pain is more common in

females than in males, with rates reported as high as 77.8% (Graham et al., 2008).

The natural history is unclear. Neck pain has a costly impact on society because of

visits to health care providers, sick leave, disability and loss of productivity. There

are a number of treatments available for neck pain, one of which is mechanical

traction.

2.2.1 Definition, etiology, risk factors and diagnosis of mechanical neck

pain

The term mechanical neck pain (MNP) can be explained as the physical forces

acting upon the cervical spine.

Pain can be caused by abnormal stress and strain on the vertebral column

and surrounding structures through poor posture, lifting and sitting habits.

Gatterman; and Bergman et al. stated that the most common cause of mechanical

neck pain is zygapophyseal joint locking and muscle strain (Gatterman, 1998)

(Bergman et al., 1993).

According to Haldeman, the Bone and Joint Decade 2000-2010 Task Force on

Neck Pain and Associated Disorders suggested the following classification system

for neck pain (Haldeman et al., 2008):

Grade I: Neck pain with no or minor interference with daily activities

Grade II: Neck pain with major interference on activities of daily living

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Grade III: Neck pain with neurological signs and symptoms

Grade IV: Neck pain due to structural pathology

According to Binder, most patients present with “non-specific (simple) neck

pain” where the signs and symptoms have a postural or mechanical basis.

Therefore, for the purpose of this study mechanical neck pain will be

classified as either Grade I or Grade II according to the above classification

system (Binder, 2007).

Peterson and Bergman stated that any event or condition (e.g. incorrect

posture, ageing, acute injury, congenital or developmental defects) which

leads to altered joint mechanics or muscle structure or function, can result

in mechanical neck pain (Bergman & Peterson, 2002).

Risk factors for mechanical neck pain include work that is physically

demanding or of a repetitive static nature, those of lower socioeconomic

standing, individuals with a history of previous neck trauma and those with co-

morbid pathologies. It has also been shown that the incidence of neck pain

increases with age and is more common among woman (Côte et al., 2003).

The diagnosis of mechanical neck pain can be made according to the

following criteria (Grieve, 1988):

a) Local chronic cervical pain with or without arm pain

b) Juxtaposition of hypo- and hypermobile segments of the cervical

spine due to spondylitic changes

c) Asymmetrical neck pain that gets worse as the day progresses and is

aggravated by driving, reading etc.

d) Unilateral occipital pain and neck pain

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e) Restricted and painful movements, especially rotation and lateral

flexion to the painful side

f) Prominent Levator Scapulae and upper and middle Trapezeus muscle

2.2.2 Clinical Presentation

Patients complaining of MNP may experience symptoms such as a dull aching pain

which may be sharp in character during inflammatory periods. There may be

associated symptoms of decreased cervical spine range of motion, muscle

hypertonicity, pain and /or headaches. MNP may be defined as pain which is

aggravated by movement, relieved by rest and that is not associated with serious

underlying pathology (Hubka & Hall, 1994). The pain is predominantly localized to

the cervical spine. The pain may radiate into the head, shoulder or between the

scapulae, this is predominantly due to myofascial involvement (Travell et al.,

1999).

During the physical examination postural changes may be evident such as an

antalgic position of the head compared to the shoulder position, wry neck,

decreased cervical lordosis, and/or anterior head carriage (Vizniak & Carnes,

2008). Active, passive and/or resisted isometric movements may be limited

and/or painful (Vizniak & Carnes, 2008).

Probable causes of MNP may include cervical disc injuries/prolapse, whiplash,

myofascial strains, ligamentous sprains, arthritis of the cervical spine, cervical

spine injury and occupational habits such as, poor posture (Vizniak & Carnes,

2008), all pathologies that may have lead to instability and would be contra-

indicated to cervical traction were ruled out by way of an extensive history and

cervical spine regional examination.

2.3 Basic Normal Anatomy of Cervical spine

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The cervical spine consists of seven vertebrae, which are divided into typical

(C3-C6) and atypical (C1, C2 and C7) vertebrae (Gatterman, 1990). The vertebral

artery passes through the oval transverse foramina of C1 to C6 (Moore & Dalley,

1999). The vertebral body of typical cervical vertebrae is small and longer

from side to side than anteroposteriorly. The superior surface is concave

(which forms the uncinate joints laterally) and convex inferiorly. The uncinate

joints are also known as the joints of Luschka. Some consider these joints to be

degenerative spaces in the discs that are filled with extracellular fluid, while

others classify them as synovial type joints (Moore & Dalley, 1999) because they

have articular cartilage, a joint space, a synovial membrane, subchondral bone

and a joint capsule. These joints form a barrier to posterolateral disc

protrusion, thereby protecting the spinal cord. However, if they hypertrophy

narrowing of the intervertebral canal may occur which can lead to nerve root

entrapment (Porterfield & DeRosa, 1995).

On the posterior aspect of the vertebrae, the two pedicles and two laminae form

the neural arch (Panjabi & White, 1990) which forms the boundaries of the

triangular vertebral foramen (Haldeman, 1992). The spinous process, as well as

the two transverse processes, arise from the laminae (Panjabi & White, 1990).

The joints on the superior and inferior surfaces of the transverse processes are

known as zygapophyseal or facet joints. The facet joints are orientated

approximately 45° to the horizontal and 90° to the sagittal plane

(Haldeman, 1992). The superior facet of the facet joint is directed supero-

posteriorly and the inferior facet is directed in an infero-posterior direction

(Moore & Dalley, 1999). The joint capsules are richly innervated by the

sinuvertebral or recurrent meningeal nerve and nociceptive fibers. Therefore,

injury to this capsule will result in pain.

Each of the atypical vertebrae is unique in their own way. The atlas is the

first cervical vertebrae; it has no body or spinous process but instead two

lateral masses connected by anterior and posterior arches. The superior

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articular facets are concave to receive the occipital condyles of the skull.

The C2 vertebrae, known as the axis, has a odontoid peg which projects

superiorly from the body. The last cervical vertebrae (C7), also known as

vertebra prominence due to its long spinous process, which is not bifid like

the rest of the cervical spine. The transverse processes of C7 are large but the

transverse foramina are too small for the vertebral artery to pass through (Moore

& Dalley, 1999).

There are intervertebral discs in between all cervical vertebrae except C1

and C2. These discs make up one fourth of the length of the cervical spine.

They are thicker anteriorly, thereby contributing to the cervical lordosis (Moore

& Dalley, 1999).

2.4 Functional Biomechanics of Cervical Spine (Levangie & Norkin, 2005)

Although the cervical region demonstrates the most flexibility of any of the

regions of the vertebral column, stability of the cervical region, especially of the

atlanto-occipital and atlantoaxial joints, is essential for support of the head and

protection of the spinal cord and vertebral arteries. The design of the atlas is such

that it provides more free space for the spinal cord than does any other vertebra.

The extra space helps to ensure that the spinal cord is not impinged on during the

large amount of motion that occurs here. The bony configuration of the atlanto-

occipital articulation confers some stability, but the application of small loads

produces large rotations across the occipito-atlanto-axial complex and also across

the lower cervical spine.

2.4.1 Kinematics

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The cervical spine is designed for a relatively large amount of mobility. Normally,

the neck moves 600 times every hour whether we are awake or asleep. The

motions of flexion and extension, lateral flexion, and rotation are permitted in the

cervical region. These motions are accompanied by translations that increase in

magnitude from C2 to C7. However, the predominant translation occurs in the

sagittal plane during flexion and extension. Excessive anteroposterior translation

is associated with damage to the spinal cord.

The atlanto-occipital joints allow for only nodding movements between the head

and the atlas (Fig. 1). In all other respects, the head and atlas move together and

function as one unit. The deep walls of the atlantal sockets prevent translations,

but the concave shape does allow rotation to occur. In flexion, the occipital

condyles roll forward and slide backward. In extension, the occipital condyles roll

backward and slide forward. Axial rotation and lateral flexion are not physiological

motions at these joints, inasmuch as they cannot be produced by muscle action.

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Figure 1 Nodding motions of the atlanto-occipital joints. A. Flexion. B. Extension

There is little agreement about the extent of the range of motion (ROM) available

at the atlanto-occipital joints. The combined ROM for flexion-extension

reportedly ranges from 10° to 30°. The total ROM available in both axial rotation

and lateral flexion is extremely limited by tension in the joint capsules that occurs

as the occipital condyles rise up the walls of the atlantal sockets on the

contralateral side of either the rotation or lateral flexion.

Motions at the atlantoaxial joint include rotation, lateral flexion, flexion, and

extension. Approximately 55% to 58% of the total rotation of the cervical region

occurs at the atlantoaxial joints (Fig. 2). The atlas pivots about 45° to either side,

or a total of about 90°. The alar ligaments limit rotation at the atlantoaxial joints.

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The remaining 40% of total rotation available to the cervical spine is distributed

evenly in the lower joints.

The shape of the zygapophyseal joints and the interbody joints dictates the

motion at the lower cervical segments. Pure anterior translation does not occur,

because it would cause the zygapophyseal joints to abut one another. Flexion of

these segments must include anterior tilt of the cranial vertebral body coupled

with anterior translation. Given the 45° slope, tilt of the vertebral body, in

addition to anterior translation, is necessary to get full motion from these joints

(Fig. 3). Extension includes posterior tilt of the cranial vertebral body, coupled

with posterior translation. Lateral flexion and rotation are also coupled motions,

because movement of either alone would cause the zygapophyseal joints to abut

one another and prevent motion. Lateral flexion is coupled with ipsilateral

rotation, and rotation is coupled with ipsilateral lateral flexion. These motions are

also a combination of vertebral tilt to the ipsilateral side and translations at the

zygapophyseal joints.

Figure 2 Superior view of rotation at the atlantoaxial joints: The occiput and atlas pivot as one unit around the dens of the axis.

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Figure 3 A. Flexion of the lower cervical spinecombines anterior translation and sagittal plane rotation of the superior vertebra. B. Extension combines posterior translation with sagittal plane rotation.

Mercer and Bogduk suggested that the notion of lateral flexion and horizontal

rotation are an artificial construct (Mercer & Bogduk, 2001). In their view,

movement should be viewed as gliding that occurs in the plane of the

zygapophyseal joints (Fig. 4). In this plane, the coupled motions are evident.

Lower cervical segments generally favor flexion and extension ROM; however,

there is great variability in reported ranges of motion in the individual cervical

segments. In general, the range for flexion and extension increases from the

C2/C3 segment to the C5/C6 segment, and decreases again at the C6/C7 segment.

The zygapophyseal joint capsules and the ligaments, in addition to the shape of

the joints, dictate motions at all of the cervical segments. The zygapophyseal joint

capsules are generally lax in the cervical region, which contributes to the large

amount of motion available here. The height in relation to the diameter of the

disks also plays an important role in determining the amount of motion available

in the cervical spine. The height is large in comparison with the anteroposterior

and transverse diameters of the cervical disks. Therefore, a large amount of

flexion, extension, and lateral flexion may occur at each segment, especially in

young persons, when there is a large amount of water in the disks.

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Figure 4 Motion at the lower cervical interbody joints occurs in the plane of the zygapophyseal joints about an axis perpendicular to the plane.

The disk at C5/C6 is subject to a greater amount of stress than other disks

because C5/C6 has the greatest range of flexion-extension and is the area where

the mechanical strain is greatest.

2.4.2 Kinetics

Although the cervical region is subjected to axial compression, tension, bending,

torsion, and shear stresses as in the remainder of the spinal column, there are

some regional differences. The cervical region differs from the thoracic and

lumbar regions in that the cervical region bears less weight and is generally more

mobile.

No disks are present at either the atlanto-occipital or atlantoaxial articulations;

therefore, the weight of the head (compressive load) must be transferred directly

through the atlanto-occipital joint to the articular facets of the axis. These forces

are then transferred through the pedicles and laminae of the axis to the inferior

surface of the body and to the two inferior zygapophyseal articular processes.

Subsequently, the forces are transferred to the adjacent inferior disk. The laminae

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of the axis are large, which reflects the adaptation in structure that is necessary to

transmit these compressive loads. The trabeculae show that the laminae of both

the axis and C7 are heavily loaded, whereas the intervening ones are not. Loads

diffuse into the lamina as they are transferred from superior to inferior articular

facets.

The loads imposed on the cervical region vary with the position of the head and

body and are minimal in a well-supported reclining body posture. In the cervical

region from C3 to C7 compressive forces are transmitted by three parallel

columns: a single antero-central column formed by the vertebral bodies and disks

and two rod-like posterolateral columns composed of the left and right

zygapophyseal joints. The compressive forces are transmitted mainly by the

bodies and disks, with a little over one third transmitted by the two posterolateral

columns. Compressive loads are relatively low during erect stance and sitting

postures and high during the end ranges of flexion and extension. Cervical motion

segments tested in bending and axial torsion exhibit less stiffness than do lumbar

motion segments but exhibit similar stiffness in compression. In an experiment

with cadaver specimens, combinations of sagittal loads in vitro demonstrated that

the midcervical region from C2 to C5 is significantly stiffer in compression and

extension from C5 to T1. Specimens that were axially rotated before being tested

in flexion and compression failed at a lower flexion angle (17°) than at the mean

angle (25°) of nonaxially rotated specimens. The implication is that the head

should be held in a nonrotated position during flexion/extension activities to

reduce the risk of injury.

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2.5 Cervical Spine Traction

2.5.1 Introduction

Gatterman (1990) defines spinal traction as the application of a drawing or a

pulling force along the long axis of the spine in order to stretch the soft tissues,

separate joint surfaces, and to separate bony fragments (Gatterman, 1990).

Traction is a method in which a distracting force is applied in order to stretch soft

tissues and separate articulating surfaces. Traction is often used as preparation

for other mobilization or manipulation procedures, since it is believed that

stretching of the muscles will lead to relaxation, thus improving local circulation

and diminishing pain.

Traction’s main effects on the vertebral structures are mechanical, consisting of

stretching of muscles and ligaments, distraction of vertebral bodies, separation of

facet joints, and enlargement of the intervertebral foramina. Although the

etiology of long standing pain is often difficult to be established, traction as a

therapeutic modality is frequently used with success (Tollison, 1989).

The term traction refers to the process of pulling one body in relationship to

another, which results in separation of two bodies. Traction is passive

translational movement of a joint, which occurs at right angles to the plane of the

joint between two bones, resulting in separation of joint surfaces (Bergman &

Davis, 1998). If a traction force is applied to a non-uniform structure, the greatest

stretch will be found at the weakest link, which will be the cervical spine in a

human body (Kekosz et al., 1986) .

In the treatment of the cervical spine, traction may be applied either manually or

by a mechanical apparatus. With mechanical traction the head is harnessed in a

halter that is attached to a crossbar that is either weighted or connected to a

mechanical device. Traction may be applied either in an upright sitting position or

with the patient in a supine lying position. In this position, the body and the

surface on which it lies provide the necessary counterforce. The angle of pull is

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usually maintained at 20-25° of forward flexion, in an attempt to open the

intervertebral foramina (Tollison, 1989).

2.5.2 Indication for Cervical Spine Traction

General clinical indications for traction are degenerative disc disease, with or

without nerve root irritation, herniated intervertebral disc (except central disc

herniation which may induce cord compression), and facet joint osteoarthritis and

capsulitis (Kekosz et al., 1986). Gatterman (1990) states that intervertebral disc

protrusion, facet syndrome, nerve root compression, spondylolisthesis,

retrolisthesis, discogenic spondyloarthrosis and muscle spasm are indications for

traction (Gatterman, 1990).

2.5.3 Types of Cervical spine Traction

Types of spinal traction include continuous traction, sustained mechanical

traction, intermittent mechanical traction, manual traction and gravitational

traction. Continuous spinal traction can be applied for as long as several hours at

a time, with this extended time of traction, small amount of traction should be

used. Sustained mechanical traction involves traction that varies from a few

minutes to half an hour of traction, the shorter duration is accompanied with

heavier weights. Intermittent mechanical traction utilizes a mechanical device

that alternately applies and releases traction every few seconds. Manual traction

is applied for few seconds through the therapist grasping the patient.

Gravitational traction utilizes the patient’s own weight or a percentage thereof to

traction the segment, in need of traction (Saunders, 1985). Especially when

treating herniated disc or irritable conditions, static mode of traction is preferred

(Saunders & Saunders, 1993). Sustained (static) mechanical traction involves

application of a constant amount of traction for periods varying from a few

minutes to half an hour (Saunders, 1985).

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2.5.4 Most effective positions for applying cervical traction

A comparative study was conducted between sitting and supine position for

cervical traction. Eight female students, ranging in age from 21-27 years, weighing

from 40-65 Kg, and with no history of cervical spine pathology were evaluated for

traction. The students were fitted with a 45° flexion halter designed to achieve

maximum pull force when placed on the occiput. X-rays were taken at 0 Kg, 14 Kg

and 18 Kg of traction force, and then measurement from C4-C7 vertebrae were

taken which determined the amount of separation. The result supported the use

of the supine position when administering cervical traction. The advantages were

greater posterior vertebral separation, increased relaxation, decreased muscle

guarding, increased stability, less force required to overcome head weight, and

diminished anterior anatomical curve of the cervical spine (Deets et al., 1977).

2.5.5 Force to be used in cervical spine traction

With regard to the increase in traction force, one study looked at the effects, that

traction produces. They state that with the initial traction force applied there is

no appreciable joint separation because the force applied needs to nullify the

compressive forces that are the result of muscle tension and cohesive forces

between articular surfaces. Then, as the traction force increases, it produces

tightening in the tissues surrounding the joint, which is described as “taking up

slack”. Also, with the traction force increased further, it produces a stretching

effect into the tissues crossing the joint (Bergman & Davis, 1998).

2.5.6 Optimum angle for cervical spine traction

Traditionally cervical traction is done with the neck in some degree of flexion.

Some clinicians believe that the greater the angle of flexion, the greater the

intervertebral separation in the lower cervical spine. With flexion at 20° and 24°

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compression of the anterior structures actually occurs. The recommended

optimum angle for cervical traction is 15° flexion of pull for nearly every clinical

condition (Saunders & Saunders, 1993).

2.5.7 Effects of Cervical spine Traction

Saunders (1985) stated that spinal traction correctly performed can produce

many positive effects. Among these are distractions or separations of vertebral

bodies, a combination of distraction and gliding of facet joints, tensing of

ligamentous structures of the spinal segment, widening of the intervertebral

foramen, straightening of spinal curves, and stretching of spinal musculatures.

Medical treatment of musculoskeletal neck pain involves either conservative or

surgical treatment. For conservative treatment, traction is thought to be effective,

particularly in the treatment of neck pain with associated radicular symptoms.

Seventy to eighty percent of patients with radicular symptoms can be treated

conservatively, which includes oral medication, soft collars, cervical traction, and

other physiotherapy modalities (Alcantara et al., 2001).

The human body is provided with certain inherent qualities that provide for the

protection, maintenance, and restoration of health, of which the normal function

of the nervous system is major integrating force. In view of this literature review it

is clear to see that cervical spine traction have the potential to assist the body in

maintaining and restoring good health.

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CHAPTER 3 – METHODOLOGY

3.1 Introduction

The purpose of this chapter is to describe the research, the participant

recruitment process and the treatment protocol followed as well as the

assessments and the type of measurements recorded.

3.2 Aim of Study

The aim of the study is to compare the efficacy of ‘mechanical cervical traction

with conventional physiotherapy’ and ‘conventional physiotherapy alone’ in

mechanical neck pain. Here efficacy is measured on the basis of following

outcome measures: Neck Disability Index (NDI), Numerical Pain Rating Scale

(NPRS), and Goniometry for cervical range of motion.

3.3 STUDY DESIGN

This was a randomized two group parallel controlled clinical trial, utilizing

convenience sampling. A sample group of 40 symptomatic participants was used.

3.4 SUBJECT RECRUITMENT

This study was conducted using symptomatic participants only and all volunteers

were screened prior to their acceptance into the study based on the inclusion and

exclusion criteria.

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3.4.1 Sample and Selection Criteria

Non-probability convenience sampling was used to obtain 40 participants with

chronic mechanical neck pain. These participants were then randomly assigned

into one of the two treatment groups (20 per group) using a computer

generated random allocation randomized table.

3.5 INCLUSION AND EXCLUSION CRITERIA

The following criteria were used to include/exclude subjects in the research:

3.5.1 Inclusion criteria

(a) Participants/patients had to be between the ages of 18 and 45 years as this

would exclude those patients who are more likely to have osteoarthritis which

is most commonly seen in the fifth and sixth decade of life (Yochum &

Rowe, 2005).

(b) Neck pain of a minimum duration of six weeks. This classified the neck pain

as chronic (Grieve, 1988).

(c) Signed informed consent form.

(d) Numerical pain rating scale [0-10]: scores between 4-9 to ensure group

homogeneity.

(e) The diagnosis of mechanical neck pain was made using the following

criteria (Grieve, 1988):

o Local chronic cervical pain with or without arm pain

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o Juxtaposition of hypo- and hypermobile segments of the cervical spine

due to spondylitic changes

o Asymmetrical neck pain that gets worse as the day progress and is

aggravated by driving, reading etc

o Unilateral occipital and neck pain

o Restricted and painful movements, especially rotation and lateral flexion

to the painful side.

(f) Special orthopedic tests: A positive test will indicate pain at the level

of dysfunction (Gatterman, 1998). Two of the following three tests had to

be present.

Kemp’s test: Performed with the patient in the seated position with the

researcher behind them. The cervical spine was placed into a combination

of rotation, lateral flexion and extension. Pain was felt at the level of

dysfunction.

Cervical compression test: performed by applying manual downward

pressure on top of the patient’s head.

Lateral compression test: Performed with cervical spine in lateral flexion

of the head toward the painful side and applying downward pressure.

All three of these tests cause stress on the facet joint and narrowing of the

intervertebral foramen. Pain radiating down the arm indicates a

radiculopathy and local pain suggests a facet joint dysfunction (Magee,

2006).

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3.5.2 Exclusion criteria

(a) Neck pain that was not of mechanical origin (Doherty et al., 2002) e.g.:

Inflammatory – infections, rheumatoid arthritis, spondylitis,

polymyalgia rheumatica, juvenile idiopathic arthritis.

Metabolic – osteoporosis, Paget’s disease, osteomalacia.

Neoplasia – metastases, myeloma, intrathecal tumors.

Other – fibromyalgia.

Referred pain – pharynx, aortic aneurysm, Pancoast tumor,

diaphragm, angina pectoris, teeth, cervical lymph nodes.

Neurological – nerve root entrapment and disc herniations in

the cervical spine.

(b) Patients with recent major trauma or fracture of the cervical spine.

(c) Patients whose primary complaint is that of headaches or facial

pain associated with neck pain.

(d) Any patient taking anti-inflammatory or muscle relaxant medication

would need to have a three day “wash out” period before participating in

the study (Seth, 1999).

3.6 RESEARCH METHODOLOGY/PROCEDURE

Once the participant was diagnosed with chronic mechanical neck pain, they were

then given the opportunity to ask any further questions and were informed

that they may withdraw from the study should they wish to do so. The

participant was then randomly allocated via using a computer generated

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random allocation randomized table into one of two groups; group A:

Mechanical cervical traction with conventional therapy, group B: Conventional

therapy alone.

3.6.1 Treatment Group A – Mechanical cervical traction with conventional

therapy.

Group A participants; intervention will be given in the form of conventional

therapy plus Mechanical cervical traction.

Mechanical cervical traction will be given with a motorized traction machine

in the form of intermittent traction for 20 minutes with hold time 40 seconds

and rest time 10 seconds in supine position with 15° of neck flexion.

For Ultrasound, position of the participant will be in sitting with head

support. Participants will be treated with Ultrasound 1.5 Watt/cm2 for 8

minutes and after proper positioning of participant and therapist, ultrasound

is administered with proper instruction.

For Isometric neck exercises, position of the participant will be in sitting and

therapist will stand behind the patient. Isometric neck exercises are applied

with 15 repetitions for each of flexion, extension, lateral flexion and cervical

rotation with 5 seconds of hold time.

Same isometric exercises will be repeated at home in the evening.

3.6.2 Treatment Group B – Conventional therapy alone.

Group B participants; intervention will be given in the form of conventional

therapy. Participants will be treated with Ultrasound 1.5 Watt/cm2 for 8

minutes and for Ultrasound, position of the participant will be in sitting with

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head support. After proper positioning of participant and therapist,

ultrasound is administered with proper instruction.

For Isometric neck exercises, position of the participant will be in sitting and

therapist will stand behind the patient. Isometric neck exercises are applied

with 15 repetitions for each of flexion, extension, lateral flexion and cervical

rotation with 5 seconds of hold time.

Same isometric exercises will be repeated at home in the evening, that

means isometric exercise is done twice daily.

3.7 MEASUREMENTS

3.7.1 Objective measurements

To obtain objective measurements, the Universal Goniometer was used. This

instrument is discussed below:

3.7.1.1 Universal Goniometer

It was found that goniometric measurements of AROM of the cervical spine made

by the same physical therapist had ICCs greater than .80 when made with the

CROM device or the Universal Goniometer (UG). When different physical

therapists measured the same patient's cervical AROM, the CROM device had

ICCs greater than .80, whereas the UG and Visual Estimation generally had ICCs

less than .80 (Youdas et al., 1991). Though CROM device is better than universal

goniometer in measuring Cervical ROM but universal goniometer can be used as

second choice due to unavailability of CROM device.

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3.7.2 Subjective measurements

To quantify subjective outcomes, the patients were asked to complete the

Neck Disability Index form and the Numerical Pain Rating Scale form. These

two measurement tools are described below:

3.7.2.1 Neck Disability Index (NDI)

The NDI is a 10-item questionnaire that measures a patient’s self-reported neck

pain related disability. Questions include activities of daily living, such as: personal

care, lifting, reading, work, driving, sleeping, recreational activities, pain intensity,

concentration and headache. The questions are measured on a six-point scale

from 0 (no disability) to 5 (full disability). The numeric response for each item is

summed for a total score ranging from 0 to 50 (MacDermid et al., 2009). A higher

NDI score indicates a greater patient’s perceived disability. The reliability (intra-

class correlation co-efficient [ICC]: 0.73 to 0.98), construct validity, and

responsiveness to change have all been demonstrated in various populations

(MacDermid et al., 2009). For patients with cervical radiculopathy, the minimal

detectable change is 10 points, and the clinically important difference is 7 points

(Cleland et al., 2006).

3.7.2.2 Numerical Pain Rating Scale

The level of upper limb and neck pain will be captured with the NPRS. Using an

11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable),

participants will be asked to answer the following question: “On a scale of 0 to 10,

where 0 corresponds to no pain and 10 to the worst imaginable pain, evaluate t

he intensity of your neck pain at this moment”. The NPRS is frequently used in

clinical studies in association with the NDI (Young et al., 2009), (Cleland et al.,

2008), (Childs et al., 2005). The NPRS is moderately reliable (ICC = 0.76) (Cleland

et al., 2008), and has a clinically important difference of 20% (Childs et al., 2005).

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CHAPTER 4 – DATA ANALYSES AND INTERPRETATION

4.1 Statistical analyses

Since the outcome measures were measured at multiple time intervals and

generated interval data, repeated measures of ANOVA was used as primary

statistical analysis for within-group comparisons. Between-group differences at

each follow-up period were investigated with unpaired t-tests and within group

with paired t-test. For the total group correlation analysis was done. Statistical

significance was set at p<0.05 for all statistical analyses. Shapiro-Wilk test was

used to check the normality and all the data analysis was done in IBM SPSS

version 20.0.

4.2 Results

Table 1 : Demographical characteristics

Group Frequency %

Mechanical traction and conventional therapy

20 50

Conventional Therapy 20 50

Sex - Traction Group

Male 11 55

Female 9 45

Sex - Conventional Group

Male 8 40

Female 12 60

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Table 2 : Demographic & clinical characteristics

Characteristics of Treatment Groups

Mean Traction Group

SD-Traction Group

Mean Conventional

Group

SD-Conventional

Group

Age 37.9000 7.86665 47.0500 7.69467

Height 158.2750 10.06489 156.0500 9.78976

Weight 60.8500 6.59565 61.8500 8.47457

Flex_Cx_Base_Active 26.5000 3.50188 27.4500 6.12566

Ext_Cx_Base_Active 34.4500 4.52449 34.3500 4.63709

Sd_Flex_Affectd_Base_Active 26.7500 1.86025 26.6500 1.87153

Rot_Affectd_Base_Active 34.9500 5.07289 37.2500 7.72470

Flex_Cx_wk1_Active 31.7000 3.06251 30.7500 6.49595

Ext_Cx_wk1_Active 40.1000 3.66922 35.1500 4.02982

Sd_Flex_Affectd_wk1_Active 35.6000 1.72901 31.1000 1.71372

Rot_Affected_wk1_Active 44.7500 3.65449 39.1000 6.25679

Flex_Cx_wk2_Active 36.5000 3.48682 34.6500 6.15822

Ext_Cx_wk2_Active 46.1000 3.40124 39.4500 3.85903

Sd_Flex_Afftectd_wk2_Active 37.9500 2.25890 35.7500 2.98901

Rot_Affectd_wk2_Active 51.1500 2.79614 44.0000 7.25476

NPRS_Base 8.2500 .55012 8.1500 .58714

NPRS_wk1 5.1500 .93330 6.3500 .67082

NPRS_wk2 3.2500 1.11803 4.8000 .83351

NDI_Base 44.8870 7.58888 39.7725 11.45592

NDI_Wk2 17.9005 2.54663 27.3810 7.36998

4.2.1 One way repeated measure ANOVA for within group difference

Flexion

A repeated measures ANOVA with a Greenhouse-Geisser correction determined that in the traction group, the mean flexion scores differed statistically significantly between measured time points i.e. baseline, week 1 and week 2; F (1.584, 30.103) = 346.90, p < 0.0005. We can, therefore, conclude that the

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traction invention program elicits a significant improvement of 10o through the baseline to week 2. In conventional group, the mean flexion scores differed statistically significantly between measured time points i.e. baseline, week 1 and week 2; F (1.336, 25.388) = 151.727, p<0.0005. We can, therefore, conclude that the conventional program elicits a statistically significant improvement 7.2o through the baseline to week 2.

Pair-wise Comparisons of Flexion Table 3 : Measure- Flexion- Traction Group

(I) factor1 (J) factor1 Mean

Difference

(I-J)

Std. Error Sig.b 95% Confidence Interval for

Differenceb

Lower Bound Upper Bound

1 2 -5.200* .304 .000 -5.999 -4.401

3 -10.000* .465 .000 -11.219 -8.781

2 1 5.200* .304 .000 4.401 5.999

3 -4.800* .352 .000 -5.725 -3.875

3 1 10.000* .465 .000 8.781 11.219

2 4.800* .352 .000 3.875 5.725

Based on estimated marginal means

*. The mean difference is significant at the .05 level.

b. Adjustment for multiple comparisons: Bonferroni.

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Table 4 : Measure- Flexion- Conventional Group

(I) factor1 (J) factor1 Mean

Difference

(I-J)

Std. Error Sig.b 95% Confidence Interval for

Differenceb

Lower Bound Upper Bound

1 2 -3.300* .291 .000 -4.064 -2.536

3 -7.200* .536 .000 -8.607 -5.793

2 1 3.300* .291 .000 2.536 4.064

3 -3.900* .376 .000 -4.888 -2.912

3 1 7.200* .536 .000 5.793 8.607

2 3.900* .376 .000 2.912 4.888

Based on estimated marginal means

*. The mean difference is significant at the .05 level.

b. Adjustment for multiple comparisons: Bonferroni.

Extension A repeated measures ANOVA with a Greenhouse-Geisser correction determined that in the traction group, the mean extension scores differed statistically significantly between measured time points i.e. baseline, week 1 and week 2; F (1.608, 30.550) = 152.603, P < 0.0005. We can, therefore, conclude that the traction group elicits a statistically significant improvement of 11.65o through the baseline to week 2. In conventional group, the mean extension scores differed statistically significantly between measured time points (F (1.411, 26.811) = 20.295. p<0.0005. We can, therefore, conclude that the conventional intervention program elicits a statistically significant improvement of 5.1o through the baseline to week 2.

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Pair-wise Comparisons of Extension Table 5 : Measure- Extension – Traction Group

(I) factor1 (J) factor1 Mean

Difference

(I-J)

Std. Error Sig.b 95% Confidence Interval for

Differenceb

Lower Bound Upper Bound

1 2 -5.650* .670 .000 -7.409 -3.891

3 -11.650* .796 .000 -13.739 -9.561

2 1 5.650* .670 .000 3.891 7.409

3 -6.000* .503 .000 -7.319 -4.681

3 1 11.650* .796 .000 9.561 13.739

2 6.000* .503 .000 4.681 7.319

Based on estimated marginal means

*. The mean difference is significant at the .05 level.

b. Adjustment for multiple comparisons: Bonferroni.

Table 6 : Measure- Extension – Conventional Group

(I) factor1 (J) factor1 Mean

Difference (I-

J)

Std. Error Sig.b 95% Confidence Interval for

Differenceb

Lower Bound Upper Bound

1 2 -.800 1.033 1.000 -3.511 1.911

3 -5.100* .940 .000 -7.568 -2.632

2 1 .800 1.033 1.000 -1.911 3.511

3 -4.300* .524 .000 -5.675 -2.925

3 1 5.100* .940 .000 2.632 7.568

2 4.300* .524 .000 2.925 5.675

Based on estimated marginal means

*. The mean difference is significant at the .05 level.

b. Adjustment for multiple comparisons: Bonferroni.

Side-Flexion

A repeated measures ANOVA with a Greenhouse-Geisser correction determined that in the traction group, the mean side flexion scores differed statistically significantly between measured time points i.e. baseline, week 1 and week 2; F (1.941, 36.874) = 270.229, p<0.0005. We can, therefore, conclude that the

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traction group elicits a significant improvement of 11.2o through the baseline to week 2. In conventional group, the mean flexion scores differed statistically significantly between measured time points i.e. baseline, week 1 and week 2; F (1.214, 23.074) = 134.385 p<0.0005. We can, therefore, conclude that the conventional invention program elicits a statistically significant improvement 9.1o through the baseline to week 2.

Pair-wise Comparisons of Side Flexion Table 7 : Measure- Side Flexion – Traction Group

(I) factor1 (J) factor1 Mean

Difference (I-

J)

Std. Error Sig.b 95% Confidence Interval for

Differenceb

Lower Bound Upper Bound

1 2 -8.850* .488 .000 -10.131 -7.569

3 -11.200* .551 .000 -12.645 -9.755

2 1 8.850* .488 .000 7.569 10.131

3 -2.350* .483 .000 -3.617 -1.083

3 1 11.200* .551 .000 9.755 12.645

2 2.350* .483 .000 1.083 3.617

Based on estimated marginal means

*. The mean difference is significant at the .05 level.

b. Adjustment for multiple comparisons: Bonferroni.

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Table 8 : Measure- Side Flexion – Conventional Group

(I) factor1 (J) factor1 Mean

Difference

(I-J)

Std. Error Sig.b 95% Confidence Interval for

Differenceb

Lower Bound Upper Bound

1 2 -4.450* .294 .000 -5.223 -3.677

3 -9.100* .718 .000 -10.984 -7.216

2 1 4.450* .294 .000 3.677 5.223

3 -4.650* .568 .000 -6.141 -3.159

3 1 9.100* .718 .000 7.216 10.984

2 4.650* .568 .000 3.159 6.141

Based on estimated marginal means

*. The mean difference is significant at the .05 level.

b. Adjustment for multiple comparisons: Bonferroni.

Rotation

A repeated measures ANOVA with a Greenhouse-Geisser correction determined that in the traction group, the mean rotation scores differed statistically significantly between baseline, week 1 and week 2; F (1.806, 34.375) = 254.165, p<0.0005. We can, therefore, conclude that the traction group elicits a statistically significant improvement of 16.2o through the through the baseline to week 2. In conventional group, the mean rotation scores differed statistically significantly between baseline, week 1 and week 2; F (1.862, 35.370) = 127.181, p<0.0005. We can, therefore, conclude that the conventional invention program elicits a statistically significant improvement 6.789o through the baseline to week 2.

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Pair-wise Comparisons of Rotation Table 9 : Measure- Rotation – Traction Group

(I) factor1 (J) factor1 Mean

Difference

(I-J)

Std. Error Sig.b 95% Confidence Interval for

Differenceb

Lower Bound Upper Bound

1 2 -9.800* .698 .000 -11.633 -7.967

3 -16.200* .829 .000 -18.376 -14.024

2 1 9.800* .698 .000 7.967 11.633

3 -6.400* .630 .000 -8.054 -4.746

3 1 16.200* .829 .000 14.024 18.376

2 6.400* .630 .000 4.746 8.054

Based on estimated marginal means

*. The mean difference is significant at the .05 level.

b. Adjustment for multiple comparisons: Bonferroni.

Table 10 : Measure- Rotation – Conventional Group

(I) factor1 (J) factor1 Mean

Difference

(I-J)

Std. Error Sig.b 95% Confidence Interval for

Differenceb

Lower Bound Upper Bound

1 2 -1.850* .393 .000 -2.880 -.820

3 -6.750* .422 .000 -7.858 -5.642

2 1 1.850* .393 .000 .820 2.880

3 -4.900* .492 .000 -6.190 -3.610

3 1 6.750* .422 .000 5.642 7.858

2 4.900* .492 .000 3.610 6.190

Based on estimated marginal means

*. The mean difference is significant at the .05 level.

b. Adjustment for multiple comparisons: Bonferroni.

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44

NPRS

A repeated measures ANOVA with a Greenhouse-Geisser correction determined that in the traction group, the mean NPRS scores differed statistically significantly between baseline, week 1 and week 2; F (1.872, 35.568) = 261.216, p<0.0005. We can, therefore, conclude that the traction group elicits a significant improvement of pain reduction -5.000 through the baseline to week 2. In conventional group, the mean rotation scores differed statistically significantly between measured time points (F (1.737, 33.004) = 143.371, p<0.0005. We can, therefore, conclude that the conventional group treatment elicits a statistically significant improvement of pain reduction -3.330 through the baseline to week 2.

Pair-wise Comparisons of NPRS Table 11 : Measure- NPRS- Traction Group

(I) factor1 (J) factor1 Mean

Difference

(I-J)

Std. Error Sig.b 95% Confidence Interval for

Differenceb

Lower Bound Upper Bound

1 2 3.100* .191 .000 2.600 3.600

3 5.000* .229 .000 4.398 5.602

2 1 -3.100* .191 .000 -3.600 -2.600

3 1.900* .240 .000 1.271 2.529

3 1 -5.000* .229 .000 -5.602 -4.398

2 -1.900* .240 .000 -2.529 -1.271

Based on estimated marginal means

*. The mean difference is significant at the .05 level.

b. Adjustment for multiple comparisons: Bonferroni.

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45

Table 12 : Measure- NPRS – Conventional Group

(I) factor1 (J) factor1 Mean

Difference

(I-J)

Std. Error Sig.b 95% Confidence Interval for

Differenceb

Lower Bound Upper Bound

1 2 1.800* .186 .000 1.311 2.289

3 3.350* .233 .000 2.740 3.960

2 1 -1.800* .186 .000 -2.289 -1.311

3 1.550* .170 .000 1.104 1.996

3 1 -3.350* .233 .000 -3.960 -2.740

2 -1.550* .170 .000 -1.996 -1.104

Based on estimated marginal means

*. The mean difference is significant at the .05 level.

b. Adjustment for multiple comparisons: Bonferroni.

Graph 1: Comparison of NPRS between groups

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46

4.2.2 Independent t-test for between groups difference

The value of two tailed significance is more than .05 (p>.05) for all baseline

flexion, extension, side-flexion, rotation and NPRS. There is no significant

difference in between groups’ scores of week 1 and week 2 flexion scores. The

value of two tailed significance is less than .05 (p<.05) for extension week 1, side-

flexion week 1, rotation week 1, extension week 2, side-flexion week 2, rotation

week 2 and NPRS week 1 and week 2 scores between groups shows that there is

a significant difference in their scores.

Table 13 : Between Groups differences independent t-test

t df Sig. (2-tailed)

Flex_Cx_Base_Active

Equal variances assumed -.602 38 .551

Equal variances not

assumed -.602 30.220 .552

Ext_Cx_Base_Active

Equal variances assumed .069 38 .945

Equal variances not

assumed .069 37.977 .945

Sd_Flex_Affectd_Base_Act

ive

Equal variances assumed .169 38 .866

Equal variances not

assumed

.169 37.999 .866

Rot_Affectd_Base_Active

Equal variances assumed -1.113 38 .273

Equal variances not

assumed -1.113 32.818 .274

Flex_Cx_wk1_Active

Equal variances assumed .592 38 .558

Equal variances not

assumed

.592 27.048 .559

Ext_Cx_wk1_Active Equal variances assumed 4.062 38 .000

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47

Equal variances not

assumed

4.062 37.671 .000

Sd_Flex_Affectd_wk1_Acti

ve

Equal variances assumed 8.267 38 .000

Equal variances not

assumed

8.267 37.997 .000

Rot_Affected_wk1_Active

Equal variances assumed 3.487 38 .001

Equal variances not

assumed

3.487 30.612 .002

Flex_Cx_wk2_Active

Equal variances assumed 1.169 38 .250

Equal variances not

assumed

1.169 30.047 .252

Ext_Cx_wk2_Active

Equal variances assumed 5.781 38 .000

Equal variances not

assumed

5.781 37.410 .000

Sd_Flex_Afftectd_wk2_Act

ive

Equal variances assumed 2.626 38 .012

Equal variances not

assumed 2.626 35.365 .013

Rot_Affectd_wk2_Active

Equal variances assumed 4.113 38 .000

Equal variances not

assumed 4.113 24.523 .000

NPRS_Base

Equal variances assumed .556 38 .582

Equal variances not

assumed .556 37.840 .582

NPRS_wk1

Equal variances assumed -4.669 38 .000

Equal variances not

assumed -4.669 34.496 .000

NPRS_wk2

Equal variances assumed -4.971 38 .000

Equal variances not

assumed -4.971 35.136 .000

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48

4.2.3 NDI within Groups

The value of two tailed significance is less than .05 (p<.05) for traction group

shows that there is a significant difference in NDI score through the baseline and

week two with t (19) = 15.759. The mean difference was 26.98.

The value of two tailed significance is less than .05 (p<.05) for conventional group

shows that there is a significant difference in NDI score through the measure

times between baseline and week two with t (19)=6.541. The mean difference

was 14.03.

So it can be stated that the traction group benefited with more reduction of NDI

score.

Table 14 : Paired Sample t-test

Paired Differences t df Sig. (2-

tailed) Mean Std.

Deviation

Std. Error

Mean

95% Confidence Interval of

the Difference

Lower Upper

Pair

1

NDIbasetrac -

NDItracweek2 26.98650 7.65831 1.71245 23.40230 30.57070 15.759 19 .000

Pair

2

NDIbasecon -

NDIweek2con 12.94700 8.85256 1.97949 8.80387 17.09013 6.541 19 .000

4.2.4 NDI between Groups

The value of two tailed significance is more than .05 (p>.05) for NDI baseline

scores between groups shows that there is no significant difference in NDI score

t(38)=1.664. The value of two tail significance is less than .05 (p<.05) for week two

NDI scores between groups shows that there is a significant difference in NDI

score through the baseline and week 2 with t(38) = -5.437. The mean difference

was -9.480. So, the traction group benefited with more reduction of NDI score.

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49

Graph 2: Comparison of NDI between groups

Table 15 : Independent Sample t-Test

Levene's Test for

Equality of

Variances

t-test for Equality of Means

F Sig. t df Sig. (2-

tailed)

Mean

Difference

Std. Error

Difference

95% Confidence Interval

of the Difference

Lower Upper

NDI_Base

Equal variances

assumed 5.902 .020 1.664 38 .104 5.11450 3.07270 -1.10585 11.33485

Equal variances

not assumed

1.664 32.983 .105 5.11450 3.07270 -1.13707 11.36607

NDI_Wk2

Equal variances

assumed 14.047 .001 -5.437 38 .000 -9.48050 1.74359 -13.01021 -5.95079

Equal variances

not assumed

-5.437 23.473 .000 -9.48050 1.74359 -13.08336 -5.87764

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50

4.2.5 Correlation analysis for both the groups at week 2

The bivariate correlation analysis among the variables for both the two groups

showed flexion and extension at week two negatively influencing NDI score

(r= -.413, -.543). Flexion contributes to extension(r=.586) and extension and side

flexion contributes to rotation(r=.336, .443) positively. Extension negatively

influencing the NPRS scores(r=-.470) and NPRS score contributes positively to NDI

score at week two(r=.639).

Table 16 : Correlations (N=40)

Flex_Cx_wk2_A

ctive

Ext_Cx_wk2_Ac

tive

Sd_Flex_

Afftectd

_wk2_Ac

tive

Rot_Affectd

_wk2_Activ

e

NPRS_

wk2

NDI_W

k2

Flex_Cx_wk2_Active

1 .586**

.015 -.157 -.304 -.413**

.000 .926 .335 .056 .008

40 40 40 40 40

Ext_Cx_wk2_Active

1 .135 .336* -.470

** -.543

**

.406 .034 .002 .000

40 40 40 40

Sd_Flex_Afftectd_wk2_Act

ive

1 .433**

-.165 -.281

.005 .309 .079

40 40 40

Rot_Affectd_wk2_Active

1 -.024 -.111

.884 .497

40 40

NPRS_wk2

1 .639**

.000

40

NDI_Wk2

1

**. Correlation is significant at the 0.01 level (2-tailed).

*. Correlation is significant at the 0.05 level (2-tailed).

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51

4.3 Limitations of Study

In this study data should have been collected by independent observer, which

was not feasible in this study.

Misunderstanding of NPRS and NDI questionnaire may have affected their

response, and therefore the outcome of results.

Regarding the objective measurements, the results from the study could have

been faulty due to both human errors when reading calibrations and the possible

risk of incorrect user methods.

The outcome of the study could have been more significant when looking at the

sample group; the small sample group may have failed to provide significant

information that could have been available from a large sample size.

4.4 Discussion

The effect of cervical traction for mechanical neck pain in short term is subject to

debate and controversies. The aim of the present study was to find out the reality

and the present study showed some positive results in the traction group patients

with conventional physiotherapy treatment; compared with conventional

physiotherapy alone. The difference of mean score of flexion, extension, side

flexion and rotation is 2.8o, 6.4o, 2.1o and 9.4o between the traction group and

conventional group at the end of two weeks treatment; which was gained by

adding traction as treatment along with conventional physiotherapy treatment.

The extension and rotation was also convincing in terms of improvement for

inclusion of traction as treatment.

Traction therapy for the cervical spine involves a tractive force applied to the neck

via a mechanical system which improves conduction disturbance primarily by

increasing the amount of blood flow from the nerve roots to the spinal

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52

parenchyma. This can be applied intermittently or continuously. When we look at

the literature data, analysis reveals moderate evidence of benefit for intermittent

traction, but no benefit for continuous traction in mechanical neck disorders

(Hattori et al., 2002) (Graham et al., 2006).

Lecocq’s literature review (Lecocq et al., 2005) stated that cervical traction has

several different modes of action, with a very small increase in the intervertebral

space (a few tenths of a millimeter) and a reduction in intradiscal pressure, with a

possible Herniated Disc [HD] suction effect. The HD can also be pushed back by

tension in the posterior longitudinal ligament. In terms of the muscles, the effect

of cervical traction is characterized by stabilization of (or even an increase in)

activity of the trapezius muscle during the first 3 to 6 minutes. The inhibitory

‘‘gate control’’ effect on nociceptive influx transmission requires experimental

confirmation. Furthermore, placebo and psychological effects must be considered

when analyzing the effect of cervical traction.

The NPRS scale mean score difference at the end of two weeks for traction and

conventional treatment group was 1.7 on a scale of 0-10 for inclusion of traction

as treatment and between the group NDI score mean difference at the end of

two weeks also showed contribution of 9.5% more reduction on NDI for

disability.

The correlation analysis for the both groups showed significant relationship

between NPRS and NDI scores and flexion and extension contributes negatively to

NDI score. Moreover extension negatively influences the NPRS score.

4.5 Conclusion

The inclusion of cervical traction as a treatment tool along with the conventional

physiotherapy treatment for mechanical neck pain proved beneficial in terms of

improving cervical mobility, pain reduction and disability perception. Therefore

cervical traction can be recommended as complimentary modality in mechanical

neck pain.

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53

The mechanism by which ICT reduces neck and arm pain is possibly by

unloading the components of the spine by stretching muscles, ligaments and

functional units, reducing adhesions within the dural sleeve, nerve root

decompression within the central foramina, and increasing joint mobility.

Traction also decreases intervertebral disc pressure as stated by Saunders

(Saunders & Saunders, 1993). Reduced tonic muscle contraction and improved

vascular status in the epidural space and perineural structures may also

reduce pain.

The study duration was short, only 2 weeks, and the results apply to short term

only, which might differ in the longer run. Sample size taken for the study is

small and bigger sample might have led to some differences in the results. All

the measurements were taken manually and this may introduce human error

which might affect the reliability.

However, in one study, no specific effect of traction over standard

physiotherapeutic interventions was observed in adults with chronic neck pain.

Hence, it is suggested that clinicians should consider this chronic neck condition

and to focus on exercise therapy in the management of patients suffering from

chronic neck pain (Pinar et al., October 2008). Every research study has its own

set of confounding factors that may affect the study’s clinical outcome.

Hence, we conclude that, intermittent cervical traction should have a place

in the management of MNP along with neck exercises in reducing neck and arm

pain, neck disability and in improving activities of daily living.

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54

CHAPTER 5 – RECOMMENDATIONS

5.1 Recommendations

1. MNP is variable by nature; therefore, subsequent studies should consider

methods of producing a more uniform sample group, taking into account

the patient’s age, gender, chronicity of neck pain, socio-economic

background and emotional stress levels.

2. A more extensive study should be performed, with a larger sample group

to allow for the general population to be more accurately represented.

3. Have an equal ratio of males to females as participants and compare to the

results of the study.

4. Isolate gender to either males or females, this may produce a different

outcome or stronger statistical results; this may help determine whether

both sexes respond similarly to treatment.

5. Further objective measurements should be included with regards to

measuring changes in pain during study. This might take the form of an

Algometer.

6. The study could be performed isolating the level to be treated. This will

allow a more specific reading.

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55

7. Objective and subjective reading should be taken before and immediately

after treatment sessions. This would allow for both the immediate and

prolonged effects of the treatment to be investigated.

8. A follow up, one month after the cessation of the treatment sessions to

determine the long term benefits of treatment with regards to pain,

disability and cervical ROM should be included.

9. This study can also include grip strength measurement using Jamar

Dynamometer to observe the improvement in grip strength of participants

during study at week 1 and week 2 etc.

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56

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Appendices

Appendix-I: Neck Disability Index - Gujarati Version

UZNG V;DY"TF 5|`GFJ,L

VF 5|`GFJ,L TDFZL UZNGGL 5L0FG[ ;DHJF DF8[ AGFJJFDF\ VFJL K[ VG[ T[GF äFZF TDFZF ZMH AZMHGL lS|IFDF\ YTF O[ZOFZGL

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DG[ VF 1F6[ UZNGGL 5L0FDF\ 36M H JWFZM K[P

DG[ VF 1F6[ UZNGGL 5L0FDF\ B]A H JWFZM K[P

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lJEFUv# sp\RSJ]Pf

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DFZF UZNGGL 5L0F DG[ EFZ[ ;FDFG HDLG 5ZYL p\RSJF DF8[ ZMS[ K[ 5Z\T] C] C/JFYL YM0] JWFZ[ JHG p\RSL XS] K]\

HM V[ IMuI HuIFV[ ZFB[, CMIP

C]\ OST C/JM ;FDFG H p\RSL XS] K]P

C]\ S\.56 p\RSL XSTM GYLP

lJEFU v$ sJF\RGf

C]\ DFZL .rKF D]HA S\.56 N]BFJF JUZ JF\RL XS]\ K]P

C]\ YM0L 5L0F ;FY[ .rKF D]HA JF\RL XS] K]P

C]\ UZNGGL YM0L JWFZ[ 5L0FGL ;FY[ .rKF D]HA JF\RL XSTM GYLP

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C]\ EFuI[H JF\RL XS]\ K]P SFZ6 S[ DFZL 5L0FDF\ B]A H JWFZM K[P

C]\ S\. 56 JF\RL XSTM GYLP

lJEFU v5 sDFYFGM N]BFJMf

DG[ DFYFGF N]BFJFGL ;D:IF GYLP

DG[ SIFZ[S YM0F DFYFGF N]BFJFGL ;D:IF ZC[ K[ H[ SIFZ[S VFJ[ K[P

DG[ YM0F JWFZ[ DFYFGF N]BFJFGL ;D:IF ZC[ K[ H[ SIFZ[S VFJ[ K[P

DG[ YM0F JWFZ[ DFYFGF N]BFJFGL ;D:IF ZC[ K[ H[ SFIDL ZC[ K[P

DG[ 5|tI[S 1F6 DFYFGF N]BFJFGL ;D:IF B]A JWFZ[ ZC[ K[P

DG[ 5|tI[S 1F6 DFYFGF N]BFJFGL ;D:IF ZC[ H K[P

lJEFU v& sV[SFU|TFf

C]\ SM.56 D]XS[,L JUZ V[SFZU| ZCL XS] K]P

C]\ YM0L D]XS[,L ;FY[ 5]ZTM V[SFU| ZCL XS] K]P

V[SU|TF HF/JJFDF\ DG[ YM0L H DF+FDF\ D]xS[,L 50[ K[P

DG[ V[SFU|TF HF/JJFDF\ B]A H D]xS[,L 50[ K[P

C]\ V[SFU|TF HF/JL XSTM H GYLP

lJEFU v * sSFI"f

C]\ DFZL .rKF D]HA DFZ]\ AW] ZMHAZMHG]\ SFI" SZL XS] K]P

C]\ DFZ]\ ;FDFgI ZMHAZMHG]\ SFI" SZL XS] K] 56 JWFZ[ GCLP

C]\ DFZ]\ DM8FEFUG]\ SFI" SZL XS] K] 56 JWFZ[ GCLP

C]\ DFZ]\ ZMHAZMHG]\ SFI" SZL XSTM GYLP

C]\ EFuI[H S\.S SFI" SZL XS] K]P

C]\ DFZ]\ S\.56 SFI" SZL XSTM GYLP

lJEFU v(s 0=F.\JLU qC\SFZJ]f

C]\ DFZL UF0L SM.56 N]BFJF JUZ R,FJL XS] K]P

C]\ DFZF UZNGGF\ YM0F N]BFJF ;FY[ DFZL .rKF D]HA UF0L R,FJL XS] K]P

C]\ DFZL .rKF D]HA UF0L R,FJL XS] K] 5Z\T] T[GF äFZF DFZF UZNGGL 5L0FGL TLJ|TFDF\ YM0M JWFZM YFI K[P

C]\ EFuI[H UF0L R,FJL XS] K]P SFZ6 S[ T[GF äFZF DFZL UZNGGL 5L0FGL TLJ|TFDF\ 36M JWFZM YFI K[P

C]\ DFZL UF0L R,FJL H XSTM GYLP

lJEFU v )slG\ãFf

DG[ lG\ãFDF\ SM. TS,LO GYLp

DG[ lG\ãFDF YM0L H B,[, 5CM\R[ K[ sV[S S,FS SZTF VMKLf

DG[ lG\ãFDF B,[, 5CM\R[ K[P s! YL Z S,FSf

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DG[ lG\ãFDF YM0L JWFZ[ B,[, 5CM\R[ K[P sZ YL # S,FSf

DFZL lG\ãFDF B]A B,[, 5CM\R[ K[ s # YL 5 S,FSf

DFZL lG\ãFDF 5]Z[5]ZL B,[, 5CM\R[ K[P s5v* S,FSf

lJEFU v !_ sDGMZ\HGf

C]\ DFZL AWL DGMZ\HG 5|J'lTVM UZNGGF\ SM.56 N]BFJF JUZ SZL XS] K]P

C]\ DFZL AWL DGMZ\HG 5|J'lTVM UZNGGF\ YM0F N]BFJF ;FY[ SZL XS] K]P

C]\ AWL GCL 5Z\T] DM8FEFUGL DGMZ\HG 5|J'lTVM SZL XS] K]P

C]\ DFZL UZNGGL 5L0FG[ SFZ6[ YM0L 36L DGMZ\HG 5|J'lTVM SZL XS] K]P

C]\ DFZL UZNGGL 5L0FG[ SFZ6[ EFuI[ H DFZL DGMZ\HG 5|J'lTVM SZL XS] K]P

C]\ SM.56 DGMZ\HG 5|J'lTVM SZL XSTM GYLP

Appendix-II: Numerical Pain Rating Scale (NPRS).

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Appendix –III: Consent Letter

સમંિત પ�ક

મ�, .................................................. આ ફોમ� મા ંમા�હતી વાચંી છે (અથવા ત ેમને અ�ય એ

વાચંી છે). �ુ ંકોઇ પણ ��ો �છૂવા માટ� ��ુત હતો અને તેઓ એ જવાબ આ�યો છે. માર� �મર

18 વષ�ની ઉપર છે અને, માર� પસદંગી શ��ત ઉપયોગ કર�ને, આથી આ અ�યાસ મા ંસહભાગી

તર�ક� સમાવેશ સમંિત �દાન ક�ંુ � ં…………………………………………………………

.………………………………………………………………………………………………………………………………

…………………………………………. (અ�યાસ શીષ�ક).

(1) મ� આ સમંિત ફોમ� વાચંી છે અને સમ� છે અને મા�હતી મને �દાન કરવામા ંઆવેલ છે.

(2) આ સમંિત દ�તાવેજ મને સમ�વામા આવી છે.

(3) મારા અિધકારો અન ેજવાબદાર�ઓ મને તપાસ કરનાર �ારા સમ�વામા આવી છે.

(4) મને આ અ�યાસ મા ંભાગ લેવા સાથે સકંળાયેલ જોખમો �ગે સલાહ આપેલ છે.

(5) �ુ ંએ હક�કત થી પ�ર�ચત � ંક� �ુ ંકોઈપણ સમયે કોઈપણ કારણો આ�યા િવના આ અ�યાસ

માથંી બહાર જઈ શ�ુ � ંઅને તે આ હો��પટલમા ંમાર� ભિવ�યમા ંસારવાર પર અસર કરશ ેનહ�.

(6) �ુ ંઅહ� તપાસકતા�ઓને પરવાનગી આ� ુ� ંક� તેઓ આ અ�યાસમા ંભાગ લેવા પ�રણામે �

�ણકાર� મેળવી છે ત ેિનયમનકાર� સ�ાવાળાઓ, સરકાર� એજ�સીઓ, અને નીિતશા� સિમિત.

સામે �કાિશત કર� શક� છે.

(7) જો માર� મા�હતી �હ�રમા ંર�ૂ કરવામા ંઆવે તો માર� ઓળખ ��ુત રાખવામા ંઆવશે.

આ સમંિત દ�તાવેજ સાઇન કર�ને, �ુ ં�મા�ણત ક� � ંક� આ દ�તાવેજ મા ંઆપેલ મા�હતી મન ે

�પ�ટ કરવામા ંઆવેલ છે અને મને સમજ પડ� છે.

દદૉ ની સહ� : Date:

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Appendix-IV: Raw Data