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Manual Therapy, Exercise, and Traction for Patients With Cervical Radiculopathy: A Randomized Clinical Trial Ian A. Young, Lori A. Michener, Joshua A. Cleland, Arnold J. Aguilera, Alison R. Snyder Background. To date, optimal strategies for the management of patients with cervical radiculopathy remain elusive. Preliminary evidence suggests that a multi- modal treatment program consisting of manual therapy, exercise, and cervical trac- tion may result in positive outcomes for patients with cervical radiculopathy. How- ever, limited evidence exists to support the use of mechanical cervical traction in patients with cervical radiculopathy. Objective. The purpose of this study was to examine the effects of manual therapy and exercise, with or without the addition of cervical traction, on pain, function, and disability in patients with cervical radiculopathy. Design. This study was a multicenter randomized clinical trial. Setting. The study was conducted in orthopedic physical therapy clinics. Patients. Patients diagnosed with cervical radiculopathy (N81) were randomly assigned to 1 of 2 groups: a group that received manual therapy, exercise, and intermittent cervical traction (MTEXTraction group) and a group that received man- ual therapy, exercise, and sham intermittent cervical traction (MTEX group). Intervention. Patients were treated, on average, 2 times per week for an average of 4.2 weeks. Measurements. Outcome measurements were collected at baseline and at 2 weeks and 4 weeks using the Numeric Pain Rating Scale (NPRS), the Patient-Specific Functional Scale (PSFS), and the Neck Disability Index (NDI). Results. There were no significant differences between the groups for any of the primary or secondary outcome measures at 2 weeks or 4 weeks. The effect size between groups for each of the primary outcomes was small (NDI1.5, 95% confi- dence interval [CI]6.8 to 3.8; PSFS0.29, 95% CI1.8 to 1.2; and NPRS0.52, 95% CI1.8 to 1.2). Limitations. The use of a nonvalidated clinical prediction rule to diagnose cer- vical radiculopathy and the lack of a control group without treatment were limita- tions of this study. Conclusions. The results suggest that the addition of mechanical cervical traction to a multimodal treatment program of manual therapy and exercise yields no sig- nificant additional benefit to pain, function, or disability in patients with cervical radiculopathy. I.A. Young, PT, MS, OCS, SCS, Cert MDT, is Physical Therapist, Spine and Sport, Savannah, Geor- gia, and Affiliate-Associate Profes- sor, Department of Physical Ther- apy, Virginia Commonwealth University–Medical College of Vir- ginia Campus, Richmond, Vir- ginia. Mailing address: Box 961, Tybee Island, GA 31328 (USA). Address all correspondence to Mr Young at: youngian@spinesport. org. L.A. Michener, PT, PhD, ATC SCS, is Associate Professor, Department of Physical Therapy, Virginia Com- monwealth University–Medical College of Virginia Campus. J.A. Cleland, PT, PhD, OCS, FAAOMPT, is Associate Professor, Department of Physical Therapy, Franklin Pierce University, Con- cord, New Hampshire; Physical Therapist, Rehabilitation Services, Concord Hospital, Concord, New Hampshire; and Faculty, Regis University Manual Therapy Fellow- ship Program, Denver, Colorado. A.J. Aguilera, MD, is Neurologist, Neurology Associates, Fredericks- burg, Virginia. A.R. Snyder, PhD, ATC, is Assistant Professor, Athletic Training Pro- gram, A. T. Still University, Mesa, Arizona. [Young IA, Michener LA, Cleland JA, et al. Manual therapy, exercise, and traction for patients with cer- vical radiculopathy: a randomized clinical trial. Phys Ther. 2009; 89:632– 642.] © 2009 American Physical Therapy Association Research Report Post a Rapid Response or find The Bottom Line: www.ptjournal.org 632 f Physical Therapy Volume 89 Number 7 July 2009

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Page 1: ResearchReport - Mercer County Community Collegebehrensb/documents/ManualTherapy… ·  · 2013-11-01Manual Therapy, Exercise, and Traction for Patients With Cervical ... modal treatment

Manual Therapy, Exercise, andTraction for Patients With CervicalRadiculopathy: A RandomizedClinical TrialIan A. Young, Lori A. Michener, Joshua A. Cleland, Arnold J. Aguilera,Alison R. Snyder

Background. To date, optimal strategies for the management of patients withcervical radiculopathy remain elusive. Preliminary evidence suggests that a multi-modal treatment program consisting of manual therapy, exercise, and cervical trac-tion may result in positive outcomes for patients with cervical radiculopathy. How-ever, limited evidence exists to support the use of mechanical cervical traction inpatients with cervical radiculopathy.

Objective. The purpose of this study was to examine the effects of manualtherapy and exercise, with or without the addition of cervical traction, on pain,function, and disability in patients with cervical radiculopathy.

Design. This study was a multicenter randomized clinical trial.

Setting. The study was conducted in orthopedic physical therapy clinics.

Patients. Patients diagnosed with cervical radiculopathy (N�81) were randomlyassigned to 1 of 2 groups: a group that received manual therapy, exercise, andintermittent cervical traction (MTEXTraction group) and a group that received man-ual therapy, exercise, and sham intermittent cervical traction (MTEX group).

Intervention. Patients were treated, on average, 2 times per week for an averageof 4.2 weeks.

Measurements. Outcome measurements were collected at baseline and at 2weeks and 4 weeks using the Numeric Pain Rating Scale (NPRS), the Patient-SpecificFunctional Scale (PSFS), and the Neck Disability Index (NDI).

Results. There were no significant differences between the groups for any of theprimary or secondary outcome measures at 2 weeks or 4 weeks. The effect sizebetween groups for each of the primary outcomes was small (NDI�1.5, 95% confi-dence interval [CI]��6.8 to 3.8; PSFS�0.29, 95% CI��1.8 to 1.2; and NPRS�0.52,95% CI��1.8 to 1.2).

Limitations. The use of a nonvalidated clinical prediction rule to diagnose cer-vical radiculopathy and the lack of a control group without treatment were limita-tions of this study.

Conclusions. The results suggest that the addition of mechanical cervical tractionto a multimodal treatment program of manual therapy and exercise yields no sig-nificant additional benefit to pain, function, or disability in patients with cervicalradiculopathy.

I.A. Young, PT, MS, OCS, SCS,Cert MDT, is Physical Therapist,Spine and Sport, Savannah, Geor-gia, and Affiliate-Associate Profes-sor, Department of Physical Ther-apy, Virginia CommonwealthUniversity–Medical College of Vir-ginia Campus, Richmond, Vir-ginia. Mailing address: Box 961,Tybee Island, GA 31328 (USA).Address all correspondence to MrYoung at: [email protected].

L.A. Michener, PT, PhD, ATC SCS,is Associate Professor, Departmentof Physical Therapy, Virginia Com-monwealth University–MedicalCollege of Virginia Campus.

J.A. Cleland, PT, PhD, OCS,FAAOMPT, is Associate Professor,Department of Physical Therapy,Franklin Pierce University, Con-cord, New Hampshire; PhysicalTherapist, Rehabilitation Services,Concord Hospital, Concord, NewHampshire; and Faculty, RegisUniversity Manual Therapy Fellow-ship Program, Denver, Colorado.

A.J. Aguilera, MD, is Neurologist,Neurology Associates, Fredericks-burg, Virginia.

A.R. Snyder, PhD, ATC, is AssistantProfessor, Athletic Training Pro-gram, A. T. Still University, Mesa,Arizona.

[Young IA, Michener LA, ClelandJA, et al. Manual therapy, exercise,and traction for patients with cer-vical radiculopathy: a randomizedclinical trial. Phys Ther. 2009;89:632–642.]

© 2009 American Physical TherapyAssociation

Research Report

Post a Rapid Response orfind The Bottom Line:www.ptjournal.org

632 f Physical Therapy Volume 89 Number 7 July 2009

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The annual incidence of cervicalradiculopathy (CR) has beenreported to be 83 cases per

100,000 people in the population,with an increased prevalence notedin the fifth decade of life.1 This dis-order is most commonly associatedwith a cervical disk derangementor other space-occupying lesion, re-sulting in nerve root inflammation,impingement, or both.1,2 Commonsigns and symptoms of CR includeupper-extremity pain, paresthesia ornumbness, weakness, or a combina-tion of these signs and symptoms.Patients also may have scapularpain,3,4 headaches,5 and neck pain.6

Patients with both neck and upper-extremity symptoms have been re-ported to have greater functionallimitation and disability than patientswith neck pain alone.7

Diagnostic imaging (magnetic reso-nance imaging) and electrophysio-logical tests (nerve conductionvelocity, electromyography) arecommonly used to confirm a diag-nosis of CR.8–11 Using nerve conduc-tion velocity and electromyographicdata as a gold standard, a clinicalprediction rule (CPR) was derivedto identify the presence of CR usinga limited subset of variables from theclinical examination.12 The CPR foridentifying CR includes the Spurlingtest, the distraction test, the Upper-Limb Tension Test 1 (ULLT1) (me-dian nerve bias), and ipsilateral cer-vical rotation of less than 60 degrees.The CPR exhibited a specificity of94% (positive likelihood ratio�6.1,95% confidence interval [CI]�2.0 to18.6) when 3 of 4 criteria weresatisfied.

Physical therapy interventions oftenused for the management of CR in-clude cervical traction, postural edu-cation, exercise, and manual therapyapplied to the cervical spine and tho-racic spine.13 Studies indicate thatsome combination of these inter-ventions may result in improved out-

comes for patients with CR.14–23

Previous controlled clinical trials in-vestigating the treatment of patientswith CR have not used the CPR asan inclusion criteria.14,15,17,23,24 Todate, only 2 case series18,21 and acohort study22 have examined stan-dardized treatment programs in pa-tients diagnosed with CR, using thepreviously defined CPR. The pro-spective cohort study identified pre-dictor variables that can identifywhich patients with CR are likelyto have short-term successful out-comes.22 A multimodal approach tomanagement including manual ther-apy, cervical traction, and deep neckflexor strengthening was identifiedas the set of predictors; however, thestudy design does not allow for iden-tification of a cause-and-effect rela-tionship. Moreover, the treatmentprotocol in that study was not stan-dardized. A randomized clinical trialis needed to compare the effective-ness of standardized treatment ap-proaches in a homogenous sample ofpatients with CR.

The clinical use of intermittent cer-vical traction for CR is common, butits effectiveness has been examinedin only one clinical trial.17 Joghataeiet al17 found that exercise and in-termittent cervical traction weresuperior to exercise and ultrasoundin improving grip strength (force-generating capacity) following 5 vis-its in patients with C7 radiculopathy.However, the lack of a measure ofpain or disability limits application ofthese results. There remains a pau-city of quality outcome studies inves-tigating commonly used interven-tions in a homogenous population ofpatients with CR. Thus, the purposeof this study was to examine the ef-fects of manual therapy and exer-cise, with or without the addition ofintermittent cervical traction, in pa-tients with CR, as identified by thepreviously described CPR.

Materials and MethodA multicenter randomized clinicaltrial involving orthopedic physicaltherapy clinics in Virginia, Georgia,Alabama, and West Virginia (N�7clinics) was conducted between Oc-tober 2006 and December 2007. Atotal of 10 physical therapists (9male, 1 female) with an average of7 years (range�0.5–12) of experi-ence treating patients with spinalconditions participated in data col-lection. In order maximize stan-dardization, all clinicians were givenon-site training by the primary in-vestigator (I.A.Y.) and provided withan instruction manual and video onall examination, treatment, and datacollection procedures.

Our original sample size estimate fordata analysis was 80 subjects. Be-cause the outcome measures used inthis study have not been used in pre-vious clinical trials for this patientpopulation, an accurate power anal-ysis based on effect size could not becalculated. With an estimated smalleffect size ( f�0.25), a sample size of80 would have given the study apower of 94%.

Consecutive patients with reportsof unilateral upper-extremity pain,paresthesia, or numbness, with orwithout neck pain, were screenedby a physical therapist for study eli-

Available WithThis Article atwww.ptjournal.org

• eAppendix: Description ofManual Therapy and ExerciseProcedures

• The Bottom Line clinicalsummary

• The Bottom Line Podcast

• Audio Abstracts Podcast

This article was published ahead ofprint on May 21, 2009, atwww.ptjournal.org.

Manual Therapy, Exercise, and Traction for Cervical Radiculopathy

July 2009 Volume 89 Number 7 Physical Therapy f 633

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gibility. Of the patients screened forparticipation (N�121), 40 were ex-cluded or refused to participate forvariety of reasons. A flow diagramof patient recruitment and retentionis presented in Figure 1. Patientswho satisfied the eligibility criteria(Tab. 1) were invited to participatein the study. All enrolled patients(n�81) provided informed consentfor participation in the study. Fol-lowing consent, each patient under-went a standardized history andphysical examination, as well ascollection of data for all outcomemeasures.

The physical examination includedthe items in the CPR, repetitivemotion testing (cervical protractionand retraction),25 deep tendon re-flexes (biceps, brachioradialis, tri-ceps), myotomal assessment (C5–C8, T1), and grip strength bilaterally.Primary outcome measures werethe Numeric Pain Rating Scale(NPRS),26,27 the Neck Disability In-dex (NDI),28,29 and the Patient-Specific Functional Scale (PSFS).29,30

Secondary outcome measures werethe Fear-Avoidance Beliefs Question-naire (FABQ),31,32 a pain diagram,33

the Global Rating of Change Scale

(GROC),34 patient satisfaction,35 andgrip strength.36,37 Each outcomemeasure and its psychometric prop-erties are described in the Appendix.Data for the outcome measures werecollected at baseline and at 2-weekand 4-week follow-ups.

After the examination, patients wererandomly assigned to 1 of 2 treat-ment groups: a group that receivedmanual therapy, exercise, and inter-mittent cervical traction (MTEXTrac-tion group) and a group that re-ceived manual therapy, exercise, andsham intermittent cervical traction

Figure 1.CONSORT flow diagram of participants through the trial. CPR�clinical prediction rule.

Table 1.Inclusion and Exclusion Criteria

Inclusion Criteria Exclusion Criteria

● Age 18–70 y● Unilateral upper-extremity pain, paresthesia, or numbness● 3 of 4 tests of clinical prediction rule positive:

- Spurling test- Distraction test- Upper-Limb Tension Test 1- Ipsilateral cervical rotation �60°

● History of previous cervical or thoracic spine surgery● Bilateral upper-extremity symptoms● Signs or symptoms of upper motor neuron disease● Medical “red flags” (eg, tumor, fracture, rheumatoid arthritis, osteoporosis,

prolonged steroid use)● Cervical spine injections (steroidal) in the past 2 wk● Current use of steroidal medication prescribed for radiculopathy symptoms

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(MTEX group). In order to decreasethe potential effect of the clinicon treatment outcomes, concealedrandomization, stratified by clinic,was used to place patients into treat-ment groups. Numbered, sequential,sealed envelopes containing groupallocation for each clinic wereopened by the evaluating therapistafter the baseline examination. Sup-port staff, who were unaware ofgroup assignment, administered allpatient self-report measures and gripstrength testing as instructed by thetherapist.

TreatmentPatients were treated for an averageof 7 visits (SD�2.08), over an aver-age of 4.2 weeks, with a standard-ized treatment protocol. Treatmentswere performed sequentially to in-clude postural education, manualtherapy, and exercise and endedwith traction or sham traction. Allpatients received a home exerciseprogram on their first visit, includingone or more of the available exer-cises used in the standardized treat-ment protocol. The home exerciseprogram was updated, as needed, oneach visit by the physical therapist.

Posture education. On the initialtreatment visit, patients were edu-cated on importance of correct pos-tural alignment of the spine duringsitting and standing activities. Pos-ture was addressed on subsequentvisits only if the physical therapistdeemed it necessary.

Manual therapy. Manual therapywas defined as either high-velocity,low-amplitude thrust manipulationor nonthrust manipulation. Initialtreatment included manipulationprocedures directed at the upper-and mid-thoracic spines of spinalsegments identified as hypomobileduring segmental mobility testing.38

Thrust manipulation of the thoracicspine could include techniques in aprone, supine, or sitting position

based on therapist preference. Non-thrust manipulation includedposterior-anterior (P-A) glides in theprone position. Therapists were re-quired to perform at least one tech-nique targeting the upper thoracicspine and one technique targetingthe mid thoracic spine during eachvisit. Following treatment directed atthe thoracic spine, at least one set(30 seconds or 15–20 repetitions) ofa nonthrust manipulation was di-rected at each desired level of thecervical spine. The cervical spinetechniques could include retrac-tions, rotations, lateral glides in theULTT1 position, and P-A glides. Thetherapists chose the techniquesbased on patient response and cen-tralization or reduction of symptoms.

Exercise. After completing themanual therapy procedures, thetherapist instructed the patient onspecific exercises to complementthe manual procedures performed.Exercises included cervical retrac-tion, cervical extension, deep cervi-cal flexor strengthening, and scap-ular strengthening. At least oneexercise was used during each treat-ment visit. All manual therapy andexercise procedures are described inthe eAppendix (available online atwww.ptjournal.org).

Traction and sham traction. Af-ter exercise, patients received eithermechanical intermittent cervicaltraction or sham traction for 15 min-utes according to their random as-signment. Each patient was posi-tioned supine, with the cervicalspine placed at an angle of approxi-mately 15 degrees of flexion. Thetraction force was started at 9.1 kg(20 lb) or 10% of the patient’s bodyweight (whichever was less) and in-creased approximately 0.91 to 2.27kg (2–5 lb) every visit, depending oncentralization or reduction of symp-toms. The maximum force used was15.91 kg (35 lb). The on/off cyclewas set at 50/10. The sham traction

protocol included the identical set-up; however, only 2.27 kg (5 lb) orless of force was applied. All othertraction parameters were the sameas for the group that received inter-mittent cervical traction.

Data AnalysisA separate repeated-measures, mixed-model analysis was performed foreach of the primary and secondaryoutcomes, with alpha set at .05.Treatment group (MTEX versusMTEXTraction) was the between-patient factor, and time (baseline,2-week follow-up, 4-week follow-up)was defined as the repeated factor.The primary and secondary out-comes were used as the dependentvariables. To allow for correlationswithin participants and of partici-pants within clinics, we modeled pa-tient and clinic as random effectswithout interactions. The main hy-pothesis of interest was the group �time interaction. Linear contrastswere constructed to determine thebetween-group differences at eachtime point. The main effects of theinterventions were obtained by con-structing linear contrasts to comparethe mean change in outcome frombaseline to each time point. Theeffect size was calculated from thebetween-group differences in changescore from baseline to the 4-weekfollow-up in all of the primary out-come measures. Analyses followedintention-to-treat principles. All anal-yses were performed using SAS sta-tistical software (JMP version 8.0*).

Role of the Funding SourceThis study was funded by a grantfrom the Saunders Group.

ResultsPatients (N�121) were screened foreligibility, and 81 patients were eli-gible and agreed to participate(Fig. 1). Twelve patients (n�6 in

* SAS Institute Inc, PO Box 8000, Cary, NC27513.

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each group) were lost to follow-upbetween baseline (pretreatment)measures and the 4-week follow-up.Baseline demographics and datafor outcome measures are listed inTable 2.

No significant interaction or maineffects of group were found forthe primary or secondary outcomemeasures (Tab. 3). There was a sig-nificant main effect (P�.05) of time

for the NPRS, PSFS, NDI, and bodydiagram, indicating there weresignificant improvements in pain,function, disability, and symptomdistribution regardless of group as-signment (MTEX versus MTEXTrac-tion) from baseline to the 4-weekfollow-up. The adjusted effect sizefrom the mixed-models analysis foreach of the primary outcomes wassmall (NDI�1.5, 95% confidence in-terval [CI]��6.8 to 3.8; PSFS�0.29,

95% CI��1.8 to 1.2; and NPRS�0.52, 95% CI��1.8 to 1.2).

DiscussionThis randomized clinical trial investi-gated the effects of a multimodaltreatment approach including man-ual therapy and exercise, with andwithout the addition of intermittentcervical traction, in patients withCR. The results indicate that the ad-dition of supine intermittent cervical

Table 2.Baseline Variables and Treatment Visitsa

VariableMTEXTraction Group

(n�45)MTEX Group

(n�36)

Age (y) 47.8 (9.9) 46.2 (9.4)

Sex, n (%)

Male 14 (31.1) 12 (33.3)

Female 31 (68.9) 24 (66.7)

Work-related injury, n (%) 8 (18.2) 4 (11.8)

Duration of symptoms, n (%)

�3 mo 27 (60) 15 (42)

�3 mo 18 (40) 21 (58)

Neck movement alters symptoms, n (%) 35 (85.3) 30 (85.7)

Previous symptoms, n (%) 13 (28) 12 (33)

Most bothersome symptom, n (%)

Pain 33 (75) 26 (74.3)

Numbness/tingling 8 (18.2) 5 (14.3)

Both pain and numbness/tingling 3 (6.8) 4 (11.4)

Neck Disability Indexb 19.8 (8.7) 17.1 (7.4)

Patient-Specific Functional Scalec 3.5 (1.8) 3.3 (1.8)

Numeric Pain Rating Scaled 6.3 (1.9) 6.5 (1.7)

Body diagram (symptom distribution)e 22.5 (10.6) 20.7 (9.6)

Fear-Avoidance Beliefs Questionnaire

Physical activity subscalef 17.7 (7.4) 18.3 (5.7)

Work subscaleg 24.1 (17.2) 18.7 (16.2)

No. of treatment visits 7.0 (2.1) 6.9 (2.1)

Neurological examination,h n (%)

NormalExamination

Positive TestEither Category

Positive TestBoth Categories

NormalExamination

Positive TestEither Category

Positive TestBoth Categories

9 (20) 22 (48.9) 14 (31.1) 8 (22.2) 16 (44.4) 12 (33.3)

a Values are mean (SD) unless otherwise stated. MTEXTraction group�patients who received manual therapy, exercise, and intermittent cervical traction;MTEX group�patients who received manual therapy, exercise, and sham intermittent cervical traction.b Range of scores�0–50; higher scores represent higher levels of disability.c Range of scores�0–10; higher scores represent greater levels of function.d Range of scores�0–10, where 0�“no pain.”e Range of scores�0–44; higher scores represent greater area of symptom distribution.f Range of scores�0–30; higher scores represent higher levels of fear avoidance.g Range of scores�0–66; higher scores represent higher levels of fear avoidance.h 2 categories: deep tendon reflexes and myotome assessment.

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Table 3.Results of Analysis Comparing Outcomes Between Treatment Groupsa

Outcome Measure

Unadjusted Mean (SD)for Each Group Unadjusted

Mean DifferenceBetween Groups

(95% CI) P

Adjusted Mean (SD)for Each Groupb Adjusted

Mean DifferenceBetween Groupsb

(95% CI) PMTEXTraction

GroupMTEXGroup

MTEXTractionGroup

MTEXGroup

Neck Disability Indexc

2 wk 15.0 (8.2) 13.1 (7.1) 1.9 (�1.8 to 5.6) .31 14.0 (12.3) 12.2 (11.8) 1.8 (�7.0 to 3.5) .34

4 wk 12.1 (9.0) 10.9 (7.8) 1.2 (�2.9 to 5.3) .56 11.1 (12.3) 9.6 (14.1) 1.5 (�6.8 to 3.8) .42

Patient-Specific FunctionalScaled

2 wk 5.1 (2.5) 5.2 (2.4) 0.06 (�1.2 to 1.1) .91 5.3 (3.8) 5.6 (3.8) 0.22 (�1.2 to 1.7) .66

4 wk 6.6 (2.4) 6.3 (2.5) 0.27 (0.91 to 1.5) .66 7.0 (3.8) 6.7 (4.3) 0.29 (�1.8 to 1.2) .57

Numeric Pain Rating Scalee

2 wk 4.5 (2.3) 5.1 (2.4) 0.65 (�1.7 to 0.4) .24 4.2 (3.0) 5.2 (3.0) 0.61 (�0.90 to 2.1) .25

4 wk 3.7 (2.7) 3.2 (2.5) 0.55 (�0.68 to 1.7) .38 3.4 (3.1) 3.2 (3.4) 0.52 (�1.8 to 1.2) .33

Body diagram (symptomdistribution)f

2 wk 17.8 (12.5) 16.4 (12.2) 1.5 (�4.2 to 7.0) .60 16.5 (31.4) 16.6 (30.7) 0.04 (�8.0 to 8.1) .98

4 wk 15.2 (13.8) 12.8 (13.5) 2.3 (�3.8 to 8.4) .46 13.1 (31.7) 12.7 (34.7) 0.45 (�8.6 to 7.7) .87

Fear-Avoidance BeliefsQuestionnaireg

2 wk

Physical activity subscaleh 16.4 (7.5) 18.1 (6.0) 1.6 (�0.48 to 1.6) .31 15.5 (10.4) 17.0 (10.5) 1.5 (�3.3 to 6.2) .37

Work subscalei 21.9 (18.4) 20.3 (17.2) 1.5 (�6.8 to 9.8) .71 16.8 (28.3) 15.1 (28.2) 1.7 (�12.6 to 9.2) .65

4 wk

Physical activity subscale 14.0 (7.8) 15.3 (7.9) 1.7 (�5.5 to 2.1) .38 12.4 (10.5) 14.2 (11.9) 1.8 (�6.6 to 3.0) .29

Work subscale 18.5 (16.9) 17.8 (16.8) 0.68 (�7.4 to 8.8) .87 14.5 (28.3) 11.6 (31.7) 2.9 (�8.1 to 13.9) .44

Satisfaction ratingj

2 wk 5.5 (3.0) 5.6 (2.5) �0.14 (�1.4 to 1.2) .83 6.1 (4.5) 6.2 (4.6) 0.12 (�1.5 to 1.2) .85

4 wk 6.8 (3.0) 6.9 (3.0) �0.30 (�1.7 to 1.3) .83 7.1 (4.6) 7.5 (5.2) 0.44 (�1.8 to 0.9) .52

Global Rating of ChangeScalek

2 wk 9.7 (2.2) 9.6 (1.9) 0.12 (�0.81 to 1.1) .76 10.1 (3.4) 10.0 (3.4) 0.16 (�1.13 to 0.79) .74

4 wk 10.8 (2.0) 10.5 (2.4) 0.25 (0.81 to 1.3) .65 11.1 (3.3) 10.8 (3.9) 0.27 (�0.70 to 1.2) .58

Improved at 4 wk (%) 68 69

a Values are mean (SD) unless otherwise stated. MTEXTraction group�patients who received manual therapy, exercise, and intermittent cervical traction;MTEX group�patients who received manual therapy, exercise, and sham intermittent cervical traction; CI�confidence interval.b Adjusted values from mixed-models analysis.c Range of scores�0–50; higher scores represent higher levels of disability.d Range of scores�0–10; higher scores represent greater levels of function.e Range of scores�0–10, where 0�“no pain.”f Range of scores�0–44; higher scores represent greater area of symptom distribution.g Range of scores�0–30; higher scores represent higher levels of fear avoidance.h Range of scores�0–66; higher scores represent higher levels of fear avoidance.i 2 categories: deep tendon reflexes and myotome assessment.j Range of scores�0–10, where 10�“completely satisfied.”k Range of scores�0–13; scores �10 signify clinically meaningful improvement.

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traction yielded no additional benefitto a program of manual therapy andexercise. Regardless of group assign-ment (MTEX versus MTEXTraction),patients with CR experienced signif-icant improvements in both primaryand secondary outcomes following 4weeks of standardized physical ther-apy intervention.

Although there were no significantdifferences between groups withany of the outcome measures, theprecision of the point estimates ofthe treatment effects must be con-sidered. At the 2-week follow-up,the lower boundary of the 95% CIfor the NDI was �7.0 (Tab. 3). Thisvalue meets the threshold for mean-ingful clinically important change ofthe NDI (7.0). Furthermore, at the4-week follow-up, the lower bound-ary of the 95% CI for the NPRS was�1.8 (Tab. 3). This value exceedsthe threshold for meaningful clini-cally important change of the NPRS(1.3) adopted for this study. Thus,we cannot confidently exclude atreatment effect for these variables atthese specific time points.

Although statistically significantchanges over time were found inboth groups with all of the primaryoutcome measures, the thresholdfor minimum clinically importantchange was surpassed with the NPRS(n�47 [67%]) and the PSFS (n�44[64%]) for those patients who com-pleted the 4-week follow-up. A totalof 2 points of change on the PSFShas been found to exceed the thresh-old for minimal clinically importantchange in patients with CR.29 Achange of 1.3 points on the NPRSrecently was found to meet thethreshold for minimal clinically im-portant change in patients with neckpain.27 As no study has identified aminimal clinically important changevalue in patients with CR, thischange score (1.3 points) on theNPRS was adopted for this study. Ofthe patients who completed the

4-week follow-up, only 32 (46%) sur-passed the minimal clinically impor-tant change of at least 7 points onthe NDI.29 A recent study27 suggeststhat the minimal clinically importantchange on the NDI may be morethan twice as high as the originalreported threshold of 7 points in pa-tients with mechanical neck pain.With these inconsistencies regardingthe appropriate threshold for clini-cally important difference, perhapsthe responsiveness to change of theNDI may not be sufficient in this pa-tient population. As the NDI is acommonly used self-report measurein patients with all neck-related dis-orders, future studies with largersample sizes should investigate to de-tect change in patient status in con-junction with the NPRS, PSFS, andGROC in patients with CR.

The present study used a CPR toidentify the presence of CR.12 TheCPR has a sensitivity of 0.39 (95%CI�0.16 to 0.61), a specificity of0.99 (95% CI�0.97 to 1.00), and apositive likelihood ratio of 30.3 (95%CI�1.7 to 538.2) when all 4 testitems are positive. The CPR has asensitivity of 0.24 (95% CI�0.05 to0.43), a specificity of 0.94 (95%CI�0.88 to 1.00), and a positive like-lihood ratio of 6.1 (95% CI�2.0 to18.6)] when 3 of 4 tests are positive.We used 3 of 4 criteria that are pos-itive for eligibility despite other stud-ies using 4 of 4 criteria, due to thenarrower CI and the lower-bound es-timate for 3 of 4 criteria. To date, theCPR used in the present study hasnot been validated.

The protocol for the intermittentcervical traction may have been thereason a treatment effect was notidentified. Although a multitude oftraction parameters are used in theclinical setting, there is no con-vincing evidence to suggest whichparameters are most effective in themanagement of CR. Cleland et al21

used an on/off cycle of 30/10 and a

traction angle of approximately 25degrees, increasing force by 0.45 to0.91 kg (1–2 lb) per visit, whereasWaldrop et al18 used an on/off cycleof 20/10 and a 15- to 24-degree angleof traction. Each of these case stud-ies started with a traction forceof 8.18 kg (18 lb) and monitoredthe centralization and reduction ofsymptoms to determine progressionof force. Furthermore, both studiesperformed traction for 15 minutesand used a minimum traction forceduring the off cycle.

In the clinical trial by Joghataei etal,17 a 13.64-kg (30-lb) traction forceat a 24-degree angle of pull was usedfor a period of 20 minutes, with anon/off cycle of 7/5. In the presentstudy, we used a longer duration ofpull (on/off cycle of 50/10), a 15-degree flexion angle, and no tractionforce during the off cycle. In thisstudy, the average traction force was11.64 kg (SD�2.8, range�9.09–14.09) (25.6 lb, SD�2.8, range�20–31) for the MTEXTraction group andan average of 1.65 kg (SD�0.70,range�0.90–4.52) (3.5 lb, SD�1.1,range�2.0–5.0) for the MTEXgroup. Interestingly, Zybergold andPiper24 found no significant differ-ence in pain reduction amonggroups of patients with CR who re-ceived static traction, intermittenttraction, manual traction, and treat-ment without traction. Possibly,more-aggressive traction protocols(more force or greater frequency)may have had a greater effect on thepatient sample in the present study.Moreover, we are unable to deter-mine whether the sham tractionforce of no greater than 2.3 kg (5 lb)had a treatment effect on the pa-tients in this study. Although a con-trol group receiving a “subtherapeu-tic” traction force has its limitations,we feel this was the best controlchoice to address the setup, subse-quent force production, and treat-ment time involved with this modal-ity. In this study, there appeared to

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be no relationship between theamount of traction force used andperceived recovery (Fig. 2).

The manual therapy proceduresused in this study were a combina-tion of thrust and nonthrust manip-ulation techniques designed to cen-tralize and reduce the cervical andupper-extremity symptoms. In orderto simulate clinical practice, the ther-apist was allowed to select individualtechniques based on centralizationor reduction of symptoms and thepatient’s response to treatment. If amanual therapy procedure central-ized or reduced the patient’s symp-toms, this procedure continued tobe used until there was no furtherbenefit. Conversely, if a manual pro-cedure worsened or peripheralizedthe patient’s symptoms, this proce-dure was abandoned and anothertechnique was selected. The proce-dures are modifications of tech-niques first described by McKen-zie,25 Maitland,38 Greenman,39 andVicenzino et al.40 An average of 2manual procedures were performedon both the thoracic and cervicalspines during each visit. Supine tho-racic thrust manipulation, cervicalretraction nonthrust manipulation,and cervical retraction exercise werethe most commonly used proce-dures in the study (Fig. 3). Althoughthoracic manipulation procedureshave been shown to have a signifi-cant short-term treatment effect onpatients with mechanical neckpain,41,42 these techniques have notbeen studied in patients with CR.Restoration of normal biomechanicsto the thoracic spine may have a rolein lowering mechanical stresses andimproving distribution of joint forcesin the cervical spine.41,43,44 Manipu-lations directed at the cervical spinewere not performed in this study, assupporting evidence is sparse in pa-tients with CR45 and considerable at-tention has been devoted to the riskof serious complications.46–48

The exercises used in this studyincluded strengthening of the scapu-lothoracic and deep neck flexors,as well as cervical retraction and ex-tension exercises. Scapular strength-ening and deep neck flexor exerciseshave provided some benefit in previ-ous studies.21,22 Cervical retractionis thought to improve resting neckposture, relieve neck pain or radicu-lar or referred pain,25 and possiblydecompress neural elements in pa-tients with CR.49 An average of 2exercises per visit were used in thepresent study.

This clinical trial supports previousrandomized clinical trials demon-strating effective conservative man-

agement of CR17,23,24 and cervicobra-chial pain14,15,24 Prior to the presentstudy, only one randomized clinicaltrial isolated the effect of intermit-tent cervical traction, finding thatexercise and intermittent cervicaltraction were superior to exercise(cervical isometrics) and ultrasoundon the outcome of grip strength after5 visits in patients with C7 radiculop-athy.17 However, there were no sig-nificant differences between groupsat 10 visits (discharge from physicaltherapy).17

We acknowledge several limitationsof this study. First, we used a CPR toidentify the presence of cervical ra-diculopathy that has yet to be vali-

Figure 2.Average force of traction (per subject) versus Global Rating of Change Scale (GROC)scores (range�0–13; scores �10 signify clinically meaningful improvement). Thereappears to be no relationship between the amount of traction force used and perceivedrecovery. MTEXTraction group�patients who received manual therapy, exercise, andintermittent cervical traction; MTEX group�patients who received manual therapy,exercise, and sham intermittent cervical traction.

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dated, which may imply less-than-optimal diagnostic accuracy of thiscondition. Second, we are unsure ofhow effective the blinding was dur-ing the course of treatment, as thepatients were not asked whetherthey could identify which groupthey were in at the 4-week follow-up. If the patients thought they werereceiving the sham treatment, thismay have had an influence on theiroutcome. Third, the lack of a strictlyrecorded, dose-specific home exer-cise program maintained during thecourse of treatment was a limitation.Fourth, without a control group (agroup not receiving treatment), weare unsure whether there was a

spontaneous resolution of symptomsover the course of this 4-weektreatment.

ConclusionThe addition of mechanical intermit-tent traction does not appear to im-prove outcomes for patients with CRwho are already receiving manualtherapy and exercise. Although trac-tion provided no additional benefitin this study, subsequent investiga-tions examining traction at differentdosages may be of interest in thispatient population. The effect of CRcan be disabling, and continued re-search in the areas of diagnosis and

treatment of this condition is of par-amount importance.

Mr Young, Dr Michener, Dr Cleland, and DrAguilera provided concept/idea/research de-sign. Mr Young, Dr Michener, Dr Cleland,and Dr Snyder provided writing. Mr Young,Dr Michener, Dr Aguilera, and Dr Snyderprovided data analysis. Mr Young and DrMichener provided project managementand fund procurement. Dr Michener, Dr Cle-land, Dr Aguilera, and Dr Snyder providedconsultation (including review of manuscriptbefore submission).

The authors thank Advance Rehabilitationand Fredericksburg Orthopaedics for theirsupport of this study; physical therapistsChris Brown, Dan Walker, Jon Lamb, andRichard Linkonis for their patient recruiting

C

A

B

Figure 3.(A) Supine thoracic thrust manipulation, (B) cervical retraction mobilization, (C) cervical retraction exercise.

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and treatment efforts; Amee Seitz for herhelp with data analysis; and JenniferChastain for her help with study/data man-agement. A final thanks to Robin Saundersfor her support of this study.

The study was approved by the Rocky Moun-tain University of Health Professions InternalReview Board.

Platform presentations of this research weregiven at the Combined Section Meetingsof the American Physical Therapy Associa-tion; February 6–9, 2008; Nashville, Tennes-see; and February 9–12, 2009; Las Vegas,Nevada.

This study was funded by a grant from theSaunders Group.

This article was received September 13, 2008,and was accepted March 25, 2009.

DOI: 10.2522/ptj.20080283

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18 Waldrop MA. Diagnosis and treatment ofcervical radiculopathy using a clinical pre-diction rule and a multimodal interventionapproach: a case series. J Orthop SportsPhys Ther. 2006;36:152–159.

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22 Cleland JA, Fritz JM, Whitman JM, Heath R.Predictors of short-term outcome inpeople with a clinical diagnosis of cervi-cal radiculopathy. Phys Ther. 2007;87:1619–1632.

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24 Zylbergold RS, Piper MC. Cervical spinedisorders: a comparison of three types oftraction. Spine. 1985;10:867–871.

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27 Cleland JA, Childs JD, Whitman JM. Psy-chometric properties of the Neck Disabil-ity Index and Numeric Pain Rating Scale inpatients with mechanical neck pain. ArchPhys Med Rehabil. 2008;89:69–74.

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29 Cleland JA, Fritz JM, Whitman JM, PalmerJA. The reliability and construct validity ofthe Neck Disability Index and Patient-Specific Functional Scale in patients withcervical radiculopathy. Spine. 2006;31:598–602.

30 Chatman AB, Hyams SP, Neel JM, et al. ThePatient-Specific Functional Scale: measure-ment properties in patients with knee dys-function. Phys Ther. 1997;77:820–829.

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32 Landers MR, Creger RV, Baker CV, Stutel-berg KS. The use of fear-avoidance beliefsand nonorganic signs in predicting pro-longed disability in patients with neckpain. Man Ther. 2008;13:239–248.

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37 Smidt N, van der Windt DA, Assendelft WJ,et al. Corticosteroid injections, physio-therapy, or a wait-and-see policy for lateralepicondylitis: a randomised controlled tri-al. Lancet. 2002;359(9307):657–662.

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41 Cleland JA, Childs JD, McRae M, et al. Im-mediate effects of thoracic manipulationin patients with neck pain: a randomizedclinical trial. Man Ther. 2005;10:127–135.

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Appendix.Primary and Secondary Outcome Measuresa

Measure Scale and ScoringReliability(95% CI)

MCICValue

Neck Disability Index28,29 Self-report measure containing 10 items (scored0–5). Total score out of 50 possible points(0�“no disability,” 50�“severe disability”).

ICC�.68(.03 to .90)

�7 points

Patient-SpecificFunctional Scale29,30

Self-report activity limitations rated from 0(“inability to perform activity”) to 10 (“able toperform activity as well as prior to onset ofsymptoms”). Activity scores averaged (higherscore�less disability)

ICC�.82(.54 to .93)

�2 points

Numeric Pain RatingScale26,27

Self-report measure with scores ranging from0 (“no pain”) to 10 (“worst pain imaginable”).

ICC�.63(.28 to .96)

�1.3 points

Global Rating of ChangeScale34

Self-report Likert scale with scores ranging from0 (“a very great deal worse”) to 7 (“about thesame”) to 13 (“a very great deal better”). Ascore of �10 signifies improvement.

�10 points

Pain diagram33 Self-report measure indicating type and locationof symptoms on a standardized body chart.Total score is out of 44 points (higher scoresindicate greater symptom distribution).

kappa�.92 Not reported

Fear-Avoidance BeliefsQuestionnaire31,32

Self-report measure that quantifies fear andavoidance beliefs in patients with low backpain and neck pain. Physical activity subscale:range of scores�0–30; Work subscale: range ofscores�0–66; higher scores represent higherlevels of fear avoidance.

Not reported

Satisfaction rating35 Self-report measure with scores ranging from0 (“not satisfied”) to 10 (“very satisfied”) withthe use of the neck and arm.

ICC�.93 Not reported

Grip strength36,37 Average of 2 trials measured with a Jamar handdynamometerb

ICC�.87–.97 Not reported

a CI�confidence interval, MCIC�minimal clinically important change, ICC�intraclass correlation coefficient.b Sammons Preston, PO Box 5071, Bolingbrook, IL 60440-5071.

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