Research Report Manual Therapy, Exercise, and Traction for Patients With Cervical Radiculopathy: A Randomized Clinical Trial I.A. Young, PT, MS, OCS, SCS, Cert MDT, ¡s Physical Therapist, Spine and Sport, Savannah, Georgia, and Affiliate-Associdte Professor, Department ot Physical Therapy, Virginia Commonwealth University-Medical College of Virginia Campus, Richmond, Virginia. Mailing address: Box 961, Tybee Island, GA 31328 (USA). Address all correspondence to Mr Young at: youngian@spinespcrt, org. LA, Michener, PT, PhD, ATC SCS, is Associate Professor, Department of Physical Therapy, Virginia Commonwealtb University-Medical College of Virginia Campus, |,A, Cleland, PT, PhD, OCS, FAAOMPT, is Associate Professor, Department of Physical Therapy, Franklin Pierce University, Concord, New Hampshire; Physical Therapist, Rebabilitation Services, Concord Hospital, Concord, Uew Hampsbire; and Faculty, Regis University Manual Therapy Fellowship Program, Denver, Colorado. A,). Aguilera, MD, is Neurologist, Neurology Associates, Fredericksburg, Virginia. A.R. Snyder, PhD, ATC, is Assistant Professor, Athletic Training Program, A, T, Stilt University, Mesa, Arizona. [Young lA, Michener LA, Cleland ]A, et al. Manual therapy, exercise, and traction for patients witb cervical radiculopathy: a randomized clinical trial, Phys Ther. 2009; 89:632-642.] © 2009 American Physical Therapy Association Post a Rapid Response or find Tbe Bottom Line: www,ptjournal,org 632
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Ian A. Young, Lori A. Michener, Joshua A. Cleland, Arnold J. Aguilera, Alison R. Snyder
Background. To date, optimal strategics for the tiKinagemt-nt of patients wltli cervical radiculopathy remain elusive. Preliminary evidence suggests that a niiiltitiiodal treatment program consisting of manual therapy, exercise, and cervical traction may result in positive outcomes for patients with cervical radictilopathy. However, 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, atid disabilit)' in patients with cervical radiculopathy. Design. This study was a mtilticenter randomized clinical trial. Setting. The study was conducted in orthopedic physical therapy clinics. Patients. assigned to intermittent ual therapy,
Patients diagnosed with cervical rddiculopathy (N=81) were randomly 1 of 2 groups; a group that received manual therapy, exercise, and cer\ical traction (MTEXTraction group) and a group that received manexercise, 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 haseline 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 (NDI= 1.5, 95% confidence interval |CI]--6.8to3.8:PSFS=0.29, 95%CI=-1.8to 1.2; and NPRS=0.52, 9 5 % a - - 1 . 8 to 1.2). Limitations. The use of a nonvalidated clinical prediction rule to diagnose cervical radiculopathy and the lack of a control group without treatment were limitations of this study. Conclusions. The results suggest that the addition of mechanical cervical traction to a nuiltimodal treatment program of manual therapy and exercise yields no significant additional benefit to pain, ñuiction, or disabilit}' in patients with cervical radiculopathy.
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Manual Therapy, Exercise, and Traction for Cervical Radiculopathy
T
he annual incidence of cervical radiculopathy (CR> has been reported to he 83 cases per 100.()()() people in the population, with an increased prevalence noted in the fifth decade of life.' 7'his disorder is most commonly associated with a cervical disk derangement or other space-occupying lesion, resulting in nerve root inflammation, impingement, or hoth.'- Common signs and symptoms of CR include upper-extremit}' pain, paresthesia or numhness, weakness, or a comhination of these signs and symptoms. Patients also may have scapular pain.^ ' headaches,'' and neck pain.'* Patients with both neck and upperextremit\' symptoms have heen reported to have greater functional limitation and disability than patients with neck pain alone." Diagnostic imaging (magnetic resonance imaging) and electrophysio logical tests (ner\e conduction velocity, electromyography) are commonly used to confirm a diagnosis of C:R.'*-" Using ner\'e conduction velocit>' and electromyographic data as a gold standard, a clinical prediction rule (CPR) was derived to identify' the presence of CR using a limited subset of variables from the clinical examination.'' The CPR for identifying CR includes the Spurling test, the distraction test, the UpperLimb Tension Test 1 (ULLTl) (median nerve bias), and ipsilateral cervical rotation of less than 60 degrees. The CPR exhibited a speciñcit)' of 94% (positive likelihood ratio =6.1, 95% confidence interval [CI1=2.Ü to 18.6) when 3 of 4 criteria were satisfied. Physical therapy interventions often used for the management of CR include cervical traction, postural education, exercise, and manual therapy applied to the cervical spine and thoracic spine.'^ Studies indicate that some combination of these interventions may result in improved outluly 2009
comes for patients with CR.'*--^ Previous controlled clinical trials investigating the treatment of patients with CR have not used the CPR as an inclusion criteria."''^'"-^-^ To date, only 2 case series'**-^' and a cohort study-- have examined standardized treatment programs in patients diagnosed with CR. using the previously defined CPR. The prospective cohort study identified predictor variables that can identif)' which patients with CR are likely to have short-term successful outcomes.-- A multimodal approach to management including manual therapy, cer\'ical traction, and deep neck flexor strengthening was identified as the set of predictors; however, the study design does not allow for identification of a cause-and-effect relationship. Moreover, the treatment protocol in that study was not standardized. A randomized clinical trial is needed to compare the effectiveness of standardized treatment approaches in a homogenous sample of patients with CR.
Materials and Method A multicenter randomized clinical trial involving orthopedic physical therapy clinics in Virginia, Cieorgia, Alabama, and West Virginia (N=7 clinics) was conducted hetween October 2006 and December 2()()7. A total of 10 physical therapists (9 male, 1 female) with an average of 7 years (range^O.5-12) of experience treating patients with spinal conditions participated in data collection. In order maximize standardization, all clinicians were given on-site training by the primary investigator (I.A.Y.) and provided with an instruction manual and videt) on all examination, treatment, and data collection procedures.
Our original sample size estimate for data analysis was 80 suhjects. Because the outcome measures used in this study have not been used in previous clinical trials for this patient pt)pulation, an accurate power analysis based on effect size could not be calculated. With an estimated small effect size (/=0.25), a sample size of The clinical use of intermittent cer- 80 would have given the study a vical traction for C"R is common, but power of 94%. its effectiveness has been examined in only one clinical trial.'" joghataei Consecutive patients with reports et al'" found that exercise and in- of unilateral upper-extremity pain, termittent cervical traction were paresthesia, or numbness, with or superior to exercise and ultrasound without neck pain, were screened in improving grip strength (force- by a physical therapist for study eligenerating capacity) following 5 visits in patients with C.I radiculopathy. However, the lack of a measure of Available With pain ordisahilit>' limits application of This Article at these results. There remains a pauwww.ptjournal.org city of quality outcome studies investigating commonly used interven• eAppendix: Description of Manual Therapy and Exercise tions in a homogenous population of Procedures patients with CR. Thus, the purpose of this study was to examine the ef• The Bottom Line clinical fects of manual therapy and exersummary cise, with or without the additi(jn of • The Bottom Line Podcast intermittent cervical traction, in pa• Audio Abstracts Podcast tients with CR. as identified by the This anide was published ahead of previously described CPR. print on May 21, 2009, at www.ptjournai.org.
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Manual Therapy, Exercise, and Traction for Cervical Radiculopathy Screened with CPR (n=121)
Excluded (n=38) <3 of 4 CPR Items (n=28) Exclusion (history) (n-6) Refused to participate (n=4)
Randomized n=81 Excluded (n=2) D r o p o u t ^ n o data available
45 received manual therapy, exercise, and traction
36 received manual therapy, exercise, and sham traction
Lost to follow-up in-6) Prior to 2 wk (n=3) Prior to 4 wk (n=3)
Lost to follow-up (n=6) Prior to 2 wk (n=3) Prior to 4 wk (n=3)
Analyzed (n=45)
Analyzed (n=36)
Figure 1. CONSORT flow diagram of participants tbrougb tbe trial. CPR=clinical prediction rule.
gihility. Of the patients screened for Tlie physical examination included participation (N=121), 40 were ex- tbe items in the C:PR, repetitive cluded or refused to participate for motion testing (cervical protraction variety of reasons, A fiow diagram and retraction).^"* deep tendon reof patient recruitment and retention flexes (biceps, brachioradialis. triis presented in Figure 1. Patients ceps), myotomal assessment CC5who satisfied the eligibility criteria C8, Tl), and grip strength bilaterally. (Tab. 1) were invited to participate Primary' outcome measures were in the study. All enrolled patients the Numeric Pain Rating Scale (n=8n provided inibrmed consent (NPRS),-'"'^ the Neck Disability Infor panicipation in the study. Fol- dex (NDI),^«-'' and the Patientlowing consent, each patient under- Specific Functional Scale (PSFS),^*'-^"' went a standardized history and Secondary outcome measures were physical examination, as well as the Fear-Avoidance Beliefs Questioncollection of data for all outcome naire (FABQ).^''^^ a pain diagram,^^ the Global Rating of Change Scale measures.
patient satisfaction," atid grip strength.^'' *" Each outc()me measure and its psychometric properties are described in the Appendix. Data for the outcome measures were collected at baseline and at 2-week and 4-week follow-ups. After the examination, patients were randomly assigtied to 1 of 2 treatment groups: a group that received manual therapy, exercise, and intermittent cervical traction (MTEXTraction group) and a group that received manual therapy, exercise, and sham intermittent cervical traction
Table 1. Inclusion and Exclusion Criteria Exclusion Criteria
Inclusion Criteria . Age 18-70 y • Unilateral up per-extremity pain, pareslhesia, or numbness • 3 of 4 tests of clinical prediction mie positive: - Spurling test - Distraction test - Upper-Limb Tension Test 1 - Ipsilateral cervical rotation <60''
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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 steroidai medication prescribed (or radiculopathy symptoms
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Manual Therapy, Exercise, and Traction for Cervical Radiculopathy (MTEX group). In order to decrease the potential effect of the clinic on treattnent outcomes, concealed randomization, stratified by clinic, was used to place patients into treatment groups. Numbered, sequential, sealed envelopes containing group allocation for each clinic were opened by the evaluating therapist after the baseline examination. Support staff, who were unaware of group assignment, administered all patient seli-report measures and grip stretigth testing as instructed hy the therapist.
based on therapist preference. Nonthritst manipulation included posterior-anterior (P-A) glides in the prone position. Therapists were required to perform at least one technique targeting the upper thoracic spine and one technique targeting the mid thoracic spine during each visit. Following treatment directed at the thoracic spine, at least one set (30 seconds or 15-20 repetitions) of a nonthrust manipulation was directed at each desired level of the cervical spine. The cervical spine techniques could include retractions, rotations, lateral glides in the IILTTI position, and P-A glides. The therapists chose the techniques based on patient response and centralization (jr reduction of symptoms.
Treatment Patients were treated for an average of 7 visits (SD=2.08), over an average of 4.2 weeks, with a standardized treatment protocol. Treatments were performed sequentially to in- Exercise. After completing the clude postural education, manual manual thenipy procedures, the therapy, and exercise and ended therapist instructed the patient on with traction or sham traction. All specific exercises to complement patients received a home exercise the tnanual procedures pertbrmed. program on their first visit, including Exercises included cervical retracone or more of the available exer- tion, cervical extension, deep cervicises used in the standardized treat- cal flexor strengthening, and scapment protocol. The home exercise ular strengthening. At least one program was updated, as needed, on exercise was used during each treateach visit by ihe physical therapist. ment visit. All manual therapy and exercise procedures are described in Posture education. On the initial the eAppendix (available online at treatment visit, patients were edu- www.ptjoumal.org). cated on importance of correct postural alignment of the spine duritig Traction and sham traction. Afsittitig and standing activities. Pos- ter exercise, patients received either ture was addressed on subsequent mechanical intermittent cervical visits only if the physieal therapist traction or sham traction for 15 mindeemed ii necessary. utes according to their random assignment. Each patient was posiManual therapy. Manual therapy tioned sitpine, with the cervical was delinetl as either high-velocity, spine placed at an angle of approxilow-amplitude thrust manipulation mately 15 degrees of flexion. The or nonthrust manipulation. Initial traction force was started at 9.1 kg treatment included manipulation (20 Ih) or 10% of the patient's body procedures directed at the upper- weight (whichever was less) and inand mid-thoracic spines of spinal creased approximately 0.91 to 2.27 segments identified as hypomobile kg (2-5 Ib) every visit, depending on during segmental mobility testing.^" centralization or reduction of sympThrust manipttlation of the tliontcic toms. The maximum force used was spine could include techniques in a 15.91 kg (35 Ib). The on/off cycle prone, supine, or sitting position was set at 50/10. The sham traction luly 2009
protocol included the identical setup: however, only 2.27 kg (5 Ib) or less of force was applied. All other traction parameters were the same as for the group that received intermittent eervical traction. Data Analysis A separate repeated-measures, mixedmodel analysis was performed for each of the primary- and secondary outcomes, with alpha set at .05. Treatment group (MTEX versus MTEXTraction) was the hetweenpatient factor, and time (baseline, 2-week follow-up, 4-week follow-up) was defined as the repeated factor. The primary and secondary outcomes were used as the dependent variables. To allow for correlations within participants and of participants within clinics, we modeled patient and clinic as random effects without interactions. The main hypothesis of interest was the group X time interaction. Linear contrasts were constaicted to determine the between-group differences at each time point. The main effects of the interventions were obtained hy constructing linear contrasts to compare the mean change in outcome from baseline to each time point. The effect size was calculated from the between-group difterences in change score from baseline to the 4-week follow-up in all of the primary outcotne measures. Analyses followed intention-to-treat principles. Al! analyses were performed using SAS statistical software (JMP version 8.0'). Role of the Funding Source This study was funded by a grant from the Saunders Group. Results Patients (N= 121) were screened for eligibility, and 81 patients were eligible and agreed to participate (Fig. 1). Twelve patients (n=6 in • SAS Institute Inc. P() Box 8IKX), Car>'. NC 2751.Í.
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Manual Therapy, Exercise, and Traction for Cervical Radiculopathy Table 2. Baseline Variables and Treatment Visits" MTEX Croup (n=36)
MTEXTraction Croup (n=4S)
Variable
47.8(9.9)
46,2 (9.4)
Male
14(31.1)
12(33.3)
Female
31 (68.9)
24 (66.7)
8(18.2)
4(11.8)
Age (y) Sex, n (%)
Work-related injury, n (%) Duration of symptoms, n (%) 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 (%)
1 3 (28)
12(33)
33 (75)
26(74.3)
:E3
Most bothersome symptom, n (%) Pain Numbness/tingling Both pain and numbness/tingling Neck Disability index"
8(18.2)
5(14.3)
3 (6.8)
4(11.4)
19.8(8.7)
17.1 (7.4)
Patient-Specific Functional Scale'
3.5(1.8)
3.3(1,8)
Numeric Pain Rating Scale''
6.3(1.9)
6.5(1.7)
22.5(10.6)
20.7 (9.6)
Physical activity subscale'
17.7(7.4)
18.3(5.7)
Work subscale^
24.1 (17.2)
18.7(16.2)
7.0(2.1)
6.9(2.1)
Body diagram (symptom distribution)' Fear-Avoidance Beliefs Questionnaire
No. of treatment visits
Neurological examination.** n (%)
Normal Examination
Positive Test Either Category
Poiltive Teit Both Categories
Normai Examination
Positive Test Either Categoiy
Positive Test Both Categories
9(20)
22 (48.9)
14(31.1)
8 (22.2)
16 (44.4)
12(33.3)
"Values are mean (SD) unless othenwise stated. MTEXTraction groups patients who received manual therapy, exercise, and intermittent cervical traction; MTEX group ^patients who received manual therapy, exercise, and sham intermittent cervical traction. " Range of scores=0-50; higher scores represent higher levels of disability. â&#x20AC;˘^ Range of scores=0-l 0; higher scores represent greater levels of function. ''Range of scores=0-10, where 0="no pain." ' Range of scores=0-44; higher scores represent greater area of symptom distribution. 'Range of scores=0-30; higher scores represent higher levels of fear avoidance, ^ Range of scores=0-66; higher scores represent higher levels of fear avoidance. ''2 categories: deep tendon reflexes and myotome assessment.
for the NPRS, PSFS, NDI. and bod\' diagram, indicating there were significant improvements in pain, function, disability, and symptom distribution regardless of group assignment (MTEX versus MTEXTraction) from baseline to the 4-week No significant interaction or main follow-up. The adjusted effect size effects of group were found for from the mixed-models analysis for the primary or secondary outcome each of the primary outcomes was measures (Tab. 3). There was a sig- smaU CNDI=1,5, 95% confidence innificant main effect (/'<.O5) of time terval [CI] = -6.8 to 3-8: PSFS=0.29,
each group) were lost to follow-up between baseline (pretreatment) measures and the 4-week follow-up. Baseline demographies and data for outcome measures are listed in Table 2.
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95% CI=-1.8 to 1.2; and NPRS = 0.52, 95% Cl=-1.8 to 1.2).
Discussion This randomized clinical trial investigated the effects of a multimodal treatment approach including manual therapy and exercise, with and without the addition of intermittent cervical traction, in patients with CR. The results indicate that the addition of supine intermittent cervical luly 2009
Manuai Therapy, Exercise, and Traction for Cervicai Radiculopatiiy Table 3. Results of Analysis Comparing Outcomes Between Treatment Groups'^ Unadjusted Mean (5D) for Each Group
Adjusted Mean (SD) for Each Croup''
MTEXTraction Croup
MTEX Croup
Unadjusted Mean Difference Between Croups (95% CI)
2 wk
15.0(8.2)
13.1(7.1)
1.9 (-1.8 to 5.6)
.31
14.0(12.3)
)2.2(11.8)
1.8 (-7.0 to 3.5)
.34
4 wk
12.1 (9.0)
10.9(7.8)
1.2(-2.9to5.3)
.56
11.1 (12.3)
9.6(14.1)
1.5 (-6.8 to 3.8)
.42
2 wk
S.I (2.5)
5.2(2.4)
0.06(-1.2 to t . l )
.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(-1.8to1.2)
.57
2wk
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(-0.68to 1.7)
.38
3.4(3.1)
3.2(3.4)
0.52(
1-8 to 1.2)
.33
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
Physical activity subscale''
16.4(7.5)
1 8.1 (6.0)
1.6 {-0.48 to 1.6)
.31
15.5(10.4)
17-0(10.5)
1.5(-3,3to6.2)
.37
Work subscale'
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(-12.6to9.2)
.65
Physical activity subscale
14.0(7,8)
15.3(7.9)
1.7(-5.Sto2.1)
.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
2 wk
5.5 (3.0)
5.6(2.5)
- 0 . 1 4 ( - 1 . 4 to1.2)
.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)
-O.30(-1.7tol.3)
.83
7.1 (4.6)
7.5 (5.2)
0.44 (-1.8 to 0.9)
.52
2 wk
9.7(2.2)
9.6(1.9)
0.12(-0.81 t o l . 1 )
.76
lO.l (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(-O.70tol,2)
,58
Outcome Measure
P
MTEXTraction Croup
MTEX Croup
Adjusted Mean Difference Between Croups'* (95% CI)
P
Neck Disability Index"
Patient-Specific Functional Scale''
Numeric Pain Rating Scale^
Body diagram (symptom distribution)'
Fear-Avoidance Beliefs Questionnaire^ 2 wk
4 wk
Satisfaction rating'
Global Rating of Change Scale*
Improved at 4 wk (%)
68
69
•'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; Cl=confidence interval. ^Adjusted values from mixed-models analysis. ' Range of scores^O-50; higher scores represent higher levels of disability. '^ Range of scores = 0-10; higher scores represent greater levels of function. •• Range of scores=0-10. where 0 = "no pain." ' Range of scores=0-44; higher scores represent greater area of symptom distribution. y Range of scores=0-30; higher scores represent higher levels of fear avoidance. '' Range of scores=0-66; higher scores represent higher levels of fear avoidance. ' 2 categories; deep tendon reflexes and myotome assessment. 'Range of scores=0-10, where 10 = "completely satisfied." ' Range of scores = 0 - l 3; scores ^10 signify clinically meaningful improvement.
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Manual Therapy, Exercise, and Traction for Cervical Radiculopathy traction yielded no additional benefit to a program of manual therapy and exercise. Regardless of group assignment (MTEX versus MTEXTraction). patients with CR experienced significant improvements in both primary and secondary outcomes following 4 weeks of standardized physical therapy intervention. Although there were no significant differences between groups with any of the outcome tneasures, the precision of the point estimates of the treatment effects must be considered. At the 2-week follow-up, the lower boundary of the 95% C;i for the NDI was - 7 . 0 (Tab. 3). This value meets the threshold for meaningful clinically important change of the NDI (7.0). Furthermore, at the 4-week follow-up, the lower boundary' of the 95% CI for the NPRS was - 1 . 8 (Tab. 3). This value exceeds the threshold for meaningful clinically important change of the NPRS (1.3) adopted for this study. Thus. we cannot confidently exclude a treatment effect for these variables at these specific time points. Although statistically significant changes over time were found in both groups with all of the primary outcome measures, the threshold for minimum clinicalh important change was surpassed with the NPRS (n = 47 |67%|) and the PSFS (n = 44 [64%]) for those patients who completed the 4-week follow-up. A total of 2 points of change on the PSFS has been found to exceed the threshold for minimal clinically important change in patients with CR.'*' A change of 1.3 points on the NPRS recently was found to meet the tlireshold for minimal clinically important cliange in patients with neck pain.^" As no study has identified a minimal clinically important change value in patients with CR, this change score (1.3 points) on the NPRS was adopted for this study. Of the patients who completed the
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4-week follow-up, only 32 (46%) surpassed the minimal clinically important change of at least 7 points on the NDI.-'' A recent study-" suggests that the minimal clinically important change on the NDI may be more than twice as high as the original reported threshold of "^ points in patients with mechanical neck pain. With these inconsistencies regarding the appropriate threshold for clinically important difference, perhaps the responsiveness to change of the NDI may not be sufficient in this patient population. As the NDI is a commonly used self-report measure in patients with all neck-related disorders, future studies with larger sample sizes should investigate to detect change in patient status in conjunction with the NPRS, PSFS, and CiROC in patients with CR. The present study used a CPR to identify the presence of (~R.'- The CPR has a sensitivity- of 0.39 (95% CI=0.l6 to 0.61). a specificity of 0.99 (95% CI-0.97 tt) 1.00), and a po.sitive likelihood ratio of 30.3 (95% Cl-1.7 to 538.2) when all 4 test items are positive. I h e CPR has a sensitivity of 0.24 (95% CI=0.05 to 0.43), a specificity of 0.94 (95% CI^O.88 to 1.00), and a positive likelihood ratio of 6.1 (95% CI = 2.0 to 18.6)1 when 3 of 4 tests are positive. We used 3 of 4 criteria that are positive for eligibility despite other studies using 4 of 4 criteria, due to the narrower CI and the lower-bound estimate for 3 of 4 criteria. To date, the (;PR used in the present study has not been validated. The protocol for the intermittent cervical traction may have been the reason a treatment effect was not identified. Altbough a multitude of traction parameters are used in the clinical setting, there is no convincing evidence to suggest which parameters are most effective in the management of CR. Cleland et al~' used an on/off cycle of 30/10 and a
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traction angle of approximately 25 degrees, increasing forte by 0.45 to 0.91 kg (1-2 lb) per visit, whereas Waldrop et al'" u.sed an on/off cycle of 20/10 and a 15- to 24-dcgrcc angle of traction. Each of these case studies started with a traction force of 8.18 kg (18 lb) and monitored tbe centralization and reduction of symptoms to determine progression of force. Furtbermorc, both studies performed traction for 15 minutes and used a minimum traction force during the off cycle. In the clinical trial by joghataci ct al,'" a 13 64-kg (30-lb) traction force at a 24-degree angle of pull was used for a period of 20 minutes, with an on/off cycle of 7/5. In the present study, we used a longer duration of pull (on/off cycle of 50/10). a 15degree fiexion angle, and no traction force during the off cycle. In this study, tbe average traction force was 11.64 kg (SD = 2.8, range=9.0914.09) (25.6 lb. SD = 2.8. range=2031) for tbe MTEXTraction group and an average of 1.65 kg (SD^0.70, range^O.90-4.52) (3.5 lb, SD=1.1. range = 2.0-5.0) for the MTEX group. Interestingly, Zybergold and Piper-' found no significant difference in pain reduction among groups of patients with CR who received static traction, intermittent traction, manual traction, and treatment without traction. Possibly, more-aggressive tniction protocols (more force or greater frequency) may have had a greater effect on the patient sample in the present study. Moreover, we are unable to determine whether the sliam traction force of ni) greater than 2.3 kg (5 lb> had a treatment effect on the patients in this study. Although a control group receiving a siihthcrapcutic" traction force has its limitations, we feel this was the best control choice to address tbe setup, subsequent force production, and treatment time involved with this modality. In this study, there appeared to
luly 2009
Manual Therapy, Exercise, and Traction for Cervical Radiculopathy be no relationship between the amount of traetion force used and perceived recovery (Fig. 2).
1312-
o
o o oo
o
m a cn
m
D MTEXTraction Group O MTEX Group
ao o
ED
D a
GROC-
The tnanual therapy procedures used in this study were a combina00 o a a m 11tion of thnist and nonthrust manipulation techniques designed to centralize and reduce the cervical and o 0 a u a a 10upper-extremitj' s) mptoms. In order to simulate clinical practice, the thera ES n D 9o 0 apist was allowed to select individual -rttechniques based on centralization oo DD a 8or reduction of symptt)nis and the patient's response to treatment. If a 7 7 = No Better, manual therapy procedure centralOo / No Worse ized or reduced the patient s symptoms, this procedure continued to 6he used until there was no further benefit. (Conversely, if a manual pro5cedure worsened or peripheral i zed the patietit's symptoms, this procedure was abandoned and another o 4tecliiiique was selected. The procedures are modifications of tech2 4 6 8 10 12 14 niques first described by McKenAverage Traction Force (kg) zie,^*^ Maitland.^'* Greenman,-'*'-' and Figure 2. Vicenzino et al. '" An average of 2 Average force of traction (per subject) versus Global Rating of Cbange Scale (GROC) manual procedures were performed score5 (range=O-l 3; scores ^10 signify clinically meaningful improvement). There on botb the tbonicic and cervical appears to be no relationship between tbe amount of traction force used and perceived spines during eacb visit. Supine tho- recovery. MTEXTraction group=patients who received manual therapy, exercise, and racic thrust manipulation, cervical intermittent ceAiical traction; MTEX group=patients who received manual therapy, retraction nonthrust manipulation, exercise, and sham intermittent cervical traction. and cervical retraction exercise were the most commonly used procedures in the study (Fig. 3). Although The exercises used in this study agement of CR'^^^-^'* and cenieobrathoracic manipulation procediires included strengthening of the scapuchial pain" '•* -' Prior to the present have been shown to bave a signifi- lothoracic and deep neck flexors, study, only one randomized clinical cant short-term treatment effect on as well as cervical retraction and extrial isolated the effect of intermitpatients with mechanical neck tension exercises. Scapular strengthtent cervical traction, finding that pain/' '- these tecliniques have not ening and deep neck flexor exercises exercise and intermittent cervical been studied in patients witb CR. have provided some benefit in previtraction were superior to exercise Restoration of normal biomecbanics ous studies.-'-- Cervical retraction (cervical isometrics) and ultrasound to the thoracic spine may have a role is thought to improve resting neck on the outcome of grip strength after in lowering mechanical stresses and posture, relieve neck pain or radicu5 visits in patients with C7 radicuiopimproving distribution of joint forces lar or referred pain.-"^ and possiblj' athy,'^ However, there were m) sigin the cervical spine." '^^"^ Manipu- decompress neural elements in panificant differences between groups lations directed at the cervical spine tients with C;R.'•' An average of 2 at 10 visits (discbarge from physical were not performed in this study, as exercises per visit were used in the therapy).'" supporting evidence is sparse in pa- present study. tients with CR''* and considerable atWe acknowledge several limitations tention has been devoted to the risk This clinical trial supports previous of this study. First, we used a c:PR to of serious complications."'--'" randomized clinical trials demon- identify the presence of cervical rastrating effective conservative man- diculopathy that has yet to be vali-
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Manual Therapy, Exercise, and Traction for Cervical Radiculopathy
Figure 3.
''
(A) Supine thoracic thrust manipulation, (B) cervical retraction mobilization, (C) cervical retraction exercise.
dated, which may imply less-thanoptimal diagnostic accuracy of this contlititiii. Second, we arc unsure of how effective the blinding was during the course of treatment, as the patients were not asked whether they could identify which group they were in at the 4-week followup. If the patients thought they were receiving the sham treatment, this may have had an influence on their outcome. Third, the lack of a strictly recorded, dose-specific home exercise program maintained during the course of treatment was a limitation. Fourth, without a control group (a group not receiving treatment), we are unsure whether there was a 640
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spontaneous resolution of symptoms over the eourse of this 4-week treatment.
Conclusion !he addition of mechanical intermittent traction does not appear to improve outcomes for patients with CR wlio are already receiving manual therapy and exercise. Although traction provided no additional henefit in this study, suhsequent investigations examining traction at different dosages may be of interest in this patient population. The effect of CK c;ui he disabling, and continued research in the areas of diagnosis and
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treatment of this condition is of paramoiuit importance. Mr Young, Dr Michener, Dr Cleland, and Dr Aguilera provided concept/idea/research design. Mr Young, Dr Michener, Dr Cieland, and Dr Snyder provided writing. Mr Young, Dr Michener, Dr Aguilera, and Dr Snyder provided data analysis, Mr Young and Dr Michener provided project management and fund procurement, Dr Michener, Dr Cleland, Dr Aguilera, and Dr Snyder provided consultation (including review of manuscript before submission). The authors thank Advance Rehabilitation and Fredericksburg Orthopaedics tor their support of this study; physical therapists Chris Brown, Dan Walker, ]on Lamb, and Richard Linkonis for their patient recruiting
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Manual Therapy, Exercise, and Traction for Cervical Radiculopathy and treatment efforts; Amee Seitz for her help with data analysis; and Jennifer Chastain for her help with study/data management. A final thanks to Robin Saunders for her support of this study. The study was approved by the Rocky Mountain University of Health Professions Internal Review Board. Platform presentations of this research were given at the Combined Section Meetings of the American Physical Therapy Association; February 6-9, 2008; Nashville, Tennessee; and February 9-12, 2009; Las Vegas, Nevada. This study was funded by a grant from the Saunders Group. This article was received September 13, 2008, and was accepted March 25, 2009. DOI: 10.2522/ptj.20080283
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10 Nardin RA, Patel MR. Gildas TF, et al. Electromyography and magnetic resonance imaging in the evaluation of radiculopathy. Musde Serve. iy99:22il'il-l'i'j.
25 McKenzie R. Tbe Cenical and Tljoracic Spine: Mecbanical Diagnosis and Werapy. Waikanae. New Zealand: Spinal Publications Ltd: 1990.
11 Wilson DW, Pezztiti RT, Place JN Magnetic resonance imaging in the preoperative evaluation of cervical radiculopathy, Seimmtrgery: 1991:28:1"")-179.
26 Jensen MP. Karoly P. Bntver S. The measurement of clinical pain intensity : a comparison of six methods. Pain 1986;2": 117-126.
12 Wainner RS, FritzJM, irrgang JJ. et al, Reliahitity and diagnostic accuracy of the clinical examination and patient selfreport measures for cer\úcai radiculopa\.\\\.S¡}i)ie. 2003;28;'i2-62.
27 Cleland JA. Childs JD. Whitman JM. Psychometric properties ofthe Neck Disability Index and Numeric Pain Rating Scale in patients with mechanical neck pain. Arcb Phys MccI Rebahil. 2008:89:69--4.
13 Guide to Physical Tlierapist Practice, 2nd ed. Phys Tber. 2OOI:81:9-''46.
28 Vernon H. Mior S. The Neck Di.sability Index: a study of reliability and validity.
14 Allison (iT, Nagj- BM, Hall T. A randomized clinical trial of manual therapy for cer\ icohrachial pain syndrome: a pilot study. Man Wer, 2O(»2:7:9'5-IO2. 15 Coppieters MW. Stappaerts KH, Wouters LL. Janssens K. Tiie immediate effects of a cer\'ical lateral glide treatment technique in patients with neurogenic cenicobrachial pain, / Ortbnf) Sports Phys Ther, 2O()3:33:.369-378. 16 Moeti P. Marchetti G, Clinical outcome from mechanical intennitteni cervical traction for the ireatment of cer\ ieal radieiilopathy: a case .series. / Oribnp Spans Phys Ther. 2()Ol;3i:2O7-2l3. 17 Jogiiataei MT. Arah AM. Khaiisar H. The effect of cer\'ical traction combined with conventional therapy on grip strength on patients with eenical radiculopathy. Clin Rebaba. 2004:18:879-88-. 18 Waidrop MA. Diagnosis and treatment of cervical nidicuiopathy using a cliiiital prediction nile and a multimodal inien'ention approach: a case series. / Orlhn/i Sports Phys Ther. 2(H)6:36,H2-1';9. 19 Browder DA. Uriiard Ri:. Piva SR, Intermiltent cenicai traction and thonicic mimipulation for managetiieiu of mild cenical compressive myeiopathy attributed to cervical hemiated disc: a ease series.y Ortbop Sports Phys Iber. 200i:3-i:7()i-7i J, 20 Constanioyannis C;. Konstantinou D, Kourtopoulos H. Papadakis N. Intemilttent cervical traction for cervicai radiculopath)caused by large-volume hemiated disks. / Mani¡m¡ative Physioi Wer. 2002:2';: 188-192. 21 Cleland JA, Whitman JM. FritzJM. Palmer JA. Manual physical therapy, cervical traction, and strengthening exercises in patients with cenical radiculopathy: a case series. / Ortbop Sports Pbys ïher. 2005:3V;802-811. 22 Cleland JA, FritzJM, Whitman JM, Heath R. I'redictors of short-temi outcome in people with a clinical diagnosis of cenical radiculopalhy. Pbys Tber. 200-;87: 1619-1632. 23 Walker MJ. Boyles RE. Young BA. et al. The effectiveness of manual physical therapy and exercise for mechanical neck pain: a nindomized clinical trial. Spine, 2OO8:33:23"'l-2378, 24 Zylbergold RS, Piper MC. Cer\'ical spine disorders: a comparison of three types of traction. Spine. 1985:10:867-8"'l-
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Manual Therapy, Exercise, and Traction for Cervical Radiculopathy 41 Ck-lmui jA, Childs JD, McRae M. et al. Imtiicdiatc clil-'Cts of thoracic manipulation in püticnts with neck p;nn: a r-indonii/eiJ dinicai ttial. Man Jher. 2 42 CUclanil lA, Glynn P. Whitman .l.M. et al. Short-term fffects of thnist versus nonihniM mohilization/inanipiilation directed at Ihe thoracic spine in patients wiih neck pain: a randomized clinical trial. Phys Wer. 2(MI7;S7:.131-440 43 Norlander S. Nordi;ren li. Ciinieal symptoms relaicd to miiscnloskeietal neekshotilder pain and mobility in the ccrvicothoraeie spine. Sennd / Rehahll .\k'd.
44 Norlander S, Giistavsson BA, ljndell J, Nortlgren B, Reduced mobility in the cervieo thoracic motion segtiieni—a risk factor for musculoskeletal neck-shi>iilder pain: a two-year prospective lollowiip study. fbahil Med. 1997:29:167-174.' 45 Schliesser IS, Kruse R, Fallón LF. Cervical nidiculopathy treated wilh ehiropraciic flexion distraction manipulation: a retrospective stud)' in a private practice setting / Mantptilittife Physio! Ther. 20113: 26:E19. 46 Haldeman .S, Kohlheek FJ, McGregor M. Risk faeiors and precipitating neck movements causing vertehrobasiiar artery di.sseetion after eervical inuima and spinal manipulation. .S/n'ne. l999:24:7SS-794.
47 Haldeman S, Kohlheek Fj. McOrc-gür M. Stroke, cerehnil anery dissection, and etTvical spine manipulation therapy. / Neitrol. 2(K)2;249:1098-IHH. 48 Haldeman S, Kohlbeek FJ, McC.regor M. Unpredictahility of eerehrovaseular ischemia associated with cervical spine manijv Illation therapy: a review of sixty-four cases after eervical spine manipulation. S/}iiu'. 2OO2;27:49-SS. 49 AhduKvahah SS, Sahbahi M. Neck retractions, eervical root decompression, and radicular i^ain. / Orthop .Sports Phy.^ Wer. 2000:30:4-9,'
Appendix. Primary and Secondary Outcome Measures" Measure
Scale and Scoring
Reliability (95% Cl)
MClC Value
Neck Disability Index^».'''
Seif-report measure containing 10 items (scored 0-5). Total score out of 50 possible points (0="no disability," 50 = "severe disability").
ICC = .68 (.03 to .90)
s 7 points
Patient-Specific Functional Scale^'-'o
Self-report activity limitations rated from 0 ("inability to perform activity") to 10 ("able to perform activity as well as prior to onset of symptoms"). Activity scores averaged (higher score = îess disability)
ICC = .82 (.54 to .93)
>2 points
Numeric Pain Rating Scale^^-i'
Self-report measure with scores ranging from 0 ("no pain") to 10 ("worst pain imaginable").
ICC = .63 (.28 to .96)
>1.3 points
Global Rating of Change Scale^-"
Self-report Likert scale with scores ranging from 0 ("a very great deal worse") to 7 ("about the same") to 13 ("a very great deal better"). A score of s^lO signifies improvement.
Pain diagram"
Self-report measure indicating type and location of symptoms on a standardized body chart. Total score is out of 44 points (higher scores indicate greater symptom distribution).
Fear-Avoidance 8eliefs Questionnaire""
Self-report measure that quantifies fear and avoidance beliefs in patients with low back pain and neck pain. Physical activity subscale: range of scores = 0-ÎO; Work subscale: range of scores=0-66; higher scores represent higher levels of fear avoidance.
Satisfaction rating'^
Self-report measure witfi scores ranging from 0 ("not satisfied") to 10 ("very satisfied") with the use of the neck and arm.
ICC = .93
Not reported
Grip strength'*-3'
Average of 2 trials measured with a jamar hand dynamometer*"
ICC = .8?-.97
Not reported
^ 1 0 points
kappa-.92
Not reported
Not reported
"Cl=confidence interval, MCIC = minimal clinically important change, ICC = intraclass correlation coefficient. " Sammons Preston, PO Box 5071, Bolingbrook, IL 60440-5071.
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