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Exercise only, exercise with mechanical traction, or exercise with over-door traction for patients with cervical radiculopathy, with or without consideration of status on a previously described subgrouping rule: a randomized clinical trial [with consumer summary]
Fritz JM, Thackeray A, Brennan GP, Childs JD
The Journal of Orthopaedic and Sports Physical Therapy 2014 Feb;44(2):45-57
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

STUDY DESIGN: Randomized clinical trial. OBJECTIVES: To examine the effectiveness of cervical traction in addition to exercise for specific subgroups of patients with neck pain. BACKGROUND: Cervical traction is frequently used, but its effectiveness has not been adequately examined. Existing studies have failed to target patients most likely to respond. Traction is typically recommended for patients with cervical radiculopathy. A prediction rule has been described to identify a narrower subgroup of patients likely to respond to cervical traction. METHODS: Patients with neck pain and signs of radiculopathy were randomized to 4 weeks of treatment with exercise, exercise with mechanical traction, or exercise with over-door traction. Baseline assessment included subgrouping-rule status. The primary outcome measure (Neck Disability Index, scored 0 to 100) and secondary outcome measure (neck and arm pain intensity) were assessed at 4 weeks, 6 months, and 12 months after enrollment. The primary analyses examined 2-way treatment-by-time interactions. Secondary analyses examined validity of the subgrouping rule by adding 3-way interactions. RESULTS: Eighty-six patients (53.5% female; mean age 46.9 years) were enrolled in the study. Intention-to-treat analysis found lower Neck Disability Index scores at 6 months in the mechanical traction group compared to the exercise group (mean difference between groups 13.3; 95% confidence interval 5.6 to 21.0) and over-door traction group (mean difference between groups 8.1; 95% confidence interval 0.8 to 15.3), and at 12 months in the mechanical traction group compared to the exercise group (mean difference between groups 9.8; 95% confidence interval 0.2 to 19.4). Secondary outcomes favored mechanical traction at several time points. The validity of the subgrouping rule was supported on the Neck Disability Index at the 6-month time point only. CONCLUSION: Adding mechanical traction to exercise for patients with cervical radiculopathy resulted in lower disability and pain, particularly at long-term follow-ups. The study protocol was registered at http://ClinicalTrials.gov (NCT00979108). LEVEL OF EVIDENCE: Therapy, level 2b-.

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