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A randomized controlled trial to assess the efficacy of shoulder manipulation versus placebo in the treatment of shoulder pain due to rotator cuff tendinopathy |
Atkinson M, Mathews R, Brantingham JW, Globe G, Cassa T, Bonnefin D, Korporaal C |
Journal of the American Chiropractic Association 2008 Dec;45(9):11-26 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
INTRODUCTION: Shoulder pain is common, but the best treatment for it is yet to be determined. This randomized, placebo-controlled trial of manipulation (high-velocity, low amplitude shoulder adjustment) versus placebo (sham laser) was designed to assess the efficacy of manipulation in the treatment of rotator cuff tendinopathy. MATERIALS AND METHODS: Eighty-six patients were screened, and 60 volunteers, 30 per group (average age 42, range 18 to 76 years) with a diagnosis of rotator cuff tendinopathy (supraspinatus tendinopathy) were randomized into two groups. Outcome measures included the Numerical Pain Rating Scale- 101 (NRS-101), algometry, and goniometry. Full power was calculated at 95%, requiring a sample size of N = 144 with alpha set at p = 0.05. RESULTS: The unpaired t-test demonstrated a significant difference in favor of adjusting (group 1) for algometry and goniometry (p <= 0.05). Friedman's test, however, determined that for group 1, there were statistically significant and clinically meaningful decreases in the NRS-101 and significantly increased global range of motion (ROM) at final consultation in flexion, extension, abduction, adduction, external rotation, and horizontal abduction (all p < 0.05). Five patients dropped out and were replaced in the placebo group; none dropped out in the adjustment group. There were no serious adverse events. Blind assessors, longer follow-up, and functional outcome measures will improve future studies. CONCLUSION: In this study, shoulder manipulation appeared efficacious (algometry, goniometric ROM) in short-term relief of rotator cuff tendinopathy versus placebo (p <= 0.05). Regarding within-group change, there were also statistically significant and clinically meaningful decreased pain and increased global ROM with shoulder manipulation (p <= 0.05). Without full power, these data must be viewed with caution, but the results clearly merit further research.
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