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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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