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Effectiveness of radial extracorporeal shock wave therapy (rESWT) when combined with supervised exercises in patients with subacromial shoulder pain: a double-masked, randomized, sham-controlled trial
Kvalvaag E, Brox JI, Engebretsen KB, Soberg HL, Juel NG, Bautz-Holter E, Sandvik L, Roe C
The American Journal of Sports Medicine 2017 Sep;45(11):2547-2554
clinical trial
9/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: Yes; 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*

BACKGROUND: Subacromial shoulder pain is a common complaint, and radial extracorporeal shock wave therapy (rESWT) is increasingly used to treat this condition. Although many therapists use rESWT in combination with supervised exercises, no studies have evaluated the additional effect of rESWT with supervised exercises for subacromial shoulder pain. PURPOSE: To assess whether rESWT is more effective than sham rESWT when combined with supervised exercises for improving pain and function in patients with subacromial shoulder pain. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: Patients between 25 and 70 years of age with subacromial shoulder pain with and without calcification in the rotator cuff lasting at least 3 months were assessed for eligibility; 143 patients were recruited. Participants were allocated (1:1) by computer-generated randomization in blocks of 20 to receive either rESWT or sham rESWT in addition to supervised exercises. The rESWT and sham rESWT were performed once a week with additional supervised exercises once a week for the first 4 weeks. The following 8 weeks, the patients received supervised exercises twice a week. The primary outcome was change in the Shoulder Pain and Disability Index (SPADI) after 24 weeks. Patients and outcome assessors were masked to group assignment. RESULTS: At 24 weeks, participants in both the sham group and the rESWT group had improved (p < 0.001) in SPADI score compared with baseline (-23.9 points (SD 23.8 points) and -23.3 points (SD 25.0 points), respectively), but there were no differences between the groups (mean difference 0.7; 95% CI -6.9 to 8.3; p = 0.76). Prespecified subgroup analysis of patients with calcification in rotator cuff showed that the rESWT group had a greater improvement in SPADI score after 24 weeks (mean difference -12.8; 95% CI -24.8 to -0.8; p = 0.018). CONCLUSION: Radial ESWT offered no additional benefit to supervised exercises in the treatment of subacromial shoulder pain after 24 weeks, except in the subgroup of patients with calcification in the rotator cuff. REGISTRATION: NCT01441830 (ClinicalTrials.gov identifier).

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