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Supervised exercises compared with radial extracorporeal shock-wave therapy for subacromial shoulder pain: 1-year results of a single-blind randomized controlled trial
Engebretsen K, Grotle M, Bautz-Holter E, Ekeberg O, Juel N, Brox J
Physical Therapy 2010 Jan;91(1):37-47
clinical trial
7/10 [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: 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: Evidence from a recent randomized controlled trial indicated that supervised exercises (SE) were more effective than radial extracorporeal shock-wave therapy (rESWT) for the treatment of subacromial shoulder pain in the short to medium term. Little knowledge exists about the long-term results of rESWT for subacromial pain. OBJECTIVE: The aim of this study was to evaluate the results of rESWT and SE provided to patients with subacromial shoulder pain after 1 year. DESIGN: This was a single-blind randomized controlled trial. SETTING: The study was conducted in the outpatient clinic of the Physical Medicine and Rehabilitation Department at Oslo University Hospital, Ullevaal, Norway. PATIENTS: One hundred four patients with subacromial shoulder pain lasting at least 3 months participated. Patients were randomly assigned to either an rESWT group (n = 52) or an SE group (n = 52). Intervention The rESWT intervention consisted of one session weekly for 4 to 6 weeks. The SE intervention consisted of two 45-minute sessions per week for up to 12 weeks. MEASUREMENTS: The primary outcome measure was the Shoulder Pain and Disability Index. Secondary outcome measures were questions regarding pain and function and work status. RESULTS: After 1 year, an intention-to-treat analysis showed no significant differences between the 2 groups for the primary outcome measure (-7.6 points, 95% confidence interval -16.6 to 0.5) and pain, function, and medication use. Twenty-nine participants (60%) in the SE group versus 24 participants (52%) in the rESWT group were categorized as clinically improved. Thirty-eight participants in the SE group were at work compared with 30 participants in the rESWT group (odds ratio 1.1, 95% confidence interval 1.0 to 1.2). Fewer patients in the SE group had received additional treatments between 18 weeks and 1 year. LIMITATIONS: The lack of a placebo control group, the lack of a cost-benefit analysis, and the small sample size were limitations of the study. CONCLUSION: No significant difference was found between the SE and rESWT groups at the 1-year follow-up. More participants in the SE group had returned to work.

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