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Randomized controlled trial of supervised physiotherapy versus a home exercise program after hydrodilatation for the management of primary frozen shoulder
Robinson PM, Norris J, Roberts CP
Journal of Shoulder and Elbow Surgery 2017 May;26(5):757-765
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; 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*

HYPOTHESIS AND BACKGROUND: Hydrodilatation and physiotherapy are commonly used treatments for primary frozen shoulder. Little is known about the optimal form of physiotherapy. This study reports a randomized controlled trial comparing 2 forms of physiotherapy after hydrodilatation. The null hypothesis was that there would be no difference between the 2 groups at 1 year as measured by the Oxford Shoulder Score (OSS). METHODS: We randomized 41 patients undergoing hydrodilatation for primary frozen shoulder into 2 treatment groups: group 1 (n = 20) underwent supervised physiotherapy in addition to a home exercise program, and group 2 (n = 21) followed a self-directed home exercise program in isolation. Assessment was carried out by a blinded research nurse at baseline, 4 weeks, 3 months, 6 months, and 1 year. The primary outcome measure was the OSS. Other measures were range of movement, visual analog scale pain score, and EQ-5D index. RESULTS: There was no significant difference between the treatment groups at any time point as measured by the OSS or EQ-5D index. In group 1, the OSS improved significantly from 25.00 (95% confidence interval (CI) 21.92 to 28.08) at baseline to 38.29 (95% CI 34.01 to 42.58; p < 0.0001) at 4 weeks and 43.71 (95% CI 41.61 to 45.80; p < 0.0001) at 1 year. In group 2, the OSS improved significantly from 26.60 at baseline (95% CI 22.50 to 30.70) to 40.07 (95% CI 36.77 to 43.36; p < 0.0001) at 4 weeks and 43.00 (95% CI 39.69 to 46.31; p < 0.0001) at 1 year. All outcome measures improved significantly from baseline to 4 weeks. CONCLUSION: In this group of patients, after a hydrodilatation procedure for the treatment of primary frozen shoulder, there was no significant difference in clinical outcomes between supervised physiotherapy in addition to a home exercise program and a self-directed home exercise program in isolation. LEVEL OF EVIDENCE: Level II; randomized controlled trial; treatment study.

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