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Early active motion versus sling immobilization after arthroscopic rotator cuff repair: a randomized controlled trial |
Sheps DM, Silveira A, Beaupre L, Styles-Tripp F, Balyk R, Lalani A, Glasgow R, Bergman J, Bouliane M, on behalf of the Shoulder and Upper Extremity Research Group of Edmonton (SURGE) |
Arthroscopy 2019 Mar;35(3):749-760 |
clinical trial |
8/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; 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* |
PURPOSE: To compare the effect of early mobilization (EM) with standard rehabilitation (SR) over the initial 24 months following arthroscopic rotator cuff (RC) repair. METHODS: A total of 206 patients with full-thickness RC tears undergoing arthroscopic repair were randomized following preoperative assessment of shoulder range of motion (ROM), pain, strength, and health-related quality of life (HRQOL) to either EM (n = 103; self-weaned from sling and performed pain-free active ROM during the first 6 weeks) or SR (n = 103; wore a sling for 6 weeks with no active ROM). Shoulder ROM, pain, and HRQOL were reassessed at 6 weeks and 3, 6, 12, and 24 months postoperatively by a blinded assessor. At 6, 12, and 24 months, strength was reassessed. At 12 months, ultrasound verified RC integrity. Independent t tests assessed 6-week group differences and 2-way repeated measures analysis of variance assessed changes over time between groups. RESULTS: The groups were similar preoperatively (p > 0.12). The mean age of participants was 55.9 (minimum, 26; maximum, 79) years, and 131 (64%) were men. A total of 171 (83%) patients were followed to 24 months. At 6 weeks postoperatively, EM participants had significantly better forward flexion and abduction (p < 0.03) than the SR participants; no other group differences were noted. Over 24 months, there were no group differences in ROM after 6 weeks (p > 0.08), and pain (p > 0.06), strength (p = 0.35), or HRQOL (p > 0.20) at any time. Fifty-two (25%) subjects (30% EM; 33% SR) had a full-thickness tear present at 12-month postoperative ultrasound testing (p > 0.8). CONCLUSIONS: EM did not show significant clinical benefits, but there was no compromise of postoperative ROM, pain, strength, or HRQOL. Repair integrity was similar at 12 months postoperatively between groups. Consideration should be given to allow pain-free active ROM within the first 6 weeks following arthroscopic RC repair. LEVEL OF EVIDENCE: Level I, high-quality randomized controlled trial.
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