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Rehabilitation following rotator cuff repair: A multi-centre pilot & feasibility randomised controlled trial (RaCeR)

Littlewood, Christopher and Bateman, Marcus and Butler-Walley, Stephanie and Bathers, Sarah and Bromley, Kieran and Lewis, Martyn and Funk, Lennard and Denton, Jean and Moffatt, Maria and Winstanley, Rachel and Mehta, Saurabh and Stephens, Gareth and Dikomitis, Lisa and Foster, Nadine (2020) Rehabilitation following rotator cuff repair: A multi-centre pilot & feasibility randomised controlled trial (RaCeR). Clinical Rehabilitation. ISSN 0269-2155

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Abstract

Objective: To evaluate the feasibility of a multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of early patient-directed rehabilitation versus standard rehabilitation following surgical repair of the rotator cuff of the shoulder. Design: Two-arm, multi-centre pilot and feasibility randomised controlled trial. Setting: Five National Health Service hospitals in England. Participants: Adults (n = 73) with non-traumatic rotator cuff tears scheduled for repair were recruited and randomly allocated remotely prior to surgery. Interventions: Early patient-directed rehabilitation (n = 37); advised to remove their sling as soon as able and move as symptoms allow. Standard rehabilitation (n = 36); sling immobilisation for four weeks. Measures: (1) Randomisation of 20% or more eligible patients. (2) Difference in time out of sling of 40% or more between groups. (3) Follow-up greater than 70%. Results: 73/185 (39%) potentially eligible patients were randomised. Twenty participants were withdrawn, 11 due to not receiving rotator cuff repair. The between-group difference in proportions of participants who exceeded the cut-off of 222.6 hours out of the sling was 50% (80% CI = 29%, 72%), with the early patient-directed rehabilitation group reporting greater time out of sling. 52/73 (71%) and 52/53 (98%) participants were followed-up at 12 weeks when withdrawals were included and excluded respectively. Eighteen full-thickness re-tears were reported (early patient-directed rehabilitation = 7, standard rehabilitation = 11). Five serious adverse events were reported. Conclusion: A main randomised controlled trial is feasible but would require allocation of participants following surgery to counter the issue of withdrawal due to not receiving surgery.

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