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

Littlewood, Chris; Bateman, Marcus; Butler-Walley, Stephanie; Bathers, Sarah; Bromley, Kieran; Lewis, Martyn; Funk, Lennard; Denton, Jean; Moffatt, Maria; Winstanley, Rachel; Mehta, Saurabh; Stephens, Gareth; Dikomitis, Lisa; Foster, Nadine E.

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 Twenty participants were withdrawn, 11 due to not receiving rotator cuff repair.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.

• Journal Article Type: Article
• Acceptance Date: Dec 11, 2020
• Online Publication Date: Dec 11, 2020
• Publication Date: 2021-06
• Deposit Date: Nov 15, 2024
• Publicly Available Date: Nov 15, 2024
• Journal: Clinical Rehabilitation
• Print ISSN: 0269-2155
• Electronic ISSN: 1477-0873
• Publisher: SAGE Publications
• Peer Reviewed: Peer Reviewed
• Volume: 35
• Issue: 6
• Pages: 829-839
• DOI: https://doi.org/10.1177/0269215520978859
• Keywords: physiotherapy, randomized controlled trial, Rehabilitation interventions, shoulder pain