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

Authors :
Jean Denton
Martyn Lewis
Lisa Dikomitis
Rachel Winstanley
Sarah Bathers
Marcus Bateman
Lennard Funk
Stephanie Butler-Walley
Kieran Bromley
Chris Littlewood
Maria Moffatt
Nadine E. Foster
Gareth Stephens
Saurabh Mehta
Source :
Clinical Rehabilitation
Publication Year :
2020
Publisher :
SAGE Publications, 2020.

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 Twenty participants were withdrawn, 11 due to not receiving rotator cuff repair.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

Details

ISSN :
14770873 and 02692155
Volume :
35
Database :
OpenAIRE
Journal :
Clinical Rehabilitation
Accession number :
edsair.doi.dedup.....b7fe69bafba8ba8c4a70c1c90cfff0be
Full Text :
https://doi.org/10.1177/0269215520978859