Chris Littlewood
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
Authors
Marcus Bateman
Stephanie Butler-Walley
Sarah Bathers
Kieran Bromley k.bromley1@keele.ac.uk
Alyn Lewis a.m.lewis@keele.ac.uk
Lennard Funk
Jean Denton
Maria Moffatt
Rachel Winstanley
Saurabh Mehta
Gareth Stephens
Lisa Dikomitis
Nadine E Foster
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 Twenty participants were withdrawn, 11 due to not receiving rotator cuff repair.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 | Nov 16, 2020 |
Publication Date | Dec 11, 2020 |
Journal | Clinical Rehabilitation |
Print ISSN | 0269-2155 |
Publisher | SAGE Publications |
Volume | 35 |
Issue | 6 |
Pages | 829-839 |
DOI | https://doi.org/10.1177/0269215520978859 |
Keywords | Rehabilitation interventions, physiotherapy, randomized controlled trial, shoulder pain |
Publisher URL | https://doi.org/10.1177/0269215520978859 |
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Publisher Licence URL
https://creativecommons.org/licenses/by-nc/4.0/
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