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

Autor: Littlewood C; Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK.; Department of Health Professions, Faculty of Health, Psychology & Social Care, Manchester Metropolitan University, Manchester, Greater Manchester, UK., Bateman M; Derby Shoulder Unit, University Hospitals Derby & Burton NHS Foundation Trust, Derby, UK., Butler-Walley S; Keele Clinical Trials Unit, School Medicine, Keele University, Staffordshire, UK., Bathers S; Keele Clinical Trials Unit, School Medicine, Keele University, Staffordshire, UK., Bromley K; Keele Clinical Trials Unit, School Medicine, Keele University, Staffordshire, UK., Lewis M; Keele Clinical Trials Unit, School Medicine, Keele University, Staffordshire, UK., Funk L; Wrightington, Wigan and Leigh NHS Foundation Trust, Wigan, UK., Denton J; The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust, Oswestry, Shropshire, UK., Moffatt M; Wrightington, Wigan and Leigh NHS Foundation Trust, Wigan, UK., Winstanley R; Royal Stoke University Hospital, University Hospitals of North Midlands NHS Trust, Stoke, UK., Mehta S; Royal Stoke University Hospital, University Hospitals of North Midlands NHS Trust, Stoke, UK., Stephens G; The Royal Orthopaedic Hospital NHS Foundation Trust, Birmingham, UK., Dikomitis L; School of Medicine, Keele University, Keele, Staffordshire, UK., Foster NE; Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Staffordshire, UK.
Jazyk: angličtina
Zdroj: Clinical rehabilitation [Clin Rehabil] 2021 Jun; Vol. 35 (6), pp. 829-839. Date of Electronic Publication: 2020 Dec 11.
DOI: 10.1177/0269215520978859
Abstrakt: 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.
Databáze: MEDLINE