TY - JOUR
T1 - Rehabilitation following rotator cuff repair
T2 - A multi-centre pilot & feasibility randomised controlled trial (RaCeR)
AU - Littlewood, Chris
AU - Bateman, Marcus
AU - Butler-Walley, Stephanie
AU - Bathers, Sarah
AU - Bromley, Kieran
AU - Lewis, Martyn
AU - Funk, Lennard
AU - Denton, Jean
AU - Moffatt, Maria
AU - Winstanley, Rachel
AU - Mehta, Saurabh
AU - Stephens, Gareth
AU - Dikomitis, Lisa
AU - Foster, Nadine E.
N1 - Funding Information:
We thank Linda Chesterton and staff within Keele Clinical Trials Unit including Kendra Cooke, Susie Hennings, Sarah Lawton, David Whittaker, Jane Mason, Alicia Bratt, Steven Harper, Jo Smith, Tracy Whitehurst for their contribution to study set-up, delivery and data cleaning. Further acknowledgement is due to Tina Cookson as a patient representative and the Research User Group from the Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University who reviewed the developing protocol and offered advice from the patients? perspective. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by the National Institute for Health Research (NIHR) Research for Patient Benefit programme (PB-PG-0816-20009). CL is supported by a NIHR Post-Doctoral Fellowship, (PDF-2018-11-ST2-005). NEF was supported through an NIHR Research Professorship (NIHR-RP-011-015) and is an NIHR Senior Investigator. KB was supported by an NIHR Research Methods Fellowship (NIHR-RM-FI-2017-08-006). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by the National Institute for Health Research (NIHR) Research for Patient Benefit programme (PB-PG-0816-20009). CL is supported by a NIHR Post-Doctoral Fellowship, (PDF-2018-11-ST2-005). NEF was supported through an NIHR Research Professorship (NIHR-RP-011-015) and is an NIHR Senior Investigator. KB was supported by an NIHR Research Methods Fellowship (NIHR-RM-FI-2017-08-006). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
Publisher Copyright:
© The Author(s) 2020.
PY - 2021/6
Y1 - 2021/6
N2 - 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.
AB - 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.
KW - physiotherapy
KW - randomized controlled trial
KW - Rehabilitation interventions
KW - shoulder pain
UR - https://www.scopus.com/pages/publications/85097416685
UR - https://www.scopus.com/pages/publications/85097416685#tab=citedBy
U2 - 10.1177/0269215520978859
DO - 10.1177/0269215520978859
M3 - Article (journal)
C2 - 33305619
AN - SCOPUS:85097416685
SN - 0269-2155
VL - 35
SP - 829
EP - 839
JO - Clinical Rehabilitation
JF - Clinical Rehabilitation
IS - 6
ER -