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

• Published in: Clinical rehabilitation 2021-06, Vol.35 (6), p.829-839
• Main Authors: 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
• Format: Article
• Language: English
• Subjects: Aged; Clinical trials; Cost analysis; Critical incidents; Early intervention; England; Feasibility; Feasibility Studies; Female; Health services; Hospitals; Humans; Male; Middle Aged; Original; Physical therapy; Pilot Projects; Postoperative Care - adverse effects; Postoperative Care - methods; Rehabilitation; Rotator cuff; Rotator Cuff - surgery; Rotator Cuff Injuries - rehabilitation; Shoulder; Surgery; Time out
• ISSN: 0269-2155; 1477-0873
• DOI: 10.1177/0269215520978859

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 Twenty participants were withdrawn, 11 due to not receiving rotator cuff repair.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