Rehabilitation following rotator cuff repair: Multi-centre pilot and feasibility randomised controlled trial (RaCeR)

Littlewood, C.; Bateman, M.; Butler-Walley, S.; Bathers, S.; Cookson, T.; Bromley, K.; Lewis, M.; Funk, L.; Denton, J.; Moffatt, M.; Winstanley, R.; Mehta, S.; Stephens, G.; Dikomitis, L.; Chesterton, L.; Foster, N.

Abstract

Purpose: Shoulder pain is a highly prevalent complaint and disorders of the rotator cuff, including tears, are thought to be the most common cause. The number of operations to repair the torn rotator cuff has risen significantly in recent years. While surgical techniques have progressed, becoming less invasive and more secure, rehabilitation programmes have remained largely like those initially developed when surgical techniques were less advanced and more invasive.

Uncertainty remains in relation to the length of post-surgical immobilisation and the amount of early load permitted at the repair site. In the context of this uncertainty, current practice is to follow a generally cautious approach, including long periods of immobilisation in a sling and avoidance of early active rehabilitation. Systematic review evidence suggests early mobilisation might be beneficial but further high-quality studies are required to evaluate this.

The aim of the RaCeR study was to assess the feasibility of a substantive, multi-centre randomised controlled trial (RCT) to test whether, compared to standard rehabilitation (SR) incorporating sling immobilisation for four weeks, early patient-directed rehabilitation (EPDR), where the patient is directed to move their arm as symptoms allow, is more clinically- and cost-effective following surgical repair of the rotator cuff.

Methods: We conducted a two-arm, multi-centre pilot and feasibility RCT. Patients diagnosed with non-traumatic tears of the rotator cuff and listed for surgical repair were recruited from five NHS hospitals and randomly allocated to EPDR or SR.

Participants received weekly SMS text messages for 12 weeks and postal questionnaires at six and 12 weeks asking about pain, function and health-related quality of life. A blinded diagnostic ultrasound scan was undertaken at 12 weeks to assess re-tear rate. Participants also completed an exercise diary to record time out of sling over the first four weeks.

Results: Over 12-months, 73 of the anticipated 76 participants were randomised. Of the 73, there were 20 withdrawals: 11 did not receive rotator cuff repair surgery; six were withdrawn by the surgeon; three did not comply with study procedures. Response rates to SMS text messages were 87%. Postal questionnaire response rates were 94% and 96% at six and 12 weeks respectively. 51 participants underwent an ultrasound scan at 12 weeks with 47 available for analysis. Overall re-tear rate was 38% (EPDR n = 7/SR n = 11). Time out of sling was 414 h for the EPDR group and 178 for the SR group (8-hour difference/day).

Conclusion(s): The findings from this study suggest a future substantive RCT would be feasible but due consideration needs to be given to the withdrawal rate, by either inflating the sample size or randomising patients after surgery, rather than before.

Impact: Research to date suggests that there is the possibility of reducing the patient burden associated with postoperative immobilisation following surgery to repair the torn rotator cuff and improve clinical outcomes. The findings from this study provide a platform from which to conduct a high-quality, adequately powered, RCT to better inform clinical practice.

• Journal Article Type: Conference Paper
• Conference Name: Virtual Physiotherapy UK 2020 Conference
• Conference Location: Virtual
• Acceptance Date: Nov 21, 2021
• Publication Date: 2021-12
• Deposit Date: Jun 27, 2023
• Journal: Physiotherapy
• Publisher: De Gruyter
• Peer Reviewed: Peer Reviewed
• Volume: 113
• Issue: S1
• Pages: e13-e14
• DOI: https://doi.org/10.1016/j.physio.2021.10.238
• Keywords: Physical Therapy, Sports Therapy and Rehabilitation
• Additional Information: This article is maintained by: Elsevier; Article Title: Rehabilitation following rotator cuff repair: Multi-centre pilot and feasibility randomised controlled trial (RaCeR); Journal Title: Physiotherapy; CrossRef DOI link to publisher maintained version: https://doi.org/10.1016/j.physio.2021.10.238; Content Type: simple-article; Copyright: Copyright © 2021 Published by Elsevier Ltd.