Clinical and cost-effectiveness of individualised (early) patient-directed rehabilitation versus standard rehabilitation after surgical repair of the rotator cuff of the shoulder: protocol for a multi-centre, randomised controlled trial with integrated Quintet Recruitment Intervention (RaCeR 2)

Mazuquin, Bruno ORCID: https://orcid.org/0000-0003-1566-9551, Moffatt, Maria, Realpe, Alba, Sherman, Rachelle, Ireland, Katie, Connan, Zak, Tildsley, Jack, Manca, Andrea, Gc, Vijay, Foster, Nadine, Rees, Jonny, Drew, Steven, Bateman, Marcus, Fakis, Apostolos, Farnsworth, Malin and Littlewood, Chris (2024) Clinical and cost-effectiveness of individualised (early) patient-directed rehabilitation versus standard rehabilitation after surgical repair of the rotator cuff of the shoulder: protocol for a multi-centre, randomised controlled trial with integrated Quintet Recruitment Intervention (RaCeR 2). BMJ Open. ISSN 2044-6055 (In Press)

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Abstract

Introduction: Despite the high number of operations and surgical advancement, rehabilitation after rotator cuff repair has not progressed for over 20 years. The traditional cautious approach might be contributing to sub-optimal outcomes. Our aim is to assess whether individualised (early) patient-directed rehabilitation results in less shoulder pain and disability at 12 weeks after surgical repair of full-thickness tears of the rotator cuff compared to current standard (delayed) rehabilitation. Methods and analysis: The rehabilitation after rotator cuff repair (RaCeR 2) study is a pragmatic multi-centre, open label, randomised controlled trial with internal pilot phase. It has a parallel group design with 1:1 allocation ratio, full health economic evaluation, and Quintet Recruitment Intervention. Adults awaiting arthroscopic surgical repair of a full-thickness tear are eligible to participate. Upon completion of surgery, 638 participants will be randomised. The intervention (individualised early patient-directed rehabilitation) includes advice to the patient to remove their sling as soon as they feel able, gradually begin using their arm as they feel able and a specific exercise programme. Sling removal and movement is progressed by the patient over time according to agreed goals and within their own pain and tolerance. The comparator (standard rehabilitation) includes advice to the patient to wear the sling for at least four weeks and only to remove while eating, washing, dressing or performing specific exercises. Progression is according to specific timeframes rather than as the patient feels able. The primary outcome measure is the Shoulder Pain and Disability Index (SPADI) total score at 12-week post-randomisation. The trial timeline is 56 months in total, from September 2022. Registration: ISRCTN11499185 https://doi.org/10.1186/ISRCTN11499185 Strengths and limitations of this study • RaCeR 2 is a large randomised controlled trial investigating the clinical and cost-effectiveness of individualised early patient-directed rehabilitation after surgery to repair the torn rotator cuff of the shoulder. • We will explore and address barriers to recruitment with the Quintet Recruitment Intervention to optimise recruitment. • In addition to self-reported outcome measures, participants will have an ultrasound scan at 12 months to assess rotator cuff repair integrity. • The parallel health economic analysis will assess the cost-effectiveness of individualised early patient-directed rehabilitation in comparison to standard rehabilitation.