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

RESEARCH QUESTION What is the clinical and cost-effectiveness of early patient-directed rehabilitation (EPDR) versus standard (delayed) rehabilitation after surgical repair of the rotator cuff of the shoulder? BACKGROUND Tears of the tendons of the shoulder (rotator cuff) are a significant cause of shoulder pain. In 2018/2019, almost 9,000 surgical repairs were undertaken in the NHS costing up to £56.7 million in direct NHS treatment costs alone. Despite the high number of operations and surgical advancement, rehabilitation after rotator cuff repair has not advanced for over 20 years. The traditional cautious approach, where patients use a shoulder sling for about 1 month, might be contributing to sub-optimal outcomes. It is remiss that we still do not have a better understanding of the optimal approach that maximises outcomes, including early and safe return to usual activities. AIMS AND OBJECTIVES Primary Aim: To assess whether EPDR 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. Secondary Aims • To undertake a within-trial cost consequence analysis from an NHS and personal social services perspective and model-based long-term cost-effectiveness analysis • To estimate treatment effects across a range of secondary outcomes including shoulder pain and disability, quality of life, time to return to usual activities including work, further healthcare use (including number of physiotherapy sessions), repair integrity, and adverse events to 12-months • To understand and mitigate barriers to informed consent. METHODS Pragmatic multi-centre, open label, randomised controlled trial (RCT) with internal pilot phase using a parallel group design with 1:1 allocation ratio, with full economic evaluation, and integrated Quintet Recruitment Intervention (QRI). Adult patients awaiting surgical repair of a full-thickness tear will be eligible to participate. Upon completion of surgery, 638 participants will be randomised using minimisation via an online randomisation system to ensure balanced and concealed allocation. Health technologies being assessed: The intervention, EPDR, includes advice to the patient from a physiotherapist to remove their postoperative sling as soon as able and gradually begin using their arm within acceptable limits of their pain and to undertake specific exercises. Sling removal and movement is progressed by the patient over time according to agreed goals and within their own pain experience and tolerance. The comparator, standard rehabilitation includes advice to the patient from a physiotherapist to wear the sling for 4 weeks and only to remove while eating, washing, dressing or performing specific exercises. The primary outcome measure will be the total Shoulder Pain and Disability Index (SPADI) score, a validated patient-reported questionnaire, at 12-weeks post-randomisation. TIMELINES FOR DELIVERY 56-months including 24-months for recruitment and 12-months for follow-up. ANTICIPATED IMPACT AND DISSEMINATION RaCeR 2 will inform practice nationally and internationally. In addition to our trial website, we will disseminate the results to relevant stakeholders via publications and presentations at national and international conferences. We will use social media to engage stakeholders, including development of videos to report results to patients and clinicians