Title: 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)
Funder: Department of Health and Social Care

Abstract: WHY IS THIS STUDY IMPORTANT?_x000D_ Tears of the shoulder rotator cuff tendons are a common cause of pain, disability, and work absence. Over the years the number of operations to repair the torn rotator cuff has increased. Almost 9,000 operations were undertaken in 2018/19 in the NHS. Surgical techniques have also improved. Despite this, rehabilitation after surgery, a critical part of recovery, has not changed for over 20 years. Currently, most patients are advised to use a shoulder sling after surgery for one month. However, this approach could prevent patients from getting the best results from surgery. Our pilot study suggested that if patients start to move their shoulder after surgery, as soon they feel able, with support from a physiotherapist, they will have less shoulder pain and disability, less time off from driving and work, and fewer tendon re-tears. We now want to see if we can confirm these findings in a larger study._x000D_ _x000D_ WHAT IS THE AIM OF THIS STUDY?_x000D_ We aim to find the most clinically and cost-effective approach to rehabilitation after surgical repair of the shoulder rotator cuff tendons. Specifically, we and patients want to know if moving the shoulder sooner is better than current standard rehabilitation methods which includes delayed mobilisation where patients use a shoulder sling for a month after surgery. To answer this and help guide patients, doctors, physiotherapists, and the NHS, a large study is needed._x000D_ _x000D_ HOW WILL THE STUDY BE DESIGNED?_x000D_ Working with about 24 NHS hospitals, we will recruit 638 patients waiting for shoulder surgery to repair their rotator cuff. After surgery, these patients will receive one of two treatments. One group of patients will be advised to remove their sling and start to move their shoulder as soon as they feel able. The second group of patients will follow the current standard approach to rehabilitation and use a sling for one month after surgery. All patients will be supported by a physiotherapist during their rehabilitation programmes. _x000D_ _x000D_ We will explore barriers to taking part to give us the best chance of successfully completing the study. We will monitor how well patients recover from these two rehabilitation programmes using questionnaires to measure pain, benefit and satisfaction, NHS use, and time to return to usual activities. At 12 months, patients will also have an ultrasound scan to check whether their rotator cuff has healed. We will calculate the costs of the two different treatments as well as quality-adjusted life years. _x000D_ _x000D_ PATIENT AND PUBLIC INVOLVEMENT_x000D_ This question is important to patients. Thanks to them, we have already completed a pilot study (funded by NIHR). We have continued to work with five patients, who have experience of rotator cuff tears and surgical repair who have helped us design this definitive study. One of the patients is a co-applicant and will also join the Trial Management Group. Others will join the Trial Steering Committee, co-produce patient-facing materials, and help with dissemination of our findings. We have a dedicated research team member to support our PPI members, including their training needs._x000D_ _x000D_ DISSEMINATION_x000D_ We will share our findings widely with patients, physiotherapists, surgeons, commissioners and clinical guideline developers. We will publish the results in open access journals and conferences as well as sharing via social media and by making a video that patients can watch to help them make decisions about their treatment.

Lay abstract: RESEARCH QUESTION_x000D_ 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?_x000D_ _x000D_ BACKGROUND_x000D_ 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. _x000D_ _x000D_ AIMS AND OBJECTIVES_x000D_ 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._x000D_ _x000D_ Secondary Aims_x000D_ • To undertake a within-trial cost consequence analysis from an NHS and personal social services perspective and model-based long-term cost-effectiveness analysis_x000D_ • 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_x000D_ • To understand and mitigate barriers to informed consent._x000D_ _x000D_ METHODS_x000D_ 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)._x000D_ _x000D_ 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._x000D_ _x000D_ Health technologies being assessed:_x000D_ 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._x000D_ 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._x000D_ _x000D_ 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._x000D_ _x000D_ TIMELINES FOR DELIVERY_x000D_ 56-months including 24-months for recruitment and 12-months for follow-up._x000D_ _x000D_ ANTICIPATED IMPACT AND DISSEMINATION_x000D_ 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

Research activity codes: 6.7 PHYSICAL
Health categories: INJURIES AND ACCIDENTS