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)

WHY IS THIS STUDY IMPORTANT? 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. WHAT IS THE AIM OF THIS STUDY? 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. HOW WILL THE STUDY BE DESIGNED? 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. 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. PATIENT AND PUBLIC INVOLVEMENT 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. DISSEMINATION 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.