Title: Rehabilitation following Rotator Cuff RepaiR: a multi-centre pilot & feasibility RCT with nested qualitative study (the RaCeR study)
Funder: Department of Health and Social Care

Abstract: Shoulder pain is highly prevalent and disorders of the rotator cuff (RC) are the most common cause. RC disorders, including symptomatic tears, can be treated conservatively or surgically. Surgery is considered for patients who have not responded to conservative care and the incidence of such surgery is rising. Surgical techniques to repair the RC have progressed over time with less invasive and more secure operations. But, understanding of the optimal approach to post-operative rehabilitation, a critical component of the recovery process, remains limited. Rehabilitation remains similar to when surgery was less advanced and a cautious approach prevails, including long periods of immobilisation of the shoulder. A recent systematic review concluded that concern about early initiation of rehabilitation/ movement of the shoulder might not be warranted but these conclusions are based on small heterogeneous trials. Hence there is a need for a high-quality, adequately powered, randomised controlled trial (RCT). Research Question In patients undergoing surgical repair of the RC, is it feasible to conduct a future, substantive, multi-centred RCT to test the hypothesis that, compared to usual practice of delayed rehabilitation, early patient-directed rehabilitation is more clinically and cost-effective? Objectives An external pilot and feasibility RCT will be conducted to determine: 1) Availability of eligible patients and rates of recruitment, 2) Retention and follow-up rates, 3) Whether the interventions can be delivered per protocol, 4) The primary outcome measure for the main trial, 5) Feasibility of a future economic evaluation, 6) Participant satisfaction with the interventions. Integrated qualitative interviews will explore: 1) Acceptability of the interventions, 2) Barriers and enablers to adherence, 3) Which outcome measure(s) best reflect(s) participants' rehabilitation goals. Design: Two-arm, parallel group, external pilot and feasibility RCT with nested qualitative interviews. Setting: Three NHS Hospitals. Participants: Patients with degenerative symptomatic tears of the RC, listed for surgery. Intervention/ control: Participants will be allocated on a 1:1 ratio using block randomisation to: 1) Intervention; early patient-directed rehabilitation, comprising advice to remove the sling as pain allows delivered in one consultation with a physiotherapist after surgery but before discharge and one follow-up telephone conversation, with the same physiotherapist, one week later; 2) Control; usual care, comprising sling immobilisation for one month. After one month participants in both groups will commence formal structured physiotherapy as per usual care. Feasibility outcomes; 1) Numbers of patients identified and recruited; 2) Feasibility of recruiting current and future participating centres; 3) Rate of retention and response rates to questionnaires, including healthcare resource use, and SMS text messages; 4) Intervention fidelity and adherence; 5) Sensitivity to change of the outcome measures; 6) Participant satisfaction with interventions; 7) Patient and clinician views of acceptability of interventions (qualitative). Clinical outcomes; 1) Oxford Shoulder Score, Shoulder Pain & Disability Index, EQ-5D-5L at baseline, six and 12 weeks; 2) Pain and disability in the last week via weekly SMS text message for 12 weeks; 3) Days lost from work; 4) Return to driving; 5) Adverse events; 6) RC re-tear rate (12 weeks). Economic outcomes; Health care resource use over the 12 week period. Sample size; 76 participants for the RCT. Up to 20 patients and 10 clinicians for the qualitative interviews. Analysis; Analysis will focus on process outcomes (recruitment, retention, intervention fidelity). We will calculate means and confidence intervals of clinical outcomes, and determine which is most sensitive to change, in order to inform the sample size calculation for the main trial. Qualitative data will be collected using semi-structured interviews and analysed thematically. Potential benefits Approaches that facilitate early rehabilitation have the potential to reduce the significant morbidity associated with prolonged immobilisation and speed up recovery, including return to work.

Lay abstract: Disorders of the muscles and tendons of the shoulder, the rotator cuff (RC), are the most common cause of shoulder pain. Injury to the RC, e.g. a tear, can result in significant pain and disability. The number of operations to repair the torn RC has increased significantly over recent years. Surgical techniques have advanced over time but the rehabilitation after surgery has not. This is problematic because rehabilitation is key to good outcomes. We do not know when rehabilitation after surgery should begin. Currently most patients are advised to rest their arm in a sling for a month to six weeks after the operation. But, evidence suggests that starting rehabilitation early (as soon as possible after surgery) might help people return to their usual activities more quickly, which is important to patients. Before we conduct a large study, we first need to find out if it is feasible. Patients who are having surgery for a RC tear will receive one of two rehabilitation programmes; early gentle patient-led mobilisation (movement), using pain as a guide, or immobilisation of the arm in a sling for a month. After one month both groups of patients will have rehabilitation led by a physiotherapist as per standard practice. The key difference is that those in the early rehabilitation group begin moving their shoulder more quickly after the operation. Patients will report their levels of pain and disability after surgery by completing questionnaires and responding to text messages to rate their recovery. A shoulder ultrasound scan at twelve weeks will check how the RC is healing. This small study, including interviews with patients and clinicians, which will be designed together with patient representatives, will help us decide whether it is feasible to conduct a future large study to test if early rehabilitation is better for patients.

Research activity codes: 6.7 PHYSICAL
Health categories: MUSCULOSKELETAL