RaCeR 2- Comparing different approaches to physiotherapy following surgery to repair the rotator cuff of the shoulder

INTERVENTION: The study is an open‐label randomised controlled trial comparing standard rehabilitation following rotator cuff repair surgery to individualised (early) patient directed rehabilitation. In standard rehabilitation, patients are required to keep their arm in a sling for 4 weeks, whereas for patient‐directed rehabilitation, they may remove their sling and move their arm as they feel able, usually before 4 weeks. Patients undergoing arthroscopic repair for a full‐thickness rotator cuff tear, will be approached to take part in the study before their surgery. They will be asked to complete a baseline questionnaire pre‐surgery and will be randomised once arthroscopic surgery has been completed. For the first 4 weeks following surgery, they will be asked to complete a diary documenting their sling use (i.e. time out of sling). At 12 weeks, 6 months and 12 months, they will complete follow up questionnaires to inform the study outcomes. Participants will have a choice to complete these electronically via an email/text link, or postally via paper questionnaires. This will be co‐ordinated centrally by Derby Clinical Trial Support Unit (DCTSU). At 12 months, participants will return for an ultrasound scan of their shoulder to assess repair integrity. We have chosen the validated, self‐reported SPADI measure for shoulder pain and disability as we found this to be more responsive than the Oxford Shoulder Score (OSS) in our RaCeR pilot trial. The EQ‐5D‐5L is a widely used, validated measure of health‐related quality of life. The study will take place across 24 sites (with scope to increase this if necessary) across the UK to recruit (and randomise) 638 patients in 24 months. Each patient will participate in the study CONDITION: Rehabilitation after surgical repair of the rotator cuff of the shoulder ; Musculoskeletal Diseases PRIMARY OUTCOME: Shoulder pain and disability will be measured at 12 weeks post‐randomisation using the Shoulder Pain and Disability Index (SPADI) validated questionnaire INCLUSION CRITERIA: 1. Adults awaiting arthroscopic surgical repair of a full thickness tear of their shoulder rotator cuff, of any size 2. Able to return (remote or in‐person consultation) to the recruiting centre or affiliated site for rehabilitation supported by a physiotherapist trained to deliver the study interventions SECONDARY OUTCOME: ; 1. Shoulder pain and disability at 6‐ and 12‐months post‐randomisation will be measured using the total SPADI score; 2. Health‐related quality of life at 12‐weeks, 6‐ and 12‐months post‐randomisation will be measured using the EQ‐5D‐5L; 3. Time to return to usual activities, including work and driving, will be measured via self‐report questionnaire at 12‐weeks, 6‐ and 12‐months; 4. Healthcare resource use at 12‐weeks, 6‐ and 12‐months will be measured via self‐report questionnaire.; 5. Rotator cuff repair integrity (evidence of full‐thickness re‐tear; yes/ no) at 12‐months will be assessed via diagnostic ultrasound scan; 6. Number and nature of adverse events at 12‐weeks, 6‐ and 12‐months will be measured via self‐report questionnaire and clinician report.; 7. Self‐report time out of sling, measured in hours, over 4 weeks post‐surgery via self‐report diary.;