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

Not Applicable

• Conditions: Rehabilitation after surgical repair of the rotator cuff of the shoulder; Musculoskeletal Diseases

• Registration Number: ISRCTN11499185
• Lead Sponsor: niversity Hospitals of Derby and Burton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-23
• Last Update Posted: 2 September 2024
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 638

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

Exclusion Criteria

1. No full thickness tear at surgery and/or arthroscopic repair not undertaken
2. Unable to provide informed consent
3. Patients taking part in another research study that mandates the post-operative rehabilitation pathway.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shoulder pain and disability will be measured at 12 weeks post-randomisation using the Shoulder Pain and Disability Index (SPADI) validated questionnaire

Secondary Outcome Measures

Name	Time	Method
1. Shoulder pain and disability at 6- and 12-months post-randomisation will be measured using the total SPADI score <br>2. Health-related quality of life at 12-weeks, 6- and 12-months post-randomisation will be measured using the EQ-5D-5L <br>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 <br>4. Healthcare resource use at 12-weeks, 6- and 12-months will be measured via self-report questionnaire. <br>5. Rotator cuff repair integrity (evidence of full-thickness re-tear; yes/ no) at 12-months will be assessed via diagnostic ultrasound scan <br>6. Number and nature of adverse events at 12-weeks, 6- and 12-months will be measured via self-report questionnaire and clinician report. <br>7. Self-report time out of sling, measured in hours, over 4 weeks post-surgery via self-report diary.