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

Clinical and cost-effectiveness of individualised (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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11499185

Enrollment

638

Registered

2023-03-23

Start date

2023-06-01

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rehabilitation after surgical repair of the rotator cuff of the shoulder Musculoskeletal Diseases

Interventions

Current interventions as of 22/08/2024: The study is an open-label randomised controlled trial comparing standard rehabilitation following rotator cuff repair surgery to individualised (early) patie

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

England, United Kingdom

Contacts

Public ContactChris Littlewood

Uhdb.racer2@nhs.net-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026