Smallest Worthwhile Effect of Rotator Cuff Repair and Supervised Exercise

NCT07779876 — Not yet recruiting, 104 participants, Kırklareli University

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Determining the Smallest Worthwhile Effect of Rotator Cuff Repair and Supervised Exercise: A Benefit-Harm Trade-off Study

Registry	NCT07779876
Status	Not yet recruiting
Study type	Observational
Enrollment	104 (Estimated)
Sponsor	Kırklareli University (Other)
Conditions	Rotator Cuff Tears (RCTs)
Dates	start 2026-10-01 (estimated), primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-08-21, last updated 2026-08-21

-Summary

The goals of this observational study are (1) to determine the smallest worthwhile effect of rotator cuff repair surgery compared to exercise therapy in rotator cuff patients; (2) to determine the smallest worthwhile effect of supervised exercise therapy compared to unsupervised exercise therapy in rotator cuff patients. Another objective of the study is to identify the demographic and clinical factors affecting the smallest worthwhile effect.

The main questions it aims to answer are:

1. What is the smallest worthwhile effect of rotator cuff repair surgery compared to exercise therapy?
2. What is the smallest worthwhile effect of supervised exercise therapy compared to unsupervised exercise therapy?
3. Do demographic and clinical factors influence the smallest worthwhile effect? Participants will be asked to provide demographic and clinical data and to answer questions on a survey.

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+Detailed description

Baseline demographic and clinical characteristics, including age, sex, education level, employment status, annual income, activity pain, symptom duration, and previous treatment for rotator cuff tears, will be assessed. These variables will be evaluated as potential factors associated with the smallest worthwhile effect using regression analyses.

+Arms and interventions

Arm	Type	Interventions	Description
Rotator cuff tear patients

+Outcome measures

Primary outcomes

Smallest Worthwhile Effect in Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS) of Rotator Cuff Repair Compared With Supervised Exercise [Baseline]: Participants will be provided with standardized descriptions of the characteristics, benefits, limitations, and potential drawbacks of the treatment options. They will then be asked, hypothetically, how much greater reduction in activity pain they would require from rotator cuff repair compared with supervised exercise in order to prefer rotator cuff repair. Activity pain will be assessed using the Numeric Pain Rating Scale (NPRS). The SWE will be reported as the minimum additional percentage reduction in activity pain required for participants to prefer rotator cuff repair over supervised exercise.
Smallest Worthwhile Effect in Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS) of Supervised Exercise Compared With Unsupervised Exercise [Baseline]: Participants will be provided with standardized descriptions of the characteristics, benefits, limitations, and potential drawbacks of the treatment options. They will then be asked, hypothetically, how much greater reduction in activity pain they would require from supervised exercise compared with unsupervised exercise in order to prefer supervised exercise. Activity pain will be assessed using the Numeric Pain Rating Scale (NPRS). The SWE will be reported as the minimum additional percentage reduction in activity pain required for participants to prefer supervised exercise over unsupervised exercise.

Secondary outcomes

Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS) [Baseline]: Participants will rate their current shoulder pain during activity using the Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater activity pain.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Over 18 years of age
* Diagnosed with rotator cuff tear by a specialist doctor
* Having pain and functional limitation for at least 4 weeks
* Having a pain level of 3 or higher on the Numeric Pain Scale (NPS)

Exclusion Criteria:

* Presence of another pathology in the affected shoulder region
* Presence of radiculopathy originating from the cervical region or internal organs
* Presence of neurological, rheumatological, or oncological disease
* Insufficient cooperation of the patient with the procedures to be performed within the scope of the study