Smallest Worthwhile Effect of Rotator Cuff Repair and Supervised Exercise

August 18, 2026 updated by: Ozan Gür, PT, Kırklareli University

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

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:

What is the smallest worthwhile effect of rotator cuff repair surgery compared to exercise therapy?
What is the smallest worthwhile effect of supervised exercise therapy compared to unsupervised exercise therapy?
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.

Study Overview

Status

Not yet recruiting

Conditions

Rotator Cuff Tears (RCTs)

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.

Study Type

Observational

Enrollment (Estimated)

104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients who applied to the hospital's physical therapy unit and were referred for treatment in the physical therapy unit

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Rotator cuff tear patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smallest Worthwhile Effect in Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS) of Rotator Cuff Repair Compared With Supervised Exercise Time Frame: 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.	Baseline
Smallest Worthwhile Effect in Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS) of Supervised Exercise Compared With Unsupervised Exercise Time Frame: 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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS) Time Frame: 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.	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kırklareli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 12, 2026

First Submitted That Met QC Criteria

August 18, 2026

First Posted (Actual)

August 21, 2026

Study Record Updates

Last Update Posted (Actual)