Smallest Worthwhile Effect of Rotator Cuff Repair and Supervised Exercise

N/ANot Yet RecruitingNCT07779876

Kırklareli University104 enrolled

Overview

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.

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

104

Conditions

Rotator Cuff Tears (RCTs)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Smallest Worthwhile Effect in Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS) of Rotator Cuff Repair Compared With Supervised Exercise

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.

Time frame: Baseline

Smallest Worthwhile Effect in Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS) of Supervised Exercise Compared With Unsupervised Exercise

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.

Time frame: Baseline

Secondary Outcomes

Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS)

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.

Time frame: Baseline