Smallest Worthwhile Effect of Rotator Cuff Repair and Supervised Exercise
ConditionRotator Cuff Tears (RCTs)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKırklareli University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Patients who applied to the hospital's physical therapy unit and were referred for treatment in the physical therapy unit
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
104 Participants
are grouped into 1 trial groupGroup A: Rotator cuff tear patients
Trial outcomes
Primary outcomes
1
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
Baseline2
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
BaselineSecondary outcomes
1
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
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: