Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment
- Conditions
- Rotator Cuff Injuries
- Interventions
- Other: Therapeutic resistance exerciseOther: Education
- Registration Number
- NCT05913050
- Lead Sponsor
- Hospital Universitario Fundación Alcorcón
- Brief Summary
The aim of this multicenter non-controlled study is to develop a multivariable prediction model of pain/disability improvements in patients with full-thickness rotator cuff tears, after a physical therapy treatment based on therapeutic exercise and education.
- Detailed Description
A multivariable prediction model for the improvement in shoulder pain and disability will be developed based on the following predictors:
* Body mass index \[kg/m2, Fractional polynomials FP2\].
* Smoking \[Years, linear relationship\].
* Employment status \[3 categories\].
* Maximum education degree \[4 categories\].
* Previous performance of physical exercise \[2 categories\].
* Baseline disability (measured with the Shoulder Pain and Disability Index) \[Fractional polynomials FP2\].
* Baseline pain intensity (measured with a numeric pain rating scale) \[Fractional polynomials FP2\].
* Pain duration \[Weeks, linear relationship\]
* Pain catastrophizing (measured with the Pain Catastrophizing Scale) \[Linear relationship\].
* Patient's expectations (measured with the Musculoskeletal Outcomes Data Evaluation and Management System) \[Linear relationship\].
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 386
- Full-thickness supraspinatus rotator cuff tear diagnosed by ultrasound imaging or magnetic resonance imaging.
- Pain during resisted abduction and/or external rotation.
- Pain intensity equal or greater to 3 points on a numeric pain rating scale, or a degree of disability equal or greater to 15% on the Shoulder Pain and Disability Index.
- Pain lasting for at least 3 months.
- Adequate comprehension of written and spoken Spanish
- Loss of passive external rotation at 0º of shoulder abduction equal or greater to 50% compared to contralateral side.
- Suspected neck-related shoulder pain.
- Suspected visceral-related shoulder pain.
- Sings or symptoms of shoulder instability, including dislocations and/or subluxation within the last year.
- Humerus and/or scapular fractures within the last year.
- Previous rotator cuff repair surgery within the last year.
- Presence of cancer, fibromyalgia, neurological and/or other systemic diseases.
- Cognitive impairment that makes it impossible to perform therapeutic exercise.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Therapeutic exercise plus education Therapeutic resistance exercise The treatment will consist of a progressive resistance exercise program along with education. Therapeutic exercise plus education Education The treatment will consist of a progressive resistance exercise program along with education.
- Primary Outcome Measures
Name Time Method Shoulder disability Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year. Shoulder disability measured with the Shoulder Pain and Disability Index, which ranges from 0 (no disability) to 100 (maximum degree of disability).
- Secondary Outcome Measures
Name Time Method Shoulder pain intensity Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year. Shoulder pain intensity measured with a numeric pain rating scale, which ranges from 0 (no pain) to 10 (worst imaginable pain).
Need for surgery 3-month, 6-month, and 1-year. Need for surgery for the rotator cuff tear registered as a dichotomous variable (YES/NO).
Trial Locations
- Locations (1)
Hospital Univeristario Fundación Alcorcón
🇪🇸Madrid, Spain