Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment

Study Overview
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Brief Summary
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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
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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].

Official Title
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Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment (the PROTO Study): a Multivariable Prediction Model Development Study

Conditions
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Rotator Cuff Injuries

Intervention / Treatment
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* Other: Therapeutic resistance exercise
* Other: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The study will be a non-controlled multicenter clinical trial with the main aim of developing a multivariable prediction model of the improvements after a physical therapy treatment based on exercise and education.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic exercise plus education<br>The treatment will consist of a progressive resistance exercise program along with education. | Other: Therapeutic resistance exercise<br>* Therapeutic exercise program based on individualized progressive resistance exercises performed during 3 months at home, with a frequency of 1-3 sessions per week at the hospital.<br>Other: Education<br>* Education applied during all the therapeutic process, focusing on diverting the patient's attention away from the structural lesion, explaining the relationship between pain/disability and tissue injury, explaining the meaning of pain during exercises, and explaining the objectives of the implemented treatments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder disability | Shoulder disability measured with the Shoulder Pain and Disability Index, which ranges from 0 (no disability) to 100 (maximum degree of disability). | Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder pain intensity | Shoulder pain intensity measured with a numeric pain rating scale, which ranges from 0 (no pain) to 10 (worst imaginable pain). | Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year. | 
| Need for surgery | Need for surgery for the rotator cuff tear registered as a dichotomous variable (YES/NO). | 3-month, 6-month, and 1-year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical therapy, Rotator cuff, Full-thickness tear, Exercise, Education, Prediction model