Effectiveness of TheRApeutic ExercIse aNd EDucation on Patients With Massive Rotator Cuff Tears

Study Overview
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Brief Summary
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The aim of this multicenter non-controlled study will be to evaluate the effectiveness of a physical therapy treatment based on resistance exercise and education for patients with massive rotator cuff tears.

Official Title
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Effectiveness of TheRApeutic ExercIse aNd EDucation on Patients With Massive Rotator Cuff Tears (the TRAINED Study): a Multicenter Non-controlled Trial

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: Massive rotator cuff tear diagnosed by ultrasound imaging or magnetic resonance imaging. The definition of massive will be the rears including 2 or more tneonds, or the ones with an extension equal or greater to 5cm in the short or long axis. To have a degree of disability equal or greater to 15% in the Oxford Shoulder Score. 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. 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: 50 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic exercise and 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 6 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 Oxford Shoulder Score, which ranges from 0 (no disability) to 100 (maximum degree of disability). | Baseline, 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). | Baseline, 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, Massive rotator cuff tear, Therapeutic resistance exercise, Multicenter