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

Hospital Universitario Fundación Alcorcón1 site in 1 country149 target enrollmentMay 1, 2024

ConditionsRotator Cuff Injuries

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rotator Cuff Injuries
Sponsor: Hospital Universitario Fundación Alcorcón
Enrollment: 149
Locations: 1
Primary Endpoint: Shoulder disability
Status: Suspended
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 1, 2024

End Date

September 18, 2026

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hospital Universitario Fundación Alcorcón

Responsible Party

Principal Investigator

Rubén Fernández Matías

Principal Investigator

Hospital Universitario Fundación Alcorcón

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Shoulder disability

Time Frame: Baseline, change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.

Shoulder disability measured with the Oxford Shoulder Score, which ranges from 0 (no disability) to 100 (maximum degree of disability).

Secondary Outcomes

Shoulder pain intensity(Baseline, change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.)
Need for surgery(3-month, 6-month, and 1-year.)