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

Not Applicable

Recruiting

• Conditions: Rotator Cuff Injuries
• Interventions: Other: Therapeutic resistance exercise; Other: Education

• Registration Number: NCT05909930
• Lead Sponsor: Hospital Universitario Fundación Alcorcón

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-09
• Study First Posted: 2023-06-18
• Status Verified: 2024-05
• Study Start: 2024-05-01
• Last Update Submitted: 2024-05-18
• Last Update Posted: 2024-05-21
• Primary Completion: 2026-09-18
• Study Completion: 2026-09-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 149

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Therapeutic exercise and education	Education	The treatment will consist of a progressive resistance exercise program along with education.
Therapeutic exercise and education	Therapeutic resistance exercise	The treatment will consist of a progressive resistance exercise program along with education.

Primary Outcome Measures

Name	Time	Method
Shoulder disability	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 Outcome Measures

Name	Time	Method
Shoulder pain intensity	Baseline, 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 Universitario Fundación Alcorcón; 🇪🇸 Madrid, Spain