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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-09-18

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.

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Detailed Description

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Conditions

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Rotator Cuff Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Therapeutic exercise and education

The treatment will consist of a progressive resistance exercise program along with education.

Group Type EXPERIMENTAL

Therapeutic resistance exercise

Intervention Type OTHER

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.

Education

Intervention Type OTHER

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.

Interventions

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Therapeutic resistance exercise

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.

Intervention Type OTHER

Education

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.

Intervention Type OTHER

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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No