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

Hospital Universitario Fundación Alcorcón149 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

149

Conditions

Rotator Cuff Injuries

Interventions

Therapeutic resistance exerciseOTHER

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.

EducationOTHER

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.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitario Fundación Alcorcón

Madrid, Spain

Outcomes

Primary Outcomes

Shoulder disability

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

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

Secondary Outcomes

Shoulder pain intensity

Shoulder pain intensity measured with a numeric pain rating scale, which ranges from 0 (no pain) to 10 (worst imaginable pain).

Time frame: 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).

Time frame: 3-month, 6-month, and 1-year.

Data from ClinicalTrials.gov

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