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

NCT05909930 | Suspended

• 1 other identifier: 23/68
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Injuries

Keywords

Physical therapy; Massive rotator cuff tear; Therapeutic resistance exercise; Multicenter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (1)

Therapeutic exercise and education

EXPERIMENTAL

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

Other: Therapeutic resistance exercise; Other: Education

Interventions

Therapeutic resistance exercise 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.

Therapeutic exercise and education

Education 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.

Therapeutic exercise and education

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Fundación Alcorcón: lead
• Hospital Universitario La Paz: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• Hospital Universitario La Princesa: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator
• Hospital Universitario Principe de Asturias: collaborator
• Hospital Universitario de Fuenlabrada: collaborator
• Hospital Universitario Infanta Leonor - Vallecas/H. Virgen de la Torre: collaborator

Study Sites (1)

Hospital Universitario Fundación Alcorcón

Madrid, Spain

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 18, 2023
• Study Start: May 1, 2024
• Primary Completion (Estimated): September 18, 2026
• Study Completion (Estimated): September 18, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)