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

Rotator Cuff Injuries Clinical Trial

— TRAINED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05909930
• Other study ID #: 23/68
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: September 18, 2026

Study information

• Verified date: May 2024
• Source: Hospital Universitario Fundación Alcorcón
• Contact: Rubén Fernández Matías, MSc
• Phone: 916219727
• Email: ruben.fernanmat[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 149
• Est. completion date: September 18, 2026
• Est. primary completion date: September 18, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Fundación Alcorcón	Madrid

Sponsors (8)

Lead Sponsor	Collaborator
Hospital Universitario Fundación Alcorcón	Hospital General Universitario Gregorio Marañon, Hospital Universitario de Fuenlabrada, Hospital Universitario Infanta Leonor - Vallecas/H. Virgen de la Torre, Hospital Universitario La Paz, Hospital Universitario La Princesa, Hospital Universitario Principe de Asturias, Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Shoulder pain intensity	Shoulder pain intensity measured with a numeric pain rating scale, which ranges from 0 (no pain) to 10 (worst imaginable pain).	Baseline, change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.
Secondary	Need for surgery	Need for surgery for the rotator cuff tear registered as a dichotomous variable (YES/NO).	3-month, 6-month, and 1-year.