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

February 27, 2024 updated by: Rubén Fernández Matías, Hospital Universitario Fundación Alcorcón

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapeutic exercise and education
The treatment will consist of a progressive resistance exercise program along with education.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder disability
Time Frame: 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).
Baseline, change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder pain intensity
Time Frame: 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).
Baseline, change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.
Need for surgery
Time Frame: 3-month, 6-month, and 1-year.
Need for surgery for the rotator cuff tear registered as a dichotomous variable (YES/NO).
3-month, 6-month, and 1-year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Fundación Alcorcón

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

September 18, 2026

Study Completion (Estimated)

September 18, 2026

Study Registration Dates

First Submitted

June 9, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23/68

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD data will be shared with other researchers upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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