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

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

Status

Suspended

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05909930

Acronym

TRAINED

Enrollment

149

Registered

2023-06-18

Start date

2024-05-01

Completion date

2026-09-18

Last updated

2025-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Injuries

Keywords

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

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.

Interventions

OTHERTherapeutic 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.

OTHEREducation

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Shoulder disability	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).

Secondary

Measure	Time frame	Description
Shoulder pain intensity	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).
Need for surgery	3-month, 6-month, and 1-year.	Need for surgery for the rotator cuff tear registered as a dichotomous variable (YES/NO).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026