SuspendedNot Applicable

Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment

Stopped: Financial support for the project has been discontinued.

Spain386 participantsStarted 2024-05-01

Plain-language summary

The aim of this multicenter non-controlled study is to develop a multivariable prediction model of pain/disability improvements in patients with full-thickness rotator cuff tears, after a physical therapy treatment based on therapeutic exercise and education.

Who can participate

Age range

30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Full-thickness supraspinatus rotator cuff tear diagnosed by ultrasound imaging or magnetic resonance imaging. * Pain during resisted abduction and/or external rotation. * Pain intensity equal or greater to 3 points on a numeric pain rating scale, or a degree of disability equal or greater to 15% on the Shoulder Pain and Disability Index. * Pain lasting for at least 3 months. * 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. * Sings or symptoms of shoulder instability, including dislocations and/or subluxation within the last year. * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Shoulder disability

Timeframe: Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.

Trial details

NCT IDNCT05913050

SponsorHospital Universitario Fundación Alcorcón

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-18

View on ClinicalTrials.gov More Rotator Cuff Injuries trials

Who can participate

Age range

30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.