SuspendedNot Applicable

Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy (THE EFFECT TRIAL)

Stopped: The doctoral student conducting the study has discontinued their thesis. Recruitment is temporarily suspended until a new researcher is assigned to resume the project.

Spain116 participantsStarted 2028-01-01

Plain-language summary

The aim of this study will be to compare the effectiveness of an exercise therapy program with extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation and a wait and see approach in people with rotator cuff calcific tendinopathy.

Who can participate

Age range

18 Years – 75 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: * calcification deposit in the rotator cuff confirmed by diagnostic imaging (ultrasound, MRI or X-ray); * pain and loss of function in the shoulder; * not currently receiving physiotherapy or ESWT. Exclusion Criteria: * previous treatments on last year (e.g., injections, ESWT, US-PICT, surgery, etc.); * other shoulder disorders or trauma (e.g., fractures, dislocations, rotator cuff tears, frozen shoulder or shoulder instability); * known allergy to any of the pharmacological products used in the study; * taking oral anticoagulants * taking oral steroid within the six months prior to participation in the study; * cancer, systemic disease, pregnancy or infection; * neck pain.

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 Pain And Disability Index (SPADI)

Timeframe: Baseline

Shoulder Pain And Disability Index (SPADI)

Timeframe: 2 weeks

Shoulder Pain And Disability Index (SPADI)

Timeframe: 4 months

Shoulder Pain And Disability Index (SPADI)

Timeframe: 6 months

Shoulder Pain And Disability Index (SPADI)

Timeframe: 12 months

Trial details

NCT IDNCT05478902

SponsorUniversity of Valencia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-01

View on ClinicalTrials.gov More Rotator Cuff Tendinosis trials

Who can participate

Age range

18 Years – 75 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.

What they're measuring

Shoulder Pain And Disability Index (SPADI)

Timeframe: Baseline

Shoulder Pain And Disability Index (SPADI)

Timeframe: 2 weeks

Shoulder Pain And Disability Index (SPADI)

Timeframe: 4 months

Shoulder Pain And Disability Index (SPADI)

Timeframe: 6 months

Shoulder Pain And Disability Index (SPADI)

Timeframe: 12 months