Comparing non-surgical treatments for rotator cuff calcific tendinopathy
Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy: a Randomised Clinical Trial (THE EFFECT TRIAL)
This study is testing which non-surgical treatment—exercise therapy, shockwave therapy, ultrasound-guided irrigation, or doing nothing—works best to relieve pain and improve function for people with rotator cuff calcific tendinopathy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Valencia Academic / other |
| Locations | 2 sites (Xativa, Valencia and 1 other locations) |
| Trial ID | NCT05478902 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of an exercise therapy program against extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation, and a wait-and-see approach for patients with rotator cuff calcific tendinopathy. It will involve a randomized, single-blinded design with 116 participants divided into four groups. The study seeks to determine which non-surgical intervention provides the best outcomes in terms of pain relief and functional improvement. The interventions will be compared to assess their impact on the quality of life of individuals suffering from this condition.
Who should consider this trial
Good fit: Ideal candidates are individuals with confirmed calcification deposits in the rotator cuff who experience pain and loss of shoulder function.
Not a fit: Patients with other shoulder disorders, recent treatments, or systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with effective non-surgical treatment options for rotator cuff calcific tendinopathy.
How similar studies have performed: Previous studies have shown promise for non-surgical interventions in similar conditions, but the specific combination of treatments in this study is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Xativa, Valencia and 1 other locations
- Lluis Alcanyis Hospital — Xativa, Valencia, Spain (Recruiting)
- Universitat de Valencia — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Lirios Dueñas, PT, PhD
- Email: liriosclinic@gmail.com
- Phone: 0034655525373
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.