Ultrasound treatment for calcific deposits in the shoulder
Ultrasound-guided Lavage of Calcific Deposits of the Rotator Cuff: The Role of Power Doppler Sonography
This study is testing if a special ultrasound treatment can help people with calcific tendinitis in their shoulder feel better and heal by removing calcium deposits.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Schulthess Klinik Academic / other |
| Locations | 1 site (Zürich) |
| Trial ID | NCT05264935 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of ultrasound-guided puncture and lavage (UGPL) on calcific tendinitis of the rotator cuff. It aims to assess the intensity of Power Doppler ultrasound signals following the procedure, which is believed to promote neovascularization within the tendon. The study will monitor the correlation between the ultrasound signals, the amount of calcific material removed, and the clinical symptoms experienced by patients over a 12-month period. Additionally, it will evaluate the healing process of the tendon post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with specific calcific deposits in the shoulder causing pain that has not improved with conservative treatments.
Not a fit: Patients who have previously undergone UGPL or surgery on the affected shoulder may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and recovery for patients suffering from calcific tendinitis.
How similar studies have performed: While similar ultrasound-guided interventions have shown promise, this specific approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged 18 years and older * Pain in the deltoid region worsening with activities above shoulder level and/or at night with a calcific deposit * Ultrasound evaluation of the calcific deposit with type I or II characteristics, a solitary conformation, a minimum size of 1.0 x 0.5 x 0.4cm (length x width x depth) and without clear signs of resorption (PDUS grade 0 - I°, see study procedure). * In case of multiple calcific deposits, it has to be warranted that the other deposits are smaller than the minimum size of 1.0 x 0.5 x 0.4cm and with no signs of PDUS signals. * Qualification for more intensive treatment on account of no clinical improvement after a minimum of 3 months with conservative treatment (physical therapy and oral anti-inflammatory drugs). * able to understand the content of the patient information / consent form in German and give consent to take part in the project Exclusion Criteria: * Previous UGPL or surgery of the affected shoulder * Treatment with subacromial injection (SAI) or ESWT in the three months before inclusion * Other causes of shoulder complaints (e.g. rotator cuff tear, frozen shoulder, inflammatory arthritis, bursitis, ...) * Intervention failure (no retrieval of calcific material, leakage of the injected saline, disruption of the calcific rim or distribution of calcific material) * Patients with a language barrier hindering questionnaire completion * Pregnancy
Where this trial is running
Zürich
- Schulthess Klinik — Zürich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Laurent Audigé, Prof
- Email: forschung.oe@kws.ch
- Phone: +41443857580
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.