Last updated: July 18, 2023
Sponsor: Schulthess Klinik
Overall Status: Active - Recruiting
Phase
N/A
Condition
Tendon Injuries
Sprains
Treatment
Ultrasound-Guided Puncture and Lavage (UGPL)
Clinical Study ID
NCT05264935
OE-0164
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient aged 18 years and older
- Pain in the deltoid region worsening with activities above shoulder level and/or atnight with a calcific deposit
- Ultrasound evaluation of the calcific deposit with type I or II characteristics, asolitary 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 depositsare smaller than the minimum size of 1.0 x 0.5 x 0.4cm and with no signs of PDUSsignals.
- Qualification for more intensive treatment on account of no clinical improvement aftera minimum of 3 months with conservative treatment (physical therapy and oralanti-inflammatory drugs).
- able to understand the content of the patient information / consent form in German andgive consent to take part in the project
Exclusion
Exclusion Criteria:
- Previous UGPL or surgery of the affected shoulder
- Treatment with subacromial injection (SAI) or ESWT in the three months beforeinclusion
- 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 injectedsaline, disruption of the calcific rim or distribution of calcific material)
- Patients with a language barrier hindering questionnaire completion
- Pregnancy
Study Design
Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Ultrasound-Guided Puncture and Lavage (UGPL)
Phase:
Study Start date:
May 01, 2022
Estimated Completion Date:
April 01, 2024
Study Description
Connect with a study center
Schulthess Klinik
Zürich, 8008
SwitzerlandActive - Recruiting
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