Ultrasound-guided Lavage of Calcific Deposits of the Rotator Cuff

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

The primary goal of the study is to assess ultrasonographic Power Doppler signals after ultrasound-guided puncture and lavage of rotator cuff calcific tendinitis of the shoulder. Secondary outcomes are sonographic features like the course of residual calcific material and the course of tendon healing als well as the clinical symptoms of the patient.

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

In our study we investigate the intensity of the power doppler signal after ultrasound-guided puncture and lavage (UGPL) of the rotator cuff calcific tendinitis. We assume that UGPL will lead to intratendinous neovascularisation and that the amount of retrieved calcific material is associated with the PDUS signal. The measurement of the signal will be performed in pre determined time slot for 12 months. Additional we study the correlation between the PDUS signal and the clinical symptoms of the patient and the healing process.

Connect with a study center

  • Schulthess Klinik

    Zürich, 8008
    Switzerland

    Active - Recruiting

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