Ultrasound-guided Lavage of Calcific Deposits of the Rotator Cuff

Recruiting

• Conditions: Rotator Cuff Tendinitis; Ultrasonography, Interventional; Ultrasonography, Doppler, Color

• Registration Number: NCT05264935
• Lead Sponsor: Schulthess Klinik

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-03-03
• Study Start: 2022-05-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PDUS signal intensity	One year after intervention	Power doppler ultrasonography (PDUS) signal intensity

Secondary Outcome Measures

Name	Time	Method
Constant Murley Score (CMS)	One year after intervention	Constant Murley Score (CMS) from 0 (worse) to 100 (better) points
Shoulder function parameters	One year after intervention	Shoulder strength in 90° abduction position (measured also for the opposite shoulder)(Kg) measured with a spring balance.
Level of improvement	One year after intervention	Patients are reporting separately if the improvement / shoulder status regarding pain, function and quality of life is acceptable (Yes/No) or not for them.
Tendon rupture	One year after intervention	Follow up sonography will be performed to assess the occurrence of tendon rupture, which will be classified as complete, transmural or non transmural
Subjective shoulder value (SSV)	One year after intervention	Subjective shoulder value (SSV) is a patient-reported subjective outcome assessing on a scale from 0% (worse) to 100% (best) of normal shoulder condition
Pain level	One year after intervention	Pain Scale Numeric Rating Scale from 0 (no pain) to 15 (worse pain) as part of the Constant Score
Residual calcific material	One year after intervention	Residual calcific material (constant, decreasing, increasing)

Trial Locations

Locations (1)

Schulthess Klinik; 🇨🇭 Zürich, Switzerland