Rotator Cuff Tendinitis, Ultrasonography, Doppler, Color, Ultrasonography, Interventional
Conditions
Keywords
calcific deposit, ultrasound-guided puncture and lavage, power doppler ultrasound
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.
Interventions
PROCEDUREUltrasound-Guided Puncture and Lavage (UGPL)
After local anaesthesia with rapidocain the calcific deposit of the rotator cuff will be punctured and washed out with saline solution.
Sponsors
Schulthess Klinik
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PDUS signal intensity | One year after intervention | Power doppler ultrasonography (PDUS) signal intensity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Constant Murley Score (CMS) | One year after intervention | Constant Murley Score (CMS) from 0 (worse) to 100 (better) points |
| Residual calcific material | One year after intervention | Residual calcific material (constant, decreasing, increasing) |
| 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 |
| 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. |
| Shoulder function parameters | One year after intervention | Shoulder range of motion (ROM) parameters in degree including elevation (flexion), abduction, and external rotation by 0° abduction measured with a standard goniometter |
Countries
Switzerland
Contacts
Primary ContactLaurent Audigé, Prof
Outcome results
None listed