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Study population: Subjects with long standing symptoms from calcific tendonitis, non-responsive to other forms of conservative treatment
Study method: A cohort of 50 patients with symptomatic calcific tendonitis will be treated by ultrasound-guided needle lavage. At baseline all study subjects will be assessed by clinical examination, imaging of the shoulder by x-ray and sonography and by the self-report section of the American Shoulder and Elbow Surgeons score (ASES). Follow-up will be performed after 1 and 4 weeks (score only), 3 (clinical, score, ultrasound, x-ray), 6 and 12 months (score only), and after 24 months (clinical, score, ultrasound, x-ray). Patients with insufficient treatment effect will be offered physiotherapy, re-lavage or surgical treatment by acromioplasty.
Purpose of the study: The investigators want to find out
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound guided needle lavage | Experimental | Ultrasound guided needle lavage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound guided needle lavage | Procedure | A 18-gauge needle connected to a 5 ml syringe with 4 ml of saline solution will be used to puncture the calcification with freehand technique and under constant sonographic monitoring. With the tip of the needle placed in the center of the deposit, the calcification will be flushed. If backflow of calcific material can be identified in the syringe, lavage of the deposit will be performed by successive propulsion and aspiration with the syringe plunger. In cases where no material can be extracted, repeated perforation of the deposit will be performed to possibly initiate or accelerate spontaneous resorption. |
| Measure | Description | Time Frame |
|---|---|---|
| The self-report section of the American Shoulder and Elbow Surgeons score (ASES) | The self-report section of the American Shoulder and Elbow Surgeons score (ASES) consists of two equally weighted parts for pain and shoulder function, each contributing 50 points to a maximum score of 100. Pain measurement is performed on a 10 cm visual analogue scale divided into 1 cm increments. Shoulder function is measured by classifying 10 activities of daily living on a four-point ordinal scale. Change in points on the ASES scale from baseline to 24 month follow-up is the primary outcome measure of our study. | Baseline and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who need operative treatment during follow-up | Baseline to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Size of the calcific deposit as determined on X-rays of the affected shoulder | Standardized X-rays of the shoulder are taken at baseline, 3 and 24 month follow-up and the size of the calcific deposits will be measured and compared between examinations | Baseline to 3 months and 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Moosmayer, MD, PhD | Martina Hansens Hospital, Sandvika, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Martina Hansens Hospital | Sandvika | 1306 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Moosmayer S and Aasen IB. Ultrasound- Guided Percutaneous Needle Treatment and Steroid Injection for Calcific Tendinopathy of the Shoulder: Can the Orthopedic Surgeon do it?. M J Orth. 3(1): 020, 2018. |
| Label | URL |
|---|---|
| Study publication, open access | View source |
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