An interventional study of Ultrasound guided needle lavage in Calcific Tendinitis, sponsored by Martina Hansen's Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-31.
Sponsored by Martina Hansen's Hospital · Not applicable, Interventional, and Treatment
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
413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.
This study's enrollment of 52 is close to the median of 50 across 339 interventional studies indexed under Tendinopathy.
Browse Tendinopathy studies →Martina Hansen's Hospital is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Ultrasound guided needle lavage
Procedure: Ultrasound guided needle lavage
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.
Also known as: Barbotage
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.
Time frame: Baseline and 24 months
Number of patients who need operative treatment during follow-up
Time frame: Baseline to 24 months
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
Time frame: Baseline to 3 months and 24 months
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Martina Hansen's Hospital