Clinical Trials Directory

Trials / Completed

CompletedNCT01832376

Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
52 (actual)
Sponsor
Vestre Viken Hospital Trust · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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 * if shoulder function, measured by a shoulder score, will increase during follow-up * how much of the calcific material can be aspirated (in ml) * to which extend the calcific deposit disappears on x-rays and sonographic images * how many patients will need surgical treatment

Conditions

Interventions

TypeNameDescription
PROCEDUREUltrasound guided needle lavageA 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.

Timeline

Start date
2011-06-01
Primary completion
2016-02-01
Completion
2018-05-01
First posted
2013-04-16
Last updated
2018-10-31

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT01832376. Inclusion in this directory is not an endorsement.