Treatment of Calcific Tendinitis of the Rotator Cuff
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 210
Summary
- Conditions
- Calcinosis
- Shoulder Impingement Syndrome
- Shoulder Pain
- Tendonitis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 30 years and 100 years
- Gender
- Both males and females
Description
Barbotage is a sonographically guided percutaneous needle aspiration and lavage of the calcium deposit in calcific tendinitis of the shoulder. Persisting pain in cacific tendinitis is considered to be a consequence of increased tendon volume or changed tendon texture in the area of the calcification...
Barbotage is a sonographically guided percutaneous needle aspiration and lavage of the calcium deposit in calcific tendinitis of the shoulder. Persisting pain in cacific tendinitis is considered to be a consequence of increased tendon volume or changed tendon texture in the area of the calcification which leads to secondary impingement and inflammation. Consequently, removal of the deposit should be a causal treatment measure. Scientific evidence for the efficacy of the barbotage procedure in patients with persistent symptoms from calcific tendinitis is still limited. The cyclic often self-limiting course of the disease, and an anticipated placebo effect, questions about the method's efficacy can only be answered by high-quality randomized studies. In this trial the investigators want to randomize a cohort of patients to (1) Ultrasound guided needling, lavage and subacromial steroid injection, (2) Ultrasound guided subacromial steroid injection or (3) Ultrasound guided lidocain injection (sham). The investigators want to follow the patients over two years with repeated testing with a set of validated outcome measures together with radiologic re-examinations. The investigators want to find out whether the active treatments (1, 2) are more effective than the sham treatment and whether there are differences in outcome between the two active treatments. To increase the generalizability of the investigators' results, the investigators want to perform the study as a multi-centre study.
Tracking Information
- NCT #
- NCT02419040
- Collaborators
- Helse Fonna
- Oslo University Hospital
- Sykehuset i Vestfold HF
- Haraldsplass Deaconess Hospital
- University of Oxford
- University Hospital, Linkoeping
- Investigators
- Principal Investigator: Stefan Moosmayer, MD, PhD MHH Martine Hansens Hospital