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COMPLETED
NCT02538939
PHASE2

Efficacy and Tolerance of Sodium Thiosulfate Injection After Ultrasound-guided Percutaneous Irrigation of Calcific Tendinopathy of the Rotator Cuff

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

Summary

Calcific tendinitis of the rotator cuff is a common cause of chronic pain of the shoulder. US- guided needling and lavage of the calcification is one of the therapeutic options after failure of conservative management with physiotherapy and anti-inflammatory drugs. The goal of this procedure is to remove the calcific deposit that is believed to cause the sub-acromial impingement. However, studies have shown that complete and rapid disappearance of the calcification deposit after irrigation is rare. The treatment is thought to promote the spontaneous resorption that occurs the weeks and months after the procedure. However, due to this slow process, time to complete recovery can be long. Moreover, it has been shown an association between the amount of removed calcium and improved outcome. Therefore, there is a need to find a way to remove quickly and completely the calcific deposit after irrigation. Sodium thiosulfate has been used successfully in the treatment of calciphylaxis and subcutaneous calcification deposit. The mechanism of action involves chelation of calcium into calcium thiosulfate salts which are much more soluble than other salts of calcium. Our hypothesis is that injection of sodium thiosulfate after irrigation of the calcification will help to dissolve the calcific deposit and thus prompt the disappearance of the calcification.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

17

Start Date

2015-12-02

Completion Date

2017-11-13

Last Updated

2026-09-14

Healthy Volunteers

No

Interventions

DRUG

Sodium thiosulfate

Locations (1)

Nantes University Hospital

Nantes, France