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

Phase 2

Completed

• Conditions: Calcific Tendinitis of the Rotator Cuff
• Interventions: Drug: Sodium thiosulfate

• Registration Number: NCT02538939
• Lead Sponsor: Nantes University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-02
• Study Start: 2015-12-02
• Primary Completion: 2017-09-18
• Study Completion: 2017-11-13
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-17
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Injection of sodium thiosulfate	Sodium thiosulfate	Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of sodium thiosulfate

Primary Outcome Measures

Name	Time	Method
Decrease the size of the calcific deposit after the PFL	1 month	Percentage of patient having more than 50% decrease in the size of the calcific deposit 1 month after the PFL

Secondary Outcome Measures

Name	Time	Method
The Disabilities of the Arm, Shoulder and Hand (DASH) Score	1 month and 3 months
VAS pain at rest (0-10)	7 days, 1 month and 3 months
Size of the calcific deposit assessed by X-Ray of the affected shoulder	7 days, 1 month and 3 months
Self-reported quality of life assessed by the EQ-5D questionnaire	1 month and 3 months
Number of day off work due to the shoulder pain	up to 3 months
VAS pain during daily activity (0-10)	7 days, 1 month and 3 months
Size of the calcific deposit assessed by ultrasound of the affected shoulder	7 days, 1 month and 3 months

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France