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

NCT02538939 | Completed Phase 2

• 1 other identifier: RC14_0394
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Calcific Tendinitis of the Rotator Cuff

Keywords

Calcific tendinitis, Shoulder, Needle lavage, Sodium thiosulfate

Outcome Measures

Primary Outcomes (1)

• Decrease the size of the calcific deposit after the PFL

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

  1 month

Secondary Outcomes (7)

• VAS pain during daily activity (0-10)

  7 days, 1 month and 3 months

• VAS pain at rest (0-10)

  7 days, 1 month and 3 months

• The Disabilities of the Arm, Shoulder and Hand (DASH) Score

  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

• Size of the calcific deposit assessed by ultrasound of the affected shoulder

  7 days, 1 month and 3 months

Study Arms (1)

Injection of sodium thiosulfate

EXPERIMENTAL

Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of sodium thiosulfate

Drug: Sodium thiosulfate

Interventions

Sodium thiosulfate DRUG

Injection of sodium thiosulfate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Critères d'inclusion : * Patients de plus de 18 ans * Patients affiliés à un régime de sécurité sociale * Consentement éclairé et signé des patients * Douleur de l'épaule depuis plus de 3 mois * Douleur compatible avec une origine péri-articulaire : * aggravation lors de l'élévation de l'épaule * 1 des 3 tests de conflit sous-acromial positif (Yocum, Hawkins, Neer) * Présence d'une calcification dure \> 5 mm sur la radiographie standard (calcification de type A de la société Française d'Arthroscopie) (Mole, 1993) * Contraception efficace obligatoire pour les femmes en âge de procréer à maintenir jusqu'au lendemain de l'administration du thiosulfate de sodium. Critères de non-inclusion : * Allergie connue à l'anesthésique, au cortivazol ou au thiosulfate de sodium * Hypersensibilité connue au métabisulfite de sodium (agent de conservation et anti-oxydant connu sous le code E224) * Patients asthmatiques * Insuffisance rénale (Clairance \< 30 mL/min) * Patients sous anticoagulants, troubles de la coagulation * Tableau de résorption aiguë de la calcification (épaule aiguë hyperalgique) * Aspect flou de la calcification sur les radiographies standards évoquant une résorption (calcification de type C de la société Française d'Arthroscopie) (Mole, 1993) ou calcifications fragmentées à contours nets (type B) * Rupture de la coiffe des rotateurs mise en évidence sur l'échographie initiale * Antécédent de PFL sur la calcification étudiée dans les 3 mois précédent l'inclusion * Autre pathologie d'épaule associée (arthrose gléno-humérale, acromio-claviculaire), * Diabète déséquilibré * Contre-indication à la prise d'anti-inflammatoires non stéroïdiens et de paracétamol * Infection locale ou générale, ou suspicion d'infection * Contre-indication à la Xylocaïne 1% : (porphyrie récurrente, β-bloquant dans l'insuffisance cardiaque) * Femmes enceintes, mineurs, majeurs sous tutelle * Femmes en âge de procréer refusant de maintenir une contraception efficace jusqu'au lendemain de la PFL * Patients participant à un autre protocole de recherche clinique (à l'exception de recherches non-interventionnelles) * Patients incapables de suivre le protocole, selon le jugement de l'investigateur

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44000, France

Location

Related Publications (1)

• Darrieurtort-Laffite C, Bertrand-Vasseur A, Garraud T, Planche L, Le Goff B. Tolerance and effect of sodium thiosulfate in calcific tendinitis of the rotator cuff. Clin Rheumatol. 2020 Feb;39(2):561-569. doi: 10.1007/s10067-019-04793-x. Epub 2019 Nov 1.

  PMID: 31673978 DERIVED

MeSH Terms

Interventions

sodium thiosulfate

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 2, 2015
• Study Start: December 2, 2015
• Primary Completion: September 18, 2017
• Study Completion: November 13, 2017
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

FR (1)