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

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.

Study Overview

• Status: Completed
• Conditions: Calcific Tendinitis of the Rotator Cuff
• Intervention / Treatment: Drug: Sodium thiosulfate

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Injection of sodium thiosulfate; Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of sodium thiosulfate	Drug: Sodium thiosulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2015
• Primary Completion (Actual): September 18, 2017
• Study Completion (Actual): November 13, 2017

Study Registration Dates

• First Submitted: August 31, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Calcific tendinitis, Shoulder, Needle lavage, Sodium thiosulfate
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Protective Agents; Anti-Bacterial Agents; Antioxidants; Antidotes; Antitubercular Agents; Chelating Agents; Sequestering Agents; Sodium thiosulfate
• Other Study ID Numbers: RC14_0394

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No