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

Study Overview
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Brief Summary
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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.

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

Conditions
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Calcific Tendinitis of the Rotator Cuff

Intervention / Treatment
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* Drug: Sodium thiosulfate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calcific tendinitis, Shoulder, Needle lavage, Sodium thiosulfate