Efficacy and Tolerance of Sodium Thiosulfate Injection After Ultrasound-guided Percutaneous Irrig… (NCT02538939) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Tolerance of Sodium Thiosulfate Injection After Ultrasound-guided Percutaneous Irrigation of Calcific Tendinopathy of the Rotator Cuff
France17 participantsStarted 2015-12-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Decrease the size of the calcific deposit after the PFL