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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injection of sodium thiosulfate | Experimental | Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of sodium thiosulfate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium thiosulfate | Drug |
|
| 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 |
| 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 |
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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 :
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 :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes University Hospital | Nantes | 44000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31673978 | Derived | 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. |
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| 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 |
| ID | Term |
|---|---|
| C017717 | sodium thiosulfate |
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