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Completed

NCT Number: NCT02538939

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

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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Key information

Conditions

Calcific Tendinitis of the Rotator Cuff

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nantes University Hospital

Nantes, 44000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium thiosulfate

Drug

Primary outcomes

  1. Decrease the size of the calcific deposit after the PFL

    Time frame: 1 month

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

Secondary outcomes

  1. VAS pain during daily activity (0-10)

    Time frame: 7 days, 1 month and 3 months

  2. VAS pain at rest (0-10)

    Time frame: 7 days, 1 month and 3 months

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

    Time frame: 1 month and 3 months

  4. Size of the calcific deposit assessed by X-Ray of the affected shoulder

    Time frame: 7 days, 1 month and 3 months

  5. Size of the calcific deposit assessed by ultrasound of the affected shoulder

    Time frame: 7 days, 1 month and 3 months

  6. Self-reported quality of life assessed by the EQ-5D questionnaire

    Time frame: 1 month and 3 months

  7. Number of day off work due to the shoulder pain

    Time frame: up to 3 months

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: THIOCAL

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 2, 2015
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.