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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-02

Study Completion Date

2017-11-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Sodium Thiosulfate in Shoulder Pain in Calcific Tendinitis of the Rotator Cuff

NCT04251832

Sodium Thiosulfate Calcific Tendinitis Shoulder Pain

UNKNOWN PHASE2

Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection

NCT02403856

Calcifying Tendinitis of Shoulder

COMPLETED PHASE4

Ultrasound-guided Lavage of Calcific Deposits of the Rotator Cuff

NCT05264935

Rotator Cuff Tendinitis Ultrasonography, Interventional Ultrasonography, Doppler, Color

UNKNOWN

Efficacy Study of Fine Needle Technique on Calcific Tendinitis

NCT00506038

Tendinitis

TERMINATED PHASE2

What Factors Are Associated With Prognosis of Rotator Cuff Disorder After Subacromial Hyaluronic Acid Injection

NCT03677895

Rotator Cuff Impingement Syndrome

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Calcific Tendinitis of the Rotator Cuff

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Injection of sodium thiosulfate

Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of sodium thiosulfate

Group Type EXPERIMENTAL

Sodium thiosulfate

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sodium thiosulfate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No