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Can a Calcium-Binding chemical melt away painful shoulder deposits?

NCT ID NCT02538939

Symptom relief Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Calcific tendinitis of the rotator cuff causes long-lasting shoulder pain when calcium builds up in the tendon. Standard treatment flushes the deposit with fluid, but the calcium often dissolves slowly. Researchers are testing whether injecting sodium thiosulfate, a chemical that binds calcium, right after the flush helps the deposit shrink faster and eases pain. The trial enrolls adults with shoulder pain lasting more than three months and a calcium deposit larger than 5 mm.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sodium thiosulfate, a chemical that binds calcium, injected into the shoulder after the calcium deposit is flushed with fluid
What this could lead to
If it works, this could offer a faster way to dissolve painful calcium deposits in the shoulder and shorten recovery time after standard irrigation.
What could go wrong
This is a small Phase 2 trial with 17 participants, so results may not hold in larger groups. Injecting a new substance into the shoulder could cause irritation or other side effects, and the calcium may not dissolve as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

17 people

The number who actually took part.

Started

Dec 2015

Finished

Nov 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

calcific tendinitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Calcific tendinitis of the rotator cuff

Contacts and locations

Locations

  • Nantes University Hospital

    Nantes, 44000, France