Calcific Tendinitis of the Rotator CuffPhase 2THIOCALNCT02538939
Efficacy and Tolerance of Sodium Thiosulfate Injection After Ultrasound-guided Percutaneous Irrigation of Calcific Tendinopathy of the Rotator Cuff
A Phase 2 study testing Sodium thiosulfate in people with Calcific Tendinitis of the Rotator Cuff, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcific Tendinitis of the Rotator Cuff
- What is being tested?
- Sodium thiosulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2015to 13 Nov 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Calcific Tendinitis of the Rotator Cuff
- Being tested
- Sodium thiosulfate
- Keywords
- Calcific tendinitis, Shoulder, Needle lavage, Sodium thiosulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium thiosulfateDrug
| Study group | Role | What they receive |
|---|---|---|
| Injection of sodium thiosulfate | Experimental | Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of sodium thiosulfate Receives: Drug: Sodium thiosulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (7)
VAS pain during daily activity (0-10)
Measured: 7 days, 1 month and 3 months
VAS pain at rest (0-10)
Measured: 7 days, 1 month and 3 months
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Measured: 1 month and 3 months
Size of the calcific deposit assessed by X-Ray of the affected shoulder
Measured: 7 days, 1 month and 3 months
Size of the calcific deposit assessed by ultrasound of the affected shoulder
Measured: 7 days, 1 month and 3 months
Self-reported quality of life assessed by the EQ-5D questionnaire
Measured: 1 month and 3 months
Number of day off work due to the shoulder pain
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study start2 Dec 2015
- Primary completion18 Sep 2017
- Study completion13 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Calcific Tendinitis of the Rotator CuffStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538939
- Sponsor's protocol ID
- RC14_0394
- Acronym
- THIOCAL
- Status last verified
- Aug 2018
- First submitted
- 31 Aug 2015
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31673978
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance of Sodium Thiosulfate Injection After Ultrasound-guided Percutaneous Irrigation of Calcific Tendinopathy of the Rotator Cuff
- ClinicalTrials.gov ID
- NCT02538939
- Acronym / sponsor ID
- THIOCAL / RC14_0394
- Conditions
- Calcific Tendinitis of the Rotator Cuff
- Keywords
- Calcific tendinitis, Shoulder, Needle lavage, Sodium thiosulfate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 2 Dec 2015 (actual)
- Primary completion
- 18 Sep 2017 (actual)
- Study completion
- 13 Nov 2017 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injection of sodium thiosulfate | Experimental | Drug: Sodium thiosulfateNeedling and lavage of calcific tendinitis of the rotator cuff followed by the injection of sodium thiosulfate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium thiosulfate | Drug | Injection of sodium thiosulfate |
Primary outcome
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
7 secondary outcomes
VAS pain during daily activity (0-10)
Time frame: 7 days, 1 month and 3 months
VAS pain at rest (0-10)
Time frame: 7 days, 1 month and 3 months
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time frame: 1 month and 3 months
Size of the calcific deposit assessed by X-Ray of the affected shoulder
Time frame: 7 days, 1 month and 3 months
Size of the calcific deposit assessed by ultrasound of the affected shoulder
Time frame: 7 days, 1 month and 3 months
Self-reported quality of life assessed by the EQ-5D questionnaire
Time frame: 1 month and 3 months
Number of day off work due to the shoulder pain
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 31673978Darrieurtort-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium thiosulfate in people with Calcific Tendinitis of the Rotator Cuff, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease the size of the calcific deposit after the PFL (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02538939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.