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Calcifying Tendinitis of ShoulderPhase 4CALCECHONCT02403856

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

A Phase 4 study testing Sodium Chloride 0.9%, Methylprednisolone acetate and Ultrasound-guided Needling and Lavage in people with Calcifying Tendinitis of Shoulder, run by Nantes University Hospital at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Calcific tendinitis of the rotator cuff is a common cause of chronic pain of the shoulder. 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
Calcifying Tendinitis of Shoulder
What is being tested?
Sodium Chloride 0.9%, Methylprednisolone acetate and Ultrasound-guided Needling and Lavage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
3 sitesFrance
Study dates
4 Apr 2015to 13 Nov 2017
Phase
Phase 4
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

Who may be able to join

  • Shoulder pain for at least 3 month
  • Positive Hawkins, Yocum and/or Neer test for impingement
  • Calcific deposit >= 5 mm on shoulder x-ray in one the tendon of the rotator cuff

Who cannot join

  • Allergy to lidocaïne or methylprednisolone acetate
  • Acute pain suggestive of resorption of the calcification with ill-defined - calcification on X-Ray
  • Other shoulder diseases : ostearthritis of the gleno-humeral or acromio-clavicular joint
  • Sonographic findings of rotator cuff tear
  • Subacromial steroid injection in the previous month
  • Uncontrolled diabetes
  • Pregnant women
  • Contraindication for the use of nonsteroidal antiinflammatory drugs or paracetamol/acetaminophene

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • La Roche sur Yon Hospital

    La Roche-sur-Yon

  • Nantes University Hospital

    Nantes, 44093

  • Rennes University hospital

    Rennes

Other trials in France

About this study

Official title: Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection: A Double Blind Controlled Study

Calcific tendinitis of the rotator cuff is a common cause of chronic pain of the shoulder. Needling and lavage of the calcification is one of the therapeutic options after failure of conservative management with physiotherapy and anti-inflammatory drugs. Needling is usually followed by a corticosteroid injection in the subacromial bursae in order to prevent acute pain reaction due to the intervention. However, the relevance of this injection has never been proven. Moreover, corticosteroid could prevent the inflammatory reaction induced by the needling and thus the body's natural calcium resorption processes. Finally, corticosteroids could have deleterious effect on the tendon structures and favour local infection. Our hypothesis is that corticosteroid have no significant effect on acute pain after needling and therefore should not been performed systematically after needling.

Being tested
Sodium Chloride 0.9%, Methylprednisolone acetate, Ultrasound-guided Needling and Lavage
Keywords
calcifying tendinitis, Needle lavage, Shoulder, Corticosteroid injection, Ultrasound-guided
Medical subject headings
Rotator Cuff Tear Arthropathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium Chloride 0.9%Drug

    Also called NaCl 0.9%

    Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of sterile physiological Saline (Sodium Chloride 0.9%) in the subacromial bursae.

  • Methylprednisolone acetateDrug

    Also called Dépomédrol

    Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae

  • Ultrasound-guided Needling and LavageProcedure or surgery

Study groups in NCT02403856
Study groupRoleWhat they receive
Experimental group (Sodium Chloride 0.9%)ExperimentalNeedling and lavage of calcific tendinitis of the rotator cuff followed by the injection of sterile physiological Saline (Sodium Chloride 0.9%) in the subacromial bursae.
Receives: Drug: Sodium Chloride 0.9%; Procedure: Ultrasound-guided Needling and Lavage
Control group (Methylprednisolone Acetate)Active comparatorNeedling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae
Receives: Drug: Methylprednisolone acetate; Procedure: Ultrasound-guided Needling and Lavage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum pain (VAS scale)

    Maximum pain on a VAS scale (0-10) reported by the patient in the seven days following the needling.

    Measured: 7 days

Secondary outcomes (24)

  1. Anti-inflammatory and analgesic intake

    Measured: 7 days

  2. Size of the calcific deposit

    Measured: 7 days

  3. Size of the calcific deposit

    Measured: 3 months

  4. Size of the calcific deposit

    Measured: 12 months

  5. Number of frozen shoulder in each group

    Measured: 7 days

  6. Number of frozen shoulder in each group

    Measured: 6 weeks

  7. Number of frozen shoulder in each group

    Measured: 3 months

  8. Number of frozen shoulder in each group

    Measured: 6 months

  9. Number of frozen shoulder in each group

    Measured: 12 months

  10. VAS pain during daily activity

    Measured: 7 days

  11. VAS pain during daily activity

    Measured: 6 weeks

  12. VAS pain during daily activity

    Measured: 3 months

  13. VAS pain during daily activity

    Measured: 6 months

  14. VAS pain during daily activity

    Measured: 12 months

  15. VAS pain at rest

    Measured: 7 days

  16. VAS pain at rest

    Measured: 6 weeks

  17. VAS pain at rest

    Measured: 3 months

  18. VAS pain at rest

    Measured: 6 months

  19. VAS pain at rest

    Measured: 12 months

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

    Measured: 7 days

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

    Measured: 6 weeks

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

    Measured: 3 months

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

    Measured: 6 months

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2015 (estimated)
  2. Study start4 Apr 2015
  3. Primary completion2 Apr 2017
  4. Study completion13 Nov 2017

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02403856
Sponsor's protocol ID
RC15_0019
Acronym
CALCECHO
Status last verified
Oct 2018
First submitted
20 Mar 2015
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No

Publications

  • Darrieutort-Laffite C, Varin S, Coiffier G, Albert JD, Planche L, Maugars Y, Cormier G, Le Goff B. Are corticosteroid injections needed after needling and lavage of calcific tendinitis? Randomised, double-blind, non-inferiority trial. Ann Rheum Dis. 2019 Jun;78(6):837-843. doi: 10.1136/annrheumdis-2018-214971. Epub 2019 Apr 11.

    PubMed 30975645

  • Dumoulin N, Cormier G, Varin S, Coiffier G, Albert JD, Le Goff B, Darrieutort-Laffite C. Factors Associated With Clinical Improvement and the Disappearance of Calcifications After Ultrasound-Guided Percutaneous Lavage of Rotator Cuff Calcific Tendinopathy: A Post Hoc Analysis of a Randomized Controlled Trial. Am J Sports Med. 2021 Mar;49(4):883-891. doi: 10.1177/0363546521992359.

    PubMed 33719606

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sodium Chloride 0.9%, Methylprednisolone acetate and Ultrasound-guided Needling and Lavage in people with Calcifying Tendinitis of Shoulder, run by Nantes University Hospital at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. 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 3 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Maximum pain (VAS scale) (time frame: 7 days). 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 NCT02403856, which also lists 2 linked publications.

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.

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