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RecruitingNCT06376981ACCTEUpdated Jul 10, 2026

Hyaluronic Acid in Shoulder Tendinopathy

A Phase 3 interventional study of Hyaluronic acid injection and Corticosteroid injection in Shoulder Tendinitis, sponsored by Centre Hospitalier Departemental Vendee. Recruiting at 2 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Centre Hospitalier Departemental Vendee · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 1 month later.
Phase
Phase 3
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Multicentric, randomised study to compare the effectiveness on activity pain at 3 months of corticosteroid injection associated with hyaluronic acid with corticosteroids injection alone in patients with tendinopathy of the supraspinatus with clinical reevaluation at one, three and six months.

02

Conditions studied

  • Shoulder Tendinitis

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Keywords

  • Shoulder tendinitis
  • Hyaluronic acid
  • Corticosteroid injection
03

In context

Tendinopathy

397 studies on the registry are indexed under Tendinopathy; 77 are open to participants now.

This study's planned enrollment of 132 is above the median of 48 across 332 interventional studies indexed under Tendinopathy.

Browse Tendinopathy studies →

Lead sponsor

Centre Hospitalier Departemental Vendee is the lead sponsor of 83 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Active patient aged between 18 and 65;
  • Patient suffering from pain compatible with supraspinatus tendinopathy for at least 2 months;
  • Patient with simple tendinopathy or partial tendon rupture;
  • Patient with tendinopathy confirmed by ultrasound or MRI;
  • Patient with an active pain visual analog scale ≥ 4 for more than 6 weeks;
  • Patient with an active pain visual analog scale ≥ 4 on the day of inclusion;
  • Patient failing medical treatment (rest, analgesics, NSAIDs, physiotherapy);
  • Patient able to follow the protocol and having given oral to take part in the research;
  • Patient affiliated to the social security system or entitled person;

Exclusion criteria

Exclusion Criteria:

  • Patient suffering from a transfixing tendon rupture;
  • Patients suffering from post-traumatic tendon rupture;
  • Patients suffering from calcific tendinopathy (calcification > 5 mm);
  • Patients with associated glenohumeral osteoarthritis;
  • Patients with associated symptomatic acromioclavicular osteoarthritis;
  • Patients with shoulder pain for reasons other than tendinopathy (capsulitis, chronic inflammatory rheumatism, fibromyalgia, amyloidosis);
  • Patients who have had a subacromial infiltration in the previous 6 months;
  • Patients with a known allergy to one of the products including their (methyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl alcohol);
  • Patients with a known allergy to lidocaine;
  • Patients with a local or generalised infection, or suspected infection;
  • Patients with severe coagulation disorders or taking anticoagulants;
  • Patients with severe and/or uncontrolled hypertension > 160/100 mmHg;
  • Patients with unbalanced diabetes (last > 8.5%);
  • Patients with a history of addiction to psychoactive substances;
  • Patient participating in another clinical research protocol with an impact on the research objectives;
  • Patient already randomised in the study;
  • Patient who is pregnant, parturient, breastfeeding or able to procreate without effective * in the month prior to inclusion and up to 15 days after infiltration;
  • Patients under guardianship, curators or deprived of liberty;
  • Patient under a mandate for future protection activated ;
  • Patient under family guardianship ;
  • Patient under court protection ;
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
132 participants (estimated)

Study arms

  • Experimental
    Combination of corticosteroid and hyaluronic acid injection

    An injection of 1 ml if corticosteroids and an injection of 2 ml of hyaluronic acid

    Drug: Hyaluronic acid injection · Drug: Corticosteroid injection

  • Placebo comparator
    Corticosteroid injection alone

    An injection of 1 ml of corticosteroids and an injection of 2 ml of placebo (physiological serum).

    Drug: Corticosteroid injection · Drug: Placebo injection

Interventions

  • An injection of 2 ml of Acid hyaluronic

  • DrugCorticosteroid injection

    An injection of 1 ml of corticosteroids

  • DrugPlacebo injection

    An injection of 2 ml of placebo (physiological serum)

06

What researchers measure

Primary outcomes

  1. Visual analog scale pain on activity ranging from 0 to 100 mm at month 3.

    Visual analog scale pain on activity ranging from 0 to 100 mm at month 3. Pain is defined by the worst pain felt during active examination: anterior elevation, abduction, internal and external rotation, etc.

    Time frame: Month 3

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2024 (actual). Primary completion is estimated for Dec 2026, 27 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 11, 2024
First posted
Apr 22, 2024
StartActual
Sep 19, 2024
Primary completionEst.
Dec 19, 2026
CompletionEst.
Mar 19, 2030
Last update
Jul 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06376981
Lead sponsor
Centre Hospitalier Departemental Vendee
Responsible party
Sponsor
First posted
Apr 22, 2024
Start date
Sep 19, 2024
Primary completion
Dec 19, 2026 (estimated)
Completion
Mar 19, 2030 (estimated)
Last update
Jul 10, 2026

Study contacts

Laura SOULARD
Contact
laura.soulard@ght85.fr
0251080582 ext. +33
Céline COZIC, Dr
principal investigator · Centre Hospitalier Départemental Vendée

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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