Shoulder TendinitisPhase 3ACCTENCT06376981
Hyaluronic Acid in Shoulder Tendinopathy
A Phase 3 study testing Hyaluronic acid injection and Corticosteroid injection in people with Shoulder Tendinitis, run by Centre Hospitalier Departemental Vendee at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Tendinitis
- What is being tested?
- Hyaluronic acid injection and Corticosteroid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Sep 2024to 19 Mar 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- Patient failing medical treatment (rest, analgesics, NSAIDs, physiotherapy);
- Patient able to follow the protocol and having given oral informed consent to take part in the research;
- Patient affiliated to the social security system or entitled person;
Who cannot join
- 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);
Show all 21Show fewer
- Patients who have had a subacromial infiltration in the previous 6 months;
- Patients with a known allergy to one of the products including their excipients (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 HbA1c > 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 contraception* 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 ;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHD Vendée
La Roche-sur-Yon
Céline COZIC, Dr
- Recruiting
CHU Nantes
Nantes
Christelle DARRIEUTORT-LAFFITE, Dr
About this study
Official title: Benefit of a Subacromial Injection Combining Corticosteroid and Hyaluronic Acid Versus Corticosteroid Alone in Supraspinatus Tendinopathy
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.
- Conditions
- Shoulder Tendinitis
- Being tested
- Hyaluronic acid injection, Corticosteroid injection, Placebo injection
- Keywords
- Shoulder tendinitis, Hyaluronic acid, Corticosteroid injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid injectionDrug
An injection of 2 ml of Acid hyaluronic
Corticosteroid injectionDrug
An injection of 1 ml of corticosteroids
Placebo injectionDrug
An injection of 2 ml of placebo (physiological serum)
| Study group | Role | What they receive |
|---|---|---|
| Combination of corticosteroid and hyaluronic acid injection | Experimental | An injection of 1 ml if corticosteroids and an injection of 2 ml of hyaluronic acid Receives: Drug: Hyaluronic acid injection; Drug: Corticosteroid injection |
| Corticosteroid injection alone | Placebo comparator | An injection of 1 ml of corticosteroids and an injection of 2 ml of placebo (physiological serum). Receives: Drug: Corticosteroid injection; Drug: Placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start19 Sep 2024
- Primary completion19 Dec 2026 (estimated)
- Study completion19 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder TendinitisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline COZIC, Dr, Principal investigator, Centre Hospitalier Départemental Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376981
- Sponsor's protocol ID
- CHD23_0025
- Acronym
- ACCTE
- Status last verified
- Jul 2026
- First submitted
- 11 Apr 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of a Subacromial Injection Combining Corticosteroid and Hyaluronic Acid Versus Corticosteroid Alone in Supraspinatus Tendinopathy
- ClinicalTrials.gov ID
- NCT06376981
- Acronym / sponsor ID
- ACCTE / CHD23_0025
- Conditions
- Shoulder Tendinitis
- Keywords
- Shoulder tendinitis, Hyaluronic acid, Corticosteroid injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 19 Dec 2026 (estimated)
- Study completion
- 19 Mar 2030 (estimated)
- First posted
- 22 Apr 2024 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination of corticosteroid and hyaluronic acid injection | Experimental | Drug: Hyaluronic acid injection, Drug: Corticosteroid injectionAn injection of 1 ml if corticosteroids and an injection of 2 ml of hyaluronic acid |
| Corticosteroid injection alone | Placebo comparator | Drug: Corticosteroid injection, Drug: Placebo injectionAn injection of 1 ml of corticosteroids and an injection of 2 ml of placebo (physiological serum). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
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 |
|---|---|---|
| Hyaluronic acid injectionAn injection of 2 ml of Acid hyaluronic | Drug | Combination of corticosteroid and hyaluronic acid injection |
| Corticosteroid injectionAn injection of 1 ml of corticosteroids | Drug | Combination of corticosteroid and hyaluronic acid injection, Corticosteroid injection alone |
| Placebo injectionAn injection of 2 ml of placebo (physiological serum) | Drug | Corticosteroid injection alone |
Primary outcome
Visual analog scale pain on activity ranging from 0 to 100 mm at month 3.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Shoulder Tendinitis
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Ultrasound-Guided Extracorporeal Shock Wave Therapy for Calcific Tendinitis
Calcific Tendinitis of Shoulder
Recruiting
Electroacupuncture and Cupping for Shoulder Tendinitis
Shoulder Tendinopathy, Shoulder Tendinitis
Active, not recruiting
Eccentric Contraction Exercise For Shoulder Pain Syndrome
Shoulder Pain Syndrome, Rotator Cuff Syndrome
Recruiting
The Effect of Doppler Ultrasound on Calcified Tendinitis
Calcific Tendinitis of Shoulder
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.
Céline COZIC, Dr principal investigator
Centre Hospitalier Départemental Vendée
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyaluronic acid injection and Corticosteroid injection in people with Shoulder Tendinitis, run by Centre Hospitalier Departemental Vendee at 2 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 9 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura SOULARD (0251080582 ext. +33, laura.soulard@ght85.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale pain on activity ranging from 0 to 100 mm at month 3. (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2026.