Hyaluronic Acid in Shoulder Tendinopathy

NCT06376981 — Phase 3, Recruiting, 132 participants, Centre Hospitalier Departemental Vendee

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Benefit of a Subacromial Injection Combining Corticosteroid and Hyaluronic Acid Versus Corticosteroid Alone in Supraspinatus Tendinopathy

RegistryNCT06376981, acronym ACCTE
StatusRecruiting
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment132 (Estimated)
SponsorCentre Hospitalier Departemental Vendee (Other)
ConditionsShoulder Tendinitis
InterventionsHyaluronic acid injection, Corticosteroid injection, Placebo injection (Drug)
Datesstart 2024-09-19, primary completion 2026-12-19 (estimated), completion 2030-03-19 (estimated), first posted 2024-04-22, last updated 2026-07-10
Locations2 sites in France

Related Papers Related Patents Related Grants Related Experts
All trials for Shoulder Tendinitis All trials of Hyaluronic acid injection All trials of Corticosteroid injection

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Combination of corticosteroid and hyaluronic acid injectionExperimentalDrug: Hyaluronic acid injection; Drug: Corticosteroid injectionAn injection of 1 ml if corticosteroids and an injection of 2 ml of hyaluronic acid
Corticosteroid injection alonePlacebo comparatorDrug: Corticosteroid injection; Drug: Placebo injectionAn injection of 1 ml of corticosteroids and an injection of 2 ml of placebo (physiological serum).
  • Hyaluronic acid injection (Drug): An injection of 2 ml of Acid hyaluronic
  • Corticosteroid injection (Drug): An injection of 1 ml of corticosteroids
  • Placebo injection (Drug): An injection of 2 ml of placebo (physiological serum)

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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 informed consent to take part in the research;
* Patient affiliated to the social security system or entitled person;

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 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 ;

+Locations (2)

FacilityCityCountryStatus
CHD VendéeLa Roche-sur-YonFranceRecruiting
CHU NantesNantesFranceRecruiting

+Investigators

  • Céline COZIC, Dr, Principal investigator, Centre Hospitalier Départemental Vendée