Hyaluronic Acid in Shoulder Tendinopathy

Shoulder Tendinitis Clinical Trial

— ACCTE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376981
• Other study ID #: CHD23_0025
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2024
• Est. completion date: November 2026

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Departemental Vendee
• Contact: Laura SOULARD
• Phone: 0251080582
• Email: laura.soulard[@]ght85.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: November 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ;

Related Conditions & MeSH terms

• Shoulder Tendinitis
• Tendinopathy

Intervention

Drug:
• Hyaluronic acid injection
An injection of 2 ml of Acid hyaluronic
• Corticosteroid injection
An injection of 1 ml of corticosteroids
• Placebo injection
An injection of 2 ml of placebo (physiological serum)

Locations

Country	Name	City	State
France	CHD Vendée	La Roche-sur-Yon
France	CHU Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month 3