Hyaluronic Acid in Shoulder Tendinopathy (ACCTE)

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Tendinitis
• Intervention / Treatment: Drug: Hyaluronic acid injection; Drug: Corticosteroid injection; Drug: Placebo injection

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Laura SOULARD; Phone Number: +33 0251080582; Email: laura.soulard@ght85.fr

Study Locations

• France
  • La Roche-sur-Yon, France
    • Recruiting
    • CHD Vendee
    • Contact: Céline COZIC, Dr
  • Nantes, France
    • Not yet recruiting
    • CHU Nantes
    • Contact: Christelle DARRIEUTORT-LAFFITE, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 ;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; An injection of 2 ml of Acid hyaluronic; Drug: Corticosteroid injection; An injection of 1 ml of corticosteroids
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; An injection of 1 ml of corticosteroids; Drug: Placebo injection; An injection of 2 ml of placebo (physiological serum)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Principal Investigator: Céline COZIC, Dr, Centre Hospitalier Departemental Vendee

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2024
• Primary Completion (Estimated): December 19, 2026
• Study Completion (Estimated): March 19, 2027

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Hyaluronic acid; Corticosteroid injection; Shoulder tendinitis
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: CHD23_0025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No