Clinical trial NCT06376981: Hyaluronic Acid in Shoulder Tendinopathy
Official title: Benefit of a Subacromial Injection Combining Corticosteroid and Hyaluronic Acid Versus Corticosteroid Alone in Supraspinatus Tendinopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Shoulder Tendinitis
Keywords: Shoulder tendinitis
Hyaluronic acid
Corticosteroid injection
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 ;

Primary outcomes:
measure: Visual analog scale pain on activity ranging from 0 to 100 mm at month 3.
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Nantes
country: France
facility: CHU Nantes
Study officials:
affiliation: Centre Hospitalier Départemental Vendée
name: Céline COZIC, Dr
role: PRINCIPAL_INVESTIGATOR
References: