BridgeMD
New treatment option for Shoulder Tendinitis
Official title Hyaluronic Acid in Shoulder Tendinopathy
ClinicalTrials.gov ID: NCT06376981
What this study is testing
What is Hyaluronic acid injection?
Hyaluronic acid injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for shoulder tendinitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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;
You likely can't join if
- 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);
See the full eligibility 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;
- 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 assigned by chance 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 ;
The study team makes the final eligibility decision.
Where it's taking place
- La Roche-sur-Yon, France
- Nantes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Roche-sur-Yon, France; Nantes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.