Benefit of a Subacromial Injection Combining Corticosteroid and Hyaluronic Acid Versus Corticosteroid Alone in Supraspinatus Tendinopathy
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 132
- Locations
- 3
- Primary Endpoint
- Visual analog scale pain on activity ranging from 0 to 100 mm at month 3.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 ;
Arms & Interventions
Combination of corticosteroid and hyaluronic acid injection
An injection of 1 ml if corticosteroids and an injection of 2 ml of hyaluronic acid
Intervention: Corticosteroid injection (Drug)
Corticosteroid injection alone
An injection of 1 ml of corticosteroids and an injection of 2 ml of placebo (physiological serum).
Intervention: Placebo injection (Drug)
Corticosteroid injection alone
An injection of 1 ml of corticosteroids and an injection of 2 ml of placebo (physiological serum).
Intervention: Corticosteroid injection (Drug)
Combination of corticosteroid and hyaluronic acid injection
An injection of 1 ml if corticosteroids and an injection of 2 ml of hyaluronic acid
Intervention: Hyaluronic acid injection (Drug)
Outcomes
Primary Outcomes
Visual analog scale pain on activity ranging from 0 to 100 mm at month 3.
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported