Shoulder Tendinitis
Conditions
Keywords
Shoulder tendinitis, Hyaluronic acid, Corticosteroid injection
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.
Interventions
An injection of 2 ml of Acid hyaluronic
DRUGCorticosteroid injection
An injection of 1 ml of corticosteroids
DRUGPlacebo injection
An injection of 2 ml of placebo (physiological serum)
Sponsors
Centre Hospitalier Departemental Vendee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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 ;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale pain on activity ranging from 0 to 100 mm at month 3. | 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. |
Countries
France
Contacts
Primary ContactLaura SOULARD
Outcome results
None listed