| Eligibility |
Inclusion Criteria:
Male or female patient aged =40 years
Patient suffering from glenohumeral osteoarthritis with chronic shoulder pain. Chronic
shoulder pain is defined as follows:
- Persistence for a period of at least 6 months, but not more than 5 years;
- Pain perceived by the patient with a frequency of at least 50% of the days in the
month preceding the inclusion visit; Kellgren-Lawrence grade of 2 or 3 in the
glenohumeral joint confirmed by x-ray exam performed within 3 months prior to the
inclusion visit.
Presence, at baseline, of pain on movement, in the shoulder under study, measured by VAS
with a score between 40 and 80 mm Presence at baseline of pain in the contralateral
shoulder at least 10mm less than the study shoulder and no more than 40mm as measured by
VAS at the inclusion visit
Presence, at baseline, of limitation of shoulder motion in at least one direction in the
following ranges of motion:
- Fixed scapula abduction = 80°
- Internal rotation in abduction = 55°
- External rotation in abduction = 80° These shoulder limitations are for normal
expected excursions. Patient who has not responded adequately to non-pharmacological
conservative therapy and to taking simple analgesics Patient willing to sign and able
to understand the Informed Consent form Patient who is not pregnant or nursing. Women
of childbearing potential (including women who have been less than one year
postmenopausal) must agree to use reliable contraception for the duration of the
study.
Exclusion Criteria:
- Presence, on clinical evaluation, of adhesive capsulitis
- Evidence of rotator cuff injury
- Presence of primary extra-articular shoulder syndromes (eg impingement, bursitis,
tendonitis)
- Evidence of clinically significant shoulder deformity
- Signs, evident on X-ray radiography of the shoulder, of recent fractures, severe loss
of bone density and/or severe deformity
- Diagnosed with crystal deposition disease of calcium pyrophosphate dihydrate (CPPD) or
chondrocalcinosis of the shoulder
- Presence of pathology of the cervical vertebrae (able to alter the clinical
evaluation) which, in the three months preceding the inclusion visit, was symptomatic
and required active treatment
- Presence of any active musculoskeletal disease affecting the diagnosis/evaluation of
shoulder pain or presence of pain of any neurological etiology and acute shoulder
infection
- Presence of major surgery, arthroplasty or arthroscopy in the shoulder under study in
the 6 months prior to inclusion and/or surgery planned during the study
- Patient undergoing local radiotherapy for breast cancer
- Patient with polymyalgia rheumatica
- History of skin cancer (except basal cell carcinoma) treated for less than two years
- History of severe recurrent or immune-mediated allergic reactions
- Presence of infection and/or skin pathologies in the injection area; psoriasis
- Presence of serious gastrointestinal, renal, hepatic, pulmonary, cardiovascular,
neurological disorders that could interfere with the study results or patient's
inability to comply with the study requirements
- Known allergy or suspected allergic reactions to hyaluronate or corticosteroid
preparations
- Taking HA products intra-articularly in the month preceding the inclusion visit
- Taking bisphosphonates and/or pharmaceutical products taken orally and containing
glucosamine and/or chondroitin sulphate and/or diacerin (eg Chondrosulf, Structum 500,
Dona, Viatril, Fisiodar, Artrodar, etc.) in the month preceding the inclusion visit
unless the dosage was stable in the two months prior to the inclusion visit
- Intra-articular corticosteroid injections in the study shoulder in the three months
preceding the inclusion visit
- Intra-articular corticosteroid injections in any joint in the month preceding the
inclusion
- Taking oral corticosteroids in the month prior to the inclusion visit (only inhaled
corticosteroids are permitted)
- Previous use of HA in the study shoulder within 6 months prior to inclusion
- Changed physical therapy in the month prior to inclusion visit or unwillingness to
maintain stable regimen
- Patient with history of thyroid insufficiency
- Patient being treated with anticoagulant therapy
- Patient on phenobarbital treatment prior to study inclusion
- Taking analgesic therapies (NSAIDs, opioid analgesics, topical analgesics) for any
condition that could interfere with the evaluation of the shoulder under study
- Intake of another experimental product in the month preceding the inclusion visit
- Patient who, in the opinion of the investigator, is unwilling to comply with study
procedures or will not cooperate during the course of the study
- Pregnant or breastfeeding woman
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