This monocentric randomized open-label study aims to assess the efficacy and safety of a treatment with medium molecular weight hyaluronic acid (HA) compared to a treatment with corticosteroids on patients affected by glenohumeral osteoarthritis.
Glenohumeral osteoarthritis (OA) is a very common joint disease characterized by pain and functional limitation. No standardized protocols of treatment are available in clinical practice and literature data are confusing. This monocentric randomized open-label study aims to assess the efficacy and safety of a treatment with medium molecular weight hyaluronic acid (HA) compared to a treatment with corticosteroids on patients affected by glenohumeral osteoarthritis. A total of 80 consecutive patients with glenohumeral OA (Kellegren Lawrence degree II or III) were randomized in two different groups, intto Hymovis® (24mg/3ml) (treatment group) or into corticosteroids (control group), with a follow-up after 3 and 6 months. Modifications in terms of pain (VAS), range of motion (ROM) and quality of life (EQ-5D) were observed during the treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Patients in the treatment group received two intra-articular injections with Hymovis® (24mg/3ml) a week apart from each other
Patients in control group received two intra-articular injections with corticosteroids a week apart from each other.
Concordia Hospital
Rome, Italy
Evaluate the pain reduction in the target shoulder compared to control group
Changes of pain on movement in the target shoulder, evaluated with a 0-100 mm Visual Analogue Scale (VAS) values compared to baseline (V1).
Time frame: At 6 months
Evaluation of the Quality of Life of the patients
Changes of patient's quality of life, evaluated by administration of the EuroQol 5-Dimension Questionnaire (EQ-5D-5L) compared to baseline (V1)
Time frame: At 6 months
Evaluate the amelioration of shoulder functionality
Clinical functional assessment on movement from baseline (V1), measured by Constant Murley (CMS) shoulder test ;
Time frame: At 6 months
Evaluate the pain reduction in the target shoulder compared to baseline
Changes of pain on movement in the target shoulder, evaluated with a 0-100 mm Visual Analogue Scale (VAS) values compared to baseline (V1).
Time frame: At 6 months
Evaluation of the safety of the treatment
Safety of Hymovis® were evaluated in terms of incidence of treatment-emergent adverse events (TEAEs) over the investigational period.
Time frame: 12 months
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