Hymovis® Intra-articular Injections vs Corticosteroids Intra-articular Injections in Patients Aff… (NCT06043544) | Clinical Trial Compass
CompletedPhase 4
Hymovis® Intra-articular Injections vs Corticosteroids Intra-articular Injections in Patients Affected by Glenohumeral Osteoarthritis:
Italy80 participantsStarted 2021-05-02
Plain-language summary
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.
Who can participate
Age range40 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 stu…
What they're measuring
1
Evaluate the pain reduction in the target shoulder compared to control group