Hymovis® Intra-Articular Injections vs Corticosteroids Intra-Articular Injections in Patients Affected by Glenohumeral Osteoarthritis: A Monocentric Randomized Open-Label Trial

Abstract

Background: Glenohumeral osteoarthritis (GH 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. Methods: A total of 80 consecutive patients with GH OA (Kellegren Lawrence grade II or III) were randomized in two different groups: Hymovis® (24 mg/3 mL) (treatment group) and corticosteroids (control group), with a follow-up after 3 and 6 months. Modifications in terms of pain, range of motion and quality of life were observed during the treatment. Results: After 6 months, the treatment group presented a mean active abduction (ABD) of 67.9° ± 3.6 (baseline 56.4° ± 4.5, a gain of 11.5°), the mean internal rotation (INT) was 14.4° ± 2.0 (baseline 13.6° ± 2.1. a gain of 0.8°) and the mean external rotation (EXT) was 24.3° ± 2.5 (baseline 23.5 ° ± 2.9, a gain of 0.8°) for patients belonging to the treatment group. The mean Constant-Murley Score (CMS) in the treatment group was 76.5 ± 4.3 (baseline 59.5 ± 5.4, a gain of 17.0 from the starting point). The mean Visual Analogue Scale (VAS) was 4.6 ± 0.7 (baseline 8.0 ± 1.1, a reduction of 3.4), and the EuroQol-5 Dimension (EQ-5D) was 70.6 ± 4.3 (baseline 53.7 ± 5.1, a gain of 16.9). For patients in the control group, after 6 months, the mean active ABD was 60.4° ± 4.8 (baseline 58.9° ± 4.8, a gain of 1.5°), the mean INT was 15.3° ± 1.9 (baseline 14.9° ± 2.0, a gain of 0.4°) and the mean EXT was 22.8° ± 2.1 (baseline 23.5° ± 2.9, a gain of 0.6°). The mean CMS was 66.5 ± 4.8 points, (baseline 61.2 ± 4.7, a gain of 5.3). The mean VAS score was 7.2 ± 1.1 (baseline 7.9 ± 1.1, a reduction of 0.7), and the EQ-5D was 62.1 ± 3.8 (baseline 54.9 ± 4.7, a gain of 7.2). At 6 months follow-up, patients treated with HA showed a significant reduction in the level of pain and a significant improvement in their daily activities in comparison with the control group. Conclusion: The present study demonstrates that patients affected by mild-moderate GH OA treated with two intra-articular injections of HA (Hymovis® 24 mg/3 mL) achieved better results for a longer duration, in terms of reduction in shoulder pain and improvement in their daily activities, compared to patients treated with two intra-articular injections of corticosteroids. Clinical Trial Registration: No. NCT06043544. URL: https://clinicaltrials.gov/.