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Rehabilitation Practice and Science

Translated Title

使用客觀超音波量測之指標及主觀式自填式量表評估新型單針劑型玻尿酸用於膝退化性關節炎之療效:初步報告

Abstract

Purpose: Osteoarthritis (OA) is the most common musculoskeletal disease worldwide. Knee OA is the most common type of OA and is the main cause of disability in elderly people. Intra-articular (IA) injection of hyaluronic acid (HA) has been widely proven to improve pain, physical function, and quality of life among patients with knee OA. However, most of the previous studies have used low-to-moderate molecular weight (MW) HA and have evaluated the clinical benefits by using subjective self-reported measures. In this study, we evaluated the efficacy of a single IA injection of a novel cross-linked HA (HYAJOINT Plus) through objective ultrasonographic assessment of the thickness of quadriceps and femoral intercondylar cartilage (FIC) in addition to subjective self-reported measures. Methods: In this prospective trial with 6-month follow-up, 39 patients with knee OA (Kellgren-Lawrence grades 1 to 3) were recruited from a single medical center. These patients received one IA injection of 3 mL HYAJOINT Plus (20 mg/mL). All patients were assessed at baseline and 1, 3 and 6-months after HA injection. The outcome measures were (1) Visual Analog Scale for pain (VAS Pain); (2) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which generates three subscale scores (pain, stiffness, and physical function) and a total score; (3) Lequesne's Index, (4) thigh circumference at the injected knee site, (5) thickness of quadriceps under ultrasonography, and (6) thickness of FIC under ultrasonography. Results: A total of 37 patients completed the 6-month follow-up. One-way repeated measure analysis of variance revealed that compared with the baseline, VAS Pain, WOMAC, Lequesne's index, thigh circumference, ultrasonographic thickness of quadriceps and FIC improved significantly after HA injection by using one-way repeated measure ANOVA (p < 0.001 for all). Post-hoc analysis revealed the following results. First, compared with the baseline, VAS Pain and WOMAC-pain subscale score improved significantly 1, 3, and 6 months after HA injection (VAS Pain: p <0.001, <0.001, and <0.001 and WOMAC-pain subscale score: p =0.009, <0.001, and <0.001, respectively). Second, WOMAC-physical function subscale score, WOMAC-total score, and ultrasonographic thickness of quadriceps and FIC improved significantly 3 and 6 months after HA injection (WOMAC-physical function subscale score: p=0.004 and <0.001; WOMAC-total score: p=0.001 and <0.001; quadriceps thickness: p<0.001 and <0.001; and FIC thickness: p=0.002 and 0.039, respectively). Third, compared with the baseline, WOMAC-stiffness subscale scores, Lequesne's index, and thigh circumference improved significantly 6 months after HA injection (p=0.01, 0.008, and 0.009, respectively). No serious adverse events occurred following injections. Conclusion: A single IA injection of a novel cross-linked HA, HYAJOINT Plus, is effective and safe for 6 months in patients with knee OA. This study demonstrated the clinical benefits of HYAJOINT Plus through not only subjective self-reported measures but also objective measures comprising thigh circumference, and ultrasonographic thickness of quadriceps and FIC.

Language

Traditional Chinese

First Page

81

Last Page

92

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