Effect of Transdermal Microneedle Patch Plus Nonsteroidal Anti-Inflammatory Drug in Knee Osteoarthritis: A Randomized, Double-Blind Study

Purpose: No recent clinical study has shown the efficacy of transdermal microneedle patch (TDM) plus nonsteroidal antiinflammatory drug (NSAID) in early knee osteoarthritis (OA). This study aimed to determine the effect of TDM plus NSAID on synovial hypertrophy, knee pain, and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score in osteoarthritic knees. Methods: A randomized, controlled, double-blind trial was conducted. One hundred participants, aged 40–70 years, with painful knee OA and radiographic nonstructural changes were randomly assigned into two groups to undergo TDM plus NSAID (ketorolac 30 mg) or TDM (placebo) at the medial joint line of the knee twice (once weekly). The synovial thickness was measured using ultrasonography at pretreatment, weeks 1, 2, and 4. The visual analog scale (VAS) for pain, WOMAC score, and adverse events (AEs) were also recorded. Results: The TDM plus NSAID group demonstrated a significant reduction in synovial thickness and VAS at weeks 2 and 4 compared with the placebo group (P<0.05). At week 4, the mean synovial thickness reduction was 1.1 and 0.3 mm, and the mean VAS reduction was 3.2 and 1.7 for the TDM plus NSAID and placebo groups, respectively. The mean WOMAC scores at week 4 were significantly reduced (5.7 and 0.9 for the TDM plus NSAID and placebo groups, respectively). No complication and treatment-related AEs occurred. Conclusions: TDM plus NSAID significantly reduced synovitis and improved the pain score in knee OA after 2 weeks. The WOMAC score improved at week 4 without any AEs. Thai Clinical Trials Registry (TCTR), TCTR identification number is TCTR20200613001.