Cooled Radiofrequency Ablation Compared with a Single Injection of Hyaluronic Acid for Chronic Knee Pain: A Multicenter, Randomized Clinical Trial Demonstrating Greater Efficacy and Equivalent Safety for Cooled Radiofrequency Ablation.

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研究概要

One hundred and seventy-seven patients with chronic knee pain from knee osteoarthritis (OA) were randomized to receive cooled radiofrequency ablation (CRFA; n=89) of the genicular nerves or a single intra-articular hyaluronic acid (HA; n=88). The primary outcome of interest was the number of patients who reported a =>50% reduction in pain scores from baseline after 6 months. Additional outcomes of interest included pain scores on a Numeric Rating Scale (NRS), the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, WOMAC pain scores, WOMAC physical function scores, WOMAC stiffness scores, patient perception of treatment effect as reflected by the Global Perceived Effect (GPE) score, the Euro-Qol-5 Dimensions-5 Level (EQ-5D-5L) quality of life questionnaire, and the incidence of treatment-related and non-treatment related adverse events. Outcomes were assessed at 1, 3, and 6 months post-treatment. Results revealed a statistically significantly higher proportion of patients in the CRFA group who reported =>50% improvement in pain scores from baseline compared to the HA group (71% vs. 38%, p<0.0001). NRS pain scores, WOMAC total scores, WOMAC pain scores WOMAC physical function scores, GPE scores, and EQ-5D-5L scores were statistically significantly in favour of the CRFA group at all time points compared to the HA group (p<0.05 for all). WOMAC stiffness scores were statistically significantly in favour of the CRFA group at 3 months (p=0.0022) and 6 months (p<0.0001) post-treatment. The incidence of both treatment-related (18 vs 9) and non-treatment related (76 vs 54) adverse events were higher in the CRFA group, with the majority of adverse events being musculoskeletal in nature.