Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis

研究概要

One hundred and fifty-one patients with pain from knee osteoarthritis (OA) were randomized to receive cooled radiofrequency ablation (CRFA) of the genicular nerves (n=76) or a single intra-articular corticosteroid injection (n=75). The primary outcome of interest was the proportion of patients who reported a 50% or greater reduction in pain score on a Numeric Rating Scale (NRS) from baseline. Secondary outcomes of interest included knee function as measured with the Oxford Knee Score (OKS), patient perception of treatment effect as measured by the Global Perceived Effect (GPE) score, and opioid and non-opioid analgesic use. Outcomes were assessed at 1 month, 3 months, and 6 months post-treatment. Statistically significantly favourable NRS pain scores and OKS pain scores were observed in favour of the CRFA group compared to the corticosteroid group at all time points (p<0.05 for all). As well, 74% of patients in the CRFA group, compared to 16% of patients in the corticosteroid group, reported a 50% or greater improvement from baseline in NRS pain scores at 6 months (p<0.0001). Moreover, GPE scores were statistically significantly in favour of the CRFA group at 3 and 6 months post-treatment (p<0.0001 for both). Mean daily opioid consumption was not statistically significantly different between groups (p>0.05 for all); however, the change in non-opioid drug use at 6 months was statistically significantly in favour of the CRFA group (p=0.02). Finally, 61 and 65 adverse events were reported in the CRFA and corticosteroid group, respectively.