Prospective, Multi-center, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation to Corticosteroid Injection in the Management of Osteoarthritic Knee Pain
Tim Davis MD1, Eric Loudermilk MD2, Michael DePalma MD3, Corey Hunter MD4, David Lindley DO5, Nilesh Patel MD6, Daniel Choi MD7, Marc Soloman MD8, Anita Gupta DO, PharmD9, Asokumar Buvanendran MD10, Mehul Desai MD11, Leonardo Kapural MD, PhD12
Chronic knee pain from osteoarthritis (OA) is a significant cause of disability in the aging patient population. Cooled radiofrequency ablation (CRFA) has emerged as a minimally invasive option for pain control for these patients.
Materials & Methods
After IRB approval was obtained, 151 patients were consented and underwent diagnostic block injections at 3 locations. Patients who had ≥ 50% pain relief from the blocks were randomized to receive either CRFA (n=67) or a single IAS injection (n=71). Patients were evaluated at 1, 3, and 6 months.
The groups were homogenous at baseline. At 6 months, in the CRFA group (n = 58), 74.1% (95% CI:62.8,85.4) of patients had ≥ 50% reduction in NRS pain score compared to 16.2% (95% CI:7.4,25.0) in the IAS group (n=68) (p < 0.0001). Mean NRS scores dropped from 7.3 ± 1.2 (Mean ± SD) at BL to 2.5 ± 2.3 for the CRFA group whereas, the IAS group changed from 7.2 ± 1.0 to 5.9 ± 2.2 (p < 0.0001). and Global Perceived Effect also showed statistical improvements. No serious adverse events related to either procedure were noted, and overall adverse event profiles were similar.
These results demonstrate that CRFA is a safe and effective treatment in managing pain and improving function and quality of life for patients suffering from painful knee OA. CRFA treated patients demonstrated a significant improvement in both pain relief and overall function when compared to patients treated with IAS.