Comparison of Conventional and Cooled Radiofrequency Treatment of the Genicular Nerves Versus Sham Procedure for Patients With Chronic Knee Pain

What this Trial Is About

Researchers are investigating two types of radiofrequency (RF) treatments for people with chronic knee pain due to osteoarthritis (OA) or persistent pain after total knee replacement surgery. This condition affects many individuals, and current treatments do not always relieve the pain. The trial aims to compare the effectiveness and cost-effectiveness of conventional RF, cooled RF, and a sham procedure in reducing pain and improving quality of life over two years. The study includes three groups: one receiving conventional RF treatment where heat is applied at 80°C for 90 seconds to specific knee nerves; another receiving cooled RF treatment that uses cooled probes to create larger lesions at around 60°C to 80°C for 150 seconds; and a sham group where needles are placed but no actual RF energy is delivered. Before randomization, participants undergo a 1 to 3 month run-in period to ensure optimal conservative treatment. Patients are then followed for two years to assess outcomes. Participants will have multiple assessments including pain intensity, knee function, quality of life, psychological status, medication use, and physical tests at intervals up to 24 months after treatment. Researchers will monitor for adverse events and healthcare use throughout the study. The main outcome is measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at six months post-treatment, with ongoing evaluations to understand long-term effects and safety.

Comparison of Conventional and Cooled Radiofrequency of the Genicular Nerves in Patients With Chronic Knee Pain