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Reg Anesth Pain Med · May 2023
Randomized Controlled Trial Multicenter StudyComparison of cooled versus conventional radiofrequency treatment of the genicular nerves for chronic knee pain: a multicenter non-inferiority randomized pilot trial (COCOGEN trial).
- Thibaut Vanneste, Amy Belba, Jan Willem Kallewaard, van KuijkSander M JSMJDepartment of Clinical Epidemiology & Medical Technology Assessment, Maastricht UMC+, Maastricht, The Netherlands., Marloes Gelissen, Peter Emans, Johan Bellemans, Kristof Smeets, Chris Terwiel, Koen Van Boxem, Micha Sommer, and Jan Van Zundert.
- Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Multidisciplinary Pain Center, Ziekenhuis Oost-Limburg, Genk, Belgium Thibaut.Vanneste@zol.be.
- Reg Anesth Pain Med. 2023 May 1; 48 (5): 197204197-204.
BackgroundRadiofrequency (RF) treatment of the genicular nerves has the potential to reduce chronic knee pain due to osteoarthritis or persistent postsurgical pain, however, a direct comparison between the two main modalities used, conventional and cooled, is lacking.MethodsThis double blind, non-inferiority, pilot, randomized controlled trial compared the effects of cooled and conventional RF in chronic knee pain patients suffering from osteoarthritis or persistent postsurgical pain after total knee arthroplasty. Patients were randomized following a 1:1 rate. The primary outcome was the proportion of patients with ≥50% pain reduction at 3 months postintervention. Other outcomes were knee pain, functionality, quality of life, emotional health, and adverse events up to 6 months postintervention. Conventional RF treatment was tested for non-inferiority to cooled in reducing knee pain at 3 months follow-up.ResultsForty-nine of 70 patients were included, of which 47 completed a 3-month follow-up. The primary outcome was achieved in 4 of 23 patients treated with conventional RF (17%) vs in 8 of 24 with cooled (33%) (p=0,21). Results from the non-inferiority comparison were inconclusive in relation to the non-inferiority margin. There was no statistically significant difference between secondary outcomes. There were no serious adverse events.ConclusionsBoth conventional and cooled RF treatment reduced pain in the osteoarthritis and persistent postsurgical pain population. This pilot study did not demonstrate statistically significant differences in the proportion of patients experiencing ≥50% pain reduction between techniques. The non-inferiority analysis was inconclusive. These results warrant further research.Trial Registration NumberNCT03865849.© American Society of Regional Anesthesia & Pain Medicine 2023. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.
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