Efficacy and Safety of Cryoablation Compared with Cooled Radiofrequency Ablation of Genicular Nerves in Advanced Osteoarthritis of the Knee: A Study Protocol of Single-Centric, Assessor-Blinded, Randomized, Parallel-Group, Non-inferiority Study.

Autor: Das G; Department of Pain Medicine, Daradia: The Pain Clinic, Kolkata, West Bengal, 700067, India., Singam A; Department of Anesthesia & Pain Medicine, JNMC, Wardha, Maharashtra, 442005, India., Chakole V; Department of Anesthesia & Pain Medicine, JNMC, Wardha, Maharashtra, 442005, India., Das S; Department of Pain Medicine, Daradia: The Pain Clinic, Kolkata, West Bengal, 700067, India., Sharma V; Department of Academic Research, Maverick Medicorum®, 601, Shiv Ganga Apartment, Beltarodi, Nagpur, Maharashtra, 440034, India. dr.vikassharma31@gmail.com.
Jazyk: angličtina
Zdroj: Cardiovascular and interventional radiology [Cardiovasc Intervent Radiol] 2024 Apr; Vol. 47 (4), pp. 508-514. Date of Electronic Publication: 2024 Mar 25.
DOI: 10.1007/s00270-024-03703-2
Abstrakt: Purpose: In patients with symptomatic osteoarthritis knee (OAK), cryoneurolysis (CRYO) and cooled radiofrequency ablation (C-RFA) are reported to be effective and safe; however, they have not been compared directly. The objective of this study is to compare CRYO and C-RFA of the genicular nerve (GN) in terms of efficacy and safety profile in patients with Kellgren and Lawrence (KL) grade ≥ 3 OAK.
Methods: This single-centric, assessor-blinded, randomized, parallel-group, non-inferiority study will include 80 patients with KL grade ≥ 3 OAK. The patients with ≥ 50% pain relief on diagnostic block of three GNs will be randomized to one of the two groups, i.e., CRYO (n = 40) or C-RFA (n = 40). The three target GNs for the interventions will include: superior medial, superior lateral, and inferior medial. The primary outcome will be efficacy of CRYO or C-RFA at 2, 12, and 24 weeks post-procedure based on the 11-point Numerical Pain Rating Scale. The secondary outcomes will be functional improvement based on 12-item Oxford Knee Score and safety of both the procedures. The study is registered in the Clinical Trials Registry-India.
Conclusion: CRYO and C-RFA provide pain relief and improve functional outcome by preventing transmission of pain signals, though by distinct mechanisms. While C-RFA is an established treatment modality, recent evidence supports CRYO in patients with OAK. This study intends to demonstrate non-inferiority of CRYO against C-RFA, thereby supporting the use of CRYO as an additional treatment modality in patients with KL grade ≥ 3 OAK.
(© 2024. Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).)
Databáze: MEDLINE
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