Cooled radiofrequency ablation versus cryoneurolysis of the genicular nerves for the symptomatic pain management in knee osteoarthritis: a study protocol of a prospective, randomized, single-blinded clinical trial
Abstract Background Cooled radiofrequency ablation (CRFA) and cryoneurolysis (CRYO) are two novel methods of genicular neurolysis to relief pain in symptomatic knee osteoarthritis (KOA). In this study, the two methods will be compared, giving us the opportunity to investigate their efficacy, safety...
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| Format: | Article |
| Language: | English |
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BMC
2023-04-01
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| Series: | Journal of Orthopaedic Surgery and Research |
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| Online Access: | https://doi.org/10.1186/s13018-023-03737-1 |
| _version_ | 1827966199455023104 |
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| author | A. Panagopoulos P. Tsiplakos K. Katsanos P. Antzoulas J. Lakoumentas |
| author_facet | A. Panagopoulos P. Tsiplakos K. Katsanos P. Antzoulas J. Lakoumentas |
| author_sort | A. Panagopoulos |
| collection | DOAJ |
| description | Abstract Background Cooled radiofrequency ablation (CRFA) and cryoneurolysis (CRYO) are two novel methods of genicular neurolysis to relief pain in symptomatic knee osteoarthritis (KOA). In this study, the two methods will be compared, giving us the opportunity to investigate their efficacy, safety and complications. Methods In this prospective randomized trial 70 patients with KOA will be recruited using a diagnostic block of four genicular nerves. Two groups will be created through software randomization: a CRFA group (35 patients) and a CRYO group (35 patients). The target of the interventions will be four genicular nerves; the superior medial, superior lateral, inferior medial, as well as the medial (retinacular) genicular branch from vastus intermedius. The primary outcome of this clinical trial will be the efficacy of CRFA or CRYO at 2-, 4-, 12-and 24-weeks post-intervention using the Numerical Rating Pain Scale (NRPS). The secondary outcomes are the safety of the two techniques, as well as the clinical evaluation using the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Oxford Knee Score (OKS), and the 7-point scale of Patient Global Impression of Change (PGIC). Discussion These two novel techniques can block pain transmission through genicular nerves in different ways. In contrast to cryoneurolysis, the CRFA method has been well documented in the past. This is the first clinical trial to compare CRFA vs CRYO and draw conclusions about their safety and efficacy. Trial registration ISRCTN87455770 [ https://doi.org/10.1186/ISRCTN87455770 ]. Registered 29/3/2022, first patient recruited 31/8/2022. |
| first_indexed | 2024-04-09T17:46:13Z |
| format | Article |
| id | doaj.art-8d2a3b0424914c29a1c13434bbe4c56c |
| institution | Directory Open Access Journal |
| issn | 1749-799X |
| language | English |
| last_indexed | 2024-04-09T17:46:13Z |
| publishDate | 2023-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Orthopaedic Surgery and Research |
| spelling | doaj.art-8d2a3b0424914c29a1c13434bbe4c56c2023-04-16T11:20:06ZengBMCJournal of Orthopaedic Surgery and Research1749-799X2023-04-0118111210.1186/s13018-023-03737-1Cooled radiofrequency ablation versus cryoneurolysis of the genicular nerves for the symptomatic pain management in knee osteoarthritis: a study protocol of a prospective, randomized, single-blinded clinical trialA. Panagopoulos0P. Tsiplakos1K. Katsanos2P. Antzoulas3J. Lakoumentas4Orthopaedic Department, Patras University Hospital, University of PatrasOrthopaedic Department, Patras University Hospital, University of PatrasDepartment of Interventional Radiology, Patras University Hospital, University of PatrasOrthopaedic Department, Patras University Hospital, University of PatrasDepartment of Medical Physics, School of Medicine, Patras UniversityAbstract Background Cooled radiofrequency ablation (CRFA) and cryoneurolysis (CRYO) are two novel methods of genicular neurolysis to relief pain in symptomatic knee osteoarthritis (KOA). In this study, the two methods will be compared, giving us the opportunity to investigate their efficacy, safety and complications. Methods In this prospective randomized trial 70 patients with KOA will be recruited using a diagnostic block of four genicular nerves. Two groups will be created through software randomization: a CRFA group (35 patients) and a CRYO group (35 patients). The target of the interventions will be four genicular nerves; the superior medial, superior lateral, inferior medial, as well as the medial (retinacular) genicular branch from vastus intermedius. The primary outcome of this clinical trial will be the efficacy of CRFA or CRYO at 2-, 4-, 12-and 24-weeks post-intervention using the Numerical Rating Pain Scale (NRPS). The secondary outcomes are the safety of the two techniques, as well as the clinical evaluation using the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Oxford Knee Score (OKS), and the 7-point scale of Patient Global Impression of Change (PGIC). Discussion These two novel techniques can block pain transmission through genicular nerves in different ways. In contrast to cryoneurolysis, the CRFA method has been well documented in the past. This is the first clinical trial to compare CRFA vs CRYO and draw conclusions about their safety and efficacy. Trial registration ISRCTN87455770 [ https://doi.org/10.1186/ISRCTN87455770 ]. Registered 29/3/2022, first patient recruited 31/8/2022.https://doi.org/10.1186/s13018-023-03737-1Knee osteoarthritisGenicular nervesPainCryoneurolysisCooled radiofrequency ablation |
| spellingShingle | A. Panagopoulos P. Tsiplakos K. Katsanos P. Antzoulas J. Lakoumentas Cooled radiofrequency ablation versus cryoneurolysis of the genicular nerves for the symptomatic pain management in knee osteoarthritis: a study protocol of a prospective, randomized, single-blinded clinical trial Journal of Orthopaedic Surgery and Research Knee osteoarthritis Genicular nerves Pain Cryoneurolysis Cooled radiofrequency ablation |
| title | Cooled radiofrequency ablation versus cryoneurolysis of the genicular nerves for the symptomatic pain management in knee osteoarthritis: a study protocol of a prospective, randomized, single-blinded clinical trial |
| title_full | Cooled radiofrequency ablation versus cryoneurolysis of the genicular nerves for the symptomatic pain management in knee osteoarthritis: a study protocol of a prospective, randomized, single-blinded clinical trial |
| title_fullStr | Cooled radiofrequency ablation versus cryoneurolysis of the genicular nerves for the symptomatic pain management in knee osteoarthritis: a study protocol of a prospective, randomized, single-blinded clinical trial |
| title_full_unstemmed | Cooled radiofrequency ablation versus cryoneurolysis of the genicular nerves for the symptomatic pain management in knee osteoarthritis: a study protocol of a prospective, randomized, single-blinded clinical trial |
| title_short | Cooled radiofrequency ablation versus cryoneurolysis of the genicular nerves for the symptomatic pain management in knee osteoarthritis: a study protocol of a prospective, randomized, single-blinded clinical trial |
| title_sort | cooled radiofrequency ablation versus cryoneurolysis of the genicular nerves for the symptomatic pain management in knee osteoarthritis a study protocol of a prospective randomized single blinded clinical trial |
| topic | Knee osteoarthritis Genicular nerves Pain Cryoneurolysis Cooled radiofrequency ablation |
| url | https://doi.org/10.1186/s13018-023-03737-1 |
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