Comparison of conventional and cooled radiofrequency treatment of the genicular nerves versus sham procedure for patients with chronic knee pain: protocol for a multicentre, double-blind, randomised controlled trial (COGENIUS)
Vanneste, Thibaut; Belba, Amy; Van Kuijk, Sanderet al.
chronic pain; knee; pain management; Humans; Knee Joint; Multicenter Studies as Topic; Osteoarthritis, Knee; Pain, Postoperative; Quality of Life; Randomized Controlled Trials as Topic; Treatment Outcome; Medicine (all); General Medicine
Abstract :
[en] Introduction The prevalence of chronic knee pain is increasing. Osteoarthritis (OA) and persistent postsurgical pain (PPSP) are two important causes of knee pain. Chronic knee pain is primarily treated with medications, physiotherapy, life-style changes and intra-articular infiltrations. A radiofrequency treatment (RF) of the genicular nerves is a therapeutical option for refractory knee pain. This study investigates the effectiveness and cost-effectiveness of conventional and cooled RF in patients suffering from chronic, therapy resistant, moderate to severe knee pain due to OA and PPSP. Methods and analysis The COGENIUS trial is a double-blinded, randomised controlled trial with 2-year follow-up. Patients and outcome assessors are blinded. Patients will be recruited and treated in Belgium and the Netherlands. All PPSP after a total knee prothesis and OA patients (grades 2-4) will undergo a run-in period of 1-3 months where conservative treatment will be optimised. After the run-in period, 200 patient per group will be randomised to conventional RF, cooled RF or a sham procedure following a 2:2:1 ratio. The analysis will include a comparison of the effectiveness of each RF treatment with the sham procedure and secondarily between conventional and cooled RF. All comparisons will be made for each indication separately. The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis Index score at 6 months. Other outcomes include knee pain, physical functionality, health-related quality of life, emotional health, medication use, healthcare and societal cost and adverse events up to 24 months postintervention. Ethics and dissemination Ethics approval was obtained from the Ethics Committee of the University of Antwerp (Number Project ID 3069-Edge 002190-BUN B3002022000025), the Ethics committee of Maastricht University (Number NL80503.068.22-METC22-023) and the Ethics committee of all participating hospitals. Results of the study will be published in international peer-reviewed journals. Trial registration number NCT05407610.
Disciplines :
Anesthesia & intensive care
Author, co-author :
Vanneste, Thibaut ; Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Multidisciplinary Pain Center, Ziekenhuis Oost-Limburg, Genk, Belgium ; Department of Anesthesiology and Pain Medicine, Maastricht University Medical Center+, Maastricht, Netherlands
Belba, Amy; Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Multidisciplinary Pain Center, Ziekenhuis Oost-Limburg, Genk, Belgium ; Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium
Van Kuijk, Sander ; Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center+, Maastricht, Netherlands
Kimman, Merel; Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center+, Maastricht, Netherlands
Bellemans, Johan; Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium ; Grit Belgian Sports Clinic, Leuven, Belgium
Bonhomme, Vincent ; Centre Hospitalier Universitaire de Liège - CHU > > Service d'anesthésie - réanimation
Sommer, Micha; Department of Anesthesiology and Pain Medicine, Maastricht University Medical Center+, Maastricht, Netherlands
Emans, Pieter; Department of Orthopaedic Surgery, Caphri School for Public Health and Primary Care, Maastricht University Medical Center+, Maastricht, Netherlands
Vankrunkelsven, Patrik; Department of Public Health and Primary Care, Catholic University of Leuven Faculty of Medicine, Leuven, Belgium ; Cebam (Belgian Centre for Evidence-Based Medicine), Leuven, Belgium
Tartaglia, Katrien; Clinical Trial Unit, Ziekenhuis Oost-Limburg, Genk, Belgium
Van Zundert, Jan; Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Multidisciplinary Pain Center, Ziekenhuis Oost-Limburg, Genk, Belgium ; Department of Anesthesiology and Pain Medicine, Maastricht University Medical Center+, Maastricht, Netherlands
Language :
English
Title :
Comparison of conventional and cooled radiofrequency treatment of the genicular nerves versus sham procedure for patients with chronic knee pain: protocol for a multicentre, double-blind, randomised controlled trial (COGENIUS)
Treede R-D, Rief W, Barke A, et al. Chronic pain as a symptom or a disease: the IASP classification of chronic pain for the International classification of diseases (ICD-11). Pain 2019;160:19-27.
Safiri S, Kolahi A-A, Smith E, et al. Global, regional and national burden of osteoarthritis 1990-2017: a systematic analysis of the global burden of disease study 2017. Ann Rheum Dis 2020;79:819-28.
Kennedy S, Tambiah JRS, Lane NE. Osteoarthritis today: lost in translation. Best Pract Res Clin Rheumatol 2022;36:101810.
Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: part I. Casp J Intern Medicine 2011;2:205-12.
National Clinical Guideline Centre (UK). Osteoarthritis: Care and Management in Adults. London: National Institute for Health and Care Excellence (UK), 2014.
Vergne-Salle P. Management of neuropathic pain after knee surgery. Joint Bone Spine 2016;83:657-63.
Willinger ML, Heimroth J, Sodhi N, et al. Management of refractory pain after total joint replacement. Curr Pain Headache Rep 2021;25:42.
Loeser RF, Goldring SR, Scanzello CR, et al. Osteoarthritis: A disease of the joint as an organ. Arthritis & Rheumatism 2012;64:1697-707. 10.1002/art.34453 Available: http://doi.wiley.com/10.1002/art.v64.6
Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet 2019;393:1745-59.
Kulkarni K, Karssiens T, Kumar V, et al. Obesity and osteoarthritis. Maturitas 2016;89:22-8.
Block JA, Cherny D. Management of knee osteoarthritis: what internists need to know. Rheum Dis Clin North Am 2022;48:549-67.
Bannuru RR, Osani MC, Vaysbrot EE, et al. OARSI guidelines for the non-surgical management of knee, hip, and Polyarticular osteoarthritis. Osteoarthritis Cartilage 2019;27:1578-89.
Kolasinski SL, Neogi T, Hochberg MC, et al. 2019 American college of rheumatology/arthritis foundation guideline for the management of osteoarthritis of the hand, hip, and knee. Arthritis Rheumatol 2020;72:220-33.
Weinstein AM, Rome BN, Reichmann WM, et al. Estimating the burden of total knee replacement in the United States. J Bone Joint Surg Am 2013;95:385-92.
Gunaratne R, Pratt DN, Banda J, et al. Patient dissatisfaction following total knee Arthroplasty: A systematic review of the literature. J Arthroplasty 2017;32:3854-60.
Wylde V, Bruce J, Beswick A, et al. Assessment of chronic Postsurgical pain after knee replacement: A systematic review. Arthritis & Rheumatism 2013;65:1795-803. 10.1002/acr.22050 Available: https://onlinelibrary.wiley.com/toc/21514658/65/11
Conaghan PG, Peloso PM, Everett SV, et al. Inadequate pain relief and large functional loss among patients with knee osteoarthritis: evidence from a prospective multinational longitudinal study of osteoarthritis real-world therapies. Rheumatology (Oxford) 2015;54:270-7.
Hunter DJ, Schofield D, Callander E. The individual and socioeconomic impact of osteoarthritis. Nat Rev Rheumatol 2014;10:437-41.
Kingsbury SR, Gross HJ, Isherwood G, et al. Osteoarthritis in Europe: impact on health status, work productivity and use of Pharmacotherapies in five European countries. Rheumatology 2014;53:937-47.
Bhatia A, Peng P, Cohen SP. Cohen SP.Radiofrequency procedures to relieve chronic knee pain an evidence-based narrative review. Reg Anesth Pain Med 2016;41:501-10.
Bistolfi A, Zorzolo I, Rold I, et al. Radiofrequencies for painful total knee Arthroplasty: rationale and applications. Phys Med Rehabil Res 2017;2.
Kim PY, Cohen SP. Genicular nerve blocks and radiofrequency ablation for knee osteoarthritis: more nerves, more questions. Pain Med 2021;22:1019-21.
Fonkoué L, Behets C, Kouassi J-ÉK, et al. Distribution of sensory nerves supplying the knee joint capsule and implications for Genicular blockade and radiofrequency ablation: an anatomical study. Surg Radiol Anat 2019;41:1461-71.
Prabjit A, Lenny R, Anuj B, et al. Radiofrequency procedures for the treatment of symptomatic knee osteoarthritis: a systematic review. Pain Med 2020;21:333.
Huang Y, Deng Q, Yang L, et al. Efficacy and safety of ultrasound-guided radiofrequency treatment for chronic pain in patients with knee osteoarthritis: A systematic review and meta-analysis. Pain Res Manag 2020;2020:2537075.
Chou S-H, Shen P-C, Lu C-C, et al. Comparison of efficacy among three radiofrequency ablation techniques for treating knee osteoarthritis: A systematic review and meta-analysis. IJERPH 2021;18:7424.
Chen AF, Mullen K, Casambre F, et al. Thermal nerve radiofrequency ablation for the Nonsurgical treatment of knee osteoarthritis: A systematic literature review. J Am Acad Orthop Surg 2021;29:387-96.
Cheppalli N, Bhandarkar AW, Sambandham S, et al. Safety and efficacy of Genicular nerve radiofrequency ablation for management of painful total knee replacement: A systematic review. Cureus 2021;13:e19489.
Vanneste T, Belba A, Kallewaard JW, et al. Comparison of cooled versus conventional radiofrequency treatment of the Genicular nerves for chronic knee pain: a multicenter non-inferiority randomized pilot trial (COCOGEN trial). Reg Anesth Pain Med 2023;48:197-204.
Kapural L, Minerali A, Sanders M, et al. Cooled radiofrequency ablation provides prolonged pain relief compared to traditional radiofrequency ablation: A real-world, large retrospective clinical comparison from a single practice. J Pain Res 2022;15:2577-86.
Choi W-J, Hwang S-J, Song J-G, et al. Radiofrequency treatment relieves chronic knee osteoarthritis pain: A double-blind randomized controlled trial. Pain 2011;152:481-7.
Chan AW, Tetzlaff JM, Altman DG. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Revista Panam De Salud Publica Pan Am J Public Heal 2015;38:506-14.
Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials 2004;25:143-56.
Bang H. Random guess and wishful thinking are the best blinding scenarios. Contemp Clin Trials Commun 2016;3:117-21.
Fonkoue L, Stoenoiu MS, Behets CW, et al. Validation of a new protocol for ultrasound-guided Genicular nerve radiofrequency ablation with accurate anatomical targets: Cadaveric study. Reg Anesth Pain Med 2021;46:210-6.
Smith T, Conaghan PG, OMERACT-OARSI Hip and Knee Osteoarthritis Update Working Group. The OMERACT-OARSI Core domain set for measurement in clinical trials of hip and/or knee osteoarthritis. Rheumatology 2019;58:981-9.
Dworkin RH, Turk DC, Peirce-Sandner S, et al. Research design considerations for Confirmatory chronic pain clinical trials: IMMPACT recommendations. Pain 2010;149:177-93.
Collins NJ, Misra D, Felson DT, et al. Measures of knee function: International knee documentation Committee (IKDC) subjective knee evaluation form, knee injury and osteoarthritis outcome score (KOOS), knee injury and osteoarthritis outcome score physical function short form (KOOS-PS). Arthritis Care Res 2011;63:S208-28. 10.1002/acr.20632 Available: http://doi.wiley.com/10.1002/acr.v63. 11s
Haefeli M, Elfering A. Pain assessment. Eur Spine J 2006;15:S17-24.
Bilbao A, García-Pérez L, Arenaza JC, et al. Psychometric properties of the EQ-5D-5L in patients with hip or knee osteoarthritis: reliability, validity and responsiveness. Qual Life Res 2018;27:2897-908.
Steffen TM, Hacker TA, Mollinger L. Age-and gender-related test performance in community-dwelling elderly people: six-minute walk test, Berg balance scale, timed up & go test, and gait speeds. Phys Ther 2002;82:128-37.
Smarr KL, Keefer AL. Measures of depression and depressive symptoms. Arthritis Care Res 2020;72:608-29. 10.1002/acr.24191 Available: https://onlinelibrary.wiley.com/toc/21514658/72/S10
Ikemoto T, Hayashi K, Shiro Y, et al. A systematic review of Cross-Cultural validation of the pain Catastrophizing scale. Eur J Pain 2020;24:1228-41.
Ferguson L, Scheman J. Patient global impression of change scores within the context of a chronic pain rehabilitation program. The Journal of Pain 2009;10:S73.
Gallizzi M, Gagnon C, Harden RN, et al. Medication Quantification scale version III: internal validation of detriment weights using a chronic pain population. Pain Practice 2008;8:1-4. 10.1111/j.1533-2500.2007.00163.x Available: http://www.blackwell-synergy.com/toc/ ppr/8/1
Bouwmans C, Roijen L, Koopmanschap MA, et al. Handleiding iMTA medical cost questionnaire (iMCQ). 2013.
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 1993;4:353-65.
Chow S-C, Wang H, Shao J. Sample Size Calculations in Clinical Research. Chapman & Hall/CRC Biostatistics Series, 2003.
Cleemput I, Neyt M, Sande S, et al. Belgische Richtlijnen Voor Economische Evaluaties en budget impact analyses: Tweede Editie. KCE report 183A D/2012/10273/52. Health Technology Assessment (HTA) 2012.
Paulden M. Calculating and interpreting Icers and net benefit. Pharmacoeconomics 2020;38:785-807.
Kapural L, Mekhail N. Radiofrequency ablation for chronic pain control. Curr Pain Headache Rep 2001;5:517-25.
McCormick ZL, Reddy R, Korn M, et al. A prospective randomized trial of Prognostic Genicular nerve blocks to determine the predictive value for the outcome of cooled radiofrequency ablation for chronic knee pain due to osteoarthritis. Pain Med 2018;19:1628-38.
Sar S, Aydn ON, Turan Y, et al. Which one is more effective for the clinical treatment of chronic pain in knee osteoarthritis: radiofrequency Neurotomy of the Genicular nerves or Intra-Articular injection Int J Rheum Dis 2018;21:1772-8.
Qudsi-Sinclair S, Borrás-Rubio E, Abellan-Guillén JF, et al. A comparison of Genicular nerve treatment using either radiofrequency or analgesic block with corticosteroid for pain after a total knee Arthroplasty: A double-blind, randomized clinical study. Pain Pract 2017;17:578-88.
El-Hakeim EH, Elawamy A, Kamel EZ, et al. Fluoroscopic guided radiofrequency of Genicular nerves for pain alleviation in chronic knee osteoarthritis: A single-blind randomized controlled trial. Pain Physician 2018;21:169-77.
Chen Y, Vu T-NH, Chinchilli VM, et al. Clinical and technical factors associated with knee radiofrequency ablation outcomes: A multicenter analysis. Reg Anesth Pain Med 2021;46:298-304.
Fonkoue L, Steyaert A, Kouame J-EK, et al. A comparison of Genicular nerve blockade with corticosteroids using either classical anatomical targets vs revised targets for pain and function in knee osteoarthritis: A double-blind, randomized controlled trial. Pain Med 2021;22:1116-26.
