Article (Scientific journals)
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, Sander et al.
2023In BMJ Open, 13 (8), p. 073949
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Keywords :
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)
Publication date :
02 August 2023
Journal title :
BMJ Open
eISSN :
2044-6055
Publisher :
BMJ Publishing Group
Volume :
13
Issue :
8
Pages :
e073949
Peer reviewed :
Peer Reviewed verified by ORBi
Funders :
KCE - Belgian Health Care Knowledge Centre [BE]
Funding text :
This study (KCE-201255) is an independent research study funded by the Belgian Health Care Knowledge Centre under the KCE Trials Programme.
Available on ORBi :
since 21 November 2023

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