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Comparison of Conventional and Cooled Radiofrequency of the Genicular Nerves in Patients With Chronic Knee Pain
Sponsor: Ziekenhuis Oost-Limburg
Summary
Chronic knee pain remains a disabling disease despite current treatment strategies. There is an increase in the prevalence of osteoarthritis (OA) of the knee in the general population, presently affecting approximately 450,000 individuals in Belgium. A total knee replacement is a viable alternative for severe knee OA that does not respond to conservative therapy. Unfortunately, up to 53% of patients who undergo a total knee replacement develop persistent post-surgical pain (PPSP). There is currently no effective therapy for PPSP. A radiofrequency (RF) treatment applies high frequency current on the nerve responsible for pain conduction, resulting in an interruption of the transmission of pain. This can be applied to the nerves innervating the knee joint - the superolateral, superomedial and inferomedial genicular nerves - and could be an alternative, minimally invasive treatment for patients with knee OA who fail conservative treatments and for patients with PPSP. Data from the recent literature indicates that this treatment leads to a reduction of pain intensity and could result in an improvement of knee function, of the psychological state of the individual, and finally in an increase in health-related quality of life. Furthermore, RF of the genicular nerves could help avoid or delay a total knee replacement therefore potentially contributing to cost reduction. Both cooled and conventional RF treatments are reported in the literature to improve pain. The use of water to cool the RF electrodes results in an increased lesion size by removing heat from adjacent tissue, allowing power delivery to be increased. As a consequence, cooled RF could result in a higher chance of success and longer duration of effect. Until now, the studies performed on cooled RF are industry initiated and a direct comparison between conventional, cooled and a sham procedure is lacking. The aim of the COGENIUS trial is to investigate the effect of the two types of RF treatment on individuals experiencing chronic knee pain that is resistant to conservative treatments. For this purpose, the efficacy and cost-effectiveness of cooled and conventional RF will be compared to a sham procedure in patients suffering from knee OA and PPSP after total knee replacement.
Official title: Comparison of Conventional and Cooled Radiofrequency Treatment of the Genicular Nerves Versus Sham Procedure for Patients With Chronic Knee Pain: a Multicentre, Double Blind, Randomised Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2022-07-07
Completion Date
2026-09-01
Last Updated
2023-05-24
Healthy Volunteers
No
Interventions
Conventional Radiofrequency ablation of the genicular nerves
Conventional Radiofrequency treatment of the genicular nerves of the knee blocks the transmission of painful stimuli from the sensory genicular nerves of the knee to the central nervous system by means of a thermal lesion created using RF current.
Cooled Radiofrequency ablation of the genicular nerves
Cooled RF treatment causes a larger lesion size compared to conventional RF by means of internal cooling of the probe.
Sham procedure
Sham procedure with placing of needles subcutaneously.
Locations (15)
UZ Antwerpen
Antwerp, Belgium
AZ Klina
Brasschaat, Belgium
ULB Erasme
Brussels, Belgium
UCL Saint-Luc
Brussels, Belgium
Ziekenhuis Oost-Limburg AV
Genk, Belgium
AZ Maria Middelares
Ghent, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
AZ Groeninge
Kortrijk, Belgium
UZ Leuven
Leuven, Belgium
CHR de la Citadelle
Liège, Belgium
CHU Liège
Liège, Belgium
AZ Delta
Roeselare, Belgium
AZ Turnhout
Turnhout, Belgium
Rijnstate
Arnhem, Netherlands
MUMC
Maastricht, Netherlands