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RECRUITING
NCT05407610
NA

Comparison of Conventional and Cooled Radiofrequency of the Genicular Nerves in Patients With Chronic Knee Pain

Sponsor: Ziekenhuis Oost-Limburg

View on ClinicalTrials.gov

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

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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