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Studies

Interventional Recruiting

NCT05407610 on ClinicalTrials.gov

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

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

  • Sponsor: Ziekenhuis Oost-Limburg
  • Collaborators: Belgium Health Care Knowledge Centre, Klinische Epidemiologie en Medical Technology Assessment
  • Enrollment: 400 (Estimated)
  • Study start: 2022-07-07 (Actual)
  • Primary completion: 2025-03-01 (Estimated)
  • Study completion: 2026-09-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Three-arm, pragmatic, prospective, multicentre, double blind, randomised sham-controlled trial
  • Masking: Double (Participant, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Knee Osteoarthritis
  • Persistent Postsurgical Pain
  • Chronic Knee Pain

Intervention / Treatment

  • Procedure: Conventional Radiofrequency ablation of the genicular nerves
  • Procedure: Cooled Radiofrequency ablation of the genicular nerves
  • Procedure: Sham procedure

Primary Outcome Measures

  • The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 6 months post-intervention (6 months post-intervention.)
    The primary endpoint is the WOMAC score (range 0-96) at 6 months post-intervention. The WOMAC score is derived from a self-administered osteoarthritis-specific validated questionnaire on pain, stiffness, and physical functioning of the knee joint.The lower the score, the lower the osteoarthritis-specific symptoms are.

Countries

Belgium, Netherlands

Locations and Investigators

  • UZ Antwerpen, Antwerpen, Belgium (Recruiting)
    • Babak Baheri (Principal Investigator)
  • AZ Klina, Brasschaat, Belgium (Active not recruiting)
  • ULB Erasme, Brussel, Belgium (Recruiting)
  • UCL Saint-Luc, Brussel, Belgium (Active not recruiting)
  • Ziekenhuis Oost-Limburg AV, Genk, Belgium (Recruiting)
    • Thibaut Vanneste (Principal Investigator)
  • AZ Maria Middelares, Gent, Belgium (Recruiting)
    • Pieter Vander Cruysse (Principal Investigator)
  • Jessa Ziekenhuis, Hasselt, Belgium (Recruiting)
    • Michiel Brands (Principal Investigator)
  • AZ Groeninge, Kortrijk, Belgium (Active not recruiting)
  • UZ Leuven, Leuven, Belgium (Recruiting)
    • Bart Morlion (Principal Investigator)
  • CHR de la Citadelle, Liège, Belgium (Recruiting)
    • Caroline Dresse (Principal Investigator)
  • CHU Liège, Liège, Belgium (Active not recruiting)
  • AZ Delta, Roeselare, Belgium (Recruiting)
    • Karel Hanssens (Principal Investigator)
  • AZ Turnhout, Turnhout, Belgium (Recruiting)
    • Christophe Lebrun (Principal Investigator)
  • Rijnstate, Arnhem, Netherlands (Active not recruiting)
  • MUMC, Maastricht, Netherlands (Recruiting)
    • Micha Sommer (Principal Investigator)