NCT03865849

Cocogen Trial: COoled Versus COnventional Radiofrequency Treatment of the GENicular Nerves for Chronic Knee Pain

Comparison of Cooled Versus Conventional Radiofrequency Treatment of the Genicular Nerves for Chronic Knee Pain: a Multicentre Randomised Controlled Non-inferiority Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Ziekenhuis Oost-Limburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Knee osteoarthritis is a progressive degenerative process that affects joint cartilage and the subchondral bone. Approximately 10% to 30% of all osteoarthritis patients suffer from disabling symptoms such as pain, stiffness and loss of function leading to psychological and sleeping disorders and a diminished quality of life. When conservative treatment fails to treat the symptoms, a total knee arthroplasty can be performed. However, this procedure is not suitable for all patients. For these specific groups of patients a radiofrequent treatment of the genicular nerves might be an alternative treatment option. Multiple researchers investigated the effect of conventional and later also, cooled radiofrequent treatment of the genicular nerves, with promising results for both techniques. However, the techniques have never been compared in a randomised controlled trial. This study is designed to assess the feasibility of conducting a large RCT comparing pain relief and costs after a conventional radiofrequency treatment of the genicular nerves (superomedial, superolateral and inferomedial) versus a cooled radiofrequency treatment.

Detailed description

This pilot study is designed as a prospective, multicentre, double blind, randomised controlled non-inferiority trial. The total follow up time is 6 months with follow up assessments at 1, 3 and 6 months post intervention. It is estimated that the total duration of data collection will cover 1 year. Adult patients (\> 18 years) with chronic, moderate to severe knee pain (NRS\>4) due to osteoarthritis, radiological diagnosed to be graded 2-4 according to the Kellgren-Lawrence criteria or with persistent postoperative moderate to severe knee pain (NRS\>4) after total knee arthroplasty can be included in the study. Patients will be randomly selected for treatment with conventional radiofrequent treatment or cooled radiofrequent treatment of the SL, SM and IL genicular nerves. In total, three hospitals participate in this study: Ziekenhuis Oost-Limburg (Belgium), Maastricht UMC+ (Netherlands) and Rijnstate (Netherlands).

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Cooled radiofrequent treatment	In the cooled radiofrequency group a treatment of 60°C measured at the tip and on average 80°C in the targeted tissue is applied during 150 seconds using the Coolief system.
DEVICE	Conventional radiofrequent treatment	In the conventional radiofrequency group a treatment of 80°C at the tip is applied during 90 seconds at each nerve.

Timeline

• Start date: 2020-02-02
• Primary completion: 2021-07-28
• Completion: 2021-10-28
• First posted: 2019-03-07
• Last updated: 2023-04-13

Locations

3 sites across 2 countries: Belgium, Netherlands