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

CompletedNot applicableNCT03865849
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Comparison of Cooled Versus Conventional Radiofrequency Treatment of the Genicular Nerves for Chronic Knee Pain: a Multicentre Randomised Controlled Non-inferiority Pilot Trial
Interventions
  • Device: Cooled radiofrequent treatment
  • Device: Conventional radiofrequent treatment
Sponsor
Ziekenhuis Oost-Limburg
Collaborators
Rijnstate Hospital; Maastricht University Medical Center
Start date
2020-02-02
Primary completion
2021-07-28
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Belgium, Netherlands
Total sites listed
3

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age ≥ 18 years * Able to understand the informed consent form and provide written informed consent and able to complete outcome measures. * Chronic anterior knee pain (\> 12 months) with an NRS \> 4 on most or all days for the index knee either constantly or with motion. * Unresponsive to conventional treatments continued during 12 months including physiotherapy, oral analgesics or intra-articular infiltrations. * Radiologic confirmation of arthritis of OA grade of 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee according the Kellgren Lawrence criteria (27) diagnosed by an independent radiologist with experience in musculoskeletal imaging or patients with total knee arthroplasty of the index knee with a negative orthopaedic workout. * Other therapies (including surgical interventions) for pain in the index knee are allowed for the period of the study follow up as long as they are documented. This is necessary to correctly estimate the costs in the cost effectiveness analyses. Allowing patients to receive additional treatments will also improve the protocol compliance. * Agree to provide informed consent and to comply with the requirements of this protocol for the full duration of the study Exclusion Criteria: * Patient refusal to comply to protocol procedures or schedule * Local or systemic infection (bacteraemia) * Evidence of inflammatory arthritis or an inflammatory systemic disease responsible for knee pain * Intra-articular injections (steroids, hyaluronic acid, platelet enriched plasma, …) in the index knee during the 3 months prior to procedure * Body mass index (BMI) \> 40 kg/m2 * Pregnant, nursing or planning to become pregnant Chronic widespread pain before the treatment * Patients with psychosocial dysfunction will be referred for further psychological follow up prior to possible inclusion * Allergies to products used during the procedure * Uncontrolled coagulopathy defined as supratherapeutic dose of anticoagulation medication. * Uncontrolled immune suppression * Participating in another clinical trial/investigation within 30 days prior to signing informed consent * Patient is currently implanted with a defibrillator, neuromodulator or other electrical devices * Radicular pain in index leg * Patient received previous conventional or cooled radiofrequency of the index knee

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03865849