Comparison of Conventional and Cooled Radiofrequency of the Genicular Nerves in Patients With Chronic Knee Pain (COGENIUS)
Knee Osteoarthritis, Persistent Postsurgical Pain, Chronic Knee Pain
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Persistent Postsurgical Pain, Knee, Radiofrequency ablation
Eligibility Criteria
Inclusion Criteria:
- Signed written informed consent must be obtained before any study assessment is performed.
- Adult patients (Age ≥ 18 years old).
- Chronic anterior knee pain (> 12 months) that is moderate to severe (defined as NRS > 4 on most or all days for the index knee either constantly or with motion at time of screening and, an average NRS score reported in the patient diary >4 at the end of the run-in period).
- Unresponsive (meaning insufficient pain reduction or intolerance) to conventional treatments ongoing for at least 12 months prior to inclusion. Conventional treatments must include all of the following: active physiotherapy, pharmacological treatment of pain and intra-articular corticosteroid infiltration.
- Only for patients with Osteoarthritis (OA): Radiologic confirmation of knee osteoarthritis of grade 2 (mild), 3 (moderate) or 4 (severe) noted within 12 months prior to the screening for the index knee according the Kellgren Lawrence criteria diagnosed by an independent radiologist with experience in musculoskeletal imaging on radiography (Rx) or magnetic resonance imaging (MRI). If imaging will need to be performed at screening it is recommended to perform an MRI instead of Rx. Imaging with MRI will enable the independent radiologist to perform a better estimation of the grade of OA.
- Only for patients with Persistent Post-Surgical Pain (PPSP) after Total Knee Arthroplasty (TKA): Patients with PPSP* after TKA need to have had a negative orthopaedic work-up
Exclusion Criteria:
- 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.
- Pregnant, nursing or planning to become pregnant before the study intervention. Participants who become pregnant after the study intervention during the follow-up period will not be excluded.
- Chronic widespread pain.
- Patients with unstable psychosocial disorder.
- Allergies to products used during the procedure (lidocaine, propofol, chlorhexidine).
- 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 neurostimulator.
- Current radicular pain in index leg.
- Previous conventional or cooled radiofrequency of the index knee.
- Patients with bilateral knee pain defined as chronic knee pain (> 12 months) in both knees that is moderate to severe (defined as a numeric rating scale (NRS) > 4 on most or all days either constantly or with motion) and that is unresponsive (meaning insufficient pain reduction or intolerance) to conventional treatments ongoing for at least 12 months prior to inclusion. Conventional treatments must include all of the following: active physiotherapy, pharmacological treatment of pain and intra-articular corticosteroid infiltration.
- Patients who have a planned TKA in the near future defined as patients who already have agreed on a date for the TKA procedure.
- Patients who are unwilling or mentally incapable to complete the study questionnaires.
Sites / Locations
- UZ AntwerpenRecruiting
- AZ Klina
- ULB ErasmeRecruiting
- UCL Saint-Luc
- Ziekenhuis Oost-Limburg AVRecruiting
- AZ Maria MiddelaresRecruiting
- Jessa ZiekenhuisRecruiting
- AZ Groeninge
- UZ LeuvenRecruiting
- CHR de la CitadelleRecruiting
- CHU Liège
- AZ DeltaRecruiting
- AZ TurnhoutRecruiting
- Rijnstate
- MUMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Sham Comparator
Conventional Radiofrequency of the genicular nerves
Cooled Radiofrequency of the genicular nerves
Sham procedure
In the conventional radiofrequency group a intervention of 80°C at the tip is applied during 90 seconds at each nerve (superolateral, superomedial and inferomedial genicular nerves). The probe stays in place for 150 seconds at each nerve so that the time needed for each procedure is similar.
In the cooled radiofrequency group a intervention of 60°C measured at the tip and on average 80°C in the targeted tissue is applied for 150 seconds using the Cooled RF system at each nerve (superolateral, superomedial and inferomedial genicular nerves).
In the sham group a 18 gauge introducer and probe will be placed but no RF intervention will be applied. The generator will be turned on without connection to the probe for 150 seconds and the sound of the generator will be mimicked with a recording. The position of the needle will not be checked by fluoroscopy; however, the intervention team will position the fluoroscopy arm and mention the acquisition of the fluoroscopic image to the patient. This way no unnecessary radiation is used.