RFA or Chemical Neurolysis of the Genicular Nerves Compared to Conservative Treatment for Knee Pain Caused by OA
NCT ID: NCT06094660
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
192 participants
INTERVENTIONAL
2023-11-27
2026-11-01
Brief Summary
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Detailed Description
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Although there are numerous studies on genicular nerve block for chronic knee pain caused by OA, there are just a few small studies that compare genicular nerve block with conservative treatment.To be able to determine if genicular nerve ablation is efficacious to serve the gap between conservative treatment and TKA, this randomised controlled trial (RCT) compares two forms of genicular nerve ablation (radiofrequency and phenolisation; intervention) with conservative treatment (control) up to 6 months after treatment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Chemical ablation of the genicular nerves with Phenol 6%
Chemical ablation with phenol is done by injection of 1,5ml of phenol 6 % at the superomedial, the superolateral and the inferomedial genicular nerve.
Diagnostic genicular nerve block
Diagnostic block will be done with 1,5ml of Lidocaine 2% at the 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve.
Genicular nerve block with Phenol 6%
Genicular nerve block with Phenol 6% will be performed at 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve.
Chemical ablation with phenol is done by injection of 1 ,5ml of phenol 6 % at the 3 target sites after infiltration with contrast dye to rule out intravascular injection. Because infiltration with phenol is painless, prior infiltration of the target site with al local anaesthetic is not necessary.
Radiofrequency ablation (RFA) of the genicular nerves
In our study we will make two RFA lesions at every target with 80°C for 90 seconds with a 5mm active tip. So we will make 6 lesions in total. The targets are the superomedial, the superolateral and the inferomedial genicular nerve.
Diagnostic genicular nerve block
Diagnostic block will be done with 1,5ml of Lidocaine 2% at the 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve.
Genicular nerve block with Radiofrequency Ablation (RFA)
Genicular nerve block with RFA will be performed at 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve.
Radiofrequency ablation (RFA) is performed by creating two RFA lesions at the 3 treatment sites (6 lesions in total) after local anesthesia with 1,5ml lidocaine 2%. The lesions are made by heating the 5mm active tip of the needle to 80°C for 90 seconds.
Conservative treatment
Examples of allowed conservative treatments during the study are patient education, physical therapy, weight loss and different pharmacological treatments.
No interventions assigned to this group
Interventions
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Diagnostic genicular nerve block
Diagnostic block will be done with 1,5ml of Lidocaine 2% at the 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve.
Genicular nerve block with Radiofrequency Ablation (RFA)
Genicular nerve block with RFA will be performed at 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve.
Radiofrequency ablation (RFA) is performed by creating two RFA lesions at the 3 treatment sites (6 lesions in total) after local anesthesia with 1,5ml lidocaine 2%. The lesions are made by heating the 5mm active tip of the needle to 80°C for 90 seconds.
Genicular nerve block with Phenol 6%
Genicular nerve block with Phenol 6% will be performed at 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve.
Chemical ablation with phenol is done by injection of 1 ,5ml of phenol 6 % at the 3 target sites after infiltration with contrast dye to rule out intravascular injection. Because infiltration with phenol is painless, prior infiltration of the target site with al local anaesthetic is not necessary.
Eligibility Criteria
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Inclusion Criteria
2. OKS \< 30 on a scale from 0 (severe function) to 48 points (satisfactory function).
3. Continued pain in the target knee that is moderate to severe (defined as NRS ≥ 6 on an 11-point NRS scale) either constantly or with motion despite at least 3 months of conservative treatments. Conservative treatment can include: active physiotherapy, pharmacological treatment of pain (acetaminophen or NSAIDs) and intra-articular corticosteroid infiltration.
4. Radiologic confirmation of arthritis for the target knee. Defined as the Kellgren Lawrence (KL) score of 2 or more on X-ray or MRI.
Exclusion Criteria
2. Patient with a history of neurovascular injury or recent trauma of the lower extremities.
3. Patient with chronic widespread pain.
4. Polyneuropathy and/or radicular pain in the lower extremities.
5. Patient is currently implanted with a neurostimulator.
6. Local or systemic infection (bacteraemia).
7. Uncontrolled immune suppression.
8. Intra-articular injections (steroids, hyaluronic acid, platelet enriched plasma, stem cell, …) in the target knee within 90 days from randomisation.
9. Arthroscopic debridement/lavage into the target knee within 180 days from randomisation.
10. BMI\<18,5 kg/m2 and patients with minimal subcutaneous tissue thickness that would not accommodate ablation with phenol or radio frequency (risk of skin burns).
11. Allergies to products used during the procedure (lidocaine, phenol, contrast dye).
12. Patients who have a planned TKA in the near future, defined as patients who already have agreed on a date for the TKA procedure.
13. Patients with psychosocial problems as determined by the investigator.
35 Years
90 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Bravis Hospital
OTHER
Dijklander Ziekenhuis
OTHER
Responsible Party
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Principal Investigators
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Gezina Oei, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Academic Medical Centre Amsterdam
Markus Hollmann, Prof
Role: STUDY_CHAIR
Academic Medical Centre Amsterdam
Locations
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Dijklander Ziekenhuis
Hoorn, North Holland, Netherlands
Bravis Ziekenhuis
Roosendaal, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Gezina Oei, MD, PhD
Role: primary
Paul de Wit, MD
Role: backup
Lars Elzinga
Role: primary
Jeroen van der Heiden
Role: backup
References
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Wit PR, Beek RV, Schokker M, Wensing C, Hollmann MW, Kallewaard JW, Oei G; RADIOPHENOL collaborators; Collaborative group name. Genicular nerve radiofrequency ablation, phenol neurolysis or conservative medical management in patients with knee osteoarthritis: protocol for the RADIOPHENOL randomised controlled multicentre trial with three parallel groups. BMJ Open. 2025 Jul 6;15(7):e094576. doi: 10.1136/bmjopen-2024-094576.
Other Identifiers
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DOC 045
Identifier Type: -
Identifier Source: org_study_id