RFA or Chemical Neurolysis of the Genicular Nerves Compared to Conservative Treatment for Knee Pain Caused by OA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-90
SponsorDijklander Ziekenhuis
About this trial
A randomised controlled triall (RCT) with three parallel arms comparing the functional outcome of chemical ablation with phenol and radiofrequency ablation (RFA) of the genicular nerves with conservative treatment in patients with chronic knee pain caused by osteoarthritis (OA).
Eligibility criteria
Qualifiers
Adult patients of both sexes, >35 years who are not a candidate for TKA due to young age, old age, comorbidity or technical reasons.
OKS < 30 on a scale from 0 (severe function) to 48 points (satisfactory function).
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.
Radiologic confirmation of arthritis for the target knee. Defined as the Kellgren Lawrence (KL) score of 2 or more on X-ray or MRI.
Disqualifiers
Patient with prior ablation of the genicular nerves, prior partial, resurfacing, or TKA of the target knee (residual hardware).
Patient with a history of neurovascular injury or recent trauma of the lower extremities.
Patient with chronic widespread pain.
Polyneuropathy and/or radicular pain in the lower extremities.
Trial design
Treatments tested in this trial
- Diagnostic genicular nerve block
- Genicular nerve block with Radiofrequency Ablation (RFA)
- Genicular nerve block with Phenol 6%
Treatment groups
192 Participants
are divided into 3 treatment groupsSponsors and collaborators
Dijklander Ziekenhuis
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator
Bravis Hospital
Collaborator
Source ClinicalTrials.gov