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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Diagnostic genicular nerve block
Procedure/SurgeryDiagnostic 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)
Procedure/SurgeryGenicular 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%
Procedure/SurgeryGenicular 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.
Treatment groups
192 Participants
are divided into 3 treatment groupsGroup A: Chemical ablation of the genicular nerves with Phenol 6%Active comparator 2 interventions
Group B: Radiofrequency ablation (RFA) of the genicular nervesActive comparator 2 interventions
Group C: Conservative treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Knee function measured with the Oxford Knee score (OKS)
Questionnaire with 12 items. Scores can range from 0 to 48, with 48 being the best outcome and a lower score indicates more functional limitations and pain.
Time frame
During intake, before the intervention or study start in conservative group (T=0) and during the follow up visits (T=1 at 6weeks, T=2 at 3 months, T=3 at 6 months and T=4 at 12 months after the intervention or study start).Secondary outcomes
1
Osteoartritis (OA) measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
We will use the WOMAC in the Likert version where question are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. So the sum of the scores ranges from 0 (the best) to 96 (the worse).
Time frame
Before the intervention or study start in conservative group (T=0) and during the follow up visits (T=1 at 6weeks, T=2 at 3 months, T=3 at 6 months and T=4 at 12 months after the intervention or study start).2
Pain measured with the Numeric Rating Score (NRS)
NRS will be measured in rest and during the performance based tests.
Time frame
In rest during intake and in rest and during performance based tests before and after the diagnostic nerve block (if applicable), before the intervention (if applicable), 6 weeks, 3 months, 6 months and 1 year after the intervention3
30 seconds chair-stand test
During this test the total number of complete chair stands (up and down represents one stand) is counted. If at least a full stand is completed at 30 seconds this is counted in the total. If a person cannot stand even once then the score for the test is zero.
Time frame
Before and after the diagnostic block, before the intervention (T=0), and at 6 weeks, 3 months, 6 months and 12 months follow up. In the conservative treatment group this will only be done at the applicable follow up dates.4
40 meters (4x10m) fast-paced walk test
The total time taken to walk the 4 × 10 m, excluding turns, of one trial is recorded and expressed as speed m/s by dividing distance (40 m) by time (seconds). Timing is paused during turns.
Time frame
Before and after the diagnostic block, before the intervention (T=0), and at 6 weeks, 3 months, 6 months and 12 months follow up. In the conservative treatment group this will only be done at the applicable follow up dates.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dijklander Ziekenhuis
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator
Bravis Hospital
Collaborator
Source ClinicalTrials.gov