Clinical trial NCT06094660: RFA or Chemical Neurolysis of the Genicular Nerves Compared to Conservative Treatment for Knee Pain Caused by OA
Official title: Patients With Knee Pain Caused by Osteoarthritis: Comparison of Conservative Medical Management With RadioFrequency Ablation or Chemical Neurolysis of the Genicular Nerves With Phenol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteo Arthritis Knee
Knee Pain Chronic
Keywords: Pain
Thermal ablation
Phenol neurolysis
Genicular nerve
Lead sponsor: Dijklander Ziekenhuis
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Bravis Hospital
First posted: 2023-10-23
Enrollment: 192
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: In guidelines for knee osteoarthritis (OA), conservative treatments are physical therapy, analgesics and intra-articular injections with corticosteroids. In severe OA and persisting symptomatic cases the golden standard is joint replacing surgery. A less invasive technique is ablation of the sensory (genicular) nerves of the knee. This technique is beneficial for younger patients as a bridge to surgery or patients that cannot undergo total knee arthroplasty (TKA) due to comorbid health conditions. Nerve ablation can either be done with chemical agents or thermal energy.

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.

Eligibility criteria: Inclusion Criteria:

1. Adult patients of both sexes, \>35 years who are not a candidate for TKA due to young age, old age, comorbidity or technical reasons.
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:

1. Patient with prior ablation of the genicular nerves, prior partial, resurfacing, or TKA of the target knee (residual hardware).
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.

Primary outcomes:
measure: Knee function measured with the Oxford Knee score (OKS)
timeFrame: 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:
measure: Osteoartritis (OA) measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 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).
measure: Pain measured with the Numeric Rating Score (NRS)
timeFrame: 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 intervention
measure: 30 seconds chair-stand test
timeFrame: 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.
measure: 40 meters (4x10m) fast-paced walk test
timeFrame: 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.
measure: 9-steps stair-climb test
timeFrame: 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.
measure: Health related quality of life with the EQ-5D-5L
timeFrame: 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).
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: At T=0 (before intervention) and during T=3 (6 months after intervention)
measure: Pain Catastrophizing Score (PCS)
timeFrame: At T=0 (before intervention) and during T=3 (6 months after intervention)
measure: Diagnostic block most appropriate cut-off value
timeFrame: Before and after the diagnostic block and during T=2 (3 months after intervention).
measure: Patient satisfaction
timeFrame: 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).
measure: Patient Global Impression of Change (PGIC)
timeFrame: 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).
measure: Minimal Clinically Important Difference (MCID) of the OKS
timeFrame: MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up. .
measure: Minimal Clinically Important Difference (MCID) of the WOMAC
timeFrame: MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up.
measure: Minimal Clinically Important Difference (MCID) for the EQ-5D-5L
timeFrame: MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up.
measure: Minimal Clinically Important Difference (MCID) of the 30 seconds chair-stand test
timeFrame: MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up.
measure: Minimal Clinically Important Difference (MCID) of the 40 meters (4x10m) fast-paced walk test
timeFrame: MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up.
measure: Minimal Clinically Important Difference (MCID) of the 9-steps stair-climb test.
timeFrame: MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up.
measure: Adverse events
timeFrame: After the diagnostic block, after the intervention (T=0), and at 6 weeks, 3 months, 6 months and 12 months follow up.
measure: Medication changes
timeFrame: Before the intervention (T=0), and at 6 weeks, 3 months, 6 months and 12 months follow up.
measure: Number of Total Knee Artroplasty's (TKA's)
timeFrame: At 6 weeks, 3 months, 6 months and 12 months follow up.
measure: Procedure time
timeFrame: During the intervention visit (T=0)
Other outcomes:
Locations:
city: Hoorn
country: Netherlands
facility: Dijklander Ziekenhuis
state: Noord-Holland
city: Roosendaal
country: Netherlands
facility: Bravis Ziekenhuis
Study officials:
affiliation: Academic Medical Centre Amsterdam
name: Gezina Oei, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academic Medical Centre Amsterdam
name: Markus Hollmann, Prof
role: STUDY_CHAIR
References: