Comparing nerve ablation techniques and conservative treatment for knee pain from osteoarthritis

Patients With Knee Pain Caused by Osteoarthritis: Comparison of Conservative Medical Management With RadioFrequency Ablation or Chemical Neurolysis of the Genicular Nerves With Phenol

This study is testing whether two different nerve treatments for knee pain from osteoarthritis work better than regular care for people who can’t have knee surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 192 (estimated)
• Ages: 35 Years to 90 Years
• Sex: All
• Sponsor: Dijklander Ziekenhuis (Academic / other)
• Locations: 2 sites (Hoorn, North Holland and 1 other locations)
• Trial ID: NCT06094660 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial compares the effectiveness of two nerve ablation techniques—radiofrequency ablation (RFA) and chemical neurolysis with phenol—against conservative treatment for chronic knee pain caused by osteoarthritis. The study aims to evaluate functional outcomes in patients who are not candidates for total knee arthroplasty due to various reasons. Participants will be monitored for up to six months post-treatment to assess pain relief and functional improvement. The trial seeks to fill the gap in existing research regarding the efficacy of genicular nerve ablation compared to standard conservative treatments.

Who should consider this trial

Good fit: Ideal candidates are adults over 35 years old with moderate to severe knee pain from osteoarthritis who are not suitable for total knee arthroplasty.

Not a fit: Patients who have previously undergone nerve ablation or knee surgeries, or those with recent trauma or neurovascular injuries, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients suffering from chronic knee pain due to osteoarthritis, potentially delaying the need for surgery.

How similar studies have performed: While there are numerous studies on genicular nerve blocks, this trial is one of the few that directly compares nerve ablation techniques with conservative treatment, making it a novel approach.

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.

Where this trial is running

Hoorn, North Holland and 1 other locations

• Dijklander Ziekenhuis — Hoorn, North Holland, Netherlands (Recruiting)
• Bravis Ziekenhuis — Roosendaal, Netherlands (Not_yet_recruiting)

Study contacts

• Principal investigator: Gezina Oei, MD, PhD — Academic Medical Centre Amsterdam
• Study coordinator: Gezina Oei, MD,PhD

Conditions Osteo Arthritis Knee; Knee Pain Chronic; Pain; Thermal ablation; Phenol neurolysis; Genicular nerve