RFA or Chemical Neurolysis of the Genicular Nerves Compared to Conservative Treatment for Knee Pain Caused by OA

NCT06094660 | Recruiting

• 1 other identifier: DOC 045
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 2

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).

Conditions

Osteo Arthritis Knee; Knee Pain Chronic

Keywords

Pain; Thermal ablation; Phenol neurolysis; Genicular nerve

Outcome Measures

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.

  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 (21)

• Osteoartritis (OA) measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  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).

• Pain measured with the Numeric Rating Score (NRS)

  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

• 30 seconds chair-stand test

  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.

• 40 meters (4x10m) fast-paced walk test

  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.

• 9-steps stair-climb test

  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.

Study Arms (3)

Chemical ablation of the genicular nerves with Phenol 6%

ACTIVE COMPARATOR

Chemical ablation with phenol is done by injection of 1,5ml of phenol 6 % at the superomedial, the superolateral and the inferomedial genicular nerve.

Procedure: Diagnostic genicular nerve block; Procedure: Genicular nerve block with Phenol 6%

Radiofrequency ablation (RFA) of the genicular nerves

ACTIVE COMPARATOR

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.

Procedure: Diagnostic genicular nerve block; Procedure: Genicular nerve block with Radiofrequency Ablation (RFA)

Conservative treatment

NO INTERVENTION

Examples of allowed conservative treatments during the study are patient education, physical therapy, weight loss and different pharmacological treatments.

Interventions

Diagnostic genicular nerve block PROCEDURE

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.

Chemical ablation of the genicular nerves with Phenol 6%; Radiofrequency ablation (RFA) of the genicular nerves

Genicular nerve block with Radiofrequency Ablation (RFA) PROCEDURE

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.

Radiofrequency ablation (RFA) of the genicular nerves

Genicular nerve block with Phenol 6% PROCEDURE

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.

Chemical ablation of the genicular nerves with Phenol 6%

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patient is currently implanted with a neurostimulator.
• Local or systemic infection (bacteraemia).
• Uncontrolled immune suppression.
• Intra-articular injections (steroids, hyaluronic acid, platelet enriched plasma, stem cell, …) in the target knee within 90 days from randomisation.
• Arthroscopic debridement/lavage into the target knee within 180 days from randomisation.
• 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).
• Allergies to products used during the procedure (lidocaine, phenol, contrast dye).
• Patients who have a planned TKA in the near future, defined as patients who already have agreed on a date for the TKA procedure.
• Patients with psychosocial problems as determined by the investigator.

Sponsors & Collaborators

• Dijklander Ziekenhuis: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Bravis Hospital: collaborator

Study Sites (2)

Dijklander Ziekenhuis

Hoorn, North Holland, 1624NP, Netherlands

RECRUITING

Bravis Ziekenhuis

Roosendaal, 4708AE, Netherlands

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 40623740 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Gezina Oei, MD, PhD

  Academic Medical Centre Amsterdam

  PRINCIPAL INVESTIGATOR

• Markus Hollmann, Prof

  Academic Medical Centre Amsterdam

  STUDY CHAIR

Central Study Contacts

Gezina Oei, MD,PhD

CONTACT

0031229257257; g.t.m.l.oei@dijklander.nl

Aine Honohan, MSc

CONTACT

0031646340596; a.g.honohan@Dijklander.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: October 23, 2023
• Study Start: November 27, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: An embargo period applies: The embargo period is at least 1 year after the publication of the original study.
• Access Criteria: A de-identified dataset will be made available upon request to the corresponding author. The request must include ethics approval and a statistical analysis plan. Digital data and documentation will be preserved for 15 years.

Locations

NL (2)