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Phenol Neurolysis of Genicular Nerves for Osteoarthritic Knee Pain

Study Purpose

As the aging and obese populations continue to increase, there is a rapidly growing number of people at risk for knee osteoarthritis. Treatment typically starts conservatively with analgesics, physical therapy, and bracing. Intra-articular injections with corticosteroids and/or viscosupplementation may also be utilized in those with persistent knee pain. Genicular nerve radiofrequency ablation (GNRFA) is an increasingly employed procedure for refractory osteoarthritic knee pain with promising efficacy for pain relief. However, due to its reliance on expensive equipment, additional staff, and need for specialized rooms (eg. fluoroscopy suite), GNRFA is a costly procedure with limited availability. Chemical neurolysis is an alternative method of nerve ablation using alcohol or phenol utilized in the management of pain. Recent literature has demonstrated good efficacy for pain relief and function with chemical ablation of the genicular nerves using both alcohol and phenol. This study is a double-blind, randomized, placebo-controlled pilot study to assess the efficacy of phenol neurolysis of the genicular nerves for pain and function due to refractory osteoarthritic knee pain. We hypothesize that a significant improvement in both pain and function will be observed with chemical neurolysis of the genicular nerves using 6% phenol compared to placebo.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 40 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Radiographic knee osteoarthritis (Kellgren-Lawrence grade 2-4) - Knee pain of moderate intensity or greater (NRS of 4 or greater) - Knee pain for 3 months or longer.
  • - Persistent knee pain despite conservative treatment including oral/topical analgesics, physiotherapy, intra-articular injection with corticosteroid and/or hyaluronic acid.

Exclusion Criteria:

  • - Prior total or partial knee arthroplasty in the knee(s) to be treated.
  • - Prior radiofrequency ablation treatment in the affected knee.
  • - Other rheumatological or connective tissue disease(s) affecting the knee to be treated.
  • - History of bleeding disorder.
  • - Any psychiatric or neurologic disease (eg.
dementia, brain injury, etc.) that may preclude reliable reporting of symptoms and response to treatment.
  • - Pregnancy.
  • - Recent treatment with intraarticular hyaluronic acid, platelet-rich plasma, or corticosteroid injections to the affected knee in the past 3 months.
  • - Skin or joint infection in the knee(s) to be treated.
- Concomitant radicular pain

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04989660
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Kessler Foundation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Paul So, MD
Principal Investigator Affiliation Kessler Institute for Rehabilitation
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteoarthritis, Knee, Knee Pain Chronic
Arms & Interventions

Arms

Experimental: Treatment Group

6% aqueous phenol, 1.5 mL per target site

Placebo Comparator: Placebo Group

Isotonic saline, 1.5 mL per target site

Interventions

Drug: - 6% aqueous phenol

1.5 mL of 6% aqueous phenol will be injected at each target genicular nerve under ultrasound guidance.

Drug: - Isotonic saline

1.5 mL of isotonic saline will be injected at each target genicular nerve under ultrasound guidance.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Kessler Institute for Rehabilitation, West Orange, New Jersey

Status

Recruiting

Address

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052

Site Contact

Paul So, MD

[email protected]

973-972-3606

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