Phenol Neurolysis of Genicular Nerves for Osteoarthritic Knee Pain

NCT04989660 | Unknown Phase 4 FDA Drug

• 1 other identifier: R-1154-21
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee; Knee Pain Chronic

Outcome Measures

Primary Outcomes (1)

• Change in NRS pain score from baseline

  Participants' pain will be measured using the numeric rating scale (0-10) prior to the intervention and at 1 month, 3 months, and 6 months after the intervention. Numeric rating scale ranges from 0 (no pain) to 10 (worst pain).

  Baseline, 1 month, 3 months, 6 months

Secondary Outcomes (1)

• Change in WOMAC score from baseline

  Baseline, 1 month, 3 months, 6 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

6% aqueous phenol, 1.5 mL per target site

Drug: 6% aqueous phenol

Placebo Group

PLACEBO COMPARATOR

Isotonic saline, 1.5 mL per target site

Drug: Isotonic saline

Interventions

6% aqueous phenol DRUG

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

Also known as: Phenol

Treatment Group

Isotonic saline DRUG

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

Placebo Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Phenol; Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Paul So, MD

  Kessler Institute for Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul So, MD

CONTACT

973-972-3606; ibaool@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 4, 2021
• Study Start: November 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)