Phenol Neurolysis of Genicular Nerves for Osteoarthritic Knee Pain

NCT ID: NCT04989660

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2023-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Group

6% aqueous phenol, 1.5 mL per target site

Group Type: EXPERIMENTAL

6% aqueous phenol

Intervention Type: DRUG

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

Placebo Group

Isotonic saline, 1.5 mL per target site

Group Type: PLACEBO_COMPARATOR

Isotonic saline

Intervention Type: DRUG

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

Interventions

6% aqueous phenol

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

Intervention Type: DRUG

Isotonic saline

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

Intervention Type: DRUG

Other Intervention Names

Phenol

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul So, MD

Role: PRINCIPAL_INVESTIGATOR

Kessler Institute for Rehabilitation

Locations

Kessler Institute for Rehabilitation

West Orange, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Paul So, MD

Role: CONTACT

ibaool@gmail.com

973-972-3606

Facility Contacts

Paul So, MD

Role: primary

Other Identifiers

R-1154-21

Identifier Type: -

Identifier Source: org_study_id