Phenol Neurolysis of Genicular Nerves for Osteoarthritic Knee Pain

Osteoarthritis, Knee Clinical Trial

Official title:

Phenol Neurolysis of Genicular Nerves for Osteoarthritic Knee Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04989660
• Other study ID #: R-1154-21
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2021
• Est. completion date: October 2023

Study information

• Verified date: March 2022
• Source: Kessler Foundation
• Contact: Paul So, MD
• Phone: 973-972-3606
• Email: ibaool[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Pain Chronic
• Osteoarthritis, Knee

Intervention

Drug:
• 6% aqueous phenol
1.5 mL of 6% aqueous phenol will be injected at each target genicular nerve under ultrasound guidance.
• Isotonic saline
1.5 mL of isotonic saline will be injected at each target genicular nerve under ultrasound guidance.

Locations

Country	Name	City	State
United States	Kessler Institute for Rehabilitation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in WOMAC score from baseline	Participants' function as measured by WOMAC will be measured prior to the intervention and at 1 month, 3 months, and 6 months after the intervention. WOMAC score ranges from 0 (best) to 100 (worst).	Baseline, 1 month, 3 months, 6 months