Clinical trial NCT04989660: Phenol Neurolysis of Genicular Nerves for Osteoarthritic Knee Pain
Official title: Phenol Neurolysis of Genicular Nerves for Osteoarthritic Knee Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Knee Pain Chronic
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in NRS pain score from baseline
timeFrame: Baseline, 1 month, 3 months, 6 months
Secondary outcomes:
measure: Change in WOMAC score from baseline
timeFrame: Baseline, 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
Study officials:
affiliation: Kessler Institute for Rehabilitation
name: Paul So, MD
role: PRINCIPAL_INVESTIGATOR
References: