Recruiting

Phenol Neurolysis

Sponsor:

Kessler Foundation

Code:

NCT04989660

Conditions

Osteoarthritis, Knee

Knee Pain Chronic

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

Interventions

6% aqueous phenol

Isotonic saline

Study Details

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 ID

NCT04989660

Start date

Nov 1, 2021

Status verified date

Mar, 2022

Completion date

Oct, 2023

Anticipated

Primary completion date

Aug, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

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.

Primary outcome measure

  • Change in NRS pain score from baseline [ Time Frame: Baseline, 1 month, 3 months, 6 months ]

Central Contacts and Locations

Central contacts

Locations

Kessler Institute for Rehabilitation

Recruiting

West Orange, New Jersey, United States, 07052

More Information

Sponsor

Kessler Foundation

Last update posted

Mar 31, 2022

Last verified

Mar, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2022-03-31.