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Phenol Neurolysis of Genicular Nerves for Osteoarthritic Knee Pain

Primary Purpose

Osteoarthritis, Knee, Knee Pain Chronic

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
6% aqueous phenol
Isotonic saline
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kessler Institute for RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group

Placebo Group

Arm Description

6% aqueous phenol, 1.5 mL per target site

Isotonic saline, 1.5 mL per target site

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
July 27, 2021
Last Updated
March 30, 2022
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04989660
Brief Title
Phenol Neurolysis of Genicular Nerves for Osteoarthritic Knee Pain
Official Title
Phenol Neurolysis of Genicular Nerves for Osteoarthritic Knee Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Knee Pain Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
6% aqueous phenol, 1.5 mL per target site
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Isotonic saline, 1.5 mL per target site
Intervention Type
Drug
Intervention Name(s)
6% aqueous phenol
Other Intervention Name(s)
Phenol
Intervention Description
1.5 mL of 6% aqueous phenol will be injected at each target genicular nerve under ultrasound guidance.
Intervention Type
Drug
Intervention Name(s)
Isotonic saline
Intervention Description
1.5 mL of isotonic saline will be injected at each target genicular nerve under ultrasound guidance.
Primary Outcome Measure Information:
Title
Change in NRS pain score from baseline
Description
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).
Time Frame
Baseline, 1 month, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Change in WOMAC score from baseline
Description
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).
Time Frame
Baseline, 1 month, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul So, MD
Phone
973-972-3606
Email
ibaool@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul So, MD
Organizational Affiliation
Kessler Institute for Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Institute for Rehabilitation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul So, MD
First Name & Middle Initial & Last Name & Degree
Matthew Delbert, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Phenol Neurolysis of Genicular Nerves for Osteoarthritic Knee Pain

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