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Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections

Primary Purpose

Osteoarthritis, Knee, Chronic Knee Pain

Status

Not yet recruiting

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

6% aqueous phenol

MethylPREDNISolone 40 MG

Intraarticular Knee Placebo

Genicular Nerve Placebo

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Phenol, Injections, Intra-Articular, Steroids, Nerve Block

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Severe knee pain for more than 6 months, defined as Numeric rating scale (NRS) score of 6 and greater, unresponsive to conservative medical treatment Radiological OA grade 2 to 4 (Kellgren-Lawrence scale) Exclusion Criteria: Previous total knee replacement on the index knee Prior knee radiofrequency ablation on the index knee Connective tissue diseases with knee involvement (e.g. rheumatoid arthritis) Body mass index ≥ 40 kg/m2 Uncontrolled coagulopathy, defined as supratherapeutic dose of anticoagulation medication Allergy to local anesthetics Unstable opioid consumption, defined as an increase >10% in dosage during the last 3 months prior to recruitment.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound-guided Genicular Nerve Phenol Neurolysis

Ultrasound-guided Intraarticular Steroid Injection

Arm Description

One time injection of 1.5 mL of phenol 6% at 3 target locations: superomedial, superolateral and inferomedial genicular nerves

Intraarticular knee injection of 40 mg of methylprednisolone acetate in a volume of 5 mL of saline

Outcomes

Primary Outcome Measures

Pain scores (Numeric Rating Scale) at 3 months

Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

Secondary Outcome Measures

Pain scores (Numeric Rating Scale) at baseline, 1 and 6 months

Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

Proportion of patients experiencing a 50% or greater decrease in baseline knee pain scores (NRS)

Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

Brief Pain Inventory Score (BPI)

Functional activity measurement using the Brief Pain Inventory (short form)

WOMAC index

The WOMAC index consists of three subscales: pain, stiffness, and physical function (17 questions overall)

Incidence of adverse events

Determined by the presence of hypoesthesia, paresthesia, puncture site hematoma, and worsening pain or infection

Full Information

NCT ID

NCT06000709

First Posted

August 14, 2023

Last Updated

October 7, 2023

Sponsor

University of Manitoba

1. Study Identification

Unique Protocol Identification Number

NCT06000709

Brief Title

Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections

Official Title

Randomized, Double-blinded, Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 20, 2023 (Anticipated)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Genicular nerve neurolysis (GN) constitutes a relatively novel technique, whereby different chemical compounds (i.e. alcohol, phenol) are injected in close proximity to the genicular nerves of the knee joint, with the intention to exert a neurolytic effect by denaturing proteins resulting in Wallerian degeneration distal to the lesion. Based on the preliminary evidence and considering the potential benefits of the technique, we hypothesized that ultrasound-guided genicular chemical neurolysis with phenol is superior in terms of pain relief at 3 months, when compared to intra-articular steroid (IAS) injection.

Detailed Description

This study will allow us to determine if ultrasound-guided phenol genicular neurolys is superior to intra-articular steroid injection in terms of analgesia and functional outcomes, providing a more effective and long-lasting alternative for patients with chronic knee pain secondary to osteoarthritis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee, Chronic Knee Pain

Keywords

Phenol, Injections, Intra-Articular, Steroids, Nerve Block

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ultrasound-guided Genicular Nerve Phenol Neurolysis

Arm Type

Experimental

Arm Description

One time injection of 1.5 mL of phenol 6% at 3 target locations: superomedial, superolateral and inferomedial genicular nerves

Arm Title

Ultrasound-guided Intraarticular Steroid Injection

Arm Type

Active Comparator

Arm Description

Intraarticular knee injection of 40 mg of methylprednisolone acetate in a volume of 5 mL of saline

Intervention Type

Drug

Intervention Name(s)

6% aqueous phenol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

MethylPREDNISolone 40 MG

Intervention Description

40 mg of methylprednisolone diluted in 5 mL of 0.9% normal saline will be injected inside the knee joint capsule under ultrasound guidance

Intervention Type

Drug

Intervention Name(s)

Intraarticular Knee Placebo

Other Intervention Name(s)

0.9% normal saline

Intervention Description

Single injection 1.5 mL of 0.9% normal saline outside the knee joint capsule under ultrasound guidance

Intervention Type

Drug

Intervention Name(s)

Genicular Nerve Placebo

Other Intervention Name(s)

0.9% normal saline

Intervention Description

1.5 mL of 0.9% normal saline will be injected subcutaneously at each target genicular nerve under ultrasound guidance

Primary Outcome Measure Information:

Title

Pain scores (Numeric Rating Scale) at 3 months

Description

Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Pain scores (Numeric Rating Scale) at baseline, 1 and 6 months

Description

Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

Time Frame

baseline, 1 month, 6 months

Title

Proportion of patients experiencing a 50% or greater decrease in baseline knee pain scores (NRS)

Description

Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

Time Frame

1 months, 3 months, 6 months

Title

Brief Pain Inventory Score (BPI)

Description

Functional activity measurement using the Brief Pain Inventory (short form)

Time Frame

baseline, 1 month, 3 months, 6 months

Title

WOMAC index

Description

The WOMAC index consists of three subscales: pain, stiffness, and physical function (17 questions overall)

Time Frame

baseline, 1 month, 3 months, 6 months

Title

Incidence of adverse events

Description

Determined by the presence of hypoesthesia, paresthesia, puncture site hematoma, and worsening pain or infection

Time Frame

from injection up to 1 month after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Javier Webar, MD

Phone

2047873018

javier.webar@umanitoba.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Sebastian Layera, MD

Phone

2047873018

layerars@myumanitoba.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Javier Webar, MD

Organizational Affiliation

University of Manitoba

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29514315

Citation

Walega DR, McCormick ZL. Chemical Neurolysis of the Genicular Nerves for Chronic Knee Pain: Reviving an Old Dog and an Old Trick. Pain Med. 2018 Sep 1;19(9):1882-1884. doi: 10.1093/pm/pny023. No abstract available.

Results Reference

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PubMed Identifier

33277760

Citation

Risso RC, Ferraro LHC, Nouer Frederico T, Peng PWH, Luzo MV, Debieux P, Sakata RK. Chemical Ablation of Genicular Nerve with Phenol for Pain Relief in Patients with Knee Osteoarthritis: A Prospective Study. Pain Pract. 2021 Apr;21(4):438-444. doi: 10.1111/papr.12972. Epub 2020 Dec 29.

Results Reference

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PubMed Identifier

22124002

Citation

Park Y, Lee SC, Nam HS, Lee J, Nam SH. Comparison of sonographically guided intra-articular injections at 3 different sites of the knee. J Ultrasound Med. 2011 Dec;30(12):1669-76. doi: 10.7863/jum.2011.30.12.1669.

Results Reference

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PubMed Identifier

29095245

Citation

Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.

Results Reference

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Learn more about this trial

Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections

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