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

October 7, 2023 updated by: Javier Webar, University of Manitoba

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound-guided Genicular Nerve Phenol Neurolysis
One time injection of 1.5 mL of phenol 6% at 3 target locations: superomedial, superolateral and inferomedial genicular nerves
Drug: 6% aqueous phenol
1.5 mL of aqueous phenol will be injected at each target genicular nerve under ultrasound guidance
Drug: Intraarticular Knee Placebo
Single injection 1.5 mL of 0.9% normal saline outside the knee joint capsule under ultrasound guidance
Other Names:
  • 0.9% normal saline
Active Comparator: Ultrasound-guided Intraarticular Steroid Injection
Intraarticular knee injection of 40 mg of methylprednisolone acetate in a volume of 5 mL of saline
Drug: MethylPREDNISolone 40 MG
40 mg of methylprednisolone diluted in 5 mL of 0.9% normal saline will be injected inside the knee joint capsule under ultrasound guidance
Drug: Genicular Nerve Placebo
1.5 mL of 0.9% normal saline will be injected subcutaneously at each target genicular nerve under ultrasound guidance
Other Names:
  • 0.9% normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores (Numeric Rating Scale) at 3 months
Time Frame: 3 months
Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores (Numeric Rating Scale) at baseline, 1 and 6 months
Time Frame: baseline, 1 month, 6 months
Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
baseline, 1 month, 6 months
Proportion of patients experiencing a 50% or greater decrease in baseline knee pain scores (NRS)
Time Frame: 1 months, 3 months, 6 months
Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
1 months, 3 months, 6 months
Brief Pain Inventory Score (BPI)
Time Frame: baseline, 1 month, 3 months, 6 months
Functional activity measurement using the Brief Pain Inventory (short form)
baseline, 1 month, 3 months, 6 months
WOMAC index
Time Frame: baseline, 1 month, 3 months, 6 months
The WOMAC index consists of three subscales: pain, stiffness, and physical function (17 questions overall)
baseline, 1 month, 3 months, 6 months
Incidence of adverse events
Time Frame: from injection up to 1 month after intervention
Determined by the presence of hypoesthesia, paresthesia, puncture site hematoma, and worsening pain or infection
from injection up to 1 month after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Investigators

  • Principal Investigator: Javier Webar, MD, University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 20, 2023

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Estimated)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 7, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS25899

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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