Genicular Nerve Phenol Neurolysis Versus Radiofrequency Ablation for Pain Relief in Grade 4 Knee Osteoarthritis

March 6, 2025 updated by: Ain Shams University

The goal of this clinical trial is to compare the efficiency and efficacy of genicular nerves blockade by chemical phenol neurolysis versus radiofrequency ablation in managing pain in patients suffering from grade IV KOA in term of NRS pain score.

The participants will be evaluated by numeric rating scale and oxford knee score for assessment of pain relief up to 16 weeks.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

114

Phase

  • Not Applicable

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Grade 4 knee osteoarthritis according to Kellgren-Lawrence radiological classification.
  • Failure to manage pain with conservative methods.

Exclusion Criteria:

  • Prior knee replacement
  • Patients with cardiac pacemakers or implantable cardiac defibrillators.
  • Septic knee or systemic sepsis.
  • Allergy to any of the drugs used in the study.
  • Coagulopathy or patients on anticoagulants.
  • Patients with psychiatric illness.

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: genicular nerve phenol neurolysis
chemical neurolysis using 2 mL of 9% phenol solution prepared from crystallized phenol will be applied to each genicular nerve.
Procedure: genicular nerve neurolysis
The superior medial genicular nerve (SMGN), superior lateral genicular nerve (SLGN), and inferior medial genicular nerve (IMGN) will be blocked either by phenol neurolysis or radiofrequency ablation
Experimental: genicular nerve radiofrequency ablation
Radiofrequency thermocoagulation will be applied to each nerve at 80 degrees for 90 seconds.
Procedure: genicular nerve neurolysis
The superior medial genicular nerve (SMGN), superior lateral genicular nerve (SLGN), and inferior medial genicular nerve (IMGN) will be blocked either by phenol neurolysis or radiofrequency ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric rating scale
Time Frame: baseline, 2, 4, 8,12 and 16 weeks after the procedure
By an independent physician pain will be recorded using numeric rating scale which is a screening tool used to assess pain severity using a 0 - 10 scale with zero meaning no pain and 10 meaning the worst pain ever.
baseline, 2, 4, 8,12 and 16 weeks after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oxford knee score
Time Frame: baseline, 4, 8, 12, 16 weeks after the procedure
This score is used to assess both function and pain of the knee on a scale ranging from 0 (worst pain and function) and 48 (best function and no pain) this score will be recorded by an independent physician
baseline, 4, 8, 12, 16 weeks after the procedure

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Ahmed Boeith, MD, Ain Shams University

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)

April 1, 2025

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R17/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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