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

NCT06864390 | Not Yet Recruiting

• 1 other identifier: FMASU R17/2025
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Joint Pain

Keywords

phenol neurolysis; radiofrequency; Knee osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Numeric rating scale

  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 Outcomes (1)

• oxford knee score

  baseline, 4, 8, 12, 16 weeks after the procedure

Study Arms (2)

genicular nerve phenol neurolysis

EXPERIMENTAL

chemical neurolysis using 2 mL of 9% phenol solution prepared from crystallized phenol will be applied to each genicular nerve.

Procedure: genicular nerve neurolysis

genicular nerve radiofrequency ablation

EXPERIMENTAL

Radiofrequency thermocoagulation will be applied to each nerve at 80 degrees for 90 seconds.

Procedure: genicular nerve neurolysis

Interventions

genicular nerve neurolysis PROCEDURE

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

genicular nerve phenol neurolysis; genicular nerve radiofrequency ablation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Arthralgia; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Rheumatic Diseases

Study Officials

• Ahmed Boeith, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmed boeith, MD

CONTACT

02001003074795; ahmedabdelrahamn2008@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: March 7, 2025
• Study Start: April 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-02