Unipolar Versus Bipolar Radiofrequency Ablation in Knee Osteoarthritis Pain

NCT07789340 | Not Yet Recruiting

• 1 other identifier: 36265PR110/6/26
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy of unipolar versus bipolar radiofrequency ablation (RFA) in knee osteoarthritis pain.

Conditions

Bipolar Radiofrequency Ablation; Unipolar Radiofrequency Ablation; Knee Osteoarthritis; Pain

Outcome Measures

Primary Outcomes (1)

• Proportion of successful responders with a reduction 50% of pain

  The proportion of successful responders with a reduction 50% of Visual Analog Scale (VAS) will be recorded.

  24 weeks after the procedure

Secondary Outcomes (2)

• Degree of pain

  24 weeks after the procedure

• Oxford Knee Score (OKS)

  24 weeks after the procedure

Study Arms (2)

Unipolar RFA (URFA) Group

EXPERIMENTAL

Patients will undergo radiofrequency ablation (RFA) of three genicular nerves (superior medial, superior lateral and inferior medial) with one cannula.

Procedure: Unipolar radiofrequency ablation

Bipolar RFA (BRFA) Group

EXPERIMENTAL

Patients will undergo radiofrequency ablation (RFA) as unipolar RFA but with two cannulas.

Procedure: Bipolar radiofrequency ablation

Interventions

Unipolar radiofrequency ablation PROCEDURE

Patients will undergo radiofrequency ablation (RFA) of three genicular nerves (superior medial, superior lateral and inferior medial) with one cannula.

Unipolar RFA (URFA) Group

Bipolar radiofrequency ablation PROCEDURE

Patients will undergo radiofrequency ablation (RFA) as unipolar RFA but with two cannulas.

Bipolar RFA (BRFA) Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 50 years.
• Both genders.
• Diagnosed with chronic knee osteoarthritis (KOA) according to the American College of Rheumatology (ACR) criteria and confirmed with plain radiography as the gold standard for the diagnosis of KOA.
• One chronic KOA pain not responding to other treatments as physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids.
• Kellgren-Lawrence grade (II-IV).

You may not qualify if:

• Chronic knee pain induced by infection, inflammation, tumors, and fractures.
• Prior knee surgery.
• Acute knee pain.
• Connective tissue diseases.
• Neurologic or psychiatric disorders.
• Intra-articular knee corticosteroid or hyaluronic acids in the past 3 months.
• Anticoagulant medication.
• Local infection of the site of intervention.
• Cognitive impairment.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mohammed S Elsharkawy, MD

CONTACT

00201148207870; mselsharkawy@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)