Comparative Effectiveness of Genicular Nerve Radiofrequency Thermocoagulation and Intra-Articular Pulsed Radiofrequency in the Management of Knee Osteoarthritis Pain (GNRFT & IAPRF)

May 21, 2026 updated by: Ali ÇOŞTU, Ankara City Hospital Bilkent

Osteoarthritis (OA) is a degenerative disease characterized by progressive cartilage deterioration, osteophyte formation, subchondral sclerosis, and a number of biochemical and morphological changes in weight-bearing joints that are affected by genetic, mechanical, and biochemical factors. The prevalence of secondary chronic knee pain in OA is more than 12% in individuals over the age of 60. It is one of the most common musculoskeletal disorders in elderly patients and has become a global health problem. Standard treatments for OA include physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), tramadol, opioids, intra-articular hyaluronic acid, or steroids. In more severe cases, surgical knee arthroplasty should be considered. But long-term use of NSAIDs is associated with stomach bleeding, adverse cardiovascular events, and kidney failure. Opioids are often used, but a large number of side effects are encountered, especially in the elderly. Knee surgery is not always possible and can cause complications such as hematomas, infections, and damage to the surrounding tissue.

Radiofrequency (RF) application (pulsed or continuous) is a neuromodulatory or neurolytic technique that represents an alternative in pain due to osteoarthritis. RF therapy is one of the conservative treatments that has many advantages, such as minimal invasiveness, rapid recovery, and less negative response. Radiofrequency thermocoagulation (RFT) destroys the integrity of peripheral nerves using hyperthermia and thereby blocks the transmission of pain signals, while pulsed radiofrequency (PRF) regulates neurological functions or inhibits the production of immunoinflammatory factors (e.g., IL-1β, TNF-α, IL-6) by using electric fields to affect their production, thereby relieving pain in patients.

Genicular nerve radiofrequency thermocoagulation application and knee intra-articular pulsed radiofrequency application are the two radiofrequency methods routinely applied in the treatment of gonarthrosis-induced pain in our clinic. In this study, it is aimed to evaluate the effectiveness of these two methods and compare their outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

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 Locations

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:

  • Patients over 18 years of age;
  • Patients who have pain due to knee osteoarthritis
  • Patients who agree to undergo knee geniculate nerve thermocoagulation or knee intra-articular pulsed radiofrequency therapy and follow-up.

Exclusion Criteria:

  • Patients using anticoagulants and those with coagulation disorders,
  • Patients with psychomotor disorders,
  • Patients who have undergone intra-articular injections, interventional procedures, or surgery for knee osteoarthritis in the last year,
  • Patients with bacterial infection or infectious discharge in the area to be treated,
  • Patients with allergies to local anesthetics, and pregnant and breastfeeding patients

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GNRFT - Genicular Nerve Radiofrequency Ablation
Patients in this group will undergo ultrasound-guided genicular nerve radiofrequency ablation.
Procedure: GNRFT- genicular nerve radiofrequency ablation
Ultrasound-guided genicular nerve radiofrequency ablation will be performed
Experimental: IAPRF - Intra-articular pulsed radiofrequency
KNEE INTRAARTICULAR PULSED RADIOFREQUENCY WILL BE APPLIED TO PATIENTS IN THIS GROUP
Procedure: IAPRF- Intraarticular pulsed radiofrequency
Intra-articular pulsed radiofrequency will be applied under fluoroscopy guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS
Time Frame: baseline, at the 3rd month
Pain intensity was measured using an 11-point Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. Patients rated their pain intensity based on their average pain during the defined time frame. Changes in NRS scores over time were used to evaluate treatment response.
baseline, at the 3rd month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GPE
Time Frame: baseline, 3rd month
Overall patient-perceived change in symptoms was assessed using the Global Perceived Effect scale. Patients rated their overall condition compared with baseline on a Likert-type scale ranging from "very much worse" to "very much improved." The GPE was used to capture the patient's global assessment of treatment effectiveness.
baseline, 3rd month
WOMAC
Time Frame: baseline; 3rd month
Functional status was assessed using the WOMAC questionnaire, a validated disease-specific instrument for osteoarthritis. The WOMAC consists of 24 items across three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Higher scores indicate worse pain, stiffness, and functional limitation.
baseline; 3rd month

Collaborators and Investigators

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

Sponsor

Ankara City Hospital Bilkent

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 (Actual)

August 21, 2025

Primary Completion (Actual)

March 1, 2026

Study Completion (Actual)

April 20, 2026

Study Registration Dates

First Submitted

July 10, 2025

First Submitted That Met QC Criteria

July 31, 2025

First Posted (Actual)

August 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2-25-10611

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

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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