Comparison of Conventional and Cooled Radiofrequency Ablation in Knee Osteoarthritis

February 25, 2026 updated by: Ayse Naz Kalem, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Comparison of the Effectiveness of Conventional and Cooled Radiofrequency Ablation in Advanced Knee Osteoarthritis

The aim of this study was to examine and compare the effects of conventional and cooled radiofrequency ablation on pain and disability levels in patients with knee pain resistant to other treatments due to knee osteoarthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

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

  • Turkey (Türkiye)
    • Çankaya
      • Ankara, Çankaya, Turkey (Türkiye), 06800
        • Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

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:

  • Knee pain lasting more than 6 months
  • Age between 50 and 80
  • Diagnosis of radiographically proven grade III or IV knee osteoarthritis according to the Kellgren-Lawrence Grading Scale, marked narrowing of the medial compartment of the tibiofemoral joint space

  • Presence of pain resistant to conservative treatment

    • Exercise
    • Physical therapy agents
    • Use of oral anti-inflammatory agents

Exclusion Criteria:

  • History of trauma to the knee area
  • History of knee surgery
  • Presence of systemic inflammatory disease affecting the knee joint
  • Presence of peripheral neuropathy or radiculopathy
  • Pregnancy
  • Hemodynamic instability
  • Presence of skin or soft tissue infection at the injection site
  • Refusal to participate in the study
  • Presence of acute knee pain with accompanying inflammatory findings
  • Presence of a serious psychiatric disorder or neurological disease Having received an intra-articular injection within the last 3 months

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Radiofrequency Ablation
Conventional radiofrequency ablation with fluoroscopy
Device: Radiofrequency ablation
Genicular nerve neurolysis with heat
Experimental: Cooled Radiofrequency Ablation
Cooled radiofrequency ablation with ultrasound
Device: Radiofrequency ablation
Genicular nerve neurolysis with heat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)
Patients will select their pain from 10 mm scale
Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)
This scale about patient's disability due to knee osteoarthritis
Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)
5-Point Likert Patient Satisfaction Scale
Time Frame: Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)
'0' =I am not happy at all, '5'=I am very pleased
Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)
Change in frequency of analgesic use
Time Frame: Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)
How many analgesic did use in past week?
Before treatment (0. week), 4 weeks after treatment (4.week), 12 weeks after treatment (12.week)

Collaborators and Investigators

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

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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)

February 1, 2025

Primary Completion (Actual)

August 12, 2025

Study Completion (Actual)

November 12, 2025

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 7, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEŞH-EK-2025-064

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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