Comparative Effectiveness of Genicular Nerve Radiofrequency Thermocoagulation and Intra-Articular Pulsed Radiofrequency in the Management of Knee Osteoarthritis Pain

NCT07098455 | Active Not Recruiting

• 1 other identifier: E2-25-10611
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthristis; Radiofrequency Ablation

Keywords

Osteoarthritis of Knee; Pulsed Radiofrequency Treatment; Radiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

• NRS

  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 Outcomes (2)

• GPE

  baseline, 3rd month

• WOMAC

  baseline; 3rd month

Study Arms (2)

GNRFT - Genicular Nerve Radiofrequency Ablation

EXPERIMENTAL

Patients in this group will undergo ultrasound-guided genicular nerve radiofrequency ablation.

Procedure: GNRFT- genicular nerve radiofrequency ablation

IAPRF - Intra-articular pulsed radiofrequency

EXPERIMENTAL

KNEE INTRAARTICULAR PULSED RADIOFREQUENCY WILL BE APPLIED TO PATIENTS IN THIS GROUP

Procedure: IAPRF- Intraarticular pulsed radiofrequency

Interventions

GNRFT- genicular nerve radiofrequency ablation PROCEDURE

Ultrasound-guided genicular nerve radiofrequency ablation will be performed

GNRFT - Genicular Nerve Radiofrequency Ablation

IAPRF- Intraarticular pulsed radiofrequency PROCEDURE

Intra-articular pulsed radiofrequency will be applied under fluoroscopy guidance.

IAPRF - Intra-articular pulsed radiofrequency

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: August 1, 2025
• Study Start: August 21, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)