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Completed

NCT Number: NCT07098455

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GNRFT- genicular nerve radiofrequency ablation

Procedure

Ultrasound-guided genicular nerve radiofrequency ablation will be performed

IAPRF- Intraarticular pulsed radiofrequency

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Acronym: GNRFT & IAPRF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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