Clinical trial NCT06894147: Genicular Radiofrequency Ablation Versus Pulsed Radiofrequency
Official title: "Comparison of the Effects of Genicular Radiofrequency Ablation and Pulsed Radiofrequency Applications on Pain Levels in Patients with Osteoarthritis, Guided by Ultrasound''
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis of Knee
Keywords: Osteoarthritis of Knee
Pulsed Radio Frequency Treatment
Radiofrequency Ablation
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomized Controlled, Double-Blind
Primary purpose: TREATMENT

Brief summary: This study investigates the effectiveness of two treatments-genicular nerve radiofrequency ablation and pulsed radiofrequency-in reducing pain and improving function in osteoarthritis patients. These techniques, used after diagnostic nerve blocks, aim to provide long-lasting pain relief. Despite both being found effective, no clear consensus exists on which method is superior. The study seeks to compare these techniques and contribute new insights to the existing literature.

Detailed description: Chronic knee pain, especially in osteoarthritis patients, is a common condition that significantly affects mobility and quality of life. In individuals over the age of 60, the incidence is 9.6% in men and 18% in women. In patients with osteoarthritis, weight loss and appropriate exercises are recommended as the primary treatments. This is followed by medical therapy, injection treatments, and, if necessary, total knee arthroplasty. However, for patients with a body mass index (BMI) of 40 or higher, total knee arthroplasty is avoided due to the high surgical risk. In recent years, genicular nerve diagnostic block and radiofrequency ablation have been shown to reduce pain and improve function in these patients . Radiofrequency ablation works by blocking the transmission of sensory nerves, thereby improving function.

The innervation of the knee joint originates from the femoral nerve's articular branches, the common peroneal, saphenous, tibial, and obturator nerves. These articular branches are known as the genicular nerves, which are superficial and can be easily accessed using both fluoroscopy and ultrasound.

In osteoarthritis patients, superior medial, superior lateral, and inferior medial genicular nerve blocks are applied. After the diagnostic block, some clinics apply radiofrequency thermocoagulation to the genicular nerve branches for a lasting effect, while others use pulsed radiofrequency. Both techniques have been found to be effective, but there is no data in the literature regarding which technique is superior. The aim of this study is to determine which of the two techniques is more effective and share the findings with the literature.

Eligibility criteria: Inclusion Criteria:

* patients over the age of 18
* osteoarthritis
* Grade 2-4 gonarthrosis according to the Kellgren-Lawrence (KL) classification
* Pain 6-10 on the Numeric Rating Scale (NRS)

Exclusion Criteria:

* Patients with chronic knee pain due to another pathology (e.g., meniscopathy, trauma, rheumatoid arthritis) History of previous knee surgery History of intra-articular injection in the last 3 months Coagulopathy, use of antiplatelet or anticoagulant medications Infection Severe psychiatric disorders Patients with a cardiac pacemaker or defibrillator Renal or hepatic failure

Primary outcomes:
measure: Numeric rating scale (NRS) ,
timeFrame: Baseline, 3 weeks, 3 months.
Secondary outcomes:
measure: Western Ontario and McMaster (WOMAC) Osteoarthritis Index
timeFrame: Baseline, 3 weeks, 3 months.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Cankaya
Study officials:
References:
citation: Kirdemir P, Catav S, Alkaya Solmaz F. The genicular nerve: radiofrequency lesion application for chronic knee pain. Turk J Med Sci. 2017 Feb 27;47(1):268-272. doi: 10.3906/sag-1601-171.
citation: Fitzpatrick B, Cowling M, Poliak-Tunis M, Miller K. Effect of Genicular Nerve Radiofrequency Ablation for Knee Osteoarthritis: A Retrospective Chart Review. WMJ. 2021 Jul;120(2):156-159.