Genicular Radiofrequency Ablation Versus Pulsed Radiofrequency

NCT ID: NCT06894147

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-05-30

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.

Conditions

Osteoarthritis of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Radiofrequency ablation

After performing a diagnostic block with 1 mL of 1% lidocaine on the superior medial, lateral, and inferior medial genicular nerve branches, patients who experience more than 50% benefit from the procedure will undergo radiofrequency ablation on the genicular nerve branches.

Group Type: EXPERIMENTAL

Genicular nerve pulse radiofrequency

Intervention Type: PROCEDURE

After performing a diagnostic block with 1 mL of 1% lidocaine on the superior medial, lateral, and inferior medial genicular nerve branches, patients who experience more than 50% benefit from the procedure will undergo pulsed radiofrequency aplication.

Pulsed radiofrequency

After performing a diagnostic block with 1 mL of 1% lidocaine on the superior medial, lateral, and inferior medial genicular nerve branches, patients who experience more than 50% benefit from the procedure will undergo either pulsed radiofrequency on the genicular nerve branches.

Group Type: EXPERIMENTAL

Genicular nerve pulse radiofrequency

Intervention Type: PROCEDURE

After performing a diagnostic block with 1 mL of 1% lidocaine on the superior medial, lateral, and inferior medial genicular nerve branches, patients who experience more than 50% benefit from the procedure will undergo pulsed radiofrequency aplication.

Interventions

Genicular nerve pulse radiofrequency

After performing a diagnostic block with 1 mL of 1% lidocaine on the superior medial, lateral, and inferior medial genicular nerve branches, patients who experience more than 50% benefit from the procedure will undergo pulsed radiofrequency aplication.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Ülkü Sabuncu

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Bilkent City Hospital

Ankara, Cankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 28263500 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34255959 (View on PubMed)

Other Identifiers

TABED-1-24-88

Identifier Type: -

Identifier Source: org_study_id