Genicular Radiofrequency Ablation Versus Pulsed Radiofrequency

NCT06894147 | Active Not Recruiting DMC

• 1 other identifier: TABED-1-24-88
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis of Knee

Keywords

Osteoarthritis of Knee; Pulsed Radio Frequency Treatment; Radiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

• Numeric rating scale (NRS) ,

  The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable

  Baseline, 3 weeks, 3 months.

Secondary Outcomes (1)

• Western Ontario and McMaster (WOMAC) Osteoarthritis Index

  Baseline, 3 weeks, 3 months.

Study Arms (2)

Radiofrequency ablation

EXPERIMENTAL

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.

Procedure: Genicular nerve pulse radiofrequency

Pulsed radiofrequency

EXPERIMENTAL

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.

Procedure: Genicular nerve pulse radiofrequency

Interventions

Genicular nerve pulse radiofrequency 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; Radiofrequency ablation

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Cankaya, 06680, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 28263500 BACKGROUND

• 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.

  PMID: 34255959 BACKGROUND

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patient Blinding (Single Blind for Patients): The patients will not be informed about which treatment group they have been assigned to. They will only know that they are participating in a clinical trial, but not the specifics of the treatment or control group. Investigator Blinding (Double Blind for Investigators): The principal investigator and all clinical staff involved in the treatment administration and assessment of outcomes will also be blinded to the patients' group assignments. The study medications or interventions will be labeled with codes, and the investigators will not have access to the key linking these codes to the specific treatments. Randomization: Random assignment will be used to allocate participants to one of the two groups (treatment group or control group) to ensure unbiased distribution of participants. Randomization will be performed using a computerized random number generator.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Randomized Controlled, Double-Blind

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 25, 2025
• Study Start: April 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: May 30, 2025
• Last Updated: March 25, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)