Comparison of Two Types of Radiofrequency Treatment for Trigeminal Neuralgia

NCT07013500 | Not Yet Recruiting

• 1 other identifier: MERSINALG-TN-RFA-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Trigeminal neuralgia (TN) is a chronic pain condition that affects the face, often causing sharp, electric shock-like pain in areas served by the trigeminal nerve. When medications are no longer effective, interventional procedures such as radiofrequency ablation (RFA) may be used. This retrospective study compares two different RFA techniques in patients with classical TN: (1) conventional thermal RFA applied to the Gasserian ganglion, and (2) pulsed RFA applied peripherally to the nerve branches. The purpose of the study is to evaluate pain relief, patient satisfaction, and complication rates between these two commonly used techniques. A total of 60 patients aged 55-80 years, who were treated at the Mersin University Pain Clinic between January 2015 and June 2025, were included. The study uses clinical records and follow-up data to assess outcomes at 6 months post-procedure. This study aims to provide clinicians with more evidence to guide the selection of safer and more effective treatments for trigeminal neuralgia, with the goal of improving patients' quality of life and reducing treatment-related side effects.

Conditions

Trigeminal Neuralgia; Tic Douloureux; Neuropathic Facial Pain

Keywords

Trigeminal Neuralgia; Radiofrequency Ablation; Pulsed Radiofrequency; Gasserian Ganglion; Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Reduction

  Change in pain intensity score measured on the Numerical Rating Scale (NRS) from baseline to 6 months post-procedure.

  Baseline and 6 months after intervention

Secondary Outcomes (1)

• Patient Satisfaction Score

  6 months post-procedure

Study Arms (2)

Conventional Radiofrequency

ACTIVE COMPARATOR

Patients in this group received conventional thermal radiofrequency (RFA) treatment targeting the Gasserian ganglion. The procedure was performed under fluoroscopic guidance using standard techniques. Lesioning was applied at 70-75°C for 60-90 seconds after correct positioning was confirmed with sensory and motor stimulation.

Procedure: Conventional Gasserian Ganglion Radiofrequency

Peripheral Pulsed Radiofrequency

EXPERIMENTAL

Patients in this group received pulsed radiofrequency (PRF) applied peripherally to the affected branch of the trigeminal nerve (V1, V2, or V3), depending on the pain distribution. The procedure was performed under fluoroscopic guidance. PRF was applied at 42°C for two cycles of 120 seconds.

Procedure: Peripheral Pulsed Radiofrequency

Interventions

Conventional Gasserian Ganglion Radiofrequency PROCEDURE

Conventional RFA was performed at the Gasserian ganglion under fluoroscopic guidance with thermal lesioning at 70-75°C for up to 90 seconds. Sensory and motor stimulation were used to verify needle placement.

Conventional Radiofrequency

Peripheral Pulsed Radiofrequency PROCEDURE

PRF was applied to the peripheral branch of the trigeminal nerve at 42°C for two cycles of 120 seconds using fluoroscopic guidance. This technique was preferred in our clinic to avoid thermal complications such as hypoesthesia or motor dysfunction.

Peripheral Pulsed Radiofrequency

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 55 and 80 years with a diagnosis of classical trigeminal neuralgia according to the International Classification of Headache Disorders, 3rd edition (ICHD-3). Patients must have experienced pain refractory to medical management for at least 6 months and have complete clinical and procedural records available, including follow-up data for a minimum of 6 months.

You may not qualify if:

• Patients with secondary trigeminal neuralgia due to structural causes such as multiple sclerosis or tumors, those with a history of prior craniofacial surgery or neuroablative procedures, patients lacking sufficient follow-up data, and those with contraindications to sedation or with uncontrolled systemic comorbidities are excluded from the study.

Sponsors & Collaborators

• Mesut Bakır: lead

Study Sites (1)

Mersin University Faculty of Medicine, Department of Algology

Mersin, Mersin, 33110, Turkey (Türkiye)

Location

Related Publications (2)

• Chua NH, Vissers KC, Sluijter ME. Pulsed radiofrequency treatment in interventional pain management: mechanisms and potential indications-a review. Acta Neurochir (Wien). 2011 Apr;153(4):763-71. doi: 10.1007/s00701-010-0881-5. Epub 2010 Nov 30.

  PMID: 21116663 BACKGROUND

• Bakir M, Turkyilmaz GG, Teker N, Yavuz K, Ilcan B, Rumeli S. Comparison of Gasserian ganglion conventional radiofrequency ablation and peripheral nerve pulsed radiofrequency in trigeminal neuralgia: a retrospective cohort study. J Oral Facial Pain Headache. 2026 Jan;40(1):119-126. doi: 10.22514/jofph.2025.063. Epub 2026 Jan 12.

  PMID: 41607329 DERIVED

MeSH Terms

Conditions

Trigeminal Neuralgia; Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mesut Bakır, Assoc. Prof

  Mersin University Faculty of Medicine, Pain Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mesut Bakır, Assoc.Prof

CONTACT

+905457450655; mesutbakir@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participants and investigators know which intervention is being received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof. Dr. Mesut Bakır, Mersin University, Department of Algology

Model Details: Participants are assigned to one of two or more groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: June 15, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 30, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified individual participant data and selected supporting documents will be available upon request beginning 6 months after publication. Data will remain available for 5 years.
• Access Criteria: Researchers affiliated with academic institutions may request access to anonymized individual participant data and related documents for non-commercial research. Requests must include a brief study proposal and will be reviewed by the principal investigator. Data will be shared via institutional email upon approval.

Locations

TU (1)