Skip to main content
Clinical Trials/NCT07013500
NCT07013500Not yet recruitingNot Applicable

Comparison of Gasserian Ganglion Conventional Radiofrequency and Peripheral Pulsed Radiofrequency in Trigeminal Neuralgia

Mesut Bakır1 site in 1 country60 target enrollmentStarted: June 15, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Pain Intensity Reduction

Study Overview

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.

Detailed Description

Trigeminal neuralgia (TN) is a debilitating neuropathic condition characterized by recurrent episodes of severe, lancinating facial pain in the distribution of one or more branches of the trigeminal nerve. Although most patients initially respond to medical therapy such as carbamazepine or oxcarbazepine, a subset remains refractory and requires interventional treatment.

Radiofrequency ablation (RFA) has been widely used in the management of refractory TN, especially conventional thermal RFA targeting the Gasserian ganglion. While this approach offers substantial pain relief, it may lead to complications such as facial numbness, dysesthesia, or weakness due to irreversible nerve damage. As an alternative, pulsed RFA (PRF) offers neuromodulation without causing structural nerve injury and is often preferred for peripheral branch interventions.

This retrospective cohort study aims to compare the effectiveness and safety of two RFA techniques in patients with classical TN:

Group A: Conventional RFA applied to the Gasserian ganglion

Group B: Pulsed RFA applied peripherally to the affected branch (V1, V2, or V3)

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Masking Description

Participants and investigators know which intervention is being received.

Eligibility Criteria

Ages
55 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Arms & Interventions

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.

Intervention: Conventional Gasserian Ganglion Radiofrequency (Procedure)

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.

Intervention: Peripheral Pulsed Radiofrequency (Procedure)

Outcomes

Primary Outcomes

Pain Intensity Reduction

Time Frame: Baseline and 6 months after intervention

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

Secondary Outcomes

  • Patient Satisfaction Score(6 months post-procedure)

Investigators

Sponsor
Mesut Bakır
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Mesut Bakır

Assoc. Prof. Dr. Mesut Bakır, Mersin University, Department of Algology

Mersin University

Study Sites (1)

Loading locations...

Similar Trials

Comparison of Two Types of Radiofrequency... | Clinical Trial