Clinical trial NCT07013500: Comparison of Two Types of Radiofrequency Treatment for Trigeminal Neuralgia
Official title: Comparison of Gasserian Ganglion Conventional Radiofrequency and Peripheral Pulsed Radiofrequency in Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trigeminal Neuralgia
Tic Douloureux
Neuropathic Facial Pain
Keywords: Trigeminal Neuralgia
Radiofrequency Ablation
Pulsed Radiofrequency
Gasserian Ganglion
Neuropathic Pain
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study.
Primary purpose: TREATMENT

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)

Patients were selected from the records of the Pain Clinic of Mersin University Faculty of Medicine between January 1, 2015, and June 1, 2025. A total of 60 patients aged 55-80 years, who had been diagnosed with classical TN (per ICHD-3 criteria), were included. All patients had failed medical management for at least 6 months and underwent either of the RFA techniques described above. Patients with secondary TN, prior craniofacial surgery, or missing follow-up data were excluded.

PRF was specifically chosen for peripheral interventions in our clinic to avoid thermal-related complications. PRF was applied at 42°C for two cycles of 120 seconds. Thermal RFA was applied with standard lesioning parameters following contrast-confirmed Gasserian ganglion targeting.

Outcome measures included:

Primary: Pain relief measured using a numerical rating scale (NRS) at baseline and 6 months post-procedure

Secondary: Patient satisfaction (5-point Likert scale), rate of complications, and recurrence of pain requiring reintervention

All procedures were performed under fluoroscopic guidance by experienced pain specialists. Data was extracted from electronic records and procedure reports. Statistical comparisons will be made using appropriate parametric or non-parametric tests based on data distribution.

This study seeks to contribute real-world evidence to guide clinicians in selecting safer, more effective RFA strategies for managing TN, particularly in patients at risk for complications or those preferring less invasive approaches.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity Reduction
timeFrame: Baseline and 6 months after intervention
Secondary outcomes:
measure: Patient Satisfaction Score
timeFrame: 6 months post-procedure
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University Faculty of Medicine, Department of Algology
state: İçel
Study officials:
affiliation: Mersin University Faculty of Medicine, Pain Clinic
name: Mesut Bakır, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.