跳至主要内容
临床试验/NCT07013500
NCT07013500尚未招募不适用

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

Mesut Bakır2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
2
主要终点
Pain Intensity Reduction

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Participants and investigators know which intervention is being received.

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Pain Intensity Reduction

时间窗: 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.

次要结局

  • Patient Satisfaction Score(6 months post-procedure)

研究者

发起方
Mesut Bakır
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mesut Bakır

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

Mersin University

研究点 (2)

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