A Prospective, Randomized Comparison of the Radiofrequency of Gasserian Ganglion Versus Peripheral Branches of the Trigeminal Nerve for the Treatment of Trigeminal Neuralgia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The modified Barrow Neurological Institute Pain Intensity Score
研究概览
简要总结
The aim of this study is to compare the efficacy of radiofrequency of the Gasserian ganglion versus peripheral branches of the trigeminal nerve for the treatment of trigeminal neuralgia.
详细描述
Trigeminal neuralgia (TN) is defined as sudden, severe, short-term, stabbing and recurrent pain in the distribution of one or more branches of the trigeminal nerve. Many invasive treatments are available for patients who respond poorly to medical therapy. Among them, radiofrequency therapy is a viable option with a reliable initial and long-term clinical efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Primary Trigeminal Neuralgia meets the criteria of the International Classification of Headache Disorders.
- •Suffering from severe trigeminal neuralgia that cannot be alleviated effectively with conservative therapy.
- •Agree to participate in the study
排除标准
- •Infection at the puncture site.
- •Coagulation disorder.
- •Abnormal blood test (hepatic or renal function)
- •History of receiving invasive treatment (glycerol rhizolysis, radiofrequency thermocoagulation, balloon compression, gamma knife treatment, microvascular decompression)
结局指标
主要结局
The modified Barrow Neurological Institute Pain Intensity Score
时间窗: six months
The efficacy of the treatment will be assessed using the modified Barrow Neurological Institute Pain Intensity Score (I: No pain, off medications; II: Occasional pain, off medications; IIIa: No pain, continued use of medications; IIIb: Pain persists, but adequately controlled with medications; IV: Pain not adequately controlled with medications; V: No relief).
次要结局
- Patient satisfaction(six months)
- Numeric rating scale(baseline to six months)
研究者
Selin Guven Kose
Principal Investigator
Diskapi Teaching and Research Hospital