Pulsed Radiofrequency in Treatment of Classic Trigeminal Neuralgia (Prolonged Duration Versus Higher Voltage)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Pain amplitude reduction
研究概览
简要总结
The current study investigated the efficacy of pulsed radiofrequency in pain reduction in TN patients and compared the efficacy and the impact on the quality of life of the standard technique with a prolonged duration technique and a higher voltage one.
Entire enrolled patients were diagnosed as classic TN according to the international headache society classification (IHS, 2013) and underwent brain MRI and MRA to exclude secondary causes. Patients were randomly divided into three groups, Group A patients underwent PRF using the standard settings, group B patients underwent PRF with prolonged duration and Group C patients underwent PRF with higher voltage. VAS and pain amplitude reduction were recorded before the intervention and 1 hour, 1 day, 1week, 1 month, 6 months and 1year after it. Quality of life was assessed before and 1 year after the intervention.
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
- Single (Investigator)
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
- •Patients are diagnosed as classic TN according to the international headache society classification of headache disorders
- •Visual analogue scale (VAS) for pain of at least 4 or more.
- •Pain is refractory to medical treatment (for at least 3 months with three drugs including carbamazepine with optimum dosage) or patients who developed intolerable side effects from medications.
排除标准
- •Symptomatic (secondary) TN: which is causes by structural lesion other than neurovascular compression such as multiple sclerosis, tumors, stroke or trauma according to the international headache society classification (IHS, 2013).
- •Local infection at the site of the needle puncture. Bleeding tendency or coagulopathy. Previous treatment with invasive treatments such as radiofrequency thermo coagulation, destructive chemical injection, gamma knife treatment, percutaneous balloon micro-compression or microvascular decompression.
- •Major mental or psychiatric disorders. History of drug abuse.
结局指标
主要结局
Pain amplitude reduction
时间窗: 1 year
compare the pain amplitude reduction in the three groups using the visual analogue pain scale
次要结局
- RAND 36-Item Health Survey(1 year)