Treatment of Primary Trigeminal Neuralgia: A Comparative Study of Microvascular Decompression and Stereotactic Gamma Knife Radiosurgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 主要终点
- Barrow Neurological Institute Pain Intensity scale (1-5)
研究概览
简要总结
Clinical randomized study to compare the clinical effectiveness between two modalities of treatment of trigeminal neuralgia namely gamma knife radio surgery and microvascular decompression
详细描述
A randomized prospective study conducted in The Neurosciences Hospital, Baghdad, from January 2016 to January 2018, patients had either GKR treatment or treated with MVD. The pain evaluated pre- and post-operatively using the Barrow Neurological Institute Pain Intensity scale (BNIPI), visual analog scale (VAS) and Brief Pain Inventory Facial (BPI-Facial) scoring systems. In GKR procedure, the trigeminal root entry zone targeted with a radiation dose of 80 Gy. MVD was performed using retro-sigmoid approach. Follow-up period for two years
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary idiopathic trigeminal neuralgia
排除标准
- •secondary trigeminal neuralgia
结局指标
主要结局
Barrow Neurological Institute Pain Intensity scale (1-5)
时间窗: Two years
The pain evaluated pre- and post-operatively with the use of analgesic drugs the best is 1 indicates free of pain, the worst is 5. It is dependent score
visual analog scale (0-10)
时间窗: Two years
Pain severity described subjectively by the patient himself pre and post treatment , the 0 is free of pain and worst is 10. It is dependent score
Brief Pain Inventory (1-7)
时间窗: ُTwo years
Assess pain severity as impact to functional activities, the 7 is normal live activity and the worst is 1. It is dependent score
次要结局
未报告次要终点
研究者
Dr. Moneer k. Faraj
Consultant neurosurgeon
University of Baghdad