Recurrence Rate of Trigeminal Neuralgia in Patients Treated With Percutaneous Stereotactic Continuous Radiofrequency Rhizotomy at 80 Degrees Celsius for 90 Seconds- a Single Center Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 主要终点
- Recurrence rate of trigeminal neuralgia after stereotactic rhizotomy
研究概览
简要总结
This study aims to find recurrence rate of the trigeminal neuralgia after patients undergo stereotactic rhizotomy by radiofrequency ablation at 80 degrees Celsius for 90 seconds under fluoroscopic guidance, a protocol that was modified from the originally described parameters for rhizotomy by John Tew, Chad J. Morgan and Andresw Grande et al. The presumption being that the higher temperature of the probe tip would lead to a more long-lasting lesion and lesser recurrence, but at the cost of more frequent sensory and motor deficits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 27 Years 至 91 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients fulfilling ICHD criteria:
- •Recurrent paroxysms of unilateral facial pain in the distribution(s) of one or more divisions of the trigeminal nerve, with no radiation beyond, and fulfilling criteria B and C
- •A. Pain has all of the following characteristics:
- •lasting from a fraction of a second to 2 minutes
- •severe intensity
- •electric shock-like, shooting, stabbing or sharp in quality B. Precipitated by innocuous stimuli within the affected trigeminal distribution C. Not better accounted for by another ICHD-3 diagnosis.
- •Age: Adults of both sexes
- •MRI brain ruled out organic or structural pathologies
排除标准
- •Patient with concomitant co-morbid conditions like brain tumours, vascular pathologies or coagulopathies.
- •Patients who had previously undergone trigeminal ganglion neurolysis with either alcohol or phenol.
- •Patients who were lost to follow-up before the completion of 6-month period or had not visited back after the procedure
- •Patients on oral anticoagulants
- •Patients declared high risk or ASA 3 and above for general anaesthesia.
结局指标
主要结局
Recurrence rate of trigeminal neuralgia after stereotactic rhizotomy
时间窗: Recurrence within 12 months of the intervention
Recurrence of pain in the same distribution of the trigeminal nerve branch or branches for which the stereotactic rhizotomy was originally performed
Proportion of patients with neurological deficits after stereotactic rhizotomy
时间窗: 5 years
locally deviced protocol for stereotactic rhizotomy of the involved trigeminal gangion dictates the use of higher temperature of 80 degree Celsius for 90 seconds, which translates into better pain relief and longer pain free intervals at the cost of higher percentage of sensory and motor deficits
次要结局
未报告次要终点
研究者
Muhammad Hasan Wasim
Fellow Pain Medicine
Shifa Clinical Research Center