Early Administration of Botulinum Toxin Type A (Botox®) in Neuropathic Pain Due to Thoracoscopy or Thoracotomy: a Randomized, Double Blind, Placebo Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- decrease in average pain intensity as measured by the Brief Pain Inventory (BPI)
研究概览
简要总结
Botulinum toxin type A has been reported to inhibit the release of various pain neurotransmitters (SP, CGRP, glutamate) responsible for neurogenic inflammation, a process that results from the sensitization of C-fiber nociceptors (peripheral sensitization). This action is probably responsible for the analgesic effect of botulinum toxin type A recently demonstrated in patients with neuropathic pain of peripheral origin.In those studies, patients had been suffering for years. The investigators can hypothesizes that earlier administration of Botox in the course of neuropathic pain might prevent central sensitization, that is secondary to peripheral sensitization. The investigators can hope to increase efficacy of Botulinum toxin type A injections and to prevent chronification of pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, 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
- •daily pain, for 3 months, secondary to thoracoscopy or thoracotomy, of neuropathic origin (DN4 questionary)
排除标准
- •contraindications for botulinum toxin
研究组 & 干预措施
PLACEBO
Patients will receive in one session multiple intradermal injections of placebo , in order to cover the whole painful area
干预措施: PLACEBO (Other)
BOTOX
Patients will receive in one session multiple intradermal injections of Botox, in order to cover the whole painful area
干预措施: BOTOX (Drug)
结局指标
主要结局
decrease in average pain intensity as measured by the Brief Pain Inventory (BPI)
时间窗: one month
次要结局
- VAS in the last 24 hours(24 hours)
- Neuropathic Pain Inventory(6 months)