Randomized Placebo-controlled Study of the Efficacy of Botulinum Toxin Type A (Botox) in Spontaneous Pain and Allodynia Related to Traumatic Nerve Injury or Postherpetic Neuralgia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Self-reported pain (numerical scales) on patients diaries
研究概览
简要总结
Objectives : to investigate the analgesic effects and safety of intradermal botulinum toxin A injection in the treatment of focal painful neuropathies (eg, postherpetic neuralgia, nerve trauma)
详细描述
The study will be randomized, performed in parallel group and double blind versus saline and will include 30 patients. Botulinum toxin injection will be injected intradermally in the painful area (one single injection) following a method adapted from that used in hyperhidrosis. The patients will be followed for 6 months after the injection. Primary outcome will be self-reported pain from the patients diaries. Secondary outcomes will be neuropathic symptoms, quality of life, allodynia to brush and pressure, detection and pain thresholds, proportion of responders, pain relief and clinical global impression. Clinical assessment will take place before injection then at 1 month, 3 months and 6 months.
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
- Quadruple (Participant, 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
- •daily pain for at least 6 months of at least moderate intensity clearly attributed to the nerve lesion
- •limited area of pain
- •mechanical allodynia in the painful area
排除标准
- •contraindication to BTXA formulation
- •coagulation disorders
- •another painful condition
- •current major depression
- •history of drug or alcohol abuse
- •compensation claim or litigation
- •facial neuropathic pain
研究组 & 干预措施
botulinum toxin A
active treatment arm using botulinum toxin A max 200 U injected into the painful area using SC injections 2 cm apart
干预措施: botulinum toxin A (Drug)
placebo
saline injection with the same dosages injected using the same procedure as botulinum toxin A
干预措施: botulinum toxin A (Drug)
结局指标
主要结局
Self-reported pain (numerical scales) on patients diaries
时间窗: prospective
pain intensity on numerical rating scales
次要结局
- mean pain (VAS) at each visit Quality of life Proportion of responders % pain relief Clinical global impression Assessment of blindedness(prospective)
研究者
Nadine ATTAL
MD PhD coordinator
Hospital Ambroise Paré Paris