NCT01579500已完成4 期
The Effect of Botulinum Toxin A in Post Spinal Cord Injury Neuropathic Pain
Catholic University of Korea Saint Paul's Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Visual analogue scale
研究概览
简要总结
The purpose of this study is to determine whether botulinum toxin A is effective in the treatment of neuropathic pain in spinal cord injury patients.
详细描述
Neuropathic pain remains a significant cause of life quality deterioration. This study includes spinal cord injury patients with refractory chronic neuropathic pain and investigates whether injection with botulinum toxin A improves pain scores.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •more than twenty years of age
- •paraplegic or tetraplegic due to cervical and thoracic spinal cord injury
- •more than 12 months since spinal cord injury and ASIA impairment scale unchanged for more than 6 months
- •persistence of neuropathic pain for more than three months or remission and recurrence of neuropathic pain for more than six months
- •a pain score of 40mm or more on the visual analogue scale
排除标准
- •neuropathic pain caused by confounding factors other than spinal cord injury
- •contraindicated for botulinum toxin type A
- •a change in pain medication one month prior to study enrollment
- •a condition involving neuromuscular junction (Ex. Eaton Lambert disease, myasthenia gravis)
- •person who received botulinum toxin type A within three months prior to study enrollment
研究组 & 干预措施
botulinum toxin A
Active Comparator
干预措施: Botulinum toxin type A (Drug)
normal saline
Placebo Comparator
干预措施: normal saline (Drug)
结局指标
主要结局
Visual analogue scale
时间窗: 4 weeks after intervention
次要结局
未报告次要终点
研究者
Myung Eun, Chung
clinical assistant proffessor
Catholic University of Korea Saint Paul's Hospital
研究点 (1)
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