Can Pregabalin Prevent the Development of Neuropathic Pain Following Spinal Cord Injury? A Double-Blind, Randomized, Placebo Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The primary outcome measures will be the development of Neuropathic Pain and intensity of pain .
研究概览
简要总结
This research study will test to see if people who receive pregabalin after their spinal cord injury will develop less nerve damage pain than people who do not receive it.
详细描述
Pregabalin is one of the few agents that have demonstrated effectiveness in the treatment of central NeP in SCI. Research is now proving that it is possible to prevent the development of pain in certain conditions. Pregabalin has been proven effective in this area with post surgical pain. Therefore, after traumatic SCI there may be a small window of time where we could prevent the development of NeP by administering an agent like Pregabalin.
Objective
To test the hypothesis that pregabalin is an effective treatment in preventing post-spinal cord injury neuropathic pain.
Design: double-blind, placebo controlled, randomized, trial Setting: Spinal cord injury program, neurosurgery and tertiary care rehabilitation center Subjects: 30 patients with acute traumatic spinal cord injury Method: Pregabalin will be offered to patients with acute traumatic spinal cord injury pain in a double blind crossover, placebo control design.
Main Outcome Measures: The primary outcome measures will be the development of Neuropathic Pain and intensity of pain Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores.
Results: To be determined. Conclusion: To be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants will be 18 years of age or older
- •Have suffered a traumatic spinal cord injury (complete or incomplete)
- •Be free of Neuropathic pain
- •Be in stable medical condition
排除标准
- •Pregnant or lactating women: Because we do not know the risks of pregabalin in pregnancy, females of child bearing years must have a negative pregnancy test (performed on screening and subsequent follow up visits) and be using a reliable method of birth control including oral or injectible birth control hormones, barriers, intrauterine devices or tubal ligation, or abstinence throughout the duration of the study.
- •Should a female become pregnant while participating in the study she will be un-blinded and, if on pregabalin, she will be weaned from the medication as quickly as is safe and withdrawn from the study. Appropriate follow-up for any pregnancy complications will be conducted.
- •Persons with known hypersensitivity to pregabalin or its constituents
- •Persons with Neuropathic pain at the time of enrollment
- •Persons with a chronic pain diagnoses that may interfere with the evaluation of the presence of Neuropathic pain
研究组 & 干预措施
Pregabalin, (other name) Lyrica
Study subjects wil be randomized to either the Pregabalin or Placebo group. There is a 5o ,50 chance of being in either group.
干预措施: Lyrica (Drug)
pregabalin, drug
study subjects that are randomized to the placebo group will receive matching placebo
干预措施: matching placebo (Drug)
结局指标
主要结局
The primary outcome measures will be the development of Neuropathic Pain and intensity of pain .
时间窗: the trial is 74 weeks in length
次要结局
- Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores.(trail is 74 weeks in length)
研究者
Christine Short
MD, FRCPC, FACP
Nova Scotia Health Authority