Study of Pregabalin in the Prevention of Central Neuropathic Pain in Acute Spinal Cord Injury
Can Pregabalin Prevent the Development of Neuropathic Pain Following Spinal Cord Injury? A Double-Blind, Randomized, Placebo Controlled Trial.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Nova Scotia
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Halifax、Nova Scotia、加拿大、B3h 4K4
- N.S Rehabilitation Center ,Capital Health
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：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.
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study participants will start will be on 150mg of Pregabalin or placebo capsules by mouth , twice a day.They will be on drug approx.
49 weeks and followed for another 49 weeks after stopping the medication.
其他名称：
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安慰剂比较：pregabalin, drug
study subjects that are randomized to the placebo group will receive matching placebo
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150 mg by mouth ,twice a day for 49 weeks
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The primary outcome measures will be the development of Neuropathic Pain and intensity of pain .
大体时间：the trial is 74 weeks in length
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the trial is 74 weeks in length
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Secondary outcome measures will be Ashworth's Scale for spasticity and ASIA motor and Sensory Scores.
大体时间：trail is 74 weeks in length
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trail is 74 weeks in length
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合作者和调查者
调查人员
- 首席研究员：Christine A. Short, Md FRCPC、Capital Health DHA Canada
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- Pregabalin and SCI-Short
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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