The Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among Spinal Cord Injury Patients Who Have Yet to Develop Central Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Central pain
研究概览
简要总结
Patients arriving to rehabilitation up to 3 months following SCI will be given (study group) or not (control group) Lyrica (75X2). They will be followed for central pain development.
详细描述
Patients arriving to rehabilitation up to 3 months following SCI will be recruited, if they have not yet developed central pain. Two thirds (the study group) will be treated with Lyrica (Pregabalin75X2) for 3 months. One third (the control group) will not receive preventative treatment. Participants will be followed for central pain development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Up to 3 months following traumatic or non-traumatic SCL
- •Ability to give informed consent and cooperate
排除标准
- •Pregnancy
- •Neurological or other medical conditions that may interfere with sensation
- •Neuropathic-like pain before recruitment (described as painful sensation of electric current, burning, numbness, tingling, pricking, or squeezing)
- •Being treated with Pregabalin
- •Blood creatinine levels >1.2 or creatinine clearance <60
- •Sensitivity to lactose
研究组 & 干预措施
Pregabalin
Pregabalin 75 mg X2
干预措施: Pregabalin 75mg (Drug)
结局指标
主要结局
Central pain
时间窗: 1 year
development of central pain by interview (yes /no )
McGill Pain Questionnaire
时间窗: 3 months
Range 0 -78. higher scores mean worse outcome.
次要结局
未报告次要终点
研究者
amiram-catz
Principal Investigator
Loewenstein Hospital