Effects of Marijuana on Neuropathic Pain and Spasticity in Spinal Cord Injury Patients
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
The goal of this clinical trial is to compare effects of marijuana or cannabis on neuropathic pain and spasticity in spinal cord injury patients. The main question is: Does the cannabis product from KhonKaen University reduce neuropathic pain and spasticity in spinal cord injury patients? The research design is a crossover study. The participants will be randomly into 2 groups: group 1 and group 2. The participants received either cannabis or placebo for 2 weeks. After completing treatment, participants were swapped to the other group for 2 weeks, a wash-out period is 2 weeks. The outcome measurements are pain and spasticity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal cord injury more than 6 months
- •Neuropathic pain
- •Pain score > 3
- •Do not response to standard medical treatment
- •Given inform consent
排除标准
- •Allergy to cannabis
- •Unstable cardiovascular and pulmonary diseases
- •Chronic kidney and liver diseases
- •Psychological disease
- •Pregnancy or breastfeeding
研究组 & 干预措施
Experimental group
The participants will receive cannabis product for 2 weeks. The participants will receive the cannabis product (THC 30mg / 1 ml) manufactured by Faculty of pharmaceutical science KhonKaen University. The participants will gradually increase using the product starting from 1 drop (1.5 mg THC) per day sublingually and can increase using not more than 1 drop per day, until pain or spasticity can be controlled.
干预措施: Cannabis (Drug)
Placebo group
The participants will receive placebo product manufactured by Faculty of Pharmaceutical Science KhonKaen University for 2 weeks. The participants will gradually increase using the product starting from 1 drop per day sublingually and can increase using not more than 1 drop per day,
干预措施: Placebo (Drug)
结局指标
主要结局
Pain score
时间窗: 2 weeks
Visual analog scale
次要结局
- Spasticity(2 weeks)
- Activities of daily living(2 weeks)
- Quality of life score(2 weeks)
- H-reflex(2 weeks)
研究者
Nuttaset Manimmanakorn
Rehabilitation Medicine Department Faculty of Medicine
Khon Kaen University