Randomized Double Blind Cross Over Study Assessing the Effect of Cannabiniods on Spasticity in Spinal Cord Injured Persons :A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Ashworth scale in most involved group muscles
研究概览
简要总结
Objectives: To determine whether nabilone, a synthetic cannabinoid, alleviates spasticity in people with spinal cord injury (SCI).
Methods: Twelve subjects were enrolled in this double-blind, placebo-controlled, crossover study. They received either nabilone or placebo during the first four-week period (0.5mg OD with option to increase to 0.5mg BID), then outcome measures were assessed. After a two-week washout, subjects were crossed-over to the opposite arm.
The primary outcome was the Ashworth scale for spasticity in the most involved muscle group, chosen by the subject and clinician. The secondary outcomes included Spasm Frequency Scale, Visual Analog Scale, Wartenberg Pendulum Test, sum of the Ashworth Scale in eight muscle groups of each side of the body, and the Clinician's and Subject's Global Impression of Change .
研究设计
- 研究类型
- Interventional
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
- •Patients with spinal cord injury were eligible for the study if they are 18-65 years old, have C5 (ASIA A-D) and below and the injury occurred greater than 1 year previously. They had to have stable neurological level of injury with moderate spasticity (Ashworth >/= 3) and no cognitive impairments. The spasticity medications needed to be unchanged for at least 30 days before inclusion, and no botulinum toxin injections for > 4 months.
排除标准
- •They were excluded if they had:
- •Heart disease as cannabinoids can reduce heart rate and blood pressure
- •History of psychotic disorders, schizophrenia or any active psychological disorder
- •Previously documented sensitivity to marijuana or other cannabinoid agents
- •Severe liver dysfunction
- •Cognitive impairment
- •Major illness in another body area
- •If they were pregnant or nursing mother
- •Had history of drug dependency
- •Used smoked cannabis < 30 days before the onset of the study or were unwilling not to smoke during the study; OR
- •If they fixed tendon contractures
研究组 & 干预措施
1
first on treatment then on Placebo
干预措施: nabilone then placebo (Drug)
2
first on placebo then on treatment
干预措施: placebo then nabilone (Drug)
结局指标
主要结局
Ashworth scale in most involved group muscles
时间窗: 10 weeks
次要结局
- The secondary outcomes included Spasm Frequency Scale, Visual Analog Scale, Wartenberg Pendulum Test, sum of the Ashworth Scale in eight muscle groups of each side of the body, and the Clinician's and Subject's Global Impression of Change .(10 weeks)