Low Dose Administration of Delta9-Tetrahydrocannabinol for the Prevention of Hyperalgesia and Chronic Pain in Patients With Acute Complex Regional Pain Syndrome (CRPS) of the Upper Limb
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence of chronic pain at one year assessed with Visual Analogue Scale (VAS)
研究概览
简要总结
The purpose of this study is to determine whether application of low dose Delta9-Tetrahydrocannabinol can prevent the development of chronic pain in patients with acute CRPS.
详细描述
Recent animal data suggest that the endocannabinoid system is a promising target in the prevention of chronic pain. It has been shown that the endocannabinoid system modifies excitatory and inhibitory currents in structures involved in the development of chronic pain such as the amygdala.
CRPS is a neuropathic pain condition, which is known to become chronic in a significant percentage. The study compares the effect of low dose Delta9-Tetrahydrocannabinol (90 days) and placebo in acute CRPS. All patients will receive a standard treatment consisting of drug therapy and physiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double
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 clinical diagnosis of acute CRPS (time from inciting event less than 16 weeks) of the upper extremity
- •No risk of dependency in a psychological assessment
排除标准
- •History of alcohol or drug abuse
- •Cardiac arrhythmias
- •Acute or chronic renal failure
- •ASA physical status classification III or higher
- •Psychiatric disorders
- •Pregnancy and breast feeding
结局指标
主要结局
Incidence of chronic pain at one year assessed with Visual Analogue Scale (VAS)
次要结局
- Changes in somatosensory phenotype at one year assessed with Quantitative Sensory Testing (QST)
- Motor function of the affected extremity at one year assessed with a biometric evaluation
- Changes in Health Related Quality of Life at one year assessed with SF-36
- Changes in plasma endocannabinoid levels at 30, 60, 90 days and at one year