A Single Center, Double Blind, Randomized, Parallel-group Study to Assess the Effect of 200mg Caffeine,400mg Caffeine and Decaffeinated on Acupuncture Analgesia With the Human Pain Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change of pain will be measured with Von Frey Hair for capsaicin pain
研究概览
简要总结
This is a single center, double blind, randomized, parallel-group study to assess the effect of 200mg caffeine,400mg caffeine and decaffeinated on acupuncture analgesia with the human pain model.
详细描述
Aim: To evaluate the effect of caffeine on acupuncture analgesia with the human pain model.
Design: Double blind, randomized controlled trial will be performed in Chengdu. The study including two pain models : Potassium pain model and Capsaicin pain model. Both models including the following several groups: 200mg caffeine group, 400mg caffeine group, and decaffeinated group. Participants will be randomly assign to the three groups. Each participants will receive coffee drinking and acupuncture intervention. Each subjects of the Potassium pain model will receive be measured the pain at baseline, 30 minutes after drinking coffee, 10, 20, 30 minutes during acupuncture and 30 minutes after acupuncture intervention completed. Blood samples will be collected at baseline, 30 minutes after drinking coffee, 30 minutes during acupuncture and 30 minutes after acupuncture intervention completed. Each subjects of the capsaicin pain model will be measured the spontaneous pain with VAS scale and the area of hyperalgesia with Von Frey hair at the time of 5 minutes after topical application of capsaicin , 30 minutes after drinking coffee, 10, 20, 30 minutes during acupuncture and 30 minutes after acupuncture intervention completed. Blood samples will be collected at the time of 5 minutes after topical application of capsaicin, 30 minutes after drinking coffee, 30 minutes during acupuncture and 30 minutes after acupuncture intervention completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of a subject is between 18 and 40 years old, male or female
- •No known active ongoing disease, in good general health, with a BMI ranging from 18 to 30 kg/m2
- •No history of mental disorders,infectious diseases and bleeding disorders. No history of allergic reaction. Females who are not pregnant, lactating, of child-bearing potential, or have no a pregnancy plan within 3 months
- •No smoking, drinking alcohol
- •No intake of beverage, food and alcohol ,which contains caffeine at least two hours
- •No use of any of the methyl purine drugs. No use of any of the drugs ,which can affect the half-life of caffeine, such as: cimetidine, steroids, growth hormone, etc
- •No previous experience with acupuncture or other related treatments within 3 days
- •Reliable, cooperative, and of adequate intelligence to record the requested information on the questionnaire form
- •Informed consent form must be signed by subjects
排除标准
- •Subject with serious blood, heart, liver, kidney disease, digestive, or hematopoietic system disease
- •Subject with serious mental disorders, infectious diseases and bleeding disorders. Subject has a history of allergic reaction. Females who are pregnant, lactating, of child-bearing potential, or have a pregnancy plan within 3 months;
- •Prior use of any type of analgesic drugs before study within 5 half-lives of the drugs
- •Use of any of the methyl purine drugs. Use of any of the drugs, which can affect the half-life of caffeine, such as: Sympathomimetic drugs, theophylline drugs , α or β-blockers drugs, and any antihypertensive drugs, etc
- •Ingestion of any caffeine-containing beverage, food or alcohol 6 hours or less before study
- •Subject has a previous experience with acupuncture or other related treatments within 7 days
- •Suffered from medical or psychiatric disorders that prevented them from participating in the study
- •Subject who belongs to acupuncture-phobia
研究组 & 干预措施
400mg caffeine plus acupuncture
In healthy subjects
干预措施: 400mg caffeine (Dietary Supplement)
Decaffeinated plus acupuncture
In healthy subjects
干预措施: acupuncture (Device)
Decaffeinated plus acupuncture
In healthy subjects
干预措施: Decaffeinated (Dietary Supplement)
400mg caffeine plus acupuncture
In healthy subjects
干预措施: acupuncture (Device)
200mg caffeine plus acupuncture
In healthy subjects
干预措施: acupuncture (Device)
200mg caffeine plus acupuncture
In healthy subjects
干预措施: 200mg caffeine (Dietary Supplement)
结局指标
主要结局
Change of pain will be measured with Von Frey Hair for capsaicin pain
时间窗: 5 minutes after topical application of capsaicin , 30 minutes after drinking coffee, 10, 20, 30 minutes during acupuncture and 30 minutes after acupuncture intervention completed.
Change of pain will be measured with Visual Analog Scale for capsaicin pain
时间窗: 5 minutes after topical application of capsaicin , 30 minutes after drinking coffee, 10, 20, 30 minutes during acupuncture and 30 minutes after acupuncture intervention completed.
Change of pain threshold will be measured with Potassium Pain Tester for potassium pain
时间窗: Baseline, 30 minutes after drinking coffee,10,20,30 minutes during acupuncture and 30 minutes after acupuncture intervention completed
次要结局
- The concentration of caffeine in plasma measured by high performance liquid chromatography in both models(one day after the study( blood samples were collected at Baseline, 30 minutes after drinking coffee,30 minutes during acupuncture and 30 minutes after acupuncture intervention completed.)
- The concentration of adenosine in plasma measured by high performance liquid(one day after the study( blood samples were collected at Baseline, 30 minutes after drinking coffee,30 minutes during acupuncture and 30 minutes after acupuncture intervention completed.)