The Effect of Caffeine on Acupuncture Analgesia With the Human Pain Model

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Pain

Intervention / Treatment
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* Device: acupuncture
* Dietary Supplement: 200mg caffeine
* Dietary Supplement: 400mg caffeine
* Dietary Supplement: Decaffeinated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 200mg caffeine plus acupuncture<br>In healthy subjects | Device: acupuncture<br>* therapeutic acupuncture treatment with actual needles<br>Dietary Supplement: 200mg caffeine<br>* 8g coffee, po<br>|
| Experimental: 400mg caffeine plus acupuncture<br>In healthy subjects | Device: acupuncture<br>* therapeutic acupuncture treatment with actual needles<br>Dietary Supplement: 400mg caffeine<br>* 16g coffee, po<br>|
| Placebo Comparator: Decaffeinated plus acupuncture<br>In healthy subjects | Device: acupuncture<br>* therapeutic acupuncture treatment with actual needles<br>Dietary Supplement: Decaffeinated<br>* decaffeinated coffee, po<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pain threshold will be measured with Potassium Pain Tester for potassium pain |  | Baseline, 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 |  | 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 Von Frey Hair for capsaicin pain |  | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, caffeine, pain