The Effect of Caffeine on Acupuncture Analgesia With the Human Pain Model
NCT ID: NCT02577770
Last Updated: 2020-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2015-05-31
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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200mg caffeine plus acupuncture
In healthy subjects
acupuncture
therapeutic acupuncture treatment with actual needles
200mg caffeine
8g coffee, po
400mg caffeine plus acupuncture
In healthy subjects
acupuncture
therapeutic acupuncture treatment with actual needles
400mg caffeine
16g coffee, po
Decaffeinated plus acupuncture
In healthy subjects
acupuncture
therapeutic acupuncture treatment with actual needles
Decaffeinated
decaffeinated coffee, po
Interventions
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acupuncture
therapeutic acupuncture treatment with actual needles
200mg caffeine
8g coffee, po
400mg caffeine
16g coffee, po
Decaffeinated
decaffeinated coffee, po
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
40 Years
ALL
Yes
Sponsors
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University of Leipzig
OTHER
Boston University
OTHER
Chengdu University of Traditional Chinese Medicine
OTHER
Responsible Party
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Locations
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Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China
Countries
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Other Identifiers
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2014TD0018
Identifier Type: -
Identifier Source: org_study_id
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