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NCT Number: NCT02577770

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610075, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture

Device

therapeutic acupuncture treatment with actual needles

200mg caffeine

Dietary Supplement

8g coffee, po

400mg caffeine

Dietary Supplement

16g coffee, po

Decaffeinated

Dietary Supplement

decaffeinated coffee, po

Primary outcomes

  1. Change of pain threshold will be measured with Potassium Pain Tester for potassium pain

    Time frame: Baseline, 30 minutes after drinking coffee,10,20,30 minutes during acupuncture and 30 minutes after acupuncture intervention completed

  2. Change of pain will be measured with Visual Analog Scale for capsaicin pain

    Time frame: 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.

  3. Change of pain will be measured with Von Frey Hair for capsaicin pain

    Time frame: 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 outcomes

  1. The concentration of caffeine in plasma measured by high performance liquid chromatography in both models

    Time frame: 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.

  2. The concentration of adenosine in plasma measured by high performance liquid

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chengdu University of Traditional Chinese Medicine

Other

Collaborators

  • Boston University
  • University of Leipzig

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 16, 2015
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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