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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: acupuncture; Dietary supplement: 200mg caffeine; Dietary supplement: 400mg caffeine; Dietary supplement: Decaffeinated

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610075
      • Chengdu University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 200mg caffeine plus acupuncture; In healthy subjects	Device: acupuncture; therapeutic acupuncture treatment with actual needles; Dietary supplement: 200mg caffeine; 8g coffee, po
Experimental: 400mg caffeine plus acupuncture; In healthy subjects	Device: acupuncture; therapeutic acupuncture treatment with actual needles; Dietary supplement: 400mg caffeine; 16g coffee, po
Placebo Comparator: Decaffeinated plus acupuncture; In healthy subjects	Device: acupuncture; therapeutic acupuncture treatment with actual needles; Dietary supplement: Decaffeinated; decaffeinated coffee, po

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Chengdu University of Traditional Chinese Medicine
• Collaborators: Boston University; University of Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: September 12, 2015
• First Submitted That Met QC Criteria: October 15, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: pain; Acupuncture; caffeine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: 2014TD0018