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

NCT02577770 | Completed

• 1 other identifier: 2014TD0018
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Acupuncture; caffeine; pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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.

Study Arms (3)

200mg caffeine plus acupuncture

EXPERIMENTAL

In healthy subjects

Device: acupuncture; Dietary Supplement: 200mg caffeine

400mg caffeine plus acupuncture

EXPERIMENTAL

In healthy subjects

Device: acupuncture; Dietary Supplement: 400mg caffeine

Decaffeinated plus acupuncture

PLACEBO COMPARATOR

In healthy subjects

Device: acupuncture; Dietary Supplement: Decaffeinated

Interventions

acupuncture DEVICE

therapeutic acupuncture treatment with actual needles

200mg caffeine plus acupuncture; 400mg caffeine plus acupuncture; Decaffeinated plus acupuncture

200mg caffeine DIETARY_SUPPLEMENT

8g coffee, po

200mg caffeine plus acupuncture

400mg caffeine DIETARY_SUPPLEMENT

16g coffee, po

400mg caffeine plus acupuncture

Decaffeinated DIETARY_SUPPLEMENT

decaffeinated coffee, po

Decaffeinated plus acupuncture

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead
• University of Leipzig: collaborator
• Boston University: collaborator

Study Sites (1)

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610075, China

Location

MeSH Terms

Conditions

Pain

Interventions

Acupuncture Therapy; Caffeine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2015
• First Posted: October 16, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

CN (1)