Anti-histamines Promote Electroacupuncture Analgesia: Basic and Clinical Research

Not Applicable

Completed

• Conditions: Pain
• Interventions: Device: electroacupuncture; Device: acupuncture; Drug: antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate); Drug: antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate)

• Registration Number: NCT03805035
• Lead Sponsor: China Medical University Hospital

Brief Summary

Acupuncture has been used in traditional Chinese medicine for around 3,000 years and is increasingly practiced worldwide. The effects of acupuncture in chronic pain have been investigated in many clinical trials. Histamine H1 receptor antagonists are commonly used for treating allergy. Recently, investigators found that histamine H1 receptor antagonists at relatively low doses facilitate EA analgesia in the acetic acid-induced abdominal writhing test. Investigators aim to further explore whether histamine H1 receptor antagonists also facilitate EA analgesia in humans.The aims of the proposed studies are to: Conduct a clinical trial to demonstrate that H1 receptor antagonists at relatively low doses facilitate EA analgesia in healthy volunteers. This study will recruit 40 healthy normal subjects (aged between 20 and 30 years) who will be randomly assigned to one of four groups: (1) Sham acupuncture (Shallow needling without electrical stimulation) at ST36 and GB34; (2) EA at ST36 and GB34; (3) EA at ST36 and GB34 plus low-dose chlorpheniramine (2 mg); (4) EA at ST36 and GB34 plus regular-dose chlorpheniramine (4 mg). The primary endpoint will be the pain threshold. It is expected that the completion of this proposed study will enhance our knowledge as to how acupuncture analgesia can be promoted by antihistamine drugs given at a low dose and help to define its application for clinical use.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-13
• Study First Posted: 2019-01-15
• Study Start: 2019-01-24
• Primary Completion: 2019-06-27
• Study Completion: 2019-06-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. . Age: 20 to 30 years of age.
2. . Agrees to undergo a comprehensive medical history and physical examination.
3. . No history of analgesic, sedative, dietary/appetite medication intake for more than 3 weeks prior to enrolment.

Exclusion Criteria

1. . An ongoing medical condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being (e.g., hypertension, diabetes mellitus, or epilepsy).
2. . A compromised skin barrier (e.g., skin disease, allergy) that would interfere with the conduct of the EA procedure and assessments of the study.
3. . An implant such as a pacemaker, defibrillator, or electronic medical equipment.
4. . Pregnancy, or planning for pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EA+antihistamine(low dose) group	antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate)	EA at ST36 and GB34 plus low-dose chlorpheniramine( Dexchlorpheniramine maleate 2mg/tab, 1 tab; n=10)
EA+antihistamine(high dose) group	antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate)	EA at ST36 and GB34 plus high-dose chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 2 tabs; n=10)
EA+antihistamine(low dose) group	electroacupuncture	EA at ST36 and GB34 plus low-dose chlorpheniramine( Dexchlorpheniramine maleate 2mg/tab, 1 tab; n=10)
EA+antihistamine(high dose) group	electroacupuncture	EA at ST36 and GB34 plus high-dose chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 2 tabs; n=10)
true EA group	electroacupuncture	EA at ST36 and GB34 (n=10)
sham EA group	acupuncture	Minimal needling at ST36 and GB34 (n=10)

Primary Outcome Measures

Name	Time	Method
pain threshold in each group:the current intensity of Transcutaneous electrical stimulation (TCES)	baseline and 10min after treatment	Transcutaneous electrical stimulation (TCES) is used as a method of inducing pain in the study. The procedure is to attach two electrode patches on the inside of the upper arm of the subject and then connect the electric stimulator. The current intensity will gradually increase from 0 mA, and each time increase 0.5amps until the subject feels pain in the visual analogy. Transcutaneous electrical stimulation (TCES) will be stopped at the visual analog scale of 5 (that means the moderate pain). The current intensity will be compared within and between each group.

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan