Anti-histamines Promote Electroacupuncture Analgesia: Basic and Clinical Research

Pain Clinical Trial

Official title:

Anti-histamines Promote Electroacupuncture Analgesia: Basic and Clinical Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805035
• Other study ID #: CMUH107-REC3-019
• Status: Completed
• Phase: N/A
• Start date: January 24, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: January 2020
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• electroacupuncture
Group 2 (n=10) EA at ST36 and GB34;intensity (2 mA), pulse width (1 ms), frequency (2 Hz)

Drug:
• antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate)
Group 3 (n=10) EA at ST36 and GB34 plus chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 1 tab);intensity (2 mA), pulse width (1 ms), frequency (2 Hz)
• antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate)
Group 4 (n=10) EA at ST36 and GB34 plus chlorpheniramine (Dexchlorpheniramine maleate2mg/tab, 2 tabs);intensity (2 mA), pulse width (1 ms), frequency (2 Hz)

Device:
• acupuncture
Minimal needling at ST36 and GB34

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Traiffort E, Pollard H, Moreau J, Ruat M, Schwartz JC, Martinez-Mir MI, Palacios JM. Pharmacological characterization and autoradiographic localization of histamine H2 receptors in human brain identified with [125I]iodoaminopotentidine. J Neurochem. 1992 Jul;59(1):290-9. — View Citation

Zhang WT, Jin Z, Luo F, Zhang L, Zeng YW, Han JS. Evidence from brain imaging with fMRI supporting functional specificity of acupoints in humans. Neurosci Lett. 2004 Jan 2;354(1):50-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain threshold in each group:the current intensity of Transcutaneous electrical stimulation (TCES)	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.	baseline and 10min after treatment

External Links

•   Evidence from brain imaging with fMRI supporting functional specificity of acupoints in humans
•   Pharmacological Characterization and Autoradiographic Localization of Histamine H2 Receptors in Human Brain Identified with [125I]Iodoaminopotentidine