Change Temperature of Skin Surface at the Acupuncture Site, the Neck and the Face When Using Tonifying Acupuncture Manipulations or Dispersing Acupuncture Manipulations at Dazhui in Healthy Volunteers

NCT05578014 | Completed

• 1 other identifier: 678/HDDD-DHYD
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Acupuncture is a treatment method since ancient times and it has been recognized as an international treatment method by the World Health Organization. Although the structure and physiological effects of acupoints have been extensively studied, they have not been fully elucidated. A lot of studies on physiological effects of acupoints on the 12 main merdians have been published, but acupoints outside the meridians or acupoints on the eight extraordinary vessels have not been noticed. In particular, the Dazhui is one of the acupoints on the Du Merdian that is often used clinically. In the other side, several researches have shown that using different acupuncture manipulations can achieve different therapeutic effects. In our study, we want to determinate and compare the change temperature of skin surface at the acupuncture site, the neck and the face when using tonifying acupuncture manipulations or dispersing acupuncture manipulations at Dazhui in healthy volunteers.

Conditions

Healthy Volunteers

Keywords

Acupuncture Manipulations; Tonifying Acupuncture Manipulations; Dispersing Acupuncture Manipulations

Outcome Measures

Primary Outcomes (2)

• Change temperature of skin surface at at the acupuncture site, the neck and the face when using tonifying acupuncture manipulations at Dazhui

  During procedure

• Change temperature of skin surface at at the acupuncture site, the neck and the face when using dispersing acupuncture manipulations at Dazhui

  During procedure

Study Arms (3)

Group STD

EXPERIMENTAL

19 participant received sham acupuncture at EX-B2 T3 point in right side or acupuncture with tonyfying or dispersing manipulations at Dazhui point, corresponding to 3 times of acupuncture in 14 days, each time is 7 days aparts. In each time, temperature of skin surface at the acupuncture site, the neck and the face will be recorded. Procedure/Surgery: Acupuncture with disposable acupuncture needles (the size of 0.30 x 25 mm) at EX-B2 T3 point in right side as sham acupoint in the first trial phase. We used the same type of acupuncture needles as aboved to acupuncture at Dazhui with tonifying manipulations in the second trial phase and with dispersing manipulatiuons in the third trial phase.

Procedure: Acupuncture

Group TDS

EXPERIMENTAL

19 participant received acupuncture with tonyfying or dispersing manipulations at Dazhui or sham acupuncture at EX-B2 T3 point in right side, corresponding to 3 times of acupuncture in 14 days, each time is 7 days aparts. In each time, temperature of skin surface at the acupuncture site, the neck and the face will be recorded. Procedure/Surgery: Acupuncture with disposable acupuncture needles (the size of 0.30 x 25 mm) at Dazhui with tonifying manipulations in the first trial phase and with dispersing manipulatiuons in the second trial phase. We used the same type of acupuncture needles as aboved to acupuncture at EX-B2 T3 point in right side as sham acupoint in the third trial phase.

Procedure: Acupuncture

Group DST

EXPERIMENTAL

19 participant received acupuncture with tonyfying or dispersing manipulations at Dazhui or sham acupuncture at EX-B2 T3 point in right side, corresponding to 3 times of acupuncture in 14 days, each time is 7 days aparts. In each time, temperature of skin surface at the acupuncture site, the neck and the face will be recorded. Procedure/Surgery: Acupuncture with disposable acupuncture needles (the size of 0.30 x 25 mm) at Dazhui with tonifying manipulations in the first trial phase and with dispersing manipulatiuons in the second trial phase. We used the same type of acupuncture needles as aboved to acupuncture at EX-B2 T3 point in right side as sham acupoint in the third trial phase.

Procedure: Acupuncture

Interventions

Acupuncture PROCEDURE

To conduct this intervention, we used disposable acupuncture needles with the size of 0.30 x 25 mm to acupuncture the sham acupoint (EX-B2 T3 point) or Dazhui point.

Group DST; Group STD; Group TDS

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers, regardless of gender or profession
• Age between enough 18 and 30 years old.
• BMI: 18.5 - 23 kg/m2
• Mental alertness, good contact, cooperation with researchers.
• DASS 21 score within normal limits.
• Have no disease which change the body temperature, like hyperthyroidism, hypothyroidism.
• Vital sign within normal limits:
• Heart rates from from 60 to 100 beats/minute.
• Systolic blood pressure between 90 and 139 mmHg.
• Diastolic blood pressure between 60 and 89 mmHg.
• Body temperature: 36.59 ± 0.43 0C.
• SpO2 from 95 to 99%.
• Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials.
• Not currently participating in other intervention studies.
• Have no acupuncture experience yet.

You may not qualify if:

• Having an inflammatory injury in the site of the skin to be investigated.
• Using heat therapy, for example massage, cupping therapy, acupuncture in the site of the skin to be investigated within 24h.
• Applying chemical or pharmaceutical products to the site of the skin to be survey before conducting the study.
• Other diseases that could affect or interfere with outcomes, including common cold or flu.
• Curently having neck-pain or having skin diseases, for example: tinea versicolor, eczema in the site of the skin to be investigated.
• Taking stimulant (alcohol, beer, coffee, tobacco) within 24h.
• Staying up at night or having insomnia before the day of the study.
• Playing sport within 2h.
• Pregnant woman or breastfeeding woman or woman in period.
• Currently using certain drugs which dilate blood vessels and drop in blood pressure.
• Anxiety, depression, stress before conducting the study with DASS 21 score \< 15.

Sponsors & Collaborators

• Bui Pham Minh Man: lead

Study Sites (1)

Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City

Ho Chi Minh City, Vietnam

Location

Related Links

• World Health Organization. Acupuncture : review and analysis of reports on controlled clinical trials. World Health Organization; 2014.May 16, 2022.
• Z. Lu, H. Dong, Q. Wang, et al. Perioperative acupuncture modulation: more than anaesthesia. doi:10.1093/bja/aev227British Journal of Anaesthesia.2015;115(2):183-193.
• Jia-Min Yang, Xiao-Yu Shen, Ling Zhang, et al. The Effect of Acupuncture to SP6 on Skin Temperature Changes of SP6 and SP10: An Observation of "Deqi". Evidence-Based Complementary and Alternative Medicine. 2014;2014: 595963. Doi: 10.1155/2014/595963
• Ali Mohammadi, Liang-Xiao Ma, Yang Yang, et al. Immediate Analgesic Effect of Perpendicular Needling or Transverse Needling at SP6 in Primary Dysmenorrhea: A Pilot Study. Medical Acupuncture. 2019;31(4): 207-217. Doi:10.1089/acu.2019.1362
• Weihui Li, Andrew Ahn. Effect of Acupuncture Manipulations at LI4 or LI11 on Blood Flow and Skin Temperature. Journal of Acupuncture \& Meridian Studies. 2016;9(3):128-133. doi:10.1016/j.jams.2015.08.005

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Model Details: A pilot study

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: October 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

VN (1)