Change in Skin Surface Temperature at the Neck When Using Acupuncture at Houxi Point in Healthy Volunteers

NCT05581329 | Completed

• 1 other identifier: 679/HDDD-DHYD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Acupuncture is a method of inserting very thin needles into special points on the body which are called acupoints, to treat diseases. This treatment has been widely applied in health care for over 2500 years. Currently, by synthesizing the results of many clinical studies, the World Health Organization (WHO) has recognized the importance of acupuncture as an effective treatment for various diseases. However, the specific effect of acupoints is still controversial. Until now, several studies have shown that acupoints are associated with certain areas of the human body that are far from the acupoints and can alter the temperature of those area. In our study, we will survey on the change in skin surface temperature at the neck when using acupuncture at Houxi point in healthy volunteers.

Conditions

Healthy Volunteers

Keywords

Acupuncture; Skin surface temperature

Outcome Measures

Primary Outcomes (2)

• The change in skin surface temperature at the neck when using acupuncture at Houxi point on each hand.

  During procedure

• Survey the change in temperature at the neck area respectively when using acupuncture at the left and right research acupoints (Houxi - SI3) compared with the control acupoints group (Yuji - LU10).

  During procedure

Study Arms (2)

Group A: acupoints on the left hand

EXPERIMENTAL

Participants will be received acupuncture at the control acupoint (Yuji - LU10) in the first trial phase, and the second trial phase will be conducted after 07 days at the research acupoint (Houxi - SI3). In each time, skin surface temperature at the neck area will be recorded.

Procedure: Acupuncture

Group B: acupoints on the right hand

EXPERIMENTAL

Participants will be received acupuncture at the control acupoint (Yuji - LU10) in the first trial phase, and the second trial phase will be conducted after 07 days at the research acupoint (Houxi - SI3). In each time, skin surface temperature at the neck area will be recorded.

Procedure: Acupuncture

Interventions

Acupuncture PROCEDURE

Acupuncture is a method of inserting very thin needles into special points on the body which are called acupoints. To conduct this intervention, we will use disposable acupuncture needles the size of 0.30 x 13 mm to acupuncture the control acupoint (Yuji - LU10) in the first session and the research acupoint (Houxi - SI3) in the second session.

Group A: acupoints on the left hand; Group B: acupoints on the right hand

Eligibility Criteria

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

You may qualify if:

• Healthy males and females were individual age between enough 18 and 30 years old.
• BMI: 18.5 - 23 kg/m2
• Mental alertness, good contact, cooperation with researchers.
• Having no psychiatric stress problem during acupuncture day (confirmed by answering the DASS21 questionnaire with stress point less than 15 points).
• Vital sign within normal limits:
• Heart rates from from 60 to 99 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.
• Breathing rate: 16 ± 3 respirations/minute .
• Having no disease or using drugs that change the body temperature.
• Not currently participating in other intervention studies.
• Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials.
• Having no acupuncture knowledge and experience yet.

You may not qualify if:

• Playing sport 2 hours before the study.
• Taking stimulant (alcohol, beer, coffee and tobacco) within 24 hours before conducting the study.
• Staying up late at night or having insomnia before the day of the study.
• Women who were in menstruation period, pregnancy, or breastfeeding.
• Having skin injuries, dermatitis-skin infections or wounds in the area to be investigated.
• Curently having neck-pain or other diseases that could affect or interfere with outcomes, including common cold.
• Currently taking sedatives or drugs that cause vasodilation, affect blood pressure and heart rate.
• Applying chemical or pharmaceutical products to the site of the skin to be investigated before conducting the study.
• Using physical therapy, heat therapy, cupping therapy, massage, acupuncture in the site of the skin to be investigated within 24 hours.
• 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

• Mo MJ, Hwang DR, Lee JH, et al. Analysis on the Acupuncture Contents of the Domestic Neck Pain and HIVD-Cervical Spine Clinical Studies: a literature review. 2017;34(2):113-125.
• Guan L, Li G, Yang Y, Deng X, Cai PJNRR. Infrared thermography and meridian-effect evidence and explanation in Bell's palsy patients treated by moxibustion at the Hegu (LI4) acupoint: Overall regulation or a specific target?. 2012;7(9):680.
• Ots T, Kandirian A, Szilagyi I, DiGiacomo SM. The selection of dermatomes for sham (placebo) acupuncture points is relevant for the outcome of acupuncture studies: a systematic review of sham (placebo)-controlled randomized acupunc
• Molsberger A, Manickavasagan J, Abholz H, Maixner W, Endres HJEJoP. Acupuncture points are large fields: the fuzziness of acupuncture point localization by doctors in practice. 2012;16(9):1264-1270.

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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Model Details: 2-arm parallel design, randomized, controlled and single blinded trial

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 14, 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)