Change in Skin Surface Temperature at the Neck When Using Acupuncture at Houxi Point in Healthy Volunteers: a Randomized Controlled Trial

  • STATUS
    Recruiting
  • days left to enroll
    22
  • participants needed
    60
  • sponsor
    Bui Pham Minh Man
Updated on 22 October 2022
Accepts healthy volunteers

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.

Description

Participants and Methods: A randomize controlled trial will be conducted by comparing the change in the skin surface temperature before and after using acupunture at the control acupoint (Yuji - LU10) and the research acupoint (Houxi - SI3) on either the left or right hand in healthy volunteers. A total of 60 participants will be randomly assigned to 2 group (A and B) and the allocation was 1:1. Both groups will undergo two trial phases 07 days apart, corresponding to one acupoint on the same hand in each step. Group A (acupoints on the left hand): participants will be received acupuncture at the control acupoint (Yuji - LU10) in the first trial phase, and the second phase will be conducted after 07 days at the research acupoint (Houxi - SI3). Group B: proceeding similarly to group A, but the points are on the right hand. The primary outcome will be the change in skin surface temperature at the neck when using acupuncture at Houxi point on each hand. This trial will be performed as a 2-arm parallel design, randomize, controlled and single blinded.

Details
Condition Healthy Volunteers
Treatment Acupuncture
Clinical Study IdentifierNCT05581329
SponsorBui Pham Minh Man
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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\
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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