The Change in Cutaneous Temperature When Using Acupuncture at TB-3 and BL-65 Acupoints in Healthy Participants

NCT06200337 | Completed DMC

• 1 other identifier: 1064/HĐĐĐ-ĐHYD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

For more than 2,500 years, traditional medicine, especially acupuncture, has been widely used in health care and recognized by the World Health Organization (WHO) to manage various diseases. Besides, many molecular biological mechanisms of acupuncture in pain management have been elucidated. Acupuncture is a safe, effective, and cost-effective therapy, reducing the overuse of opioid pain relievers. In neck pain treatment, many clinical studies used remote acupoints, which have specific effects on the neck. Among them, the Stream points in the Five Stream acupoints system are the most used acupuncture points in the treatment of neck pain. However, the relationship between these acupoints and the neck has not been proven. The goal of this trial is to compare the change in skin surface temperature at the neck and the cutaneous zone before and after using acupuncture at the control acupoint (SP3) and two research acupoints (TB3 and BL65) in healthy volunteers. The main questions it aims to answer are:

• Whether the Zhongzhu and Shugu acupoints change the skin temperature in the neck area?
• How does the change in temperature correlate with the cutaneous zone distribution of the Shaoyang and Taiyang meridians, respectively?

Conditions

Healthy Participants

Keywords

acupuncture; skin surface temperature

Outcome Measures

Primary Outcomes (2)

• The change in skin surface temperature at the neck

  The change in skin surface temperature (in degree Celsius) at the neck area when using acupuncture at Zhongzhu (TB3) and Shugu (BL65), in comparison with Taibai (SP3).

  Five time points: baseline; 6 minutes (after needled and fisrt rotation); 12 minutes (after second rotation); 17 minutes (after rejection); and 22 minute

• The change in skin surface temperature at the cutaneous zone of Taiyang and Shaoyang meridians

  The change in skin surface temperature (in degree Celsius) at the cutaneous zone of the Taiyang meridian compared with the Shaoyang meridian when using acupuncture at Zhongzhu (TB3) and Shugu (BL65).

  Five time points: baseline; 6 minutes (after needled and fisrt rotation); 12 minutes (after second rotation); 17 minutes (after rejection); and 22 minute

Secondary Outcomes (2)

• Adverse effects

  During and 7-day after procedure

• The adaptation to acupoints effects

  Five time points: baseline; 6 minutes (after needled and fisrt rotation); 12 minutes (after second rotation); 17 minutes (after rejection); and 22 minute

Other Outcomes (3)

• Blood pressure

  Baseline and 5 minutes after needle rejection

• Pulse rate

  Baseline and 5 minutes after needle rejection

• Body temperature

  Baseline and 5 minutes after needle rejection

Study Arms (3)

Group A

OTHER

In the first session, acupuncture was applied at BL65, the second at TB3, and the third at SP3. Each session was seperated 24 hours interval.

Procedure: Fine needle acupuncture

Group B

OTHER

In the first session, acupuncture will be applied at SP3, the second at BL65, and the third at TB3. Each session was seperated 24 hours interval.

Procedure: Fine needle acupuncture

Group C

OTHER

In the first session, acupuncture will be applied at TB3, the second at SP3, and the third at BL65. Each session was seperated 24 hours interval.

Procedure: Fine needle acupuncture

Interventions

Fine needle acupuncture PROCEDURE

All participants underwent three 24-hour apart sessions. In each session, the acupuncturist inserted two sterile needles into the left and right acupoints with a 90-degree angle and 0.5 to 1 cun in depth for TB3, 0.3 to 0.5 cun for BL65, and 0.3 to 0.5 cun for SP3. The acupuncturist rotated the needle at an angle of 180-270 degrees within 1 minute, with a frequency of 60 - 120 times/minute for stimulation.

Group A; Group B; Group C

Eligibility Criteria

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

You may qualify if:

• Healthy participants.
• 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 points less than 15 points).
• Vital signs within normal limits:
• Heart rate from 60 to 99 beats per minute.
• Systolic blood pressure between 90 and 139 mmHg.
• Diastolic blood pressure between 60 and 89 mmHg.
• Body temperature: 36.59 ± 0.43 degrees Celsius.
• Breathing rate: 16 ± 3 breaths per minute.
• Having no disease or using drugs which may 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 yet.

You may not qualify if:

• Participate in vigorous physical activities 2 hours before the procedure.
• Taking stimulants (alcohol, beer, coffee, and tobacco) within 24 hours before participating the study.
• Staying up late at night or having a sleep disorder before the procedure
• Women who were in menstruation period, pregnancy, or breastfeeding.
• Having skin injuries, dermatitis-skin infections, or wounds in the area to be investigated.
• Applying chemical or pharmaceutical products to the site of the skin to be investigated before participating the study.
• Using physical therapy, heat therapy, cupping therapy, massage, and acupuncture on the site of the skin to be investigated within 24 hours before participating the study.

Sponsors & Collaborators

• Loc Cong Dai Tran, MD: lead
• University of Medicine and Pharmacy at Ho Chi Minh City: collaborator

Study Sites (1)

School of Medicine, Vietnam National University at Ho Chi Minh City

Ho Chi Minh City, 70000, Vietnam

Location

Related Publications (6)

• Molsberger AF, Manickavasagan J, Abholz HH, Maixner WB, Endres HG. Acupuncture points are large fields: the fuzziness of acupuncture point localization by doctors in practice. Eur J Pain. 2012 Oct;16(9):1264-70. doi: 10.1002/j.1532-2149.2012.00145.x. Epub 2012 Apr 10.

  PMID: 22492604 BACKGROUND

• Huang T, Huang X, Zhang W, Jia S, Cheng X, Litscher G. The influence of different acupuncture manipulations on the skin temperature of an acupoint. Evid Based Complement Alternat Med. 2013;2013:905852. doi: 10.1155/2013/905852. Epub 2013 Feb 13.

  PMID: 23476709 BACKGROUND

• Ots T, Kandirian A, Szilagyi I, DiGiacomo SM, Sandner-Kiesling A. 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 acupuncture trials. Acupunct Med. 2020 Aug;38(4):211-226. doi: 10.1177/0964528419889636. Epub 2020 Feb 6.

  PMID: 32026725 BACKGROUND

• Amalu W, Block J, Chaudhry A. International academy of clinical thermology quality assurance guidelines. Standards and protocols in clinical thermographic imaging. Current Revision July 2015; July 2018. 2021.

  BACKGROUND

• Guan L, Li G, Yang Y, Deng X, Cai P. 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? Neural Regen Res. 2012 Mar 25;7(9):680-5. doi: 10.3969/j.issn.1673-5374.2012.09.007.

  PMID: 25745463 BACKGROUND

• 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.

  BACKGROUND

Study Officials

• Bay Thi Nguyen, MD., PhD.

  University of Medicine and Pharmacy at Ho Chi Minh City

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants: They did not know about acupuncture, meridian theory, and acupoints. The investigator informs the information about the specific location of the acupoints used and the purpose of the study. The investigator provided a questionnaire to assess the participants' knowledge of meridian and acupressure theory, expectations, and motivation to participate. Infrared image analyst: The person analyzing the infrared images is not familiar with acupuncture methods. We trained them for two weeks on using FLIR Thermal Studio software and identifying experimental skin areas. After analysis, the infrared image analyst encodes the data and sends it back to the data analyst. Data analyst: The investigator analyzed the data and was not involved in the randomization and data collection stages.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 11, 2024
• Study Start: February 20, 2023
• Primary Completion: March 30, 2023
• Study Completion: April 6, 2023
• Last Updated: January 11, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 1 years after the publication of results

Locations

VN (1)