- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06200337
The Change in Cutaneous Temperature When Using Acupuncture at TB-3 and BL-65 Acupoints in Healthy Participants
The Change in Cutaneous Temperature When Using Acupuncture at Zhongzhu (TB-3) and Shugu (BL-65) Acupoints in Healthy Participants: A Pilot, Randomized, Double-blind, Self-controlled Trial
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?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ho Chi Minh City, Vietnam, 70000
- School of Medicine, Vietnam National University at Ho Chi Minh City
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Group A
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.
|
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.
|
Other: Group B
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.
|
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.
|
Other: Group C
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change in skin surface temperature at the neck
Time Frame: 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 (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
Time Frame: 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 (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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse effects
Time Frame: During and 7-day after procedure
|
Investigating the adverse events (in percentage) when using acupuncture at Zhongzhu (TB3), Shugu (BL65), and Taibai (SP3) acupoints
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During and 7-day after procedure
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The adaptation to acupoints effects
Time Frame: Five time points: baseline; 6 minutes (after needled and fisrt rotation); 12 minutes (after second rotation); 17 minutes (after rejection); and 22 minute
|
Comparision of the change in skin surface temperature (in degree Celsius) at the neck between 3 groups when using acupuncture at Zhongzhu (TB3), Shugu (BL65), Taibai (SP3), respectively
|
Five time points: baseline; 6 minutes (after needled and fisrt rotation); 12 minutes (after second rotation); 17 minutes (after rejection); and 22 minute
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: Baseline and 5 minutes after needle rejection
|
Comparison of the blood pressure in mmHg when acupuncture at Zhongzhu (TB3), Shugu (BL65), Taibai (SP3). Comparison of the blood pressure, heart rate, body temperature, and skin surface temperature at the neck before acupuncture at Zhongzhu (TB3), Shugu (BL65), Taibai (SP3). |
Baseline and 5 minutes after needle rejection
|
Pulse rate
Time Frame: Baseline and 5 minutes after needle rejection
|
Comparison of the pulse rate in rate per minute when acupuncture at Zhongzhu (TB3), Shugu (BL65), Taibai (SP3).
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Baseline and 5 minutes after needle rejection
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Body temperature
Time Frame: Baseline and 5 minutes after needle rejection
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Comparison of the body temperature in degree Celsius when acupuncture at Zhongzhu (TB3), Shugu (BL65), Taibai (SP3).
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Baseline and 5 minutes after needle rejection
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Bay Thi Nguyen, MD., PhD., University of Medicine and Pharmacy at Ho Chi Minh City
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1064/HĐĐĐ-ĐHYD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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