Healthy ParticipantsNCT06200337
The Change in Cutaneous Temperature When Using Acupuncture at TB-3 and BL-65 Acupoints in Healthy Participants
A study testing Fine needle acupuncture in people with Healthy Participants, run by Loc Cong Dai Tran, MD at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Fine needle acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteVietnam
- Study dates
- 20 Feb 2023to 6 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
School of Medicine, Vietnam National University at Ho Chi Minh City
Ho Chi Minh City, 70000
About this study
Official title: 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?
Read the detailed description
Participants and Methods: The change in skin surface temperature before and after acupuncture at the control acupoint (SP3) and two research acupoints (TB3 and BL65) in healthy volunteers will be compared in a randomized, double-blinded, self-controlled trial. A total of 30 participants will be assigned to 3 groups (A, B, and C), and the allocation will be 1:1:1. Every group will go through three trial stages spaced out by 24 hours, with each stage corresponding to one acupoint on both sides. Group A: In the first trial stage, acupuncture will apply at BL65, the second trial stage at TB3, and the third trial stage at SP3. Group B: In the first trial stage, acupuncture will apply at SP3, the second stage at BL65, and the third stage at TB3. Group C: In the first trial stage, acupuncture will apply to participants at TB3, the second stage at SP3, and the third stage at BL65. The primary outcome of acupuncture at the TB3, BL65, and SP3 acupoints will be the alteration in skin surface temperature at the neck area and the cutaneous zone. The skin surface temperature was measured by an Infrared Thermal Camera brand FLIR C5 and thermal images were analyzed by FLIR Thermal Studio software.
- Conditions
- Healthy Participants
- Being tested
- Fine needle acupuncture
- Keywords
- acupuncture, skin surface temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine needle acupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Fine needle acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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
Investigating the adverse events (in percentage) when using acupuncture at Zhongzhu (TB3), Shugu (BL65), and Taibai (SP3) acupoints
Measured: During and 7-day after procedure
The adaptation to acupoints effects
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
Measured: Five time points: baseline; 6 minutes (after needled and fisrt rotation); 12 minutes (after second rotation); 17 minutes (after rejection); and 22 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start20 Feb 2023
- Primary completion30 Mar 2023
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loc Cong Dai Tran, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Loc Cong Dai Tran, MD, School of Medicine - Vietnam National University at Ho Chi Minh city
- Investigators
- Bay Thi Nguyen, MD., PhD., Study director, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200337
- Sponsor's protocol ID
- 1064/HĐĐĐ-ĐHYD
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic characteristic and outcome data will be shared
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.
PubMed 22492604Huang 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.
PubMed 23476709Ots 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.
PubMed 32026725Amalu 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 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.
PubMed 25745463Mo 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 at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06200337
- Acronym / sponsor ID
- 1064/HĐĐĐ-ĐHYD
- Conditions
- Healthy Participants
- Keywords
- acupuncture, skin surface temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Loc Cong Dai Tran, MDUniversity, hospital or other
- Collaborators
- University of Medicine and Pharmacy at Ho Chi Minh City
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Participants and Methods: The change in skin surface temperature before and after acupuncture at the control acupoint (SP3) and two research acupoints (TB3 and BL65) in healthy volunteers will be compared in a randomized, double-blinded, self-controlled trial. A total of 30 participants will be assigned to 3 groups (A, B, and C), and the allocation will be 1:1:1. Every group will go through three trial stages spaced out by 24 hours, with each stage corresponding to one acupoint on both sides. Group A: In the first trial stage, acupuncture will apply at BL65, the second trial stage at TB3, and the third trial stage at SP3. Group B: In the first trial stage, acupuncture will apply at SP3, the second stage at BL65, and the third stage at TB3. Group C: In the first trial stage, acupuncture will apply to participants at TB3, the second stage at SP3, and the third stage at BL65. The primary outcome of acupuncture at the TB3, BL65, and SP3 acupoints will be the alteration in skin surface temperature at the neck area and the cutaneous zone. The skin surface temperature was measured by an Infrared Thermal Camera brand FLIR C5 and thermal images were analyzed by FLIR Thermal Studio software.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Procedure: Fine needle acupunctureIn the first session, acupuncture was applied at BL65, the second at TB3, and the third at SP3. Each session was seperated 24 hours interval. |
| Group B | Other | Procedure: Fine needle acupunctureIn 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. |
| Group C | Other | Procedure: Fine needle acupunctureIn 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fine needle acupunctureAll 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. | Procedure or surgery | Group A, Group B, Group C |
Primary outcome
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).
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).
2 secondary outcomes
Adverse effects
Time frame: During and 7-day after procedure
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Background: PubMed 22492604Molsberger 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.
- Background: PubMed 23476709Huang 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.
- Background: PubMed 32026725Ots 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.
- BackgroundAmalu 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: PubMed 25745463Guan 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.
- BackgroundMo 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.
- Individual participant dataSharing planned: Yes. Demographic characteristic and outcome data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bay Thi Nguyen, MD., PhD. study director
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fine needle acupuncture in people with Healthy Participants, run by Loc Cong Dai Tran, MD at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06200337, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.