Healthy VolunteersNCT05578014
Change Temperature of Skin Surface at the Acupuncture Site, the Neck and the Face When Using Tonifying Acupuncture Manipulations or Dispersing Acupuncture Manipulations at Dazhui in Healthy Volunteers
A study testing Acupuncture in people with Healthy Volunteers, run by Bui Pham Minh Man at 1 site in Vietnam.
Trial summary
Acupuncture is a treatment method since ancient times and it has been recognized as an international treatment method by the World Health Organization. Although the structure and physiological effects of acupoints have been extensively studied, they have not been fully 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 Volunteers
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Oct 2022to 30 Jun 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 volunteers, regardless of gender or profession
- Age between enough 18 and 30 years old.
- BMI: 18.5 - 23 kg/m2
- Mental alertness, good contact, cooperation with researchers.
- DASS 21 score within normal limits.
- Have no disease which change the body temperature, like hyperthyroidism, hypothyroidism.
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- Vital sign within normal limits:
- Heart rates from from 60 to 100 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.
- SpO2 from 95 to 99%.
- Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials.
- Not currently participating in other intervention studies.
- Have no acupuncture experience yet.
Who cannot join
- Having an inflammatory injury in the site of the skin to be investigated.
- Using heat therapy, for example massage, cupping therapy, acupuncture in the site of the skin to be investigated within 24h.
- Applying chemical or pharmaceutical products to the site of the skin to be survey before conducting the study.
- Other diseases that could affect or interfere with outcomes, including common cold or flu.
- Curently having neck-pain or having skin diseases, for example: tinea versicolor, eczema in the site of the skin to be investigated.
- Taking stimulant (alcohol, beer, coffee, tobacco) within 24h.
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- Staying up at night or having insomnia before the day of the study.
- Playing sport within 2h.
- Pregnant woman or breastfeeding woman or woman in period.
- Currently using certain drugs which dilate blood vessels and drop in blood pressure.
- Anxiety, depression, stress before conducting the study with DASS 21 score < 15.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City
Ho Chi Minh City
About this study
Official title: Survey on Change Temperature of Skin Surface at the Acupuncture Site, the Neck and the Face When Using Tonifying Acupuncture Manipulations or Dispersing Acupuncture Manipulations at Dazhui in Healthy Volunteers: a Pilot Study
Acupuncture is a treatment method since ancient times and it has been recognized as an international treatment method by the World Health Organization. Although the structure and physiological effects of acupoints have been extensively studied, they have not been fully elucidated. A lot of studies on physiological effects of acupoints on the 12 main merdians have been published, but acupoints outside the meridians or acupoints on the eight extraordinary vessels have not been noticed. In particular, the Dazhui is one of the acupoints on the Du Merdian that is often used clinically. In the other side, several researches have shown that using different acupuncture manipulations can achieve different therapeutic effects. In our study, we want to determinate and compare the change temperature of skin surface at the acupuncture site, the neck and the face when using tonifying acupuncture manipulations or dispersing acupuncture manipulations at Dazhui in healthy volunteers.
Read the detailed description
Participants and Methods: A pilot study is conducted by comparing the change in skin surface temperature before and after using sham or tonifying or dispersing acupuncture manipulations at EX-B2 T3 in right side and Dazhui in heatlhy volunteers. A total of 57 participants will be randomly divided into 3 groups (group STD, group TDS and group DST). Each group has 19 participants and undergo 3 trial phases, corresponding to 3 times of acupuncture in 14 days, each time is 7 days apart. For group STD, the first trial phase: participants received acupuncture at EX-B2 T3 point in right side as sham acupuncture; the second trial phase: participants received acupuncture with tonifying manipulations at Dazhui point and tonifying manipulations was replaced by dispersing ones in the third trial phase. For group TDS, the first trial phase: participants received acupuncture with tonifying manipulations at Dazhui point; the second trial phase: participants received acupuncture with dispersing manipulations at Dazhui point and participants received acupuncture at EX-B2 T3 point in right side as sham acupuncture in the third trial phase. Similarly, for group DST, the first trial phase: participants received acupuncture with dispersing manipulations at Dazhui point; the second trial phase: participants received acupuncture at EX-B2 T3 point in right side as sham acupuncture and sham acupuncture was replaced byacupuncture with tonifying manipulations at Dazhui in the third trial phase. The primary outcome was the change temperature of skin surface at the acupuncture site, the neck and the face when using tonifying or dispersing acupuncture manipulations at Dazhui point. This trial will be performed as a pilot study.
- Conditions
- Healthy Volunteers
- Being tested
- Acupuncture
- Keywords
- Acupuncture Manipulations, Tonifying Acupuncture Manipulations, Dispersing Acupuncture Manipulations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
To conduct this intervention, we used disposable acupuncture needles with the size of 0.30 x 25 mm to acupuncture the sham acupoint (EX-B2 T3 point) or Dazhui point.
| Study group | Role | What they receive |
|---|---|---|
| Group STD | Experimental | 19 participant received sham acupuncture at EX-B2 T3 point in right side or acupuncture with tonyfying or dispersing manipulations at Dazhui point, corresponding to 3 times of acupuncture in 14 days, each time is 7 days aparts. In each time, temperature of skin surface at the acupuncture site, the neck and the face will be recorded.
Procedure/Surgery: Acupuncture with disposable acupuncture needles (the size of 0.30 x 25 mm) at EX-B2 T3 point in right side as sham acupoint in the first trial phase. We used the same type of acupuncture needles as aboved to acupuncture at Dazhui with tonifying manipulations in the second trial phase and with dispersing manipulatiuons in the third trial phase. Receives: Procedure: Acupuncture |
| Group TDS | Experimental | 19 participant received acupuncture with tonyfying or dispersing manipulations at Dazhui or sham acupuncture at EX-B2 T3 point in right side, corresponding to 3 times of acupuncture in 14 days, each time is 7 days aparts. In each time, temperature of skin surface at the acupuncture site, the neck and the face will be recorded.
Procedure/Surgery: Acupuncture with disposable acupuncture needles (the size of 0.30 x 25 mm) at Dazhui with tonifying manipulations in the first trial phase and with dispersing manipulatiuons in the second trial phase. We used the same type of acupuncture needles as aboved to acupuncture at EX-B2 T3 point in right side as sham acupoint in the third trial phase. Receives: Procedure: Acupuncture |
| Group DST | Experimental | 19 participant received acupuncture with tonyfying or dispersing manipulations at Dazhui or sham acupuncture at EX-B2 T3 point in right side, corresponding to 3 times of acupuncture in 14 days, each time is 7 days aparts. In each time, temperature of skin surface at the acupuncture site, the neck and the face will be recorded.
Procedure/Surgery: Acupuncture with disposable acupuncture needles (the size of 0.30 x 25 mm) at Dazhui with tonifying manipulations in the first trial phase and with dispersing manipulatiuons in the second trial phase. We used the same type of acupuncture needles as aboved to acupuncture at EX-B2 T3 point in right side as sham acupoint in the third trial phase. Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change temperature of skin surface at at the acupuncture site, the neck and the face when using tonifying acupuncture manipulations at Dazhui
Measured: During procedure
Change temperature of skin surface at at the acupuncture site, the neck and the face when using dispersing acupuncture manipulations at Dazhui
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Oct 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Single group
- Model description
- A pilot study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bui Pham Minh Man
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578014
- Sponsor's protocol ID
- 678/HDDD-DHYD
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic characteristic and outcome data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on Change Temperature of Skin Surface at the Acupuncture Site, the Neck and the Face When Using Tonifying Acupuncture Manipulations or Dispersing Acupuncture Manipulations at Dazhui in Healthy Volunteers: a Pilot Study
- ClinicalTrials.gov ID
- NCT05578014
- Acronym / sponsor ID
- 678/HDDD-DHYD
- Conditions
- Healthy Volunteers
- Keywords
- Acupuncture Manipulations, Tonifying Acupuncture Manipulations, Dispersing Acupuncture Manipulations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Bui Pham Minh ManUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 Oct 2022 (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.
Acupuncture is a treatment method since ancient times and it has been recognized as an international treatment method by the World Health Organization. Although the structure and physiological effects of acupoints have been extensively studied, they have not been fully elucidated. A lot of studies on physiological effects of acupoints on the 12 main merdians have been published, but acupoints outside the meridians or acupoints on the eight extraordinary vessels have not been noticed. In particular, the Dazhui is one of the acupoints on the Du Merdian that is often used clinically. In the other side, several researches have shown that using different acupuncture manipulations can achieve different therapeutic effects. In our study, we want to determinate and compare the change temperature of skin surface at the acupuncture site, the neck and the face when using tonifying acupuncture manipulations or dispersing acupuncture manipulations at Dazhui in healthy volunteers.
Detailed description
Participants and Methods: A pilot study is conducted by comparing the change in skin surface temperature before and after using sham or tonifying or dispersing acupuncture manipulations at EX-B2 T3 in right side and Dazhui in heatlhy volunteers. A total of 57 participants will be randomly divided into 3 groups (group STD, group TDS and group DST). Each group has 19 participants and undergo 3 trial phases, corresponding to 3 times of acupuncture in 14 days, each time is 7 days apart. For group STD, the first trial phase: participants received acupuncture at EX-B2 T3 point in right side as sham acupuncture; the second trial phase: participants received acupuncture with tonifying manipulations at Dazhui point and tonifying manipulations was replaced by dispersing ones in the third trial phase. For group TDS, the first trial phase: participants received acupuncture with tonifying manipulations at Dazhui point; the second trial phase: participants received acupuncture with dispersing manipulations at Dazhui point and participants received acupuncture at EX-B2 T3 point in right side as sham acupuncture in the third trial phase. Similarly, for group DST, the first trial phase: participants received acupuncture with dispersing manipulations at Dazhui point; the second trial phase: participants received acupuncture at EX-B2 T3 point in right side as sham acupuncture and sham acupuncture was replaced byacupuncture with tonifying manipulations at Dazhui in the third trial phase. The primary outcome was the change temperature of skin surface at the acupuncture site, the neck and the face when using tonifying or dispersing acupuncture manipulations at Dazhui point. This trial will be performed as a pilot study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- A pilot study
| Arm | Type | Receives |
|---|---|---|
| Group STD | Experimental | Procedure: Acupuncture19 participant received sham acupuncture at EX-B2 T3 point in right side or acupuncture with tonyfying or dispersing manipulations at Dazhui point, corresponding to 3 times of acupuncture in 14 days, each time is 7 days aparts. In each time, temperature of skin surface at the acupuncture site, the neck and the face will be recorded. Procedure/Surgery: Acupuncture with disposable acupuncture needles (the size of 0.30 x 25 mm) at EX-B2 T3 point in right side as sham acupoint in the first trial phase. We used the same type of acupuncture needles as aboved to acupuncture at Dazhui with tonifying manipulations in the second trial phase and with dispersing manipulatiuons in the third trial phase. |
| Group TDS | Experimental | Procedure: Acupuncture19 participant received acupuncture with tonyfying or dispersing manipulations at Dazhui or sham acupuncture at EX-B2 T3 point in right side, corresponding to 3 times of acupuncture in 14 days, each time is 7 days aparts. In each time, temperature of skin surface at the acupuncture site, the neck and the face will be recorded. Procedure/Surgery: Acupuncture with disposable acupuncture needles (the size of 0.30 x 25 mm) at Dazhui with tonifying manipulations in the first trial phase and with dispersing manipulatiuons in the second trial phase. We used the same type of acupuncture needles as aboved to acupuncture at EX-B2 T3 point in right side as sham acupoint in the third trial phase. |
| Group DST | Experimental | Procedure: Acupuncture19 participant received acupuncture with tonyfying or dispersing manipulations at Dazhui or sham acupuncture at EX-B2 T3 point in right side, corresponding to 3 times of acupuncture in 14 days, each time is 7 days aparts. In each time, temperature of skin surface at the acupuncture site, the neck and the face will be recorded. Procedure/Surgery: Acupuncture with disposable acupuncture needles (the size of 0.30 x 25 mm) at Dazhui with tonifying manipulations in the first trial phase and with dispersing manipulatiuons in the second trial phase. We used the same type of acupuncture needles as aboved to acupuncture at EX-B2 T3 point in right side as sham acupoint in the third trial phase. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Healthy volunteers, regardless of gender or profession
- Age between enough 18 and 30 years old.
- BMI: 18.5 - 23 kg/m2
- Mental alertness, good contact, cooperation with researchers.
- DASS 21 score within normal limits.
Key exclusion criteria (11 listed)
- Having an inflammatory injury in the site of the skin to be investigated.
- Using heat therapy, for example massage, cupping therapy, acupuncture in the site of the skin to be investigated within 24h.
- Applying chemical or pharmaceutical products to the site of the skin to be survey before conducting the study.
- Other diseases that could affect or interfere with outcomes, including common cold or flu.
- Curently having neck-pain or having skin diseases, for example: tinea versicolor, eczema in the site of the skin 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 |
|---|---|---|
| AcupunctureTo conduct this intervention, we used disposable acupuncture needles with the size of 0.30 x 25 mm to acupuncture the sham acupoint (EX-B2 T3 point) or Dazhui point. | Procedure or surgery | Group DST, Group STD, Group TDS |
Primary outcome
Change temperature of skin surface at at the acupuncture site, the neck and the face when using tonifying acupuncture manipulations at Dazhui
Time frame: During procedure
Change temperature of skin surface at at the acupuncture site, the neck and the face when using dispersing acupuncture manipulations at Dazhui
Time frame: During procedure
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 23 Oct 2023.
- World Health Organization. Acupuncture : review and analysis of reports on controlled clinical trials. World Health Organization; 2014.May 16, 2022.Link provided by the sponsor.
- Z. Lu, H. Dong, Q. Wang, et al. Perioperative acupuncture modulation: more than anaesthesia. doi:10.1093/bja/aev227British Journal of Anaesthesia.2015;115(2):183-193.Link provided by the sponsor.
- Jia-Min Yang, Xiao-Yu Shen, Ling Zhang, et al. The Effect of Acupuncture to SP6 on Skin Temperature Changes of SP6 and SP10: An Observation of "Deqi". Evidence-Based Complementary and Alternative Medicine. 2014;2014: 595963. Doi: 10.1155/2014/595963Link provided by the sponsor.
- Ali Mohammadi, Liang-Xiao Ma, Yang Yang, et al. Immediate Analgesic Effect of Perpendicular Needling or Transverse Needling at SP6 in Primary Dysmenorrhea: A Pilot Study. Medical Acupuncture. 2019;31(4): 207-217. Doi:10.1089/acu.2019.1362Link provided by the sponsor.
- Weihui Li, Andrew Ahn. Effect of Acupuncture Manipulations at LI4 or LI11 on Blood Flow and Skin Temperature. Journal of Acupuncture \& Meridian Studies. 2016;9(3):128-133. doi:10.1016/j.jams.2015.08.005Link provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Healthy Volunteers, run by Bui Pham Minh Man 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 15 inclusion and 11 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 23 Oct 2023. 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?
Change temperature of skin surface at at the acupuncture site, the neck and the face when using tonifying acupuncture manipulations at Dazhui (time frame: During procedure). 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?
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 23 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.