Healthy VolunteersNCT05581329
Change in Skin Surface Temperature at the Neck When Using Acupuncture at Houxi Point 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 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. 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
- 60 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 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.
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- 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.
Who cannot join
- 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.
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- 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.
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: Change in Skin Surface Temperature at the Neck When Using Acupuncture at Houxi Point in Healthy Volunteers: a Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Healthy Volunteers
- Being tested
- 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.
AcupunctureProcedure or surgery
Acupuncture is a method of inserting very thin needles into special points on the body which are called acupoints. To conduct this intervention, we will use disposable acupuncture needles the size of 0.30 x 13 mm to acupuncture the control acupoint (Yuji - LU10) in the first session and the research acupoint (Houxi - SI3) in the second session.
| Study group | Role | What they receive |
|---|---|---|
| Group A: acupoints on the left hand | Experimental | Participants will be received acupuncture at the control acupoint (Yuji - LU10) in the first trial phase, and the second trial phase will be conducted after 07 days at the research acupoint (Houxi - SI3). In each time, skin surface temperature at the neck area will be recorded. Receives: Procedure: Acupuncture |
| Group B: acupoints on the right hand | Experimental | Participants will be received acupuncture at the control acupoint (Yuji - LU10) in the first trial phase, and the second trial phase will be conducted after 07 days at the research acupoint (Houxi - SI3). In each time, skin surface temperature at the neck area will be recorded. Receives: Procedure: 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 when using acupuncture at Houxi point on each hand.
Measured: During procedure
Survey the change in temperature at the neck area respectively when using acupuncture at the left and right research acupoints (Houxi - SI3) compared with the control acupoints group (Yuji - LU10).
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 posted14 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
- Parallel groups
- Model description
- 2-arm parallel design, randomized, controlled and single blinded trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 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
- NCT05581329
- Sponsor's protocol ID
- 679/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
- Change in Skin Surface Temperature at the Neck When Using Acupuncture at Houxi Point in Healthy Volunteers: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05581329
- Acronym / sponsor ID
- 679/HDDD-DHYD
- Conditions
- Healthy Volunteers
- Keywords
- Acupuncture, Skin surface temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 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
- 14 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 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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2-arm parallel design, randomized, controlled and single blinded trial
| Arm | Type | Receives |
|---|---|---|
| Group A: acupoints on the left hand | Experimental | Procedure: AcupunctureParticipants will be received acupuncture at the control acupoint (Yuji - LU10) in the first trial phase, and the second trial phase will be conducted after 07 days at the research acupoint (Houxi - SI3). In each time, skin surface temperature at the neck area will be recorded. |
| Group B: acupoints on the right hand | Experimental | Procedure: AcupunctureParticipants will be received acupuncture at the control acupoint (Yuji - LU10) in the first trial phase, and the second trial phase will be conducted after 07 days at the research acupoint (Houxi - SI3). In each time, skin surface temperature at the neck area will be recorded. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| AcupunctureAcupuncture is a method of inserting very thin needles into special points on the body which are called acupoints. To conduct this intervention, we will use disposable acupuncture needles the size of 0.30 x 13 mm to acupuncture the control acupoint (Yuji - LU10) in the first session and the research acupoint (Houxi - SI3) in the second session. | Procedure or surgery | Group A: acupoints on the left hand, Group B: acupoints on the right hand |
Primary outcome
The change in skin surface temperature at the neck when using acupuncture at Houxi point on each hand.
Time frame: During procedure
Survey the change in temperature at the neck area respectively when using acupuncture at the left and right research acupoints (Houxi - SI3) compared with the control acupoints group (Yuji - LU10).
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.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Ots T, Kandirian A, Szilagyi I, DiGiacomo SM. 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 acupuncLink provided by the sponsor.
- Molsberger A, Manickavasagan J, Abholz H, Maixner W, Endres HJEJoP. Acupuncture points are large fields: the fuzziness of acupuncture point localization by doctors in practice. 2012;16(9):1264-1270.Link 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 14 inclusion and 10 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?
The change in skin surface temperature at the neck when using acupuncture at Houxi point on each hand. (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.