Skin Temperature ChangeNCT07021924
The Effect of Fu's Subcutaneous Needling on Skin Temperature in Healthy Subjects
A study testing Fu's subcutaneous needling and Acupuncture in people with Skin Temperature Change, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to investigate whether there are differences in skin temperature at local or distal sites following Fu's Subcutaneous Needling (FSN) treatment or acupuncture treatment, and compare the extent to which FSN or acupuncture induces an increase in skin temperature in healthy population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Temperature Change
- What is being tested?
- Fu's subcutaneous needling and Acupuncture
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary participants aged 18 years or older, of any sex, who are able to fully comply with the experimental procedures.
- Recent medical examination confirming the absence of cardiovascular, respiratory, gastrointestinal, urinary, hematological, endocrine, and neurological disorders.
- Normal communication ability, with the capacity to understand and follow instructions related to Fu's Subcutaneous Needling (FSN) and acupuncture treatments.
- Provision of written informed consent.
Who cannot join
- Diagnosis of psychiatric disorders, severe depression, alcohol dependence, or a history of substance abuse.
- Pregnancy or breastfeeding.
- Presence of local skin infection, ulceration, or injury at the treatment site.
- Participation in other clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
China Medical University Hospital
Taichung, 999079
Li-We Chou, PhD, +886-4-22052121 ext. 2381, chouliwe@mail.cmuh.org.tw
About this study
Official title: The Effect of Fu's Subcutaneous Needling and Acupuncture on Local and Distal Skin Temperature in Healthy Subjects
The goal of this clinical trial is to investigate whether there are differences in skin temperature at local or distal sites following Fu's Subcutaneous Needling (FSN) treatment or acupuncture treatment, and compare the extent to which FSN or acupuncture induces an increase in skin temperature in healthy population. The main questions it aims to answer are:
- Fu's Subcutaneous Needling (FSN) treatment increases local blood perfusion, thereby elevating skin temperature.
- The ability of FSN treatment to increase skin temperature is not inferior to that of acupuncture and may, in fact, be superior.
Read more
Researchers will compare the skin temperature changes among three groups which are FSN, acupuncture and control group to see if there are statistically significantly changes .
Participants will enroll into three groups which are FSN, acupuncture and no any intervention respectively.
Read the detailed description
Human physiological thermoregulation involves adjustments in heat dissipation and heat production in response to various internal and external thermal stimuli. The central control of thermoregulation is located in the preoptic/anterior hypothalamus (PO/AH) of the brain. Information about internal core and surface skin temperatures is transmitted to the PO/AH, which then coordinates appropriate responses. Skin blood flow is regulated by sympathetic nerve fibers, which release norepinephrine. When the core or surface temperature decreases, the intensity of sympathetic nerve activity increases, causing vasoconstriction at the arteriovenous anastomoses, resulting in reduced blood flow and decreased heat loss. Conversely, when the core or surface temperature increases, reduced sympathetic activity leads to vasodilation.
Numerous studies have utilized measurements of skin temperature and skin blood flow in traditional Chinese medicine research. Fu's subcutaneous needling therapy is widely used for treating conditions related to myofascial trigger points, as it is theorized to relieve the energy crisis that causes these trigger points by increasing blood perfusion in the affected muscles. However, fundamental research has not yet been completed to verify this theory. Therefore, this project aims to use skin temperature detection to determine whether Fu's subcutaneous needling can increase local skin blood perfusion and, compared to acupuncture, which method is more effective in raising skin temperature.
This study plans to recruit 60 healthy participants, who will be randomly assigned to the FSN group, acupuncture group, and control group. The participants will lie quietly in a temperature- and humidity-controlled room with nine detection points adhered to the right forearm. The entire experiment, including a 15-minute static phase, a 15-minute intervention phase, and a 3-minute post-intervention phase, will last 33 minutes. The researchers will record skin temperature every three minutes during the intervention and post-intervention phases, for a total of six recordings. Additionally, the investigator will measure changes in the hemodynamic parameters of the right forearm's radial artery using ultrasound before the static phase and after the post-intervention phase. Statistical analysis will be conducted on the changes in skin temperature at each detection point and hemodynamic parameters at radial artery.
- Conditions
- Skin Temperature Change
- Being tested
- Fu's subcutaneous needling, Acupuncture
- Keywords
- Fu's subcutaneous needling, acupuncture, skin temperature, skin blood flow, hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fu's subcutaneous needlingOther
A single-use Fu's Subcutaneous Needling (FSN) device was employed. Participants were instructed to lie supine with the tested upper limb extended in a neutral position. After a 15-minute resting period, the FSN needle was fully inserted into the subcutaneous tissue layer at the acupoint Xialian (LI18) along the Large Intestine Meridian, with the needle tip oriented toward the radial styloid process.
The needle core was retracted into the soft tube, and the needle was then manipulated by swinging the handle left and right in a fan-shaped manner, with a sweep angle of approximately 60 degrees (30 degrees in each direction) relative to the insertion axis. The swaying movements was performed 50 times back and forth (100 cycles/min) over a duration of 2 minutes.
The needle was retained in place for 15 minutes before being removed. After needle removal, participants remained resting for 3 minutes before getting up, marking the end of the experimental procedure.
AcupunctureOther
Participants were instructed to lie supine with the tested upper limb extended in a neutral position. According to WHO standard acupoint locations, the acupuncture needle was inserted at Xialian (LI18), located 4 cun below Quchi (LI11) on the line connecting Hegu (LI4) and Quchi (LI11). A 30-gauge, 1.5-inch acupuncture needle was used, and insertion continued until the Deqi sensation was achieved.
The needle was retained for 15 minutes before being removed. After a 3-minute post-removal rest period, participants were allowed to rise, completing the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Fu's subcutaneous needling | Experimental | Fu's subcutaneous needling at acupoint LI-18 Receives: Other: Fu's subcutaneous needling |
| Acupucture | Experimental | Acupuncture at acupoint LI-18 Receives: Other: Acupuncture |
| Control | No intervention | As the control group, Participants do not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Temperature
Skin temperature was measured using the EXVXE® EX 3016 multi-channel temperature testing system (Yili [Shenzhen] Technology Co., Ltd.), which collects data from 16 thermistors affixed to the skin surface. Thermistors were attached to specific acupoints on the participants' right forearm along the Large Intestine Meridian of Hand-Yangming: Hegu (LI4), Yangxi (LI5), Pianli (LI6), Wenliu (LI7), Shousanli (LI10), and Quchi (LI11). Additional thermistors were placed on acupoints along the Small Intestine Meridian of Hand-Taiyang: Yanggu (SI5), Zhizheng (SI7), and Xiaohai (SI8).
Measured: From enrollment to the end of treatment at 1 day
Secondary outcomes (9)
Hemodynamic Parameters: Peak Systolic Velocity (PSV, cm/s)
Hemodynamic parameters were assessed using the Power Doppler (PD) mode of a GE LOGIQ e ultrasound system. Measurements were taken at the radial artery of the right arm, approximately one-quarter of the way up the forearm on the radial side.
PSV:The maximum velocity of blood flow within a vessel during the systolic phase of the cardiac cycle, indicating the highest velocity achieved immediately following ventricular contraction.
Measured: From enrollment to the end of treatment at 1 day
Hemodynamic Parameters:End-Diastolic Velocity (EDV, cm/s)
Hemodynamic parameters were assessed using the Power Doppler (PD) mode of a GE LOGIQ e ultrasound system. Measurements were taken at the radial artery of the right arm, approximately one-quarter of the way up the forearm on the radial side.
EDV:The minimum velocity of blood flow measured at the end of cardiac diastole, reflecting the baseline velocity immediately before the subsequent ventricular contraction.
Measured: From enrollment to the end of treatment at 1 day
Hemodynamic Parameters: Mean Velocity (cm/s)
Hemodynamic parameters were assessed using the Power Doppler (PD) mode of a GE LOGIQ e ultrasound system. Measurements were taken at the radial artery of the right arm, approximately one-quarter of the way up the forearm on the radial side.
Mean Velocity:The average velocity of blood flow calculated over a specific cardiac cycle, representing the overall flow velocity across both systolic and diastolic phases.
Measured: From enrollment to the end of treatment at 1 day
Hemodynamic Parameters:Time-Averaged Mean Velocity (TAMV, cm/s)
Hemodynamic parameters were assessed using the Power Doppler (PD) mode of a GE LOGIQ e ultrasound system. Measurements were taken at the radial artery of the right arm, approximately one-quarter of the way up the forearm on the radial side.
TAMV:The mean velocity of blood flow averaged over multiple cardiac cycles, providing a representative steady-state measure of flow velocity.
Measured: From enrollment to the end of treatment at 1 day
Hemodynamic Parameters:Systolic/Diastolic Velocity Ratio (S/D)
Hemodynamic parameters were assessed using the Power Doppler (PD) mode of a GE LOGIQ e ultrasound system. Measurements were taken at the radial artery of the right arm, approximately one-quarter of the way up the forearm on the radial side.
S/D:A dimensionless ratio calculated by dividing the peak systolic velocity by the end-diastolic velocity, commonly used to evaluate arterial resistance and vascular compliance.
Measured: From enrollment to the end of treatment at 1 day
Hemodynamic Parameters:Arterial Diameter (d, cm)
Hemodynamic parameters were assessed using the Power Doppler (PD) mode of a GE LOGIQ e ultrasound system. Measurements were taken at the radial artery of the right arm, approximately one-quarter of the way up the forearm on the radial side.
d: The internal diameter of the artery at the measurement site, an essential parameter for calculating cross-sectional area, which directly influences flow calculations.
Measured: From enrollment to the end of treatment at 1 day
Hemodynamic Parameters:Resistance Index (RI)
Hemodynamic parameters were assessed using the Power Doppler (PD) mode of a GE LOGIQ e ultrasound system. Measurements were taken at the radial artery of the right arm, approximately one-quarter of the way up the forearm on the radial side.
RI: A dimensionless index calculated as (PSV - EDV)/PSV, quantifying arterial resistance and reflecting the vascular bed's impedance to blood flow.
Measured: From enrollment to the end of treatment at 1 day
Hemodynamic Parameters:Pulsatility Index (PI)
Hemodynamic parameters were assessed using the Power Doppler (PD) mode of a GE LOGIQ e ultrasound system. Measurements were taken at the radial artery of the right arm, approximately one-quarter of the way up the forearm on the radial side.
PI: A dimensionless index calculated as (PSV - EDV)/mean velocity, describing the pulsatile characteristics of arterial blood flow and providing insights into arterial elasticity and downstream vascular resistance.
Measured: From enrollment to the end of treatment at 1 day
Hemodynamic Parameters:Radial Artery Blood Flow (Q)
Hemodynamic parameters were assessed using the Power Doppler (PD) mode of a GE LOGIQ e ultrasound system. Measurements were taken at the radial artery of the right arm, approximately one-quarter of the way up the forearm on the radial side.
Q: Quantified as the volumetric blood flow rate (typically in cm³/s or ml/s), calculated by multiplying the vessel's cross-sectional area (derived from arterial diameter) by the time-averaged mean velocity (TAMV).
Measured: From enrollment to the end of treatment at 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Temperature ChangeStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021924
- Sponsor's protocol ID
- CMUH113-REC1-151
- Status last verified
- Jun 2025
- First submitted
- 20 Apr 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fu's Subcutaneous Needling and Acupuncture on Local and Distal Skin Temperature in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07021924
- Acronym / sponsor ID
- CMUH113-REC1-151
- Conditions
- Skin Temperature Change
- Keywords
- Fu's subcutaneous needling, acupuncture, skin temperature, skin blood flow, hemodynamics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 15 Jun 2025 (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.
The goal of this clinical trial is to investigate whether there are differences in skin temperature at local or distal sites following Fu's Subcutaneous Needling (FSN) treatment or acupuncture treatment, and compare the extent to which FSN or acupuncture induces an increase in skin temperature in healthy population. The main questions it aims to answer are:
- Fu's Subcutaneous Needling (FSN) treatment increases local blood perfusion, thereby elevating skin temperature.
- The ability of FSN treatment to increase skin temperature is not inferior to that of acupuncture and may, in fact, be superior.
Researchers will compare the skin temperature changes among three groups which are FSN, acupuncture and control group to see if there are statistically significantly changes .
Participants will enroll into three groups which are FSN, acupuncture and no any intervention respectively.
Detailed description
Human physiological thermoregulation involves adjustments in heat dissipation and heat production in response to various internal and external thermal stimuli. The central control of thermoregulation is located in the preoptic/anterior hypothalamus (PO/AH) of the brain. Information about internal core and surface skin temperatures is transmitted to the PO/AH, which then coordinates appropriate responses. Skin blood flow is regulated by sympathetic nerve fibers, which release norepinephrine. When the core or surface temperature decreases, the intensity of sympathetic nerve activity increases, causing vasoconstriction at the arteriovenous anastomoses, resulting in reduced blood flow and decreased heat loss. Conversely, when the core or surface temperature increases, reduced sympathetic activity leads to vasodilation.
Numerous studies have utilized measurements of skin temperature and skin blood flow in traditional Chinese medicine research. Fu's subcutaneous needling therapy is widely used for treating conditions related to myofascial trigger points, as it is theorized to relieve the energy crisis that causes these trigger points by increasing blood perfusion in the affected muscles. However, fundamental research has not yet been completed to verify this theory. Therefore, this project aims to use skin temperature detection to determine whether Fu's subcutaneous needling can increase local skin blood perfusion and, compared to acupuncture, which method is more effective in raising skin temperature.
This study plans to recruit 60 healthy participants, who will be randomly assigned to the FSN group, acupuncture group, and control group. The participants will lie quietly in a temperature- and humidity-controlled room with nine detection points adhered to the right forearm. The entire experiment, including a 15-minute static phase, a 15-minute intervention phase, and a 3-minute post-intervention phase, will last 33 minutes. The researchers will record skin temperature every three minutes during the intervention and post-intervention phases, for a total of six recordings. Additionally, the investigator will measure changes in the hemodynamic parameters of the right forearm's radial artery using ultrasound before the static phase and after the post-intervention phase. Statistical analysis will be conducted on the changes in skin temperature at each detection point and hemodynamic parameters at radial artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fu's subcutaneous needling | Experimental | Other: Fu's subcutaneous needlingFu's subcutaneous needling at acupoint LI-18 |
| Acupucture | Experimental | Other: AcupunctureAcupuncture at acupoint LI-18 |
| Control | No intervention | –As the control group, Participants do not receive any intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntary participants aged 18 years or older, of any sex, who are able to fully comply with the experimental procedures.
- Recent medical examination confirming the absence of cardiovascular, respiratory, gastrointestinal, urinary, hematological, endocrine, and neurological disorders.
- Normal communication ability, with the capacity to understand and follow instructions related to Fu's Subcutaneous Needling (FSN) and acupuncture treatments.
- Provision of written informed consent.
Key exclusion criteria (4 listed)
- Diagnosis of psychiatric disorders, severe depression, alcohol dependence, or a history of substance abuse.
- Pregnancy or breastfeeding.
- Presence of local skin infection, ulceration, or injury at the treatment site.
- Participation in other clinical trials.
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 |
|---|---|---|
| Fu's subcutaneous needlingA single-use Fu's Subcutaneous Needling (FSN) device was employed. Participants were instructed to lie supine with the tested upper limb extended in a neutral position. After a 15-minute resting period, the FSN needle was fully inserted into the subcutaneous tissue layer at the acupoint Xialian (LI18) along the Large Intestine Meridian, with the needle tip oriented toward the radial styloid process. The needle core was retracted into the soft tube, and the needle was then manipulated by swinging the handle left and right in a fan-shaped manner, with a sweep angle of approximately 60 degrees (30 degrees in each direction) relative to the insertion axis. The swaying movements was performed 50 times back and forth (100 cycles/min) over a duration of 2 minutes. The needle was retained in place for 15 minutes before being removed. After needle removal, participants remained resting for 3 minutes before getting up, marking the end of the experimental procedure. | Other | Fu's subcutaneous needling |
| AcupunctureParticipants were instructed to lie supine with the tested upper limb extended in a neutral position. According to WHO standard acupoint locations, the acupuncture needle was inserted at Xialian (LI18), located 4 cun below Quchi (LI11) on the line connecting Hegu (LI4) and Quchi (LI11). A 30-gauge, 1.5-inch acupuncture needle was used, and insertion continued until the Deqi sensation was achieved. The needle was retained for 15 minutes before being removed. After a 3-minute post-removal rest period, participants were allowed to rise, completing the procedure. | Other | Acupucture |
Primary outcome
Skin Temperature
Time frame: From enrollment to the end of treatment at 1 day
Skin temperature was measured using the EXVXE® EX 3016 multi-channel temperature testing system (Yili [Shenzhen] Technology Co., Ltd.), which collects data from 16 thermistors affixed to the skin surface. Thermistors were attached to specific acupoints on the participants' right forearm along the Large Intestine Meridian of Hand-Yangming: Hegu (LI4), Yangxi (LI5), Pianli (LI6), Wenliu (LI7), Shousanli (LI10), and Quchi (LI11). Additional thermistors were placed on acupoints along the Small Intestine Meridian of Hand-Taiyang: Yanggu (SI5), Zhizheng (SI7), and Xiaohai (SI8).
9 secondary outcomes
Hemodynamic Parameters: Peak Systolic Velocity (PSV, cm/s)
Time frame: From enrollment to the end of treatment at 1 day
Hemodynamic Parameters:End-Diastolic Velocity (EDV, cm/s)
Time frame: From enrollment to the end of treatment at 1 day
Hemodynamic Parameters: Mean Velocity (cm/s)
Time frame: From enrollment to the end of treatment at 1 day
Hemodynamic Parameters:Time-Averaged Mean Velocity (TAMV, cm/s)
Time frame: From enrollment to the end of treatment at 1 day
Hemodynamic Parameters:Systolic/Diastolic Velocity Ratio (S/D)
Time frame: From enrollment to the end of treatment at 1 day
Hemodynamic Parameters:Arterial Diameter (d, cm)
Time frame: From enrollment to the end of treatment at 1 day
Hemodynamic Parameters:Resistance Index (RI)
Time frame: From enrollment to the end of treatment at 1 day
Hemodynamic Parameters:Pulsatility Index (PI)
Time frame: From enrollment to the end of treatment at 1 day
Hemodynamic Parameters:Radial Artery Blood Flow (Q)
Time frame: From enrollment to the end of treatment at 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fu's subcutaneous needling and Acupuncture in people with Skin Temperature Change, run by China Medical University Hospital at 1 site in Taiwan.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 15 Jun 2025. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li-Wei Chou, PhD (+886-4-22052121 ext. 2381, chouliwe@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Temperature (time frame: From enrollment to the end of treatment at 1 day). 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 15 Jun 2025.