Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fu's subcutaneous needling | Experimental | Fu's subcutaneous needling at acupoint LI-18 |
|
| Acupucture | Experimental | Acupuncture at acupoint LI-18 |
|
| Control | No Intervention | As the control group, Participants do not receive any intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fu's subcutaneous needling | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From enrollment to the end of treatment at 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li-Wei Chou, PhD | Contact | +886-4-22052121 | 2381 | chouliwe@mail.cmuh.org.tw |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | 999079 | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Acupuncture | Other | 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | From enrollment to the end of treatment at 1 day |