The Effect of Fu's Subcutaneous Needling on Skin Temperature in Healthy Subjects

NCT ID: NCT07021924

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-05-01

Brief 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. The main questions it aims to answer are:

1. Fu's Subcutaneous Needling (FSN) treatment increases local blood perfusion, thereby elevating skin temperature.

2. 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.

Conditions

Skin Temperature Change

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fu's subcutaneous needling

Fu's subcutaneous needling at acupoint LI-18

Group Type: EXPERIMENTAL

Fu's subcutaneous needling

Intervention Type: 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.

Acupucture

Acupuncture at acupoint LI-18

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: 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.

Control

As the control group, Participants do not receive any intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fu's subcutaneous needling

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.

Intervention Type: OTHER

Acupuncture

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Central Contacts

Li-Wei Chou, PhD

Role: CONTACT

chouliwe@mail.cmuh.org.tw

+886-4-22052121 ext. 2381

Facility Contacts

Li-We Chou, PhD

Role: primary

chouliwe@mail.cmuh.org.tw

+886-4-22052121 ext. 2381

Other Identifiers

CMUH113-REC1-151

Identifier Type: -

Identifier Source: org_study_id