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

NCT07021924 | Not Yet Recruiting

• 1 other identifier: CMUH113-REC1-151
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Fu's Subcutaneous Needling (FSN) treatment increases local blood perfusion, thereby elevating skin temperature.
2. 2.The ability of FSN treatment to increase skin temperature is not inferior to that of acupuncture and may, in fact, be superior.

Conditions

Skin Temperature Change

Keywords

Fu's subcutaneous needling; acupuncture; skin temperature; skin blood flow; hemodynamics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Hemodynamic Parameters: Peak Systolic Velocity (PSV, cm/s)

  From enrollment to the end of treatment at 1 day

• Hemodynamic Parameters:End-Diastolic Velocity (EDV, cm/s)

  From enrollment to the end of treatment at 1 day

• Hemodynamic Parameters: Mean Velocity (cm/s)

  From enrollment to the end of treatment at 1 day

• Hemodynamic Parameters:Time-Averaged Mean Velocity (TAMV, cm/s)

  From enrollment to the end of treatment at 1 day

• Hemodynamic Parameters:Systolic/Diastolic Velocity Ratio (S/D)

  From enrollment to the end of treatment at 1 day

Study Arms (3)

Fu's subcutaneous needling

EXPERIMENTAL

Fu's subcutaneous needling at acupoint LI-18

Other: Fu's subcutaneous needling

Acupucture

EXPERIMENTAL

Acupuncture at acupoint LI-18

Other: Acupuncture

Control

NO INTERVENTION

As the control group, Participants do not receive any intervention

Interventions

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.

Fu's subcutaneous needling

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.

Acupucture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 999079, Taiwan

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Li-Wei Chou, PhD

CONTACT

+886-4-22052121; chouliwe@mail.cmuh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: June 15, 2025
• Study Start: July 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: May 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

TW (1)