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

NCT07021924 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-15

No results posted yet for this study

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.

Conditions

  • Skin Temperature Change

Interventions

OTHER

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 The needle core was retracted into the soft tube, and the needle was then manipulated by swinging the handle left and right in a fan-shaped manner, with a sweep angle of approximately 60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.

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.

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-07-01
Completion
2026-05-01

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07021924 on ClinicalTrials.gov