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临床试验/NCT07021924
NCT07021924尚未招募不适用

The Effect of Fu's Subcutaneous Needling and Acupuncture on Local and Distal Skin Temperature in Healthy Subjects

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Skin Temperature

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Control

No Intervention

As the control group, Participants do not receive any intervention

Fu's subcutaneous needling

Experimental

Fu's subcutaneous needling at acupoint LI-18

干预措施: Fu's subcutaneous needling (Other)

Acupucture

Experimental

Acupuncture at acupoint LI-18

干预措施: Acupuncture (Other)

结局指标

主要结局

Skin Temperature

时间窗: 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).

次要结局

  • 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)
  • Hemodynamic Parameters:Arterial Diameter (d, cm)(From enrollment to the end of treatment at 1 day)
  • Hemodynamic Parameters:Resistance Index (RI)(From enrollment to the end of treatment at 1 day)
  • Hemodynamic Parameters:Pulsatility Index (PI)(From enrollment to the end of treatment at 1 day)
  • Hemodynamic Parameters:Radial Artery Blood Flow (Q)(From enrollment to the end of treatment at 1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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