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临床试验/NCT07641374
NCT07641374尚未招募不适用

Impact of Semi-Permanent Auricular Acupuncture on Autonomic Balance and Pressure Pain Threshold in Patients With Fibromyalgia: A Longitudinal Study

Italian Association for the Research and the Scientific Update1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1

研究概览

简要总结

This longitudinal study evaluates the effects of semi-permanent auricular acupuncture on the Autonomic Nervous System (ANS) activity and pressure pain threshold in adult female patients (aged 35-64) diagnosed with Fibromyalgia according to the 2016 American College of Rheumatology (ACR) criteria. The study aims to investigate how a 5-week treatment cycle influences cardiac autonomic regulation and pain sensitivity

详细描述

Participants will undergo a series of 5 weekly sessions of auricular acupuncture using semi-permanent needles (Pyonex Seirin 0.9 mm). The needles will be applied to specific auricular points: Point Zero, Shen Men, Thalamus, and Master Cerebral Point. Each application will last for 72 hours, with the patient performing the removal

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Confirmed diagnosis of Fibromyalgia by a Rheumatologist according to the 2016 ACR (American College of Rheumatology) criteria.
  • Female sex.
  • Aged between 35 and 64 years.
  • Signed written informed consent.

排除标准

  • Presence of cardiac rhythm disorders such as permanent Atrial Fibrillation.
  • Patients with Pacemakers.
  • Subjects affected by Chronic Obstructive Pulmonary Disease (COPD)
  • Patients taking continuous medications that can alter the autonomic response (e.g., beta-blockers, antiarrhythmics, inhaled beta2-agonists).
  • Subjects with specific contraindications to auricular acupuncture.

研究者

发起方
Italian Association for the Research and the Scientific Update
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonello Lovato

Medical Doctor and Research Coordinator

Italian Association for the Research and the Scientific Update

研究点 (1)

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