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临床试验/NCT03975140
NCT03975140已完成不适用

The Preventive Value of Acupoint Sensitization Based on Stable Angina Pectoris

West China Hospital1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
202
试验地点
1
主要终点
Change of the number of angina attacks

研究概览

简要总结

This study, taking stable angina pectoris as a research carrier, aims to explore the preventive value of acupoint sensitization by conducting a double-blind multi-center randomized controlled trial to compare the effect of stimulating acupoints with different sensitivity on the prevention of angina pectoris.

After the inclusion of eligible patients, the pressure-pain threshold of disease-related acupoints will be detected by using Von Frey detector. Then, the patients will be randomly divided into experimental group and control group. The patients in experimental group will be given acupoints pressure on the five acupoints with the lowest pressure-pain threshold, while the patients in control group will be given acupoints pressure on the five acupoints with the five acupoints with the highest pressure-pain threshold. The two groups will be treated with acupoints pressure 12 times within 4 weeks. The patients will be evaluated three times at baseline, the end of treatment and four weeks after the end of treatment respectively, including angina attack frequency, CCS classification and SAQ score.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
35 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with stable angina pectoris and symptoms of chest pain
  • The duration of onset was more than 3 months, and the number of angina attacks in the past month was not less than 2
  • Not younger than 35 years old and not older than 80 years old
  • Patients will participate in the study voluntarily and have signed the informed consent

排除标准

  • Patients with mental retardation
  • Patients were contraindicated or unable to complete acupoint sensitization test
  • Patients with cardiovascular, digestive, urinary, respiratory, blood, nervous, endocrine system and other serious primary diseases
  • Patients with bleeding, allergy constitution
  • Patients with abnormal skin or peripheral nerve sensation, abnormal pain sensation, skin ulceration at the sensitization detection site
  • Patients with unsatisfactory clinical treatment of hypertension and diabetes

结局指标

主要结局

Change of the number of angina attacks

时间窗: Change from baseline to week 8

Change of the number of uncomfortable events that met the criteria for angina in study period

次要结局

  • Change of the Canadian Cardiology Society (CCS) Classification of Angina Pectoris(Change from baseline to week 8)
  • Change of the use of Therapeutic Nitroglycerin Drugs(Change from baseline to week 8)
  • Change of the Seattle Angina Questionnaire(SAQ) Score(Change from baseline to week 8)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sun Xin

the Director of Chinese Evidence-based Medicine Center

West China Hospital

研究点 (1)

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