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Completed

NCT Number: NCT03975140

The Preventive Value of Acupoint Sensitization Based on Stable Angina Pectoris

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.

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Key information

Conditions

The Clinical Value of Acupoint Sensitization

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The West China Hospital of Sichuan university

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Hypersensitive acupoint group

Procedure

The first five acupoints in the sensitization sequence were pressed using the traditional Chinese medicine acupoint pressing technique, and each acupoint was pressed for two minutes.

Hyposensitive acupoint group

Procedure

The last five acupoints in the sensitization sequence were pressed using the traditional Chinese medicine acupoint pressing technique, and each acupoint was pressed for two minutes.

Primary outcomes

  1. Change of the number of angina attacks

    Time frame: Change from baseline to week 8

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

Secondary outcomes

  1. Change of the Canadian Cardiology Society (CCS) Classification of Angina Pectoris

    Time frame: Change from baseline to week 8

    According to the patient's own condition scale, the patients were divided into 4 grades, the mildest being grade I and the most serious being grade IV

  2. Change of the Seattle Angina Questionnaire(SAQ) Score

    Time frame: Change from baseline to week 8

    The maximum score of the scale was 100, and the higher the score, the better the quality of life and the functional state of the patients

  3. Change of the use of Therapeutic Nitroglycerin Drugs

    Time frame: Change from baseline to week 8

    Change of the number of times that patients temporarily took nitroglycerin for angina attacks

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 5, 2019
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.