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.

Study Overview

• Status: Completed
• Conditions: The Clinical Value of Acupoint Sensitization
• Intervention / Treatment: Procedure: Hypersensitive acupoint group; Procedure: Hyposensitive acupoint group

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • The West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypersensitive acupoint group	Procedure: Hypersensitive acupoint group; 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.
Active Comparator: Hyposensitive acupoint group	Procedure: Hyposensitive acupoint group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the number of angina attacks	Change of the number of uncomfortable events that met the criteria for angina in study period	Change from baseline to week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the Canadian Cardiology Society (CCS) Classification of Angina Pectoris	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	Change from baseline to week 8
Change of the Seattle Angina Questionnaire(SAQ) Score	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	Change from baseline to week 8
Change of the use of Therapeutic Nitroglycerin Drugs	Change of the number of times that patients temporarily took nitroglycerin for angina attacks	Change from baseline to week 8

Collaborators and Investigators

• Sponsor: West China Hospital

Publications and helpful links

General Publications

• Huang S, Li L, Liu J, Li X, Shi Q, Li Y, Liu Y, Li M, Ma L, Ning L, Liao X, Ying X, Cai W, Yang F, Wang T, Guo R, Ma W, Chen W, Chen J, Sun X. The Preventive Value of Acupoint Sensitization for Patients with Stable Angina Pectoris: A Randomized, Double-Blind, Positive-Controlled, Multicentre Trial. Evid Based Complement Alternat Med. 2021 Nov 2;2021:7228033. doi: 10.1155/2021/7228033. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): February 22, 2021
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable
• Other Study ID Numbers: 81590955

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No