The Preventive Value of Acupoint Sensitization Based on Stable Angina Pectoris
Primary Purpose
The Clinical Value of Acupoint Sensitization
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hypersensitive acupoint group
Hyposensitive acupoint group
Sponsored by
About this trial
This is an interventional prevention trial for The Clinical Value of Acupoint Sensitization
Eligibility Criteria
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
Sites / Locations
- The West China Hospital of Sichuan university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hypersensitive acupoint group
Hyposensitive acupoint group
Arm Description
Outcomes
Primary Outcome Measures
Change of the number of angina attacks
Change of the number of uncomfortable events that met the criteria for angina in study period
Secondary Outcome Measures
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 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 of the use of Therapeutic Nitroglycerin Drugs
Change of the number of times that patients temporarily took nitroglycerin for angina attacks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03975140
Brief Title
The Preventive Value of Acupoint Sensitization Based on Stable Angina Pectoris
Official Title
The Preventive Value of Acupoint Sensitization Based on Stable Angina Pectoris
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
February 22, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Clinical Value of Acupoint Sensitization
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypersensitive acupoint group
Arm Type
Experimental
Arm Title
Hyposensitive acupoint group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Hypersensitive acupoint group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hyposensitive acupoint group
Intervention Description
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 Outcome Measure Information:
Title
Change of the number of angina attacks
Description
Change of the number of uncomfortable events that met the criteria for angina in study period
Time Frame
Change from baseline to week 8
Secondary Outcome Measure Information:
Title
Change of the Canadian Cardiology Society (CCS) Classification of Angina Pectoris
Description
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
Time Frame
Change from baseline to week 8
Title
Change of the Seattle Angina Questionnaire(SAQ) Score
Description
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
Time Frame
Change from baseline to week 8
Title
Change of the use of Therapeutic Nitroglycerin Drugs
Description
Change of the number of times that patients temporarily took nitroglycerin for angina attacks
Time Frame
Change from baseline to week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The West China Hospital of Sichuan university
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
34765004
Citation
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.
Results Reference
derived
Learn more about this trial
The Preventive Value of Acupoint Sensitization Based on Stable Angina Pectoris
We'll reach out to this number within 24 hrs