Clinical trial NCT03975140: 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
Overall status: COMPLETED
Phase: NA
Conditions: The Clinical Value of Acupoint Sensitization
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 202
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change of the number of angina attacks
timeFrame: Change from baseline to week 8
Secondary outcomes:
measure: Change of the Canadian Cardiology Society (CCS) Classification of Angina Pectoris
timeFrame: Change from baseline to week 8
measure: Change of the Seattle Angina Questionnaire(SAQ) Score
timeFrame: Change from baseline to week 8
measure: Change of the use of Therapeutic Nitroglycerin Drugs
timeFrame: Change from baseline to week 8
Other outcomes:
Locations:
city: Chengdu
country: China
facility: The West China Hospital of Sichuan university
state: Sichuan
Study officials:
References:
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.