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An exploratory randomized controlled study of electroacupuncture for chronic coronary syndrome based on acupoint sensitization theory

Registration number：

ITMCTR2024000467

Date of Last Refreshed on：

2024-09-22

Date of Registration：

2024-09-22

Registration Status：

Retrospective registration

Public title：

An exploratory randomized controlled study of electroacupuncture for chronic coronary syndrome based on acupoint sensitization theory

English Acronym：

Scientific title：

An exploratory randomized controlled study of electroacupuncture for chronic coronary syndrome based on acupoint sensitization theory

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Yang Shudi

Study leader：

Qiao Haifa

Applicant telephone：

13109639341

Study leader's telephone：

18220046518

Applicant Fax：

Study leader's fax：

Applicant E-mail：

2280204618@qq.com

Study leader's E-mail：

1511006@sntcm.edu.cn

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Shaanxi xianyang qindu shaanxi university of traditional Chinese medicine hospital

Study leader's address：

Shaanxi University of Traditional Chinese Medicine Xixian Avenue Xixian New Area Shaanxi Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Shaanxi University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

SZFYIEC-YJ-2024年第［223］号

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of the Affliated Hospital of shaanxi University of Traditional chinese Medicine hospital

Date of approved by ethic committee：

2024/8/27 0:00:00

Contact Name of the ethic committee：

Zhong Huihui

Contact Address of the ethic committee：

Ethics Committee of the Affliated Hospital of shaanxi University of Traditional chinese Medicine hospital

Contact phone of the ethic committee：

029-33377941

Contact email of the ethic committee：

szfyllwyh@163.com

Primary sponsor：

Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

Primary sponsor's address：

Shaanxi xianyang qindu shaanxi university of traditional Chinese medicine hospital

Secondary sponsor：

Country：

China

Province：

Shaanxi

City：

Xianyang

Institution
hospital：

shaanxi university of traditional chinese medicine hospital

Address：

Shaanxi xianyang qindu shaanxi university of traditional Chinese medicine hospital

Source(s) of funding：

Classification of Project

Target disease：

chronic coronary syndrome

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

Taking patients with chronic coronary syndrome as the research object, a randomized controlled design was used to explore the efficacy of using electroacupuncture sensitization sites and traditional acupuncture for chronic coronary syndrome, evaluate the effectiveness and safety of electroacupuncture treatment of chronic coronary syndrome, and thus enhance clinical efficacy.

Description for medicine or protocol of treatment in detail：

Ninety patients who met the diagnostic criteria for chronic coronary syndrome were included as observations. Randomized grouping was conducted using randomized numerical tables. The subjects were divided into the sensitized site treatment group, the conventional acupuncture group, and the waiting treatment group, each group of 30 patients. Patients in all three groups were treated with conventional drugs; The sensitized site treatment group was treated with electroacupuncture on the basis of conventional drug therapy, and the stimulation sites were 4 sensitized sites of the inner side of the left arm, namely S1, S2, S3, S4; On the basis of routine western medicine treatment, the patients in the routine acupuncture group were treated with electroacupuncture. The stimulation sites were Neiguan, Tongli, Ximen and Shenmen points on the left side. The acupoints were selected based on previous literatures and expert consensus on angina pectoris. The waiting treatment group was treated with only conventional drugs. The frequency of angina pectoris was observed before treatment, 4 weeks after treatment and 4 weeks after treatment. Secondary outcomes were duration of each episode of angina pectoris, VAS score, Seattle angina pectoris questionnaire, 6 min walk distance, self rating anxiety scale, self rating depression scale, changes in pain threshold, and adverse events. To evaluate the effectiveness and safety of electrical acupuncture site treatment for chronic coronary syndrome.

Inclusion criteria

(1) In accordance with the diagnostic criteria for chronic coronary syndrome (European Society of Cardiology (ESC) published in 2019 "Diagnosis and Guidelines for Chronic Coronary Syndrome") [5] ; (2) Ambulatory or inpatient patients who respond clearly and meet the above diagnostic criteria; (3) Age between 18 and 65 years;(4)Have a history of angina pectoris at least 2 times per week and the degree and duration of each episode are basically stable;(5) Patients who have not received the corresponding acupuncture treatment in almost 3 months;(6) A person who wishes to participate in the trial and signs an informed consent form. Note: Patients who meet the above six criteria can only be included in this study.

Exclusion criteria：

(1)Previous myocardial infarction serious heart failure valvular heart disease serious arrhythmias primary cardiomyopathy or hematologic disorders; People with pre-existing high blood pressure and high blood sugar; And those with other serious cerebrovascular diseases. (2) People with abnormal nerve sensation in the local skin endings; (3) Pregnant and lactating women patients with mental illness; (4) People with other serious heart and brain conditions; (5)Participate in other clinical trials at the same time; (6) People with bleeding or allergies. Note: Any compliance with any of the above paragraphs is excluded.

Study execute time：

From 2024-08-27

To      2025-08-27

Recruiting time：

From 2024-08-27

To      2025-08-27

Interventions：

30

Group：

Conventional acupuncture group

Sample size：

Intervention：

On the basis of conventional western medicine treatment, the patient was treated with electroacupuncture. The stimulation sites were left Neiguan, Tongli, Cleft men and Shenmen points. The selection of acupoints was based on previous literatures and expert consensus on the treatment of angina pectoris with acupuncture. The patient received acupuncture treatment for 4 weeks, 3 times a week, 30 min each time, the frequency was 2 Hz.

Intervention code：

30

Group：

Waiting group

Sample size：

Intervention：

The patients were treated with conventional drugs and no intervention was performed during 4 weeks of treatment and 4 weeks of follow-up.

Intervention code：

30

Group：

Sensitized site treatment group

Sample size：

Intervention：

The patient was treated with electroacupuncture on the basis of conventional drug treatment and the stimulation sites were 4 sensitized sites in the inner left arm. The sensitized sites were determined mainly according to the principle of "taking pain as the Shu" and the first four points with the most obvious pain sensitivity were selected. The patient received acupuncture treatment for 4 weeks 3 times a week (1 3 5 days) for continuous tre

Intervention code：

Total sample size ： 90

Countries of recruitment
and research settings：

Country：

China

Province：

Shaanxi

City：

Primary indicator

Institution/hospital：

shaanxi university of traditional chinese medicine hospital

Level of the institution：

Third.cas hosptal

Outcomes：

Outcome：

Seattle angina questionnaire

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

VAS score of pain degree at onset of strangulation

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

（SAS、SDS）

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The duration of each attack of angina

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Changes in pain threshold

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

6min walking distance

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Frequency of angina attacks

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

不良事件

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

urine

Tissue：

Fate of sample 

Others

Note：

Sample Name：

hematology

Tissue：

Fate of sample 

Others

Note：

Recruiting

18
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

The random number table method was used to randomly group the qualified subjects into the sensitized site treatment group, the routine acupuncture group and the waiting treatment group according to the ratio of 1:1:1.

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

No public

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

An Excel datasheet was created and the data from the subjects on the CRF sheet was entered as raw data.

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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