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A cross-sectional study on the characteristics and distribution of acupoint sensitization in patients with chronic coronary syndrome

Registration number：

ITMCTR2024000102

Date of Last Refreshed on：

2024-06-18

Date of Registration：

2024-06-18

Registration Status：

Retrospective registration

Public title：

A cross-sectional study on the characteristics and distribution of acupoint sensitization in patients with chronic coronary syndrome

English Acronym：

Scientific title：

A cross-sectional study on the characteristics and distribution of acupoint sensitization in patients with chronic coronary syndrome

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Ma Xinyu

Study leader：

Qiao Haifa

Applicant telephone：

18691130683

Study leader's telephone：

18220046518

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1017639494@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 Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

SZFYIEC-PJ-2023年第［47］号

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of the Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

Date of approved by ethic committee：

2023/5/19 0:00:00

Contact Name of the ethic committee：

Zhong Huihui

Contact Address of the ethic committee：

Shaanxi xianyang qindu 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：

Shaanxi University of Chinese Medicine

Primary sponsor's address：

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

Secondary sponsor：

Country：

Province：

City：

Institution
hospital：

Address：

Source(s) of funding：

Classification of Project

Target disease：

Chronic coronary syndrome

Target disease code：

Study type：

Observational study

Study design：

Cross-sectional

Study phase：

Pilot clinical trial

Objectives of Study：

To explore the surface sensitization points of patients with chronic coronary syndrome (CCS), observe the skin morphological changes, compare the pressure pain threshold and skin temperature of patients with sensitization points, their own contralateral side and healthy subjects at the same position, analyze the different sensitization characteristics under the disease state, and summarize the distribution law of sensitization points. Expectations for chronic coronary syndromes of specific clinical diagnosis and treatment, optimization of den plan to provide the reference.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

For patients with chronic coronary syndromes: (1) meet the diagnostic criteria of chronic coronary syndrome; (2) Patients were not limited in activity, with clear answers and good compliance; (3) 18≤ 85 years old, male or female; (4) those who voluntarily signed the informed consent; Healthy subjects: (1) 18≤ age ≤85 years old, male or female; (2) no history of chronic coronary syndrome or other heart diseases; (3) No obvious discomfort symptoms, clear answers, good compliance; (4) those who voluntarily signed the informed consent;

Exclusion criteria：

For patients with chronic coronary syndromes: (1) there are serious arrhythmia, heart failure, valvular heart disease, congenital heart disease, primary cardiomyopathy, aortic dissection, and other heart disease, and patients with severe cerebrovascular disease; (2) patients with malignant tumors, severe hematological diseases, severe liver and kidney dysfunction, and mental disorders who are unable to cooperate; (3) has a tendency to bleeding or allergic constitution; (4) patients with severe osteoporosis; (5) pain in shoulder, back and arm caused by muscle strain, myofasciitis, cervical spine and thoracic spine lesions; (6) detection area skin damage of the operator, (7) pregnant and lactating women; (8) those who participated or are participating in other clinical trials within the past 3 months. Healthy subjects: (1) during pregnancy and lactation women; (2) the skin damage of the exploration area affects the operator; (3) for nearly three months had attended or is in other clinical subjects.

Study execute time：

From 2023-05-19

To      2026-05-19

Recruiting time：

From 2023-05-19

To      2026-05-19

Interventions：

1035

Group：

Patients with chronic coronary syndrome

Sample size：

Intervention：

Detection of sensitization

Intervention code：

30

Group：

health volunteer

Sample size：

Intervention：

Detection of sensitization

Intervention code：

Total sample size ： 1065

Countries of recruitment
and research settings：

Country：

China

Province：

Shaanxi

City：

Xianyang

Institution/hospital：

Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

Level of the institution：

Third-class hospital

Outcomes：

Outcome：

Skin morphological changes

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

pressure pain threshold

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

skin temperature

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Recruiting

18
Min age years
85
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

The type of cross-sectional survey used in this study is sampling survey, which means that a certain number of representative individuals (statistically called samples) are randomly selected from a population (that is, all the research objects determined according to the purpose of the study) in accordance with certain principles to conduct an investigation, and then the prevalence rate or certain characteristics of a disease in the population are calculated using the survey results of this sample.

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 data sheet was established to enter the data of the subjects on the CRF form, which was used as the 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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