Clinical Observation on the Efficacy of Electroacupuncture in Treating Neurogenic Bowel Dysfunction (Constipation Type) After Ischemic Stroke

Registration number:

ITMCTR2024000184

Date of Last Refreshed on:

2024-08-07

Date of Registration:

2024-08-07

Registration Status:

Retrospective registration

Public title:

Clinical Observation on the Efficacy of Electroacupuncture in Treating Neurogenic Bowel Dysfunction (Constipation Type) After Ischemic Stroke

English Acronym:

Scientific title:

Clinical Study of Electroacupuncture Treatment for Neurogenic Bowel Dysfunction (Constipation Type) in Patients with Ischemic Stroke

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

Applicant:

Yu Li

Study leader:

Yu Li

Applicant telephone:

13972028178

Study leader's telephone:

13972028178

Applicant Fax:

Study leader's fax:

Applicant E-mail:

hsly63620@163.com

Study leader's E-mail:

hsly63620@163.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

21 Xiling 1st Road, Xiling District, Yichang City, Hubei Province

Study leader's address:

21 Xiling 1st Road, Xiling District, Yichang City, Hubei Province

Applicant postcode:

Study leader's postcode:

Applicant's institution:

The Second People's Hospital of China Three Gorges University

Approved by ethic committee:

Approved No. of ethic committee:

202422

Approved file of Ethical Committee:

View

Name of the ethic committee:

Ethics Committee of The Second People's Hospital of China Three Gorges University

Date of approved by ethic committee:

2024/2/26 0:00:00

Contact Name of the ethic committee:

Chanchan Tian

Contact Address of the ethic committee:

21 Xiling 1st Road, Xiling District, Yichang City, Hubei Province

Contact phone of the ethic committee:

13972028178

Contact email of the ethic committee:

hsly63620@163.com

Primary sponsor:

The Second People's Hospital of China Three Gorges University

Primary sponsor's address:

21 Xiling 1st Road, Xiling District, Yichang City, Hubei Province

Secondary sponsor:

Country:

China

Province:

Hubei

City:

Institution
hospital:

The Second People's Hospital of China Three Gorges University

Address:

21 Xiling 1st Road, Xiling District, Yichang City, Hubei Province

Source(s) of funding:

The Second People's Hospital of China Three Gorges University

Target disease:

neurogenic bowel dysfunction(constipation type)

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(parallel group design)

Study phase:

Others

Objectives of Study:

Observing the clinical efficacy of acupuncture at the Zusanli (ST36) point on neurogenic bowel dysfunction (constipation type) in patients with ischemic stroke, with the aim of providing a reference for the treatment of neurogenic bowel dysfunction in Traditional Chinese Medicine.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

Imaging findings meet the diagnostic criteria for ischemic stroke; the patient experiences a significant reduction in bowel movements, decreased defecation frequency (once every 2-3 days or less), dry stools, and at least two of the following symptoms: difficulty in defecation. These symptoms occur after neurological impairment due to stroke. The patient must be 18 years or older, have clear consciousness, stable vital signs, and be able to cooperate with treatment. Enrollment requires a thorough understanding of the study and signing an informed consent form.

Exclusion criteria:

Exclusion criteria include patients with malignant tumors of the nervous or digestive systems; those with a history of rectal, colonic organic lesions, or bowel surgery; individuals with a history of habitual constipation or diarrhea, indicating bowel dysfunction; those with severe cardiac, hepatic, or renal dysfunction and/or hematologic diseases; individuals with fecal incontinence; and those with psychiatric disorders.

Study execute time:

From 2024-02-01

To      2024-09-30

Recruiting time:

From 2024-02-27

To      2024-08-31

Interventions:

30

Group:

Control Group

Sample size:

Intervention:

Oral lactulose solution was administered at a dose of 10 ml per intake, three times daily. Dosage and duration were adjusted based on the individual patient's condition. The total treatment period was 4 weeks.

Intervention code:

30

Group:

Treatment group

Sample size:

Intervention:

Building upon the control group, acupuncture was performed at the Zusanli point. After local disinfection, a sterile, single-use acupuncture needle was quickly inserted into the acupoint, followed by gentle twirling and lifting movements. The needle was withdrawn after achieving the deqi sensation. Treatments were administered once daily, three times per week, for a total duration of 4 weeks.

Intervention code:

Total sample size : 60

Countries of recruitment
and research settings:

Country:

China

Province:

Hubei

City:

Institution/hospital:

The Second People's Hospital of China Three Gorges University

Level of the institution:

Tertiary A

Outcomes:

Outcome:

Neurogenic Bowel Dysfunction Score

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

patient-assessment of constipation quality of life

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Wexner Constipation Score

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Bowel movement frequency

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Bowel movement time

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

fecal

Tissue:

Fate of sample 

Destruction after use

Note:

Sample Name:

blood

Tissue:

Fate of sample 

Destruction after use

Note:

Recruiting

18
Min age years
95
Max age years

Recruiting status:

Participant age:

Gender:

Both

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

none

Blinding:

IPD sharing:

Yes

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

ResMan (http://www.medresman.org.cn/login.aspx).

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

none

Data Managemen Committee:

No

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

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above