ChiCTR2400083303 版本V1.2 版本创建时间2024/06/21 16:41:30 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2400083303 

最近更新日期：

Date of Last Refreshed on：

 2024-06-21 16:20:28 

注册时间：

Date of Registration：

 2024-04-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

立体动态干扰电联合穴位刺激治疗卒中后便秘的临床研究

Public title：

Clinical study of stereo dynamic interferential electricity combined with acupoint stimulation in the treatment of post-stroke constipation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

立体动态干扰电联合穴位刺激治疗卒中后便秘的临床研究

Scientific title：

Clinical study of stereo dynamic interferential electricity combined with acupoint stimulation in the treatment of post-stroke constipation

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

王书婷 

研究负责人：

刘玲 

Applicant：

Shuting Wang 

Study leader：

Ling Liu 

申请注册联系人电话：

Applicant telephone：

 +86 150 8449 2194

研究负责人电话：

Study leader's
telephone：

+86 138 8399 3072

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 1831441954@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 313846875@qq.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

重庆市渝中区石油路街道医学院路1号

研究负责人通讯地址：

重庆市渝中区友谊路1号

Applicant address：

1 Medical College Road, Petroleum Road Street, Yuzhong District, Chongqing, China

Study leader's address：

1 Youyi Road, Yuzhong District, Chongqing

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

重庆医科大学

Applicant's institution：

Chongqing Medical University

研究负责人所在单位：

重庆医科大学附属第一医院

Affiliation of the Leader：

The First Hospital Affiliated to Chongqing Medical University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 202406703

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

重庆医科大学附属第一医院伦理委员会

Name of the ethic committee：

Ethics Committee of The First Hospital Affiliated to Chongqing Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-05-27 00:00:00

伦理委员会联系人：

严青

Contact Name of the ethic committee：

Qing Yan

伦理委员会联系地址：

重庆市渝中区友谊路1号

Contact Address of the ethic committee：

1 Youyi Road, Yuzhong District, Chongqing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 23 8901 1876

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

重庆医科大学附属第一医院

Primary sponsor：

The First Hospital Affiliated to Chongqing Medical University

研究实施负责（组长）单位地址：

重庆市渝中区友谊路1号

Primary sponsor's address：

1 Youyi Road, Yuzhong District, Chongqing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

重庆

市(区县)：

Country：

China

Province：

Chongqing

City：

单位(医院)：

重庆医科大学附属第一医院

具体地址：

重庆市渝中区友谊路1号

Institution
hospital：

The First Hospital Affiliated to Chongqing Medical University

Address：

1 Youyi Road, Yuzhong District, Chongqing

经费或物资来源：

研究生培养经费

Source(s) of funding：

Postgraduate training fund

研究疾病：

脑卒中后便秘  

Target disease：

post-stroke constipation

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究主要探讨立体动态干扰电联合穴位刺激对脑卒中患者便秘症状的影响，并分析比较单纯立体动态干扰电和联合穴位刺激的疗效。以期为脑卒中后便秘人群提供现代物理与传统中医穴位相融合的安全、有效、经济的治疗方法。  

Objectives of Study：

This study focuses on the effects of stereo-dynamic interferential electricity combined with acupoint stimulation on the symptoms of constipation in stroke patients and analyzes and compares the therapeutic efficacy of stereo-dynamic interferential electricity alone and combined acupoint stimulation. To provide a safe, effective, and economical treatment method for post-stroke constipation population with the integration of modern physics and traditional Chinese medicine acupoints.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

①符合《中国急性缺血性脑卒中诊治指南2018》或《中国脑出血诊治指南（2019）诊断标准，影像学确诊为脑卒中； ②出现便秘的临床表现符合罗马Ⅳ诊断标准和国际胃肠病学组织指南，表现为排便次数减少、粪便干硬和(或)排便困难；排便次数减少指每周排便少于3次。排便困难包括排便费力、排出困难、排便不尽感、排便费时及需手法辅助排便； ③知情同意，自愿参加本研究。

Inclusion criteria

① Meet the diagnostic criteria of China Acute Ischemic Stroke Diagnosis and Treatment Guidelines 2018 or China Cerebral Hemorrhage Diagnosis and Treatment Guidelines (2019), and the diagnosis of stroke was confirmed by imaging; ② The clinical manifestations of constipation in line with the Rome Ⅳ diagnostic criteria and the International Organization of Gastroenterology guidelines, manifested in a reduced number of bowel movements, hard and dry feces and/or defecation difficulties; reduced number of bowel movements refers to defecation less than three times a week. Difficulty in defecation includes straining to defecate, difficulty in evacuating, a feeling of incomplete evacuation, time-consuming defecation, and the need for manual assistance in defecation; ③ Informed consent and voluntary participation in this study.

排除标准：

①无法耐受本次研究治疗方案者；②干扰电疗法禁忌症如急性化脓性炎症，有出血倾向，局部有金属固定物，体内植入心脏起搏器者；③卒中合并胃肠道手术史或严重胃肠道疾病者。

Exclusion criteria：

①those who could not tolerate the treatment regimen of this study;②contraindications to stereokinetic interferential electrotherapy such as acute septic inflammation, a tendency to bleed, localized metal fixation, and internal implantation of a pacemaker; and ③history of gastrointestinal surgery for stroke comorbidities or severe gastrointestinal disorders.

研究实施时间：

Study execute time：

从 From 2024-06-24 00:00:00至 To 2026-06-24 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-06-24 00:00:00 至 To 2026-06-24 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 70

Group：

Control group

Sample size：

干预措施：

（1）便秘相关知识健康教育，讲解便秘的原因、临床表现、潜在危险性及预防便秘的重要性；讲解正确排便姿势及方法。 （2）饮食指导：多吃膳食纤维丰富、清淡易消化食物，多喝水，多食新鲜的蔬菜水果，嘱患者少食多餐。 （3）运动锻炼：病情允许时，嘱患者适量活动，促进肠蠕动。 （4）心理护理：与患者多沟通，鼓励说出内心真实想法，尽量满足其合理需求，讲解疾病治疗原理，增加治疗信心。 （5）腹部按摩：排便时用手沿结肠解剖位置自右向左环形按摩，促使降结肠内容物向下移动，并可增加腹内压，促使排便。也可指端轻压肛门后端促进排便。 （6）药物治疗：若住院3天未解便，给予患者口服泻药（例如乳果糖、聚乙二醇）或灌肠以促进排便。

干预措施代码：

Intervention：

(1) health education about constipation, explaining the cause, clinical manifestation, potential danger and the importance of preventing constipation, and explaining the correct defecation posture and method. (2) dietary guidance: eat more dietary fiber-rich, light and easy to digest food, drink more water, eat more fresh fruits and vegetables, told patients to eat small meals. (3) exercise: when the condition permits, instruct the patient to do some exercise to promote intestinal peristalsis. (4) psychological nursing: communicate with patients more, encourage them to tell their true thoughts, try their best to meet their reasonable needs, explain the principle of disease treatment, increase treatment confidence. (5) abdominal massage: when defecating, massage with hand from right to left along the anatomical position of colon to promote the downward movement of contents of descending colon and increase intraabdominal pressure to promote defecation. It can also be used to gently press the back of the anus to promote defecation. (6) medication: if the stool is not relieved within 3 days of hospitalization, the patient is given an oral laxative (e.g. lactulose, Polyethylene glycol) to facilitate defecation.

Intervention code：

组别：

干预组1

样本量：

 69

Group：

intervention group

Sample size：

干预措施：

在常规护理的基础上予以按解剖位置使用立体动态干扰电治疗，机器选用广州龙之杰科技有限公司的立体动态干扰电治疗仪，型号LGT-2800V2。患者取仰卧位，采用6个电极，分为3组同时进行。分别放置于上腹部剑突下、肚脐下、左右季肋区、左右髂前上棘旁。

干预措施代码：

Intervention：

Based on routine care, the patient was treated with three-dimensional dynamic interferon therapy according to the anatomical position, and the machine was selected from Guangzhou Longzhijie Science and Technology Co., Ltd. three-dimensional dynamic interferon therapeutic instrument, model LGT-2800V2. The patient was placed in the supine position, and six electrodes were used, which were divided into three groups at the same time. The electrodes were placed in the upper abdomen under the xiphoid process, under the navel, in the left and right quarter rib area, and next to the left and right anterior superior iliac spines, respectively.

Intervention code：

组别：

干预组2

样本量：

 71

Group：

intervention group

Sample size：

干预措施：

在常规护理基础上予以立体动态干扰电联合穴位刺激，机器选用广州龙之杰科技有限公司的立体动态干扰电治疗仪，型号LGT-2800V2。患者取仰卧位，采用6个电极，分为3组同时进行。分别放置于左右天枢穴、左右大肠俞穴、左右大横穴。

干预措施代码：

Intervention：

Based on routine care, the patient was treated with three-dimensional dynamic interferential electricity combined with acupoint stimulation, and the machine was chosen as the three-dimensional dynamic interferential electricity therapeutic instrument of Guangzhou Longzhijie Science and Technology Co, Ltd, model LGT-2800V2. The patient was placed in the supine position, and six electrodes were used, which were divided into three groups and carried out at the same time. The electrodes were placed on the right and left Tianshu points, the right and left large intestine points, and the right and left large transverse points, respectively.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 重庆 

市(区县)：

  

Country：

China

Province：

Chongqing

City：

单位(医院)：

 重庆医科大学附属第一医院康复医学科 

单位级别：

 三甲 

Institution
hospital：

Department of Rehabilitation, The First Affiliated Hospital of Chongqing Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

便秘改善情况

指标类型：

主要指标

Outcome：

Improvement of constipation

Type：

Primary indicator

测量时间点：

治疗前、治疗第7天、一疗程结束后（15天）、随访30天

测量方法：

Bristol粪便性状量表、自主排便次数

Measure time point of outcome：

The patients were followed up for 30 days before treatment, 7 days after treatment, 15 days after one course of treatment

Measure method：

Bristol stool character scale, frequency of spontaneous defecation, effective rate of constipation treatment

指标中文名：

营养情况

指标类型：

次要指标

Outcome：

Nutrition

Type：

Secondary indicator

测量时间点：

治疗前、一疗程结束后（15天）、随访30天

测量方法：

血清白蛋白、前白蛋白

Measure time point of outcome：

Before treatment, after a course of treatment (15 days) , 30 days of follow-up

Measure method：

Alb, prealbumin

指标中文名：

胃肠蠕动功能

指标类型：

次要指标

Outcome：

Function of gastrointestinal peristalsis

Type：

Secondary indicator

测量时间点：

治疗前、治疗第7天、一疗程结束后（15天）、随访30天

测量方法：

听肠鸣音1分钟

Measure time point of outcome：

The patients were followed up for 30 days before treatment, 7 days after treatment, 15 days after one course of treatment

Measure method：

Listen to bowel sounds for 1 minute

指标中文名：

卫生经济学指标

指标类型：

次要指标

Outcome：

Indicators of health economics

Type：

Secondary indicator

测量时间点：

一疗程结束后（15天）

测量方法：

住院天数、药品费用、住院治疗总费用以及住院期间药物费用占总费用比例。

Measure time point of outcome：

After one course of treatment (15 days)

Measure method：

The number of days in hospital, the cost of drugs, the total cost of hospitalization and the cost of drugs during hospitalization accounted for the proportion of the total cost.

指标中文名：

便秘改善情况

指标类型：

主要指标

Outcome：

Improvement of constipation

Type：

Primary indicator

测量时间点：

治疗前、一疗程结束后（15天）、随访30天

测量方法：

胃泌素

Measure time point of outcome：

Before treatment, after a course of treatment (15 days) , 30 days of follow-up

Measure method：

GAS(gastrin)

指标中文名：

灌肠次数

指标类型：

次要指标

Outcome：

Number of enemas

Type：

Secondary indicator

测量时间点：

治疗前、治疗第7天、一疗程结束后（15天）

测量方法：

通过甘油或开塞露等灌肠的次数

Measure time point of outcome：

Before treatment, 7 days after treatment and 15 days after treatment

Measure method：

Number of enemas by glycerin or Kaiselu

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 100 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

研究者按照入组顺序对符合纳入排除标准并最终进入试验的研究对象进行编号。采用SPSS 25.0 设定种子数，产生随机数列进行可视化分箱，分为干预组与对照组。

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

The researcher numbered the study subjects who met the inclusion-exclusion criteria and eventually entered the trial in the order of enrollment. SPSS 25.0 was used to set the number of seeds and generate random number columns for visualization of box splitting into intervention and control groups.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

本研究仅对研究对象和资料分析员设盲。

Blinding：

This study was blind only to the study subjects and data analysts

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

2026年6月公开，以excel形式呈现，百度云网盘或其他网盘的形式上传原始数据。

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

Public in June 2026, presented in excel form, Baidu Cloud web disk or other web disk to upload the original data.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

研究人员使用纸质版问卷收集受试者信息；电子版数据使用SPSS软件录入并存储在不同的磁盘或硬盘上。

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

General data, fall data, medical data, health data, etc. of the research objects are collected through the information system, and then the data is saved and managed by the Internet-based EDC system.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-04-19 17:21:42