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Therapeutic effect of percutaneous electroacupuncture combined with adaptive biofeedback in the treatment of outlet obstructive constipation

注册号：

Registration number：

ITMCTR2000003814

最近更新日期：

Date of Last Refreshed on：

2020-08-28

注册时间：

Date of Registration：

2020-08-28

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

经皮电针联合自适应生物反馈治疗出口梗阻型便秘的疗效观察

Public title：

Therapeutic effect of percutaneous electroacupuncture combined with adaptive biofeedback in the treatment of outlet obstructive constipation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

经皮电针联合自适应生物反馈治疗出口梗阻型便秘的疗效观察

Scientific title：

Therapeutic effect of percutaneous electroacupuncture combined with adaptive biofeedback in the treatment of outlet obstructive constipation

研究课题的正式科学名称简写：

Scientific title acronym：

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：

ChiCTR2000037449 ; ChiMCTR2000003814

申请注册联系人：

刘杰

研究负责人：

余跃

Applicant：

Liu Jie

Study leader：

Yu Yue

申请注册联系人电话：

Applicant telephone：

+86 18755196560

研究负责人电话：

Study leader's telephone：

+86 18963788890

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：

feixilj@163.com

研究负责人电子邮件：

Study leader's E-mail：

yuyuemd@163.com

申请单位网址(自愿提供)：

Study leader's 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：

安徽省合肥市庐阳区庐江路17号安徽省立医院

研究负责人通讯地址：

安徽省合肥市庐阳区庐江路17号安徽省立医院

Applicant address：

17 Lujiang Road, Luyang District, Hefei, Anhui, China

Study leader's address：

17 Lujiang Road, Luyang District, Hefei, Anhui, China

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：

安徽省立医院

Applicant's institution：

Anhui Provincial Hospital

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

2013/8/26 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

安徽省立医院

Primary sponsor：

Anhui Provincial Hospital

研究实施负责（组长）单位地址：

安徽省合肥市庐阳区庐江路17号

Primary sponsor's address：

17 Lujiang Road, Luyang District, Hefei, Anhui, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

安徽

市(区县)：

Country：

China

Province：

Anhui

City：

单位(医院)：

安徽省立医院

具体地址：

安徽省合肥市庐阳区庐江路17号安徽省立医院

Institution
hospital：

Anhui Provincial Hospital

Address：

17 Lujiang Road, Luyang District, Hefei

经费或物资来源：

安徽省对外科技合作计划项目（项目编号:1604b0602021）

Source(s) of funding：

Anhui foreign science and Technology Cooperation Program (Project No.: 1604b06020221)

研究疾病：

出口梗阻性便秘

研究疾病代码：

Target disease：

outlet obstructed constipation

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

治疗新技术临床试验

New Treatment Measure Clinical Study

研究目的：

本研究通过同步化经皮电神经刺激联合自适应生物反馈治疗出口梗阻所致的便秘，评价： （1）治疗前后便秘症状评分，临床症状改善情况(PAC．SYM)； （2）对患者治疗前后进行便秘患者生活质量问卷(PAC．QOL)； （3）应用高分辨率肛门直肠测压仪器测量治疗前后便秘患者肛肠动力学变化情况； （4）检测便秘患者治疗前后血清中血管活性肠肽(VIP)、一氧化氮(NO)含量变化情况 并对上述结果进行统计学比较分析，旨在初步探讨同步化经皮电神经刺激联合自适应生物反馈治疗出口梗阻型便秘的疗效及机制。

Objectives of Study：

In this study, synchronous percutaneous electrical nerve stimulation combined with adaptive biofeedback was used to treat constipation caused by outlet obstruction (1) Constipation symptom score and improvement of clinical symptoms (PAC. Sym) before and after treatment; (2) The quality of life questionnaire for constipation patients (PAC. QOL) was conducted before and after treatment; (3) High resolution anorectal manometry was used to measure the anorectal dynamics in patients with constipation before and after treatment; (4) To detect the changes of vasoactive intestinal peptide (VIP) and nitric oxide (no) in serum of patients with constipation before and after treatment The purpose of this study was to explore the effect and mechanism of synchronized percutaneous electrical nerve stimulation combined with adaptive biofeedback in the treatment of outlet obstruction constipation.

药物成份或治疗方案详述：

纳入患者年龄小于65周岁（包括65周岁），男女不限；本次入选前一年内在三甲医院进行结肠镜检查，排除肠癌、溃疡、炎症或其他肠器质性疾患；入选前一年内在三甲医院进行过B超检查排除肝胆胰疾病；入选前一个月内在本中心进行心电图检查基本正常者（QT间期在正常范围）；计划筛选并纳入出口梗阻性便秘100名患者。随机分为3组：A,B,C组。其中，经皮电神经刺激+自适应生物反馈治疗+聚乙二醇4000散（C组）;假电神经刺激+自适应生物反馈治疗+聚乙二醇4000散（B组）；聚乙二醇4000散治疗组（A组）。治疗6周后随访患者的：1.便秘症状评分，临床症状改善情况(PAC．SYM)；2.对患者治疗前后进行便秘患者生活质量问卷(PAC．QOL)；3.应用高分辨率肛门直肠测压仪器测量治疗前后便秘患者肛肠动力学变化情况；4.检测便秘患者治疗前后血清中血管活性肠肽(VIP)、一氧化氮(NO)含量

Description for medicine or protocol of treatment in detail：

The included patients were less than 65 years old (including 65 years old), regardless of gender; colonoscopy was performed in grade a hospital one year before the enrollment to exclude intestinal cancer, ulcer, inflammation or other organic intestinal diseases; B-ultrasound examination was conducted in grade a hospital one year before enrollment to exclude hepatobiliary pancreatic diseases; ECG examination was conducted in the center within one month before enrollment (QT interval) 100 patients with outlet obstructive constipation were selected and included. They were randomly divided into three groups: group A, group B and group C. Among them, transcutaneous electrical nerve stimulation + adaptive biofeedback treatment + polyethylene glycol 4000 powder (Group C); false electrical nerve stimulation + adaptive biofeedback treatment + polyethylene glycol 4000 powder (group B); polyethylene glycol 4000 powder treatment group (group A). After 6 weeks of treatment, the patients were followed up for: 1. Constipation symptom score and clinical symptom improvement (PAC. Sym); 2. The constipation patients' quality of life questionnaire (PAC. QOL) before and after treatment; 3. The anorectal motility changes of constipation patients before and after treatment were measured by high-resolution anorectal manometry instrument; 4. Serum vasoactive intestinal peptide (VIP) and nitric oxide were detected before and after treatment（ No) content

纳入标准：

有检查证实出口梗阻证据并符合功能性便秘罗马IV诊断标准 ?年龄18至65周岁（包括18～65周岁），男女不限； ?本次入选前一年内在三甲医院进行结肠镜检查，排除肠癌、溃疡、炎症或其他肠器质性疾患； ?入选前一年内在三甲医院进行过B超检查排除肝胆胰疾病； ?入选前一个月内在本中心进行心电图检查基本正常者（QT间期在正常范围）；

Inclusion criteria

1. There was evidence of outlet obstruction and met Rome IV diagnostic criteria for functional constipation 2. Aged 18 to 65 years old male and female; 3. Colonoscopy was performed in a Grade-A hospital one year before the enrollment to exclude intestinal cancer, ulcer, inflammation or other organic intestinal diseases; 4. B-ultrasound examination was performed in a Grade-A hospital one year before admission to exclude hepatobiliary and pancreatic diseases; 5. The patients with normal ECG examination in our center one month before admission (QT interval was within normal range).

排除标准：

?有腹部手术史者； ?消化系统器质性疾病（包括息肉、炎症性肠病、肿瘤、乳糜泻、乳糖不耐受等） ?入选前2周内使用任何解痉止痛药、胃肠动力药、抑酸剂、微生态制剂、抗生素、抗抑郁药等； ?B超检查患肝胆胰疾病； ?患有高血压且血压控制不稳定者； ?有糖尿病、甲状腺疾病、系统性硬化症、系统性红斑狼疮等病史者； ?严重心理障碍患者； ?孕妇、哺乳期妇女或计划怀孕者； ?有服用聚乙二醇4000散过敏者； 5.观察内容： （1）基本情况采集 （2）便秘症状严重程度积分PAC-SYM （3）便秘生活质量评分PAC-QOL （4）排便时肛门括约肌压力 （5）血清精神心理相关神经递质变化（有条件单位）

Exclusion criteria：

1. Have a history of abdominal surgery; 2. Organic diseases of digestive system (including polyps, inflammatory bowel disease, tumor, celiac disease, lactose intolerance, etc.); 3. Any antispasmodic and analgesic drugs, gastrointestinal motility drugs, acid inhibitors, microecological agents, antibiotics, antidepressants, etc. were used within 2 weeks before enrollment; 4. B ultrasound examination of liver, gallbladder and pancreas diseases; 5. People with hypertension and unstable blood pressure control; 6. Patients with diabetes mellitus, thyroid disease, systemic sclerosis, systemic lupus erythematosus, etc; 7. Patients with severe psychological disorders; 8. pregnant women, lactating women or planned pregnancies; 9. There are allergic patients taking polyethylene glycol 4000 powder; 10. Observation contents: (1) Basic information collection; (2) Constipation symptom severity score pac-sym; (3) Constipation quality of life score pac-qol; (4) Anal sphincter pressure during defecation; (5) Changes of serum psychosomatic neurotransmitters (conditional units).

研究实施时间：

Study execute time：

从From 2020-10-01

至To      2021-10-01

征募观察对象时间：

Recruiting time：

从From 2020-10-01

至To      2021-10-01

干预措施：

Interventions：

组别：

试验组

样本量：

34

Group：

Experimental group

Sample size：

干预措施：

经皮电针+生物反馈+聚乙二醇4000散

干预措施代码：

Intervention：

Percutaneous electroacupuncture + biofeedback + polyethylene glycol 4000 powder

Intervention code：

组别：

对照组I

样本量：

33

Group：

Control group I

Sample size：

干预措施：

假经皮电针+生物反馈+聚乙二醇4000散

干预措施代码：

Intervention：

Sham-transcutaneous electroacupuncture + biofeedback + polyethylene glycol 4000 powder

Intervention code：

组别：

对照组II

样本量：

33

Group：

Control group II

Sample size：

干预措施：

聚乙二醇4000散

干预措施代码：

Intervention：

Macrogol 4000 Powders

Intervention code：

样本总量 Total sample size ： 100

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

安徽

市(区县)：

Country：

China

Province：

Anhui

City：

单位(医院)：

安徽省立医院

单位级别：

三级甲等

Institution/hospital：

Anhui Provincial Hospital

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

排便肛门压力

指标类型：

主要指标

Outcome：

anal defedating pressure

Type：

Primary indicator

测量时间点：

测量方法：

肛门直肠测压

Measure time point of outcome：

Measure method：

指标中文名：

患者自评生活质量评分

指标类型：

主要指标

Outcome：

PAC-QOL

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血清精神心理相关神经递质变化

指标类型：

主要指标

Outcome：

Changes of Serum Psychological Related Neurotransmitters

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者自评便秘症状评分

指标类型：

主要指标

Outcome：

PAC-SYM

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

患者人体血清标本

组织：

Sample Name：

Human serum samples from patients

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：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 65 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

采用区组，随机，平行对照，由中心专业统计人员（编盲者）负责用 SAS 软件产生中心编码分配随机数字、试验病例分配随机数字、处理组分配随机数字，以及试验病例随机编码表。并大致按1：1：1比例随机分为三组：A,B,C组。其中，经皮电神经刺激+自适应生物反馈治疗+聚乙二醇4000散（C组）;假电神经刺激+自适应生物反馈治疗+聚乙二醇4000散（B组）；聚乙二醇4000散治疗组（A组）。

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

The statistical personnel (blinders) in the center were responsible for generating the random number of center code allocation, the random number of trial cases, the random number of treatment group, and the random code table of experimental cases by using SAS software. They were randomly divided into three&#32

盲法：

本次研究属单盲试验，由中心专业统计人员进行编盲，研究对象不了解试验分组情况。

Blinding：

This study was a single blind trial, which was blinded by the professional statisticians of the center, and the subjects did not understand the grouping of the trials.

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）：

项目组根据研究进程择期选择具体方式公开原始数据

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

The project team chooses specific ways to disclose the original data according to the research process.

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：

研究者根据受试者的原始观察记录，将数据及时完整正确清晰地载入病例报告表，录入采用相应的数据库系统双人双机录入，之后对数据库进行两次对比，电子数据文件分类保存，并有多个备份保存于不同磁盘或不同介质上，妥善保存，防止损坏。

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

According to the original observation records of the subjects, the data were loaded into the case report form in time, completely, correctly and clearly. The data were input by the corresponding database system with two persons and two computers. After that, the database was compared twice. The electronic data files were classified and saved, and multiple backups were saved on different disks or different media. The data were stored properly to prevent damage.

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

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

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