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非手术指征子宫肌瘤双敏腧穴分布与指压推拿疗效研究

注册号：

Registration number：

ITMCTR2200005699

最近更新日期：

Date of Last Refreshed on：

2022-03-13

注册时间：

Date of Registration：

2022-03-13

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

非手术指征子宫肌瘤双敏腧穴分布与指压推拿疗效研究

Public title：

Study on the distribution of Shuangmin acupoints and the curative effect of finger massage for non-surgical indications of hysteromyoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

非手术指征子宫肌瘤双敏腧穴分布与指压推拿疗效研究

Scientific title：

Study on the distribution of Shuangmin acupoints and the curative effect of finger massage for non-surgical indications of hysteromyoma

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：

CYFY2021YB05

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：

ChiCTR2200057464 ; ChiMCTR2200005699

申请注册联系人：

彭聪

研究负责人：

彭聪

Applicant：

Peng Cong

Study leader：

Peng Cong

申请注册联系人电话：

Applicant telephone：

13982268823

研究负责人电话：

Study leader's telephone：

13982268823

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：

55924236@qq.com

研究负责人电子邮件：

Study leader's E-mail：

55924236@qq.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

http://www.cyfyy.cn/

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

http://www.cyfyy.cn/

申请注册联系人通讯地址：

四川省成都市新都区宝光大道278号

研究负责人通讯地址：

四川省成都市新都区宝光大道278号

Applicant address：

No. 278, Baoguang Avenue, Xindu District, Chengdu, Sichuan

Study leader's address：

No. 278, Baoguang Avenue, Xindu District, Chengdu, Sichuan

申请注册联系人邮政编码：

Applicant postcode：

610500

研究负责人邮政编码：

Study leader's postcode：

610500

申请人所在单位：

成都医学院第一附属医院

Applicant's institution：

The First Affiliated Hospital of Chengdu Medical College

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：

成都医学院第一附属医院

Primary sponsor：

The First Affiliated Hospital of Chengdu Medical College

研究实施负责（组长）单位地址：

四川省成都市新都区宝光大道278号

Primary sponsor's address：

No. 278, Baoguang Avenue, Xindu District, Chengdu, Sichuan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

四川省

市(区县)：

成都市

Country：

China

Province：

Sichuan

City：

Chengdui

单位(医院)：

成都医学院第一附属医院

具体地址：

The First Affiliated Hospital of Chengdu Medical College

Institution
hospital：

四川省成都市新都区宝光大道278号

Address：

No. 278, Baoguang Avenue, Xindu District, Chengdu, Sichuan

国家：

中国

省(直辖市)：

四川省

市(区县)：

成都市

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

成都医学院第一附属医院

具体地址：

四川省成都市新都区宝光大道278号

Institution
hospital：

The First Affiliated Hospital of Chengdu Medical College

Address：

No. 278, Baoguang Avenue, Xindu District, Chengdu, Sichuan

经费或物资来源：

成都医学院第一附属医院

Source(s) of funding：

The First Affiliated Hospital of Chengdu Medical College

研究疾病：

子宫肌瘤

研究疾病代码：

Target disease：

fibroid

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：

I期临床试验

Phase I clinical trial

研究目的：

1. 探索子宫肌瘤体表穴位敏化的规律，确定子宫肌瘤体表双敏穴区。 2. 观察子宫肌瘤双敏化穴对非手术指征子宫肌瘤患者的临床疗效，为非手术指征子宫肌瘤患者的临床保守治疗提供新思路。

Objectives of Study：

1. Explore the law of acupoint sensitization on the body surface of hysteromyoma and determine the Shuangmin acupoint area on the body surface of hysteromyoma. 2. To observe the clinical effect of shuangminhua point on patients with non-surgical indications of hysteromyoma, so as to provide new ideas for the clinical conservative treatment of patients with non-surgical indications of hysteromyoma.

药物成份或治疗方案详述：

1. 探索子宫肌瘤体表穴位敏化的规律，确定子宫肌瘤体表双敏穴区。 纳入子宫肌瘤（Uterine myoma, UM）患者及健康受试者，通过指压法及灸感法对两组患者进行力敏、热敏腧穴的探查，并将探查的双敏腧穴标注到人体神经皮节经络图上，对双敏腧穴进行计数统计，探索UM患者与健康受试者体表部位双敏腧穴的分布差异，分析UM患者双敏腧穴出现部位与神经节段、经脉及传统腧穴的位置关系，探讨UM体表穴位敏化的规律，确定UM体表双敏穴区。 2. 采用随机对照试验观察子宫肌瘤双敏化穴对非手术指征子宫肌瘤患者的临床疗效。 纳入非手术指症UM患者，1：1随机分为治疗组和对照组两组。治疗组采用研究一所确定UM敏化穴，嘱患者自行进行穴位指压推拿治疗；对照组不进行任何与子宫肌瘤相关的治疗。对比治疗前、治疗3个月、治疗6个月三个时间节点的UM体积变化、UM中医证候评分变化以及敏化穴视觉模拟评分（Visual analogue scale，VAS）评分，并记录治疗开始6月内转手术指征率，进行疗效判定。观察UM敏化穴对非手术指征UM患者的疗效，为非手术指征UM患者的临床保守治疗提供新思路。

Description for medicine or protocol of treatment in detail：

1. Explore the law of acupoint sensitization on the body surface of hysteromyoma and determine the Shuangmin acupoint area on the body surface of hysteromyoma. Patients with uterine leiomyoma (UM) and healthy subjects were included. The force sensitive and heat sensitive acupoints of the two groups were explored by finger pressing and moxibustion, and the explored Shuangmin acupoints were marked on the meridian diagram of human neurocutaneous nodes. The Shuangmin acupoints were counted and counted to explore the distribution difference of Shuangmin acupoints on the body surface between um patients and healthy subjects, Analyze the relationship between the location of Shuangmin acupoints in UM patients and the location of ganglion segments, meridians and traditional acupoints, explore the law of acupoint sensitization on UM body surface, and determine the Shuangmin acupoint area on UM body surface. 2. A randomized controlled trial was conducted to observe the clinical effect of shuangminhua point on patients with non-surgical indications of hysteromyoma. Patients with non-surgical finger um were randomly divided into treatment group and control group. In the treatment group, um sensitization point determined by the first research institute was used, and the patients were instructed to carry out acupoint finger massage treatment by themselves; The control group did not receive any treatment related to hysteromyoma. The changes of UM volume, um TCM syndrome score and visual analogue scale (VAS) score of sensitization point at three time points before treatment, 3 months of treatment and 6 months of treatment were compared, and the indication rate of conversion to operation within 6 months after the beginning of treatment was recorded for curative effect judgment. To observe the curative effect of UM sensitization point on patients with non-surgical indication um, so as to provide new ideas for clinical conservative treatment of patients with non-surgical indication um.

纳入标准：

①UM组 a.年龄18-50岁； b.符合子宫肌瘤诊断标准； c.3个月内均未使用过任何性激素类药物及避孕药物； d.无其他重大器质性病变； e.阅读并充分理解患者须知，签署知情同意书。 ②健康受试者组 a.年龄18-50岁的女性； b. 无各种器质性及功能性疾病； c.阅读并充分理解患者须知，签署知情同意书。

Inclusion criteria

① Um group a. Age 18-50 years old; b. Meet the diagnostic criteria of hysteromyoma; c. No sex hormone drugs or contraceptives were used within 3 months; d. No other major organic lesions; e. Read and fully understand the instructions to patients and sign the informed consent form. ② Healthy subjects group a. Women aged 18-50; b. No organic and functional diseases; c. Read and fully understand the instructions to patients and sign the informed consent form.

排除标准：

①患有影响敏化穴测定的急性生殖器官炎症、胸腹腔其他脏器疾病、脊柱病或其他痛症者； ②妊娠期或哺乳期妇女； ③精神状况不良、不能配合者。

Exclusion criteria：

① Suffering from acute genital inflammation, thoracic and abdominal organ diseases, spinal disease, or other pain that affect the determination of sensitization point; ② Pregnant or lactating women; ③ Poor mental condition and inability to cooperate.

研究实施时间：

Study execute time：

从From 2022-04-01

至To      2024-03-01

征募观察对象时间：

Recruiting time：

从From 2022-04-01

至To      2024-03-01

干预措施：

Interventions：

组别：

治疗组

样本量：

35

Group：

Treatment group

Sample size：

干预措施：

采用研究一结果所得双敏腧穴，嘱患者自行进行穴位指压推拿治疗，使穴位得气，即产生酸麻胀痛但不产生不适为度，每次10分钟，一日3次，3月为一疗程，连续治疗两个疗程（6个月）。

干预措施代码：

Intervention：

Using the Shuangmin acupoints obtained from the results of study 1, the patients were instructed to carry out acupoint finger pressure massage treatment on their own to make the acupoints get Qi, that is, produce acid, numbness, swelling and pain, but do not produce discomfort, 10 minutes each time, thr

Intervention code：

组别：

对照组

样本量：

35

Group：

control group

Sample size：

干预措施：

不进行任何与子宫肌瘤相关的治疗。

干预措施代码：

Intervention：

No treatment related to hysteromyoma was performed.

Intervention code：

样本总量 Total sample size ： 70

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

四川省

市(区县)：

成都市

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

成都医学院第一附属医院

单位级别：

三甲医院

Institution/hospital：

The First Affiliated Hospital of Chengdu Medical College

Level of the institution：

Class A tertiary hospital

测量指标：

Outcomes：

指标中文名：

性激素六项

指标类型：

主要指标

Outcome：

Six items of sex hormones

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

观察比较两组受试者的一般临床资料如患者的年龄、病程、病情程度等，以及既往史，比较两组患者之间的可比性。

指标类型：

次要指标

Outcome：

Observe and compare the general clinical data of the two groups, such as the patient's age, course of disease, degree of illness, and previous history, and compare the comparability between the two groups.

Type：

Secondary indicator

测量时间点：

入组、治疗三月、治疗六月三个时间节点

测量方法：

Measure time point of outcome：

There are three time nodes: enrollment, three months of treatment and six months of treatment

Measure method：

指标中文名：

子宫肌瘤中医证候评分表

指标类型：

主要指标

Outcome：

TCM syndrome score of hysteromyoma

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：

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：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 50 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

女性

Female

随机方法（请说明由何人用什么方法产生随机序列）：

将入组UM患者按照简单随机法分配入组，其随机数字由 SPSS 25.0 软件产生，由一名独立观察员将入组序列号、随机数字、组别装入不透光的牛皮纸信封中密封，在信封上标注序列号。当研究进行时，打开与纳入的UM受试者相同序列号的信封，随机分配到各组进行试验，1：1随机分成治疗组和对照组两组。

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

Um patients were assigned into the group according to the simple random method. The random number was generated by SPSS 25.0 software. An independent observer put the serial number, random number and group into an opaque kraft paper envelope, sealed, and marked the serial number on the envelope. When th

盲法：

本研究设计遵循盲法原则，采用盲法分组，即所有受试者预先都不知道自己的分组；盲法评价，由不知分组情况的第三方评价人员进行疗效评价；盲法统计，最后的试验数据交由不知分组的统计人员整理和分析，实行研究者、操作者、统计者（单盲）三分离。

Blinding：

The design of this study followed the principle of blind grouping, that is, all subjects did not know their grouping in advance; Blind evaluation, the curative effect is evaluated by the third-party evaluator who does not know the grouping; Blind statistics, the final test data are sorted and analyzed by statisticians who do not know the grouping, and the separation of researcher, operator and statistician (single blind) is implemented.

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）：

2023.12 在线

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

2023.12 Online

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：

①全部病例均按以上方案进行观察，认真填写病例报告表格（详见附件：子宫肌瘤患者敏化穴分布与疗效病例报告表）。使用德派软件北京有限公司提供的数据采集处理软件，在登陆状态下的电子终端进行病例数据采集和录入，数据及时上传至数据库。 ②认真记录UM患者治疗情况，采用打卡程序监督患者的治疗。 ③病历及病例报告表格作为原始记录。不得更改，做任何更正时不得改变原始记录，只能采用附加叙述说明理由签名并注明日期。 ④临床研究中各种实验室数据均应记录，门诊病例应将原始报告粘在病例报告表上。 ⑤在正常范围的实验室数据也应记录，对显著偏高或在临床可接受范围以外的数据须加以核实并做必要的说明。

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

① All cases were observed according to the above scheme, and the case report form was carefully filled in (see the Annex: case report form of sensitization point distribution and curative effect of hysteromyoma patients for details). Use the data acquisition and processing software provided by Depai software Beijing Co., Ltd. to collect and input case data at the electronic terminal in the login state, and upload the data to the database in time. ② Carefully record the treatment of UM patients, and use the punch in procedure to supervise the treatment of patients. ③ Medical records and case report forms are used as original records. It shall not be changed. The original record shall not be changed when making any correction. It can only be signed and dated with additional narrative explanation. ④ All kinds of laboratory data in clinical research should be recorded, and the original report of outpatient cases should be pasted on the case report form. ⑤ The laboratory data in the normal range should also be recorded. The data that are significantly high or outside the clinically acceptable range must be verified and explained as necessary.

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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