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基于静息态脑区探讨发散式体外冲击波对原发性痛经女性即时镇痛的影响
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注册号:

Registration number:

ChiCTR1900020678 

最近更新日期:

Date of Last Refreshed on:

2019-01-13 

注册时间:

Date of Registration:

2019-01-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于静息态脑区探讨发散式体外冲击波对原发性痛经女性即时镇痛的影响 

Public title:

Immediate analgesia effect of radial extracorporeal shock wave in primary dysmenorrhea based on resting state fMRI: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于静息态脑区探讨发散式体外冲击波对原发性痛经女性即时镇痛的影响 

Scientific title:

Immediate analgesia effect of radial extracorporeal shock wave in primary dysmenorrhea based on resting state fMRI: a randomized controlled trial 

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:

刘珊珊 

研究负责人:

杨坚 

Applicant:

Shanshan Liu 

Study leader:

Jian Yang 

申请注册联系人电话:

Applicant telephone:

+86 17601366723 

研究负责人电话:

Study leader's telephone:

+86 13361801366 

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:

sandy666333@163.com 

研究负责人电子邮件:

Study leader's E-mail:

dr.yj168@163.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:

上海市徐汇区淮海中路966号 

研究负责人通讯地址:

上海市徐汇区淮海中路966号 

Applicant address:

966 Huaihai Middle Road, Xuhui District, Shanghai, China 

Study leader's address:

966 Huaihai Middle Road, Xuhui District, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200031 

研究负责人邮政编码:

Study leader's postcode:

200031 

申请人所在单位:

上海市徐汇区中心医院 

Applicant's institution:

Central Hospital of Shanghai Xuhui District  

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:

2018043 

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:

上海市徐汇区中心医院伦理委员会 

Name of the ethic committee:

Approval Notice of Ethics Committee of Shanghai Xuhui Central Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-10 

伦理委员会联系人:

王燕燕 

Contact Name of the ethic committee:

Yanyan Wang 

伦理委员会联系地址:

上海市淮海中路966号 

Contact Address of the ethic committee:

966 Huaihai Road, Xuhui District, Shanghai, China  

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:

上海市徐汇区中心医院 

Primary sponsor:

Central Hospital of Shanghai Xuhui  

研究实施负责(组长)单位地址:

上海市徐汇区淮海中路966号 

Primary sponsor's address:

966 Huaihai Middle Road, Xuhui District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市徐汇区中心医院

具体地址:

上海市徐汇区淮海中路966号

Institution
hospital:

Central Hospital of Shanghai Xuhui District

Address:

966 Huaihai Road, Xuhui District, Shanghai, China

经费或物资来源:

自筹 

Source(s) of funding:

self-raised 

研究疾病:

原发性性痛经 

Target disease:

primary dysmenorrhea 

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:

研究目的:

(1)分析发散式体外冲击波对原发性痛经即时镇痛的影响; (2)基于功能磁共振成像评价干预前后原发性痛经女性自发性脑活动的改变 

Objectives of Study:

(1)To analyze the immediate analgesia effect of radial extracorporeal shock wave in primary dysmenorrhea. (2)To evaluate the alterations of spontaneous brain activity in patients with primary dysmenorrhea before and after intervention based on functional magnetic resonance imaging. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)行经前或月经期出现周期性小腹疼痛,可伴有腰酸或其他不适; (2)18-30岁未生育女性; (3)月经周期规律:28±7天; (4)连续6个月及以上月经周期疼痛; (5)VAS≥40mm; (6)治疗前6个月内未服用口服避孕药或作用于中枢神经系统性药物且24小时内未服用止痛药或抗抑郁药; (7)右利肢; (8)未接受过体外冲击波治疗; (9)自愿参加实验并签署知情同意书。 

Inclusion criteria

(1) periodic abdominal pain before menstruation or during menstruation, accompanied by lumbar acid or other discomfort; (2) childless young women aged 18-30 years; (3) no pelvic organic diseases, excluding secondary dysmenorrhea caused by endometriosis, adenomyosis, submucosal fibroids, etc.; (4) menstrual cycle: 28±7 days; (5) pain in menstrual cycle for 6 months or more; (6) VAS≥40mm; (7) no oral contraceptives or drugs acting on the central nervous system were taken within 6 months before treatment, and no painkillers or antidepressants were taken within 24 hours; (8) use the right limb; (9) not received extracorporeal shock wave therapy before; (10) voluntarily participate in the experiment and sign the informed consent form. 

排除标准:

(1)经子宫核磁检查,存在子宫内膜异位、子宫腺肌症、黏膜下肌瘤等有盆腔器质性病变引发的继发性痛经者; (2)近半年有生育计划、妊娠期及已育女性; (3)月经周期不规律者; (4)对耦合剂过敏者; (5)治疗部位皮肤或肌肉有组织学异变者; (6)严重精神疾患者; (7)合并有心、脑、肝、肾、造血系统等严重疾病者; (8)核磁共振检查禁忌者(幽闭恐惧症、体内有金属或心脏起搏器者) 

Exclusion criteria:

(1) secondary dysmenorrhea caused by pelvic organic diseases such as endometriosis, adenomyosis and submucosal fibroids; (2) women who have a birth plan in the next six months or in pregnant or has given birth; (3) irregular menstrual cycles; (4) be allergic to the coupling agent; (5) have histological changes in the skin or muscle of the treatment site; (6) patients with severe mental illness; (7) have serious diseases such as heart, brain, liver, kidney, and hematopoietic system; (8) contraindications to magnetic resonance imaging(claustrophobia, metal implants or cardiac pacemakers in the body). 

研究实施时间:

Study execute time:

From2019-01-30To 2020-06-30 

征募观察对象时间:

Recruiting time:

From2019-01-30To 2019-02-28 

干预措施:

Interventions:

组别:

对照组

样本量:

20

Group:

Group 1

Sample size:

干预措施:

非甾体类抗炎药

干预措施代码:

Intervention:

Non-steroidal anti-inflammatory drugs

Intervention code:

组别:

试验组

样本量:

20

Group:

Group 2

Sample size:

干预措施:

发散式体外冲击波

干预措施代码:

Intervention:

radial extracorporeal shock wave

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海徐汇中心医院 

单位级别:

二级甲等 

Institution
hospital:

Central Hospital of Shanghai Xuhui District  

Level of the institution:

Secondary A Hospital  

测量指标:

Outcomes:

指标中文名:

简式McGill疼痛问卷

指标类型:

主要指标 

Outcome:

short‐form mcgill pain questionnaire (SF-MPQ)

Type:

Primary indicator 

测量时间点:

卵泡期,经期干预前,经期干预后

测量方法:

SF-MPQ由疼痛分级指数(PRI)、视觉模拟评分法(VAS)和现有疼痛强度(PPI)构成。疼痛分级指数(PRI)由11个感觉类和4个情感类对疼痛的描述词组成。所有描述词用0-3分分别表示“无”、“轻”、“中”、“重”的不同程度。受试者于不同阶段实时填写。

Measure time point of outcome:

Measure method:

指标中文名:

中文版COX痛经症状量表

指标类型:

主要指标 

Outcome:

The COX menstrual symptom scale, CMSS

Type:

Primary indicator 

测量时间点:

卵泡期,经期干预前,经期干预后

测量方法:

分别计算痛经症状的严重程度及持续时间的得分。得分越高,说明痛经症状越严重。

Measure time point of outcome:

Measure method:

指标中文名:

焦虑自评量表

指标类型:

次要指标 

Outcome:

Self-Rating Anxiety Scale, SAS

Type:

Secondary indicator 

测量时间点:

卵泡期,经期干预前,经期干预后

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑郁自评量表

指标类型:

次要指标 

Outcome:

Self-Rating Depression Scale, SDS

Type:

Secondary indicator 

测量时间点:

卵泡期,经期干预前,经期干预后

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

低频波动幅度

指标类型:

次要指标 

Outcome:

amplitude of low-frequency fluctuation (ALFF)

Type:

Secondary indicator 

测量时间点:

卵泡期,经期干预前,经期干预后

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

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 years
最大 Max age 30 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

由团队的统计人员运用SPSS统计软件生成随机数字并制定随机表格,根据受试者的就诊顺序相应编入试验组和对照组。

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

Subjects will be randomly allocated into treatment and control group with a number according to the order in which the participants came to the hospital via a table designed by the statistican using SPSS software.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

通过Resman提供原始数据查询

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

IPD will be public accessible via Resman.

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:

病例记录表和电子采集和管理系统

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

Case Record Form and Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-01-13
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