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基于镇痛与免疫调节的TEAS联合三阶梯止痛治疗中重度癌的优势研究
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注册号:

Registration number:

ChiCTR-TRC-13003803 

最近更新日期:

Date of Last Refreshed on:

2016-05-30 

注册时间:

Date of Registration:

2013-08-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于镇痛与免疫调节的TEAS联合三阶梯止痛治疗中重度癌的优势研究 

Public title:

Advantages of Transcutanous Electric Acupoint Stimulation plus Three-step Analgesic Ladder Treatment for the Moderate to Severe Cancer Pain Based on Analgesia and Immunoregulation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于镇痛与免疫调节的TEAS联合三阶梯止痛治疗中重度癌的优势研究 

Scientific title:

Advantage and Analgesic Efficacy Evaluation on Transcutanous Electric Acupoint Stimulation plus Three-step Analgesic Ladder Treatment for the Moderate to Severe Cancer Pain 

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:

周杰 

研究负责人:

梁宜 

Applicant:

Jie Zhou 

Study leader:

Yi Liang 

申请注册联系人电话:

Applicant telephone:

+86 15968895450 

研究负责人电话:

Study leader's telephone:

+86 13136171416 

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:

zhoujie0111@163.com 

研究负责人电子邮件:

Study leader's E-mail:

liangyiwww@126.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:

浙江省杭州市莫干山路219号 

研究负责人通讯地址:

浙江省杭州市莫干山路219号 

Applicant address:

219 Moganshan Road, Hangzhou, Zhejiang 

Study leader's address:

219 Moganshan Road, Hangzhou, Zhejiang 

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:

浙江中医药大学附属第三医院 

Applicant's institution:

The Third Affiliated Hospital of Zhejiang Chinese Medicine 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:

ZSLL-KY-2013-016 

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:

浙江中医药大学附属第三医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of the Third Affiliated Hospital of Zhejiang Chinese Medicine University 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-07-01 

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:

浙江中医药大学附属第三医院 

Primary sponsor:

The Third Affiliated Hospital of Zhejiang Chinese Medicine University 

研究实施负责(组长)单位地址:

浙江省杭州市莫干山路219号 

Primary sponsor's address:

219 Moganshan Road, Hangzhou, Zhejiang 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江中医药大学附属第三医院

具体地址:

杭州市莫干山路219号

Institution
hospital:

The Third Affiliated Hospital of Zhejiang Chinese Medicine University

Address:

219 Moganshan Road, Hangzhou, Zhejiang

经费或物资来源:

浙江中医药大学附属第三医院医药卫生计划 

Source(s) of funding:

Science Foundation of The Third Affiliated Hospital of Zhejiang Chinese Medical University 

研究疾病:

中重度癌痛 

Target disease:

Moderate to Severe Cancer Pain 

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:

其它 

Study phase:

N/A 

研究目的:

经皮穴位电刺激(TEAS)联合三阶梯止痛对中重度癌痛患者疼痛程度、生活质量和免疫功能的疗效评价。 

Objectives of Study:

To assess the effects of pain,quality of life and immune function with Transcutanous Electric Acupoint Stimulation(TEAS) plus Three-step Analgesic Ladder Treatment on moderate to severe cancer pain patients. 

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:

年龄18-80岁,男女不限;预期寿命1个月以上;符合恶性肿瘤诊断标准,有明确的疼痛部位,且0-10疼痛数字评分≥4分或入组前24h内等效吧啡量≧20mg;意识清楚,生命体征平稳,卡氏评分(Karnofsky评分,KPS评分)≥60分;无智力及精神障碍,语言表达能力正常,对自身疼痛及一般状况有判断能力,能合作评价疼痛及生活质量内容等;患者本人或亲属签署知情同意书。 

Inclusion criteria

The age ranged 18-80 years old, both male and female; Life expectancy is more than 1 month; The patients with the cancer according to the criteria and Number Rating Scale(NRS)>=4, or equivalent morphine in 24h >=20mg; Clear mind, stable vital signs, KPS>=60; No intelligence and mental disorders, language expression ability is normal and cooperation to complete the assessment; Write informed consent file. 

排除标准:

明确诊断与癌症无关的疼痛;入组前30天内接受手术治疗,或入组前3个月内接受89Sr或53Sm治疗;有精神性疾病或有严重的认知缺损;伴有呼吸抑制者;伴有活动性脑血管疾病;对阿片类药物过敏者;穴位处皮肤有皮损、破溃患者;正在参与影响本研究结果评价的其他临床试验者。 

Exclusion criteria:

Pain is none business to cancer; Surgery within last 30 days, or with 89Sr or 53Sm treatment within last 3 months; Mental disease or severe cognitive impairment; Respiratory depression; Activity cerebrovascular disease; Opioid drug allergy; Skin lesions around acupoints; Patients participated in other clinical trials which affect this trail. 

研究实施时间:

Study execute time:

From2015-12-31To 2014-09-21 

干预措施:

Interventions:

组别:

试验组

样本量:

80

Group:

treatment group

Sample size:

干预措施:

经皮穴位电刺激联合三阶梯疗法

干预措施代码:

Intervention:

Transcutanous Electric Acupoint Stimulation plus Three-step Analgesic Ladder Treatment

Intervention code:

组别:

对照组

样本量:

80

Group:

control group

Sample size:

干预措施:

三阶梯疗法

干预措施代码:

Intervention:

Three-step Analgesic Ladder Treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江中医药大学附属第三医院 

单位级别:

三级甲等 

Institution
hospital:

The Third Affiliated Hospital of Zhejiang Chinese Medicine University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江省肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

Zhejiang Cancer Hospital  

Level of the institution:

Tertiary-A hospital 

测量指标:

Outcomes:

指标中文名:

疼痛评价

指标类型:

主要指标 

Outcome:

Pain

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量评价

指标类型:

主要指标 

Outcome:

Life quality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫功能评价

指标类型:

主要指标 

Outcome:

immune function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性评价

指标类型:

次要指标 

Outcome:

Safety evaluation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

依从性评价

指标类型:

次要指标 

Outcome:

Compliance evaluatio

Type:

Secondary 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:

静脉血

Sample Name:

Blood

Tissue:

venous blood

人体标本去向

使用后销毁 

说明

一年

Fate of sample:

Destruction after use 

Note:

one year

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

采用SPSS软件将160例患者随机分成2组(试验组和对照组)

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

160 patients were randomly divided into 2 groups using SPSS software(treatment group and control gro

盲法:

盲法评价、盲法统计(结果评估人员和统计人员由不知道分组信息的人员担任)

Blinding:

Blind evaluation,blind statistics(the assessment and statistical personnel dont know about the group information)

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:

即时公开/Real time access

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):

浙江中医药大学附属第三医院

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

The Third Affiliated Hospital of Zhejiang Chinese Medicine University

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:

浙江中医药大学附属第三医院

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

The Third Affiliated Hospital of Zhejiang Chinese Medicine University

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2013-08-27
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