针刺干预原发性纤维肌痛综合征的随机对照研究

注册号:

Registration number:

AMCTR-IOR-18000184 

注册号获得时间:

Date of releasing the registration number:

2019/9/28 22:25:17 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针刺干预原发性纤维肌痛综合征的随机对照研究 

Public title:

A Randomized Controlled Trial for Acupuncture in the treatment of Primary Fibromyalgia 

研究课题的正式科学名称:

针刺干预原发性纤维肌痛综合征的随机对照研究 

Scientific title:

A Randomized Controlled Trial for Acupuncture in the treatment of Primary Fibromyalgia 

研究课题代号(代码):

Study subject ID:

2017s381 

在其它机构的注册号:

Secondary ID:

ChiCTR1800016826 

申请注册联系人:

韩曼 

研究负责人:

韩曼 

Applicant:

MAN HAN 

Study leader:

MAN HAN 

申请注册联系人电话:

Applicant telephone:

+86 15011565229 

研究负责人电话:

Study leader's telephone:

+86 15011565229 

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:

hanman111@126.com 

研究负责人电子邮件:

Study leader's E-mail:

hanman111@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:

北京市西城区北线阁5号 

研究负责人通讯地址:

北京市西城区北线阁5号 

Applicant address:

5 Beixiange Street, Xicheng District, Beijing, China 

Study leader's address:

5 Beixiange Street, Xicheng District, Beijing, 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:

中国中医科学院广安门医院 

Applicant's institution:

Guang'an Men hospital, China Academy of Chinese Medical Sciences 

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:

2018-060-KY 

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:

中国中医科学院广安门医院伦理委员会 

Name of the ethic committee:

the Ethic Committee of Guang'anmen Hospital, China Academy of Chinese Medical Science 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-04-26 

研究实施负责(组长)单位:

中国中医科学院广安门医院 

Primary sponsor:

Guang'an Men hospital, China Academy of Chinese Medical Sciences 

研究实施负责(组长)单位地址:

北京市西城区北线阁5号 

Primary sponsor's address:

5 Beixiange Street, Xicheng District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院广安门医院

具体地址:

北京市西城区北线阁5号

Institution
hospital:

Guang'an Men hospital, China Academy of Chinese Medical Sciences

Address:

5 Beixiange Street, Xicheng District, Beijing, China

国家:

中国

省(直辖市):

广东省

市(区县):

深圳市

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

深圳市中医院

具体地址:

广州省深圳市福田区福华路1号

Institution
hospital:

Shenzhen Traditional Chinese Medicine Hospital

Address:

1 Fuhua Street, Futian District, Shenzhen, Guangdong

经费或物资来源:

中国中医科学院广安门医院国家中医临床研究示范基地科研专项暨所级科研基金, 深圳市医疗卫生三名工程 

Source(s) of funding:

Guang’anmen Hospital, China Academy of Chinese Medical Science-National Chinese Medicine Clinical Research Model Basement. Funding No. 2017s381;Shenzhen Medical and Health Project.Funding No.SZSM201 

研究疾病:

纤维肌痛综合征 

Target disease:

Fibromyalgia 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

评价针刺疗法治疗纤维肌痛综合征的效果 

Objectives of Study:

To assess the effect of acupuncture vs sham acupuncture for Primary Fibromyalgia 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

①符合1990年美国风湿病协会制定的FMS分类标准; ②年龄不小于18岁; ③无针刺禁忌症; ④无FMS用药,或停止FMS药物至少2周。 

Inclusion criteria

1. Aged at least 18 years; 2. To meet the American College of Rheumatology Criteria for primary FM; 3. Without any contraindications for acupuncture; 4. Without taking FM medicines, or have not been taking FM medicines for at least 2 weeks before the recruitment. 

排除标准:

①严重内脏疾病或体质虚弱不能耐受针刺治疗者; ②全身或局部患有急性感染性疾病者; ③继发性纤维肌痛综合征患者; ④疼痛视觉模拟量表评分小于4.0 cm/10 cm; ⑤妊娠期妇女。 

Exclusion criteria:

1. Have been having serious systemic disorders recently (lymphoma; central nervous system, renal, or pulmonary involvement; myositis; or vasculitis) or severe renal or liver failure; 2. With systemic or local acute infection; 3. Secondary FM; 4. Pain VAS under 4.0/10.0cm; 5. Currently or planning to be pregnant. 

研究实施时间:

Study execute time:

From2018-05-01To 2020-03-31 

干预措施:

Interventions:

组别:

针刺组

样本量:

34

Group:

acupuncture group

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

Acupuncture

Intervention code:

组别:

安慰针对照组

样本量:

34

Group:

Sham Acupuncture group

Sample size:

干预措施:

安慰针刺

干预措施代码:

Intervention:

Sham Acupuncture

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国中医科学院广安门医院 

单位级别:

三级甲等医院 

Institution
hospital:

Guang'anmen Hospital of China Academy of Chinese Medical Sciences  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

治疗前后疼痛视觉模拟量表的改善

指标类型:

主要指标 

Outcome:

The change of Visual Analogue Scales for pain (PVAS) from baseline to 8 weeks

Type:

Primary indicator 

指标中文名:

修订版纤维肌痛影响调查问卷的改善

指标类型:

主要指标 

Outcome:

The change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 8 weeks

Type:

Primary indicator 

指标中文名:

治疗前后多维疲劳量表的改善

指标类型:

次要指标 

Outcome:

The change of Multidimensional Assessment Fatigue (MAF) from baseline to 8 weeks

Type:

Secondary indicator 

指标中文名:

治疗前后SF-36健康状况量表的改善

指标类型:

次要指标 

Outcome:

The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline to 8 weeks

Type:

Secondary indicator 

指标中文名:

治疗前后匹兹堡睡眠质量指数量表的改善

指标类型:

次要指标 

Outcome:

The change of Pittsburgh sleep quality index (PSQI) from baseline to 8 weeks

Type:

Secondary indicator 

指标中文名:

治疗前后贝克抑郁量表的改善

指标类型:

次要指标 

Outcome:

The change of Beck depression inventory (BDI) from baseline to 8 weeks

Type:

Secondary indicator 

指标中文名:

治疗前后知觉压力量表的改善

指标类型:

次要指标 

Outcome:

The change of Perceived Stress Scale (PSS) from baseline to 8 weeks

Type:

Secondary indicator 

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:

标本中文名:

尿液

组织:

Sample Name:

Urine

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 years
最大 Max age 100 years

随机方法(请说明由何人用什么方法产生随机序列):

采用区组随机方法,由第三方统计人员应用SAS统计软件得出随机数字表,随机抽样的初值与分段长度均记录在盲底,由研究单位科研管理部门保存,需要时可以重现。随机数字表的随机号按区组分配给各分中心,将受试者随机分配到针刺组、安慰针对照组。

性别:

男女均可

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

By using the block random method, the random digital table is obtained by the third party statisticians using SAS statistical software. The initial values and segment length of random sampling are recorded at the blind bottom, which are kept by the scientific research management department of the research u

Gender:

Both

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

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):

试验完成网上公布

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

online publication after the trial completed

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

研究者将受试者的原始观察数据及时、完整、正确、清晰地载入病例报告表。确认所有病例报告表填写正确完整,并与原始资料一致。如有错误和遗漏,研究者要及时改正。修改时需保持原有记录清晰可见,改正处需经研究者签名并注明日期。数据录入前再次核查,发现问题及时通知研究者作出回答。基于epidata数据库建立ECRF表进行数据采集和管理。

The repository and management of the data(Please specify what repository will be used for management of the metadata):

The researchers recorded the subjectsundefined original observations in a timely, complete, correct, and clear form. Verify that all case report forms are correct and complete and consistent with the original data. If there are errors and omissions, the researcher should correct them in time. The original record should be clearly visible and the correction should be signed and dated by the researcher. Check the data again before entering the data, and notify the researcher to answer the problem in time. ECRF table based on Epidata is established for data acquisition and management.

创建人:

Creater Name:

 2018-06-27
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