“项八针”治疗颈椎病的临床研究

注册号:

Registration number:

AMCTR-IOC-16000021 

注册号获得时间:

Date of releasing the registration number:

2016/11/16 12:40:30 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

“项八针”治疗颈椎病的临床研究 

Public title:

The clinical research on eight nape-point acupuncture in curing cervical spondylosis 

研究课题的正式科学名称:

“项八针”治疗颈椎病的临床研究 

Scientific title:

The clinical research on eight nape-point acupuncture in curing cervical spondylosis 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

李嘉 

研究负责人:

沈卫东 

Applicant:

Li Jia 

Study leader:

Shen Weidong 

申请注册联系人电话:

Applicant telephone:

13585976617 

研究负责人电话:

Study leader's telephone:

13391019193 

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:

lijia_sunswheat@126.com 

研究负责人电子邮件:

Study leader's E-mail:

shenweidong1018@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:

上海市浦东新区张衡路528号曙光医院住院部3C病区针灸科医生办公室 

研究负责人通讯地址:

上海市浦东新区张衡路528号曙光医院住院部3C病区针灸科医生办公室 

Applicant address:

doctors' office of acupuncture department in 3C ward, No.528, Zhangheng Road, Pudong District, Shanghai 

Study leader's address:

doctors' office of acupuncture department in 3C ward, No.528, Zhangheng Road, Pudong District, Shanghai 

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:

上海中医药大学附属曙光医院 

Applicant's institution:

Shuguang Hospital affiliated with Shanghai University of TCM 

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:

2016-kykt-11 

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:

上海中医药大学附属曙光医院伦理委员会 

Name of the ethic committee:

IRB of Shuguang Hospital affiliated with Shanghai University of TCM 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-10-26 

研究实施负责(组长)单位:

上海中医药大学附属曙光医院 

Primary sponsor:

Shuguang Hospital affiliated with Shanghai University of TCM 

研究实施负责(组长)单位地址:

上海市浦东新区张衡路528号曙光医院住院部3C病区针灸科医生办公室 

Primary sponsor's address:

doctors' office of acupuncture department in 3C ward, No.528, Zhangheng Road, Pudong District, Shanghai 

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

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

申康医院发展中心

具体地址:

上海市静安区康定路2-6号

Institution
hospital:

Shanghai Hospital Development Center

Address:

No.2 to No.6, Kangding Road, Jingan District, Shanghai

经费或物资来源:

上海申康医院发展中心 

Source(s) of funding:

Shanghai Hospital Development Center 

研究疾病:

颈椎病 

Target disease:

cervical spondylosis 

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:

通过分析、比较“项八针”针刺、温针灸、针刺结合TDP治疗、“项八针”穴位经皮电刺激以及牵引治疗颈椎病的疗效,总结、优化“项八针”防治颈椎病的治疗方案,建立“项八针”特色技术的标准化操作流程,并全面推广至基层医疗机构。 

Objectives of Study:

To analysis and compare the clinical efficacy of eight nape-point acupuncture, eight nape-point acupuncture combining with warm-needle acupuncture, eight nape-point acupuncture combining with TDP,eight nape-point transcutaneous electrical stimulation and cervical traction. To optimize the therapeutic regimen of cervical spondylosis by " eight nape-point acupuncture", to build a standard implementation process of the special technology of "eight nape-point acupuncture" and promote it to fundamental medical institution. 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

(1)符合颈椎病的诊断标准; (2)自愿受试,签署知情同意书,能够配合采集临床资料者; (3)年龄在18-60周岁。 

Inclusion criteria

(1)Patients who are in accordance with the diagnostic criteria of cervical spondylosis; (2)Patients who voluntarily take the trail, sign the Informed consent, and coordinate with clinical data collection. (3)Patients whose age is in the range from 18 to 60. 

排除标准:

(1)目前正在参加或1月前参加过其他治疗颈椎病的临床试验者; (2)合并有心血管、肺部、肝脏、肾脏、造血系统等严重疾病者; (3)有颈部骨折或手术史,神经功能缺损,先天脊柱异常,系统性骨或关节疾病者; (4)孕妇及哺乳期妇女; (5)2周内曾服药物治疗颈椎病者。 

Exclusion criteria:

(1)Patients who have taken other clinical trials on cervical spondylosis now or in a month. (2)Patients who have serious diseases in cardiovascular, pulmonary, liver, kidney, hematopoietic and other systems. (3)Patients who have neck fracture or surgical history, nerve function defect, congenital anomaly of spine, Systemic bone or joint disease. (4)Pregnant women and lactating women. (5)Patients who have ever taken medicine to treat cervical spondylosis in 2 weeks. 

研究实施时间:

Study execute time:

From2016-12-28To 2019-12-28 

干预措施:

Interventions:

组别:

A

样本量:

60

Group:

A

Sample size:

干预措施:

“项八针”针刺,留针30分钟

干预措施代码:

Intervention:

Being treated by eight nape-point acupuncture and the needles are retained for 30 minutes

Intervention code:

组别:

B

样本量:

60

Group:

B

Sample size:

干预措施:

“项八针”针刺,大椎穴温针灸,治疗30分钟

干预措施代码:

Intervention:

Being treated by eight nape-point acupuncture, meanwhile the Dazhui(GV14) was given warm needling ,for 30 minutes

Intervention code:

组别:

C

样本量:

60

Group:

C

Sample size:

干预措施:

“项八针”针刺配合TDP治疗,留针30分钟

干预措施代码:

Intervention:

Being treated by eight nape-point acupuncture and TDP,and the needles are retained for 30 minutes

Intervention code:

组别:

D

样本量:

60

Group:

D

Sample size:

干预措施:

“项八针”穴位经皮电刺激30分钟

干预措施代码:

Intervention:

Being treated by eight nape-point transcutaneous electrical stimulation for 30minutes

Intervention code:

组别:

E

样本量:

60

Group:

E

Sample size:

干预措施:

牵引治疗30分钟

干预措施代码:

Intervention:

Being treated by traction for 30 minutes

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):

上海中医药大学附属曙光医院 

单位级别:

三甲医院 

Institution
hospital:

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市黄浦区东南医院 

单位级别:

二级医院 

Institution
hospital:

Dongnan Hospital of Huangpu District, Shanghai  

Level of the institution:

Secondary hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海光华中西医结合医院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai Guanghua Integrated Chinese and Western Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

Northwick Park颈痛量表评分

指标类型:

主要指标 

Outcome:

NPQ scale score

Type:

Primary indicator 

指标中文名:

健康状况调查问卷评分

指标类型:

主要指标 

Outcome:

SF-36 scale score

Type:

Primary indicator 

指标中文名:

简式Mcgill疼痛量表

指标类型:

主要指标 

Outcome:

simplified MPQ scale score

Type:

Primary indicator 

指标中文名:

医用红外热象测定颈区温度值

指标类型:

次要指标 

Outcome:

temperature of neck region measured by infrared imaging technology

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 60 years

随机方法(请说明由何人用什么方法产生随机序列):

计算机随机分组

性别:

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

computer-generated random numbers

Gender:

盲法:

N/A

Blinding:

N/A

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:

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):

试验完成后6个月公开,在中国临床试验数据管理公共平台上公布

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

The data will be shared at ResMan (clinical trial data management public platform in China) six months 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):

病例记录本,exel表格

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

CRF and Exel form.

创建人:

Creater Name:

 2016-11-03
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