今天是:2020-08-11 星期二

基于筋骨评估颈型颈椎病中医脊柱微调诊疗方案优化研究
下载XML文档

注册号:

Registration number:

ChiCTR-INR-17013763 

最近更新日期:

Date of Last Refreshed on:

2017-12-08 

注册时间:

Date of Registration:

2017-12-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于筋骨评估颈型颈椎病中医脊柱微调诊疗方案优化研究 

Public title:

Optimal research on cervical spondylosis of cervical type with spinal manipulation based on evaluation of “JinGU” 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于筋骨评估颈型颈椎病中医脊柱微调诊疗方案优化研究 

Scientific title:

Optimal research on cervical spondylosis of cervical type with spinal manipulation based on evaluation of “JinGU” 

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:

孔令军 

研究负责人:

房敏 

Applicant:

KONG Lingjun 

Study leader:

FANG Min 

申请注册联系人电话:

Applicant telephone:

+86 18918134827 

研究负责人电话:

Study leader's telephone:

+86 18930568005 

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:

chunyong01@163.com 

研究负责人电子邮件:

Study leader's E-mail:

yykyc2004@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:

上海市虹口区甘河路110号岳阳医院10号楼4楼推拿研究所 

研究负责人通讯地址:

上海市虹口区甘河路110号岳阳医院 

Applicant address:

110 Hongkou District, Shanghai, China 

Study leader's address:

110 Hongkou District, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200437 

研究负责人邮政编码:

Study leader's postcode:

200437 

申请人所在单位:

上海中医药大学附属岳阳中西医结合医院 

Applicant's institution:

Yueyang Integrated Chinese and Western Medicine Hospital Affiliated to 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:

2017-028 

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岳阳中西医结合医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Yueyang Integrated Chinese and Western Medicine Hospital Affiliated to Shanghai University of TCM 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-09-30 

伦理委员会联系人:

殷从全 

Contact Name of the ethic committee:

YIN Congquan 

伦理委员会联系地址:

上海市虹口区甘河路110号 

Contact Address of the ethic committee:

110 Hongkou District, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 021-65161782-6160 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

yyyyllwyh@163.com 

研究实施负责(组长)单位:

上海中医药大学附属岳阳中西医结合医院 

Primary sponsor:

Yueyang Integrated Chinese and Western Medicine Hospital Affiliated to Shanghai University of TCM 

研究实施负责(组长)单位地址:

上海市虹口区甘河路110号 

Primary sponsor's address:

110 Hongkou 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

市(区县):

虹口区

Country:

China

Province:

Shanghai

City:

Hongkou

单位(医院):

上海中医药大学附属岳阳中西医结合医院

具体地址:

上海市虹口区甘河路110号

Institution
hospital:

Yueyang Integrated Chinese and Western Medicine Hospital Affiliated to Shanghai University of TCM

Address:

110 Hongkou District, Shanghai, China

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

The Natural Science Foundation of China  

研究疾病:

颈型颈椎病 

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 study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

通过临床大样本多中心随机对照研究观察,为脊柱微调手法治疗颈型颈椎病的临床疗效提供证据支持。 

Objectives of Study:

The study aims to provide evidences for spinal manipulaton treatment on cervical spondylosis of cervical type,through a multicenter and randomized controlled clinical trial. 

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)符合颈型颈椎病诊断标准的患者; (2)病程2年以下; (3)椎旁肌、斜方肌、背肌紧张,伴有明显压痛; (4)颈椎CR侧位片可见颈椎曲度改变; (5)年龄在20-60岁之间,男女不限; (6)治疗期间同意不接受其它相关治疗方法的(包括肌松剂治疗药物); (7)自愿加入本实验,并签署“知情同意书”者。 

Inclusion criteria

Inclusion Criteria: 1. Meet the diagnostic criteria of cervical spondylosis of cervical type; 2. Suffer from cervical spondylosis for less than 2 years; 3. Stiff paraspinal muscle, trapezius muscle and dorsal muscle with significant tenderness; 4. Age from 20 to 60 years old, all genders; 5. X-ray shows cervical curvature go straight; 6. Consent to not take other treatments like muscular relaxants; 7. Volunteer to join in, and sign informed consent. 

排除标准:

(1)不符合颈型颈椎病诊断标准和纳入标准者; (2)伴有神经根型颈椎病、椎动脉型颈椎病、脊髓型颈椎病、交感型颈椎病; (3)颈部扭伤、肩关节周围炎、风湿性肌纤维织炎、神经衰弱及其他非因颈椎间盘退 变所致之颈、肩部疼痛; (4)处于妊娠期及哺乳期的妇女; (5)合并有心血管、脑血管、肝、肾等严重原发性疾病,精神病患者; (6)局部外伤处于急性期或局部皮肤破损者; (7)不能按规定时间坚持接受治疗者。 

Exclusion criteria:

Exclusion Criteria: 1. Not meet the diagnostic criteria and inclusion criteria of cervical spondylosis of cervical type; 2. Other types of cervical spondylosis; 3. Neck strain, shoulder periarthritis, rheumatic myofibrositis, neurasthenia, and other neck or shoulder pains not caused by Cervical Disc Degeneration; 4. Suffer from serious primary diseases of cardiovascular, cerebrovascular, liver and kidney, or mental illness; 5. Early partial trauma, or lesions of skin; 6. Pregnant or breast feeding; 7. Lost follow-up participants.  

研究实施时间:

Study execute time:

From2016-10-01To 2019-09-30 

征募观察对象时间:

Recruiting time:

From2017-12-31To 2019-08-31 

干预措施:

Interventions:

组别:

脊柱微调手法组

样本量:

176

Group:

Group of Spinal Manipulation

Sample size:

干预措施:

脊柱微调

干预措施代码:

Intervention:

Spinal Manipulation

Intervention code:

组别:

传统手法组

样本量:

176

Group:

Group of Chinese Tuina

Sample size:

干预措施:

传统推拿手法

干预措施代码:

Intervention:

Chinese Tuina

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):

虹口区 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属岳阳中西医结合医院 

单位级别:

三级甲等医院 

Institution
hospital:

Yueyang Integrated Chinese and Western Medicine Hospital Affiliated to Shanghai University of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海市 

市(区县):

徐汇区 

Country:

China 

Province:

Shanghai 

City:

Xuhui 

单位(医院):

上海市第六人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Sixth People Hospita  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海市 

市(区县):

浦东新区 

Country:

China 

Province:

Shanghai 

City:

Pudong 

单位(医院):

上海中医药大学附属曙光医院 

单位级别:

三级甲等 

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of TCM, Shanghai  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海市 

市(区县):

嘉定区 

Country:

China 

Province:

Shanghai 

City:

JIADING 

单位(医院):

上海市嘉定区中医院 

单位级别:

二级甲等 

Institution
hospital:

Jiading Hospital of TCM  

Level of the institution:

Secondary A Hospital 

测量指标:

Outcomes:

指标中文名:

VAS 评分

指标类型:

主要指标 

Outcome:

VAS (Visual Analogue Scale)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颈椎功能障碍指数量表

指标类型:

主要指标 

Outcome:

NDI (Neck Disabilitv Index)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SF-36日常生活质量

指标类型:

主要指标 

Outcome:

SF-36 (Short-form 36 Questionnaire)

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:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 60 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):

随机数字表

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

Random Series

盲法:

Blinding:

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):

研究完成6个月后在ResMan公开

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

Open access on ResMan 6 months after trial completion

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

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2017-12-08
返回列表