循经取穴针刺治疗颈型颈椎病的临床研究

注册号:

Registration number:

AMCTR-IPR-19000283 

注册号获得时间:

Date of releasing the registration number:

2019/7/19 23:29:37 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

循经取穴针刺治疗颈型颈椎病的临床研究 

Public title:

Effects of Acupuncture at Acupoints along Lung Meridian on Cervical Spondylosis of cervical type: A Randomized Controlled Trial 

研究课题的正式科学名称:

循经取穴针刺治疗颈型颈椎病的临床研究 

Scientific title:

Effects of Acupuncture at Acupoints along Lung Meridian on Cervical Spondylosis of cervical type: A Randomized Controlled Trial 

研究课题代号(代码):

Study subject ID:

2018YFC1704606 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

范琳 

研究负责人:

乔海法 

Applicant:

Fan Lin 

Study leader:

Qiao Haifa 

申请注册联系人电话:

Applicant telephone:

+86 15771809234 

研究负责人电话:

Study leader's telephone:

+86 18220046518 

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:

2295646369@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

1805355963@qq.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:

陕西省西咸新区西咸大道 

研究负责人通讯地址:

陕西省西咸新区西咸大道 

Applicant address:

Shiji Avenue, Xi'an-Xianyang New Ecomic Zone, Xianyang, Shaanxi, China 

Study leader's address:

Shiji Avenue, Xi'an-Xianyang New Ecomic Zone, Xianyang, Shaanxi, China 

申请注册联系人邮政编码:

Applicant postcode:

712046 

研究负责人邮政编码:

Study leader's postcode:

712046 

申请人所在单位:

陕西中医药大学 

Applicant's institution:

Shaanxi University of Chinese Medicine 

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:

SZFYIEC-PJ-2019年第[15]号 

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:

陕西中医药大学附属医院伦理委员会 

Name of the ethic committee:

IEC of The Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-07-03 

研究实施负责(组长)单位:

陕西中医药大学 

Primary sponsor:

陕西中医药大学 

研究实施负责(组长)单位地址:

陕西省西咸新区西咸大道 

Primary sponsor's address:

Shiji Avenue, Xi'an-Xianyang New Ecomic Zone, Xi'an, Shaanxi, 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):

陕西省

市(区县):

咸阳市

Country:

China

Province:

Shaanxi

City:

Xianyang

单位(医院):

陕西中医药大学

具体地址:

陕西省西咸新区西咸大道

Institution
hospital:

Shaanxi University of Chinese Medicine

Address:

Shiji Avenue, Xi'an-Xianyang New Ecomic Zone, Xianyang, Shaanxi, China

经费或物资来源:

国家重点研发计划,基于经脉“体表-体表”联系的循经针刺效应的临床评价及其机制,编号2018YFC1704606 

Source(s) of funding:

National Key R&D Program, Clinical Assessment of Effects of Acupuncture at Acupoints located on Meridians in terms of the connection between different body parts and the Mechanism, No. 2018YFC1704606 

研究疾病:

颈型颈椎病 

Target disease:

Cervical spondylosis of cervical type 

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:

预实验 

Study phase:

Polit 

研究目的:

采用多中心、随机、对照,从疗效验证的角度,证实循肺经取穴针刺治疗颈型颈椎病的临床疗效,并在此基础上采用多模态神经影像技术探讨循经针刺治疗颈型颈椎病的部分中枢机制。 

Objectives of Study:

Firstly, to demonstrate the effect of acupuncture at acupoints along Lung meridian on cervical spondylosis of cervical type, multi-center randomized clinical study will be carried out. Secondly, the mechanism will be explored through multimodal neuroimaging. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1.符合诊断颈型颈椎病的标准; 2.成年男性或女性,年龄18-60岁; 3.初诊视觉模拟量表(VAS)评分大于4分小于10分(范围为0-10分); 4.愿意签署知情同意书。 同时符合以上四项的患者,方可纳入本项研究 

Inclusion criteria

1. meet the diagnostic criteria of cervical spondylosis of cervical type; 2. aged 18-60 years male and female; 3. Visual Analogue Scale (VAS) score between 4-10 (Range 0-10) for initial visit; 4. volunteered to join the test, and sign "informed consent" persons. 

排除标准:

1.影像学检查显示有骨结核、肿瘤、重度骨质疏松的病例; 2.妊娠期和哺乳期女性; 3.合并有严重内科疾病; 4.非颈型颈椎病等其他原因所导致的颈痛; 5.有局部皮肤破损或严重皮肤病影响手法操作; 6.无法进行正常交流者; 7.过去一个月内因为上肢疼痛接受过针灸治疗者; 8.近3个月内接受过其它保守治疗或颈椎手术治疗; 9.正在参加其他临床试验者。 注:凡符合上述任一项者,均予以排除。 

Exclusion criteria:

1. diagnosed as bone tuberculosis, tumors and severe osteoporosis by imaging examination; 2. pregnant and lactating women; 3. complicated with serious medical diseases; 4. neck pain due to non-cervical spondylosis of cervical type; 5. lesions of skin (such as damage, burns, and so on) where acupuncture will be applied; 6. incapacitated or unable to communicate normally; 7. received acupuncture for upper limb pain in the past month; 8. received other conservative treatments or cervical surgery in the past three months; 9. join other clinical trials. 

研究实施时间:

Study execute time:

From2019-08-01To 2019-07-31 

干预措施:

Interventions:

组别:

肺经穴组

样本量:

32

Group:

Group 1

Sample size:

干预措施:

压痛点与列缺穴或尺泽穴给予电针,未电针的列缺穴或尺泽穴给予手法行针

干预措施代码:

Intervention:

Electroacupuncture is applied on the most sensitive tenderness point and LU 7 (Lieque) or LU5 (Chize ); LU 7 or LU5 without electroacupuncture is manipulated manually

Intervention code:

组别:

心经穴组

样本量:

32

Group:

Group 2

Sample size:

干预措施:

压痛点与灵道穴或少海穴给予电针,未电针的灵道穴或少海穴给予手法行针。

干预措施代码:

Intervention:

Electroacupuncture is applied on the most sensitive tenderness point and HT4(Lingdao) or HT3 (Shaohai); HT4 or HT3 without electroacupuncture is manipulated manually.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

陕西省 

市(区县):

咸阳市 

Country:

咸阳市 

Province:

 

City:

Xianyang 

单位(医院):

陕西中医药大学附属医院 

单位级别:

三级甲等医院 

Institution
hospital:

Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

陕西省 

市(区县):

西安市 

Country:

China 

Province:

Shaanxi 

City:

Xi'an 

单位(医院):

西安市中医医院 

单位级别:

三级甲等医院 

Institution
hospital:

Xi’an Hospital of TCM  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川省 

市(区县):

成都市 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

成都中医药大学 

单位级别:

大学 

Institution
hospital:

Chengdu University of TCM  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

VAS评分

指标类型:

主要指标 

Outcome:

VAS score

Type:

Primary indicator 

指标中文名:

颈椎活动度

指标类型:

次要指标 

Outcome:

Range of motion (ROM) of cervical spine

Type:

Secondary indicator 

指标中文名:

肌肉评定

指标类型:

次要指标 

Outcome:

Muscular assessment

Type:

Secondary indicator 

指标中文名:

超声变化

指标类型:

次要指标 

Outcome:

Musculoskeletal ultrasonography

Type:

Secondary indicator 

指标中文名:

MRI变化

指标类型:

次要指标 

Outcome:

MRI

Type:

Secondary indicator 

指标中文名:

情绪状态评估(SAS和SDS自评量表)

指标类型:

次要指标 

Outcome:

the Assessing emotions scale (SAS and SDS)

Type:

Secondary indicator 

指标中文名:

针刺副作用

指标类型:

主要指标 

Outcome:

Side-effects

Type:

Primary 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:

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):

委托西安康博瑞生命科学技术有限责任公司,使用中央随机系统,采用配对设计方法

性别:

男女均可

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

Xi'an Kangborui Life Science and Technology Co., Ltd. is authorized to randomize the groups with pair design through the Central Randomization System.

Gender:

Both

盲法:

Open lable

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:

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):

通过学术报告、论文、专著、陕西中医药大学医学科研中心数据库及科技部指定的平台公开数据

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

By academic reports, papers,monographs,medical research center database of Shaanxi University of Chinese Medicine and platform authorized by Ministry of Science and Technology of China

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):

CRF表采集数据,建立数据库

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

Collect data via CRF to establish database

创建人:

Creater Name:

 2019-07-19
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