针刺治疗女性慢性颈肩痛的静息态脑功能磁共振研究

注册号:

Registration number:

AMCTR-ION-20000333 

注册号获得时间:

Date of releasing the registration number:

2020/2/29 22:48:38 

注册号状态:

补注册  

Registration Status:

1008002 Retrospective registration  

注册题目:

针刺治疗女性慢性颈肩痛的静息态脑功能磁共振研究 

Public title:

Acupuncture Therapy for Chronic Neck and Shoulder Pain in Women: Resting-state fMRI study 

研究课题的正式科学名称:

针刺治疗女性慢性颈肩痛的静息态脑功能磁共振研究 

Scientific title:

Acupuncture Therapy for Chronic Neck and Shoulder Pain in Women: Resting-state fMRI study 

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:

张仪雯 

研究负责人:

张仪雯 

Applicant:

YiWen zhang 

Study leader:

YiWen zhang 

申请注册联系人电话:

Applicant telephone:

15769205493 

研究负责人电话:

Study leader's telephone:

15769205493 

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:

1159016676@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

1159016676@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:

陕西省咸阳市秦都区陕西中医药大学北校区 

研究负责人通讯地址:

陕西省咸阳市秦都区陕西中医药大学北校区 

Applicant address:

North campus of Shaanxi University of Chinese Medicine, QinDu district, XianYang city, Shaanxi province 

Study leader's address:

North campus of Shaanxi University of Chinese Medicine, QinDu district, XianYang city, Shaanxi province 

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:

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-KY-2018年第11号 

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:

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 Hospitals of Shaanxi University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-08-16 

研究实施负责(组长)单位:

陕西中医药大学附属医院 

Primary sponsor:

The Affiliated Hospitals of Shaanxi University of Chinese Medicine 

研究实施负责(组长)单位地址:

陕西省咸阳市秦都区渭阳西路副2号 

Primary sponsor's address:

Vice-2 Weiyang west road, Qindu district, Xianyang city, Shaanxi province, 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):

陕西中医药大学附属医院

具体地址:

陕西省咸阳市秦都区渭阳西路副2号

Institution
hospital:

The Affiliated Hospitals of Shaanxi University of Chinese Medicine

Address:

Vice-2 Weiyang west road, Qindu district, Xianyang city, Shaanxi province, China

经费或物资来源:

自费 

Source(s) of funding:

Self-supporting 

研究疾病:

慢性颈肩痛 

Target disease:

Chronic neck and shoulder pain 

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:

基于以中脑导水管周围灰质(Periaqueductal Gray,PAG)为种子点的全脑静息态脑功能磁共振功能连接(Functional Connectivity,FC)分析,评价针刺治疗女性慢性颈肩痛(Chronic Neck and Shoulder Pain,CNSP)的疗效,探讨针刺治疗对女性CNSP患者功能连接异常变化的调整作用,为临床针刺治疗女性CNSP提供客观的可视化依据和神经影像学生物标记。 

Objectives of Study:

Based on Functional Connectivity Analysis of Periaqueductal Gray in the whole brain Resting-state fMRI, evaluation the acupuncture treatment of female Chronic Neck and Shoulder Pain, explore the FC adjust abnormal change of acupuncture treatment in patients with female patients of CNSP.We will provides objective visualization basis and neuroimaging biomarker for clinical acupuncture treatment of female CNSP. 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1.CNSP组纳入标准 (1)年龄18~60岁; (2)符合诊断标准,确诊为慢性颈肩痛; (3)NRS>4分;NPQ>25%;颈椎棘突附近肌肉、斜方肌或肩袖压痛阳性,椎间孔挤压试验和/或臂丛神经牵拉试验阳性; (4)没有进行其他治疗,即可能影响神经影像表达的药物或针灸疗法; (5)签署知情同意书,能接受针刺治疗,自愿作为受试对象。 2.健康对照组纳入标准 (1)年龄18~60岁; (2)与CNSP组患者年龄、受教育程度相匹配; (3)MRI检查无器质性病变,无头部外伤史; (4)签署知情同意书,自愿加入本试验。 

Inclusion criteria

1.CNSP group (1) Aged from 18 to 60; (2) Meet the diagnostic criteria and be diagnosed as chronic neck and shoulder pain; (3) NRS > 4 points; NPQ > 25%; The muscle near the cervical spines, trapezius or rotator cuff was positive for tenderness, and the foramina compression test and/or brachial plexus nerve traction test were positive. (4) No other treatment, that is, drugs or acupuncture that may affect the expression of neuroimaging; (5) Signed the informed consent, accepted acupuncture treatment, and volunteered to be the subject. 2. Healthy control group (1) Aged from 18 to 60; (2) Match the age and education level of the CNSP group; (3) MRI showed no organic lesions and no history of head trauma; (4) Sign the informed consent and join the trial voluntarily. 

排除标准:

(1)合并严重心脑血管疾病、血液系统疾病、肝肾功能损伤,既往有慢性疼痛史、脑外伤史、颅内感染史、糖尿病、其他重大疾病及手术史、精神类疾病病史;或近期口服抗凝药物致凝血功能异常等原因不能耐受治疗者; (2)全身性的广泛疼痛;肌腱炎;关节感染;颈部外伤;类风湿性关节炎;纤维肌痛症。 (3)治疗前2周内服用止痛药的患者; (4)不能遵照医嘱配合进行针灸治疗者;试验阶段采用其他治疗手段者。 (5)核磁共振禁忌:幽闭恐惧症患者;体内有心脏起搏器或钢钉、钢板等。 

Exclusion criteria:

(1) Complicated with serious cardiovascular and cerebrovascular diseases, blood system diseases, liver and kidney function injury, with a history of chronic pain, brain trauma, intracranial infection, diabetes, other major diseases, surgical history, and psychiatric disease; Or cannot tolerate the treatment due to abnormal coagulation function caused by oral anticoagulant drugs recently; (2) Generalized pain; Tendonitis. Joint infection; Neck trauma; Rheumatoid arthritis; Fibromyalgia. (3) Patients taking painkillers within 2 weeks before treatment; (4) Unable to cooperate with acupuncture treatment as prescribed by the doctor; Other treatments were used during the trial period. (5) MRI contraindications: claustrophobic patients; The body has a pacemaker or steel nails, steel plate and so on. 

研究实施时间:

Study execute time:

From2018-04-17To 2019-12-17 

干预措施:

Interventions:

组别:

女性CNSP组

样本量:

30

Group:

female CNSP group

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

acupuncture

Intervention code:

组别:

健康对照组

样本量:

30

Group:

Healthy control group

Sample size:

干预措施:

干预措施代码:

Intervention:

without any thing

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:

China 

Province:

shaanxi 

City:

xianyang 

单位(医院):

陕西中医药大学附属医院 

单位级别:

省级 

Institution
hospital:

The Affiliated Hospitals of Shaanxi University of Chinese Medicine  

Level of the institution:

Province 

测量指标:

Outcomes:

指标中文名:

疼痛数字评价量表

指标类型:

主要指标 

Outcome:

Numeric Rating Scales

Type:

Primary indicator 

指标中文名:

疼痛灾难化量表

指标类型:

主要指标 

Outcome:

Pain Catastrophizing Scale

Type:

Primary indicator 

指标中文名:

颈痛量表

指标类型:

主要指标 

Outcome:

Northwick Park

Type:

Primary indicator 

指标中文名:

颈椎障碍功能指数

指标类型:

主要指标 

Outcome:

Neck Disabilitv Index

Type:

Primary indicator 

指标中文名:

磁共振功能连接度

指标类型:

主要指标 

Outcome:

Functional connectivity of rs-fMRI

Type:

Primary indicator 

指标中文名:

汉密尔顿焦虑量表

指标类型:

次要指标 

Outcome:

Hamilton Anxiety Scale

Type:

Secondary indicator 

指标中文名:

汉密尔顿抑郁量表

指标类型:

次要指标 

Outcome:

Hamilton Depression Scale

Type:

Secondary indicator 

指标中文名:

简易智能精神状态检查量表

指标类型:

次要指标 

Outcome:

Mini-mental State Examination

Type:

Secondary indicator 

指标中文名:

蒙特利尔认知评估量表

指标类型:

次要指标 

Outcome:

Montreal Cognitive Assessment Scale

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

Empty

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

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 60 years

随机方法(请说明由何人用什么方法产生随机序列):

性别:

女性

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

Empty

Gender:

Female

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):

撰写学位论文

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

Writing dissertation

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):

原始记录由研究者自行记录、整理,未录入数据库。

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

The original records shall be recorded and sorted by the researchers themselves and not entered into the database.

创建人:

Creater Name:

 2020-02-06
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