三种不同扳法对寰枢关节错位的疗效评价、技术优化以及个体化方案的研究

注册号:

Registration number:

ITMCTR2024000187

最近更新日期:

Date of Last Refreshed on:

2024-08-07

注册时间:

Date of Registration:

2024-08-07

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

三种不同扳法对寰枢关节错位的疗效评价、技术优化以及个体化方案的研究

Public title:

Evaluation of therapeutic effect, technique optimization and individual program of three different wrench methods for atlantoaxial joint dislocation

注册题目简写:

English Acronym:

研究课题的正式科学名称:

三种不同扳法对寰枢关节错位的疗效评价、技术优化以及个体化方案的研究

Scientific title:

Evaluation of therapeutic effect, technique optimization and individual program of three different wrench methods for atlantoaxial joint dislocation

研究课题的正式科学名称简写:

Scientific title acronym:

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:

金昕

研究负责人:

金昕

Applicant:

xinjin

Study leader:

xinjin

申请注册联系人电话:

Applicant telephone:

18757150116

研究负责人电话:

Study leader's telephone:

18757150116

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:

972775581@qq.com

研究负责人电子邮件:

Study leader's E-mail:

972775581@qq.com

申请单位网址(自愿提供):

Study leader's 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:

杭州市邮电路54号

研究负责人通讯地址:

杭州市邮电路54号

Applicant address:

54 Youdian Road, Hangzhou

Study leader's address:

54 Youdian Road, Hangzhou

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:

浙江省中医院

Applicant's institution:

The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2022-K-059-01

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

浙江中医药大学附属第一医院伦理委员会

Name of the ethic committee:

The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2021/7/19 0:00:00

伦理委员会联系人:

石洋洁

Contact Name of the ethic committee:

shiyanjie

伦理委员会联系地址:

杭州市邮电路54号

Contact Address of the ethic committee:

54 Youdian Road, Hangzhou

伦理委员会联系人电话:

Contact phone of the ethic committee:

15906635260

伦理委员会联系人邮箱:

Contact email of the ethic committee:

szyykyb@163.com

研究实施负责(组长)单位:

浙江省中医院

Primary sponsor:

The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

杭州市邮电路54号

Primary sponsor's address:

54 Youdian Road, Hangzhou

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

CHINA

Province:

ZheJiang

City:

HangZhou

单位(医院):

浙江省中医院

具体地址:

杭州市邮电路54号

Institution
hospital:

The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

Address:

54 Youdian Road, Hangzhou

经费或物资来源:

自筹

Source(s) of funding:

self-raised

研究疾病:

慢性非特异性颈痛(寰枢关节错位)

研究疾病代码:

Target disease:

Chronic Nonspecific Neck Pain

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

横断面

Cross-sectional

研究所处阶段:

Study phase:

II-III期临床试验

Phase II-III clinical trial

研究目的:

(1)三种不同扳法对寰枢关节错位的疗效分析 (2)基于前期建立的有限元生物力学分析平台对三类扳法进行技术优化 (3)三类扳法的个体化方案选择

Objectives of Study:

(1) Analysis of the effect of three different wrench methods on atlantoaxial joint dislocation (2) Based on the established finite element biomechanical analysis platform, the three kinds of wrench methods are optimized (3) The selection of three kinds of individualized schemes

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

①符合诊断标准;②年龄18-70岁;③病程≥1周;④VAS评分≥30/100;⑤签署知情同意书。

Inclusion criteria

① Meet the diagnostic criteria; ② Age 18-70 years old; ③ Duration ≥1 week; ④VAS score ≥30/100; ⑤ Sign informed consent.

排除标准:

①有颈椎手术史或有严重颈椎外伤史;②合并有严重骨质疏松、骨肿瘤、骨结核等;③合并有心脑血管、消化系统、血液系统等严重内科疾病;④合并精神方面疾病:如幽闭恐惧、智力低下等;⑤妊娠期或哺乳期妇女;⑥语言理解和表达障碍者;⑦磁共振的禁忌症,如体内有金属异物;心脏起搏器植入等。

Exclusion criteria:

① Have a history of cervical surgery or a history of severe cervical trauma; ② Severe osteoporosis, bone tumor, bone tuberculosis, etc. ③ Serious internal diseases such as cardiovascular and cerebrovascular diseases, digestive systems, and blood systems; Combined with mental diseases: such as claustrophobia, low intelligence, etc.; ⑤ Pregnant or lactating women; ⑥ Language comprehension and expression disabilities; 7 magnetic resonance contraindications, such as metal foreign bodies in the body; Pacemaker implantation, etc.

研究实施时间:

Study execute time:

From 2022-01-01

To      2024-12-31

征募观察对象时间:

Recruiting time:

From 2022-01-01

To      2023-12-31

干预措施:

Interventions:

组别:

慢性非特异性颈痛组

样本量:

120

Group:

CNNP组

Sample size:

干预措施:

颈椎旋转斜板组

干预措施代码:

Intervention:

tuina

Intervention code:

组别:

慢性非特异性颈痛组

样本量:

120

Group:

CNNPgroup

Sample size:

干预措施:

俯卧位颈椎复位法:

干预措施代码:

Intervention:

tuina3

Intervention code:

组别:

慢性非特异性颈痛组

样本量:

120

Group:

CNNPgroup

Sample size:

干预措施:

颈椎旋提法组

干预措施代码:

Intervention:

tuina2

Intervention code:

样本总量 Total sample size : 360

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

CHIAN

Province:

ZheJiang

City:

HangZhou

单位(医院):

浙江省中医院

单位级别:

三级甲等

Institution/hospital:

The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

Level of the institution:

3A

测量指标:

Outcomes:

指标中文名:

简化McGill疼痛量表

指标类型:

主要指标

Outcome:

sF-MPQ

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心率变异

指标类型:

次要指标

Outcome:

HRV

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颈椎X线表现评价表

指标类型:

主要指标

Outcome:

Cervical spine X-ray findings evaluation form

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨错缝”临床评价指标

指标类型:

主要指标

Outcome:

Bone fracture "clinical evaluation index

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:

标本中文名:

人体

组织:

Sample Name:

people

Tissue:

人体标本去向

其它

说明

Fate of sample 

Others

Note:

征募研究对象情况:

正在进行

Recruiting

年龄范围:

最小 25
Min age years
最大 60
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

浙江省中医院临床评价中心前期运用计算机制定随机数字,对受试者实施单盲。该过程包括:①准备随机信封:准备360只密闭不透明的信封,并按1到360进行编号;②产生随机数字:临床评价中心人员运用SPSS22.0产生360个随机数字,并按产生顺序依次转入信封中;③随机分组:规定小于120随机数字进入颈椎斜板组,120-240随机数字进入颈椎旋提手法组,大于240随机数字进入俯卧位颈椎复位组;④发放随机信封:受试者填写知情同意书,并按照招募的顺序分发随机信封;⑤临床干预:治疗师依据依据信封上的随机数字进行相应的治疗。

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

The Clinical Evaluation Center of Zhejiang Provincial Hospital of Traditional Chinese Medicine used computer to formulate random numbers in the early stage, and performed single blindness on the subjects. The process includes: (1) Preparing random envelopes: preparing 360 sealed and opaque envelopes and numbering them from 1 to 360; ② Generate random numbers: The staff of the clinical evaluation center used SPSS22.0 to generate 360 random numbers, and transferred them into the envelope in the order of generation; (3) Randomization: random numbers less than 120 were assigned to the cervical oblique plate group, random numbers from 120 to 240 were assigned to the cervical spinal manipulation group, and random numbers greater than 240 were assigned to the prone cervical spine reduction group; (4) Issue random envelopes: subjects fill in the informed consent form and distribute random envelopes in the order of recruitment; ⑤ Clinical intervention: The therapist performs the corresponding treatment according to the random number on the envelope.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

No

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):

问作者所要

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

Ask the author what he wants

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:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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