负性心理状态对火针刺督脉颈部扳机点治疗紧张型头痛患者远期疗效评价的意义研究

注册号:

Registration number:

AMCTR-IPR-20000315 

注册号获得时间:

Date of releasing the registration number:

2020/1/2 1:23:29 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

负性心理状态对火针刺督脉颈部扳机点治疗紧张型头痛患者远期疗效评价的意义研究 

Public title:

Study on the negative psychological state to evaluation of the long-term efficacy of fire acupuncture in the neck trigger points along governor meridian of tension-type headache patients 

研究课题的正式科学名称:

负性心理状态对火针刺督脉颈部扳机点治疗紧张型头痛患者远期疗效评价的意义研究 

Scientific title:

Study on the negative psychological state to evaluation of the long-term efficacy of fire acupuncture in the neck trigger points along governor meridian of tension-type headache patients 

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:

张鹏 

研究负责人:

陈陆泉 

Applicant:

Peng Zhang 

Study leader:

Lu-quan Chen 

申请注册联系人电话:

Applicant telephone:

13811674084 

研究负责人电话:

Study leader's telephone:

13611373920 

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:

ellen0326@126.com 

研究负责人电子邮件:

Study leader's E-mail:

chenluquan@hotmail.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:

北京市东城区东交民巷1号 

研究负责人通讯地址:

北京市东城区东交民巷1号 

Applicant address:

No. 1, Dongjiao Min Xiang, Dongcheng District, Beijing 

Study leader's address:

No. 1, Dongjiao Min Xiang, Dongcheng District, Beijing 

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:

首都医科大学附属北京同仁医院针灸科 

Applicant's institution:

Department of Acupuncture-Moxibustion,Beijing Tongren Hospital Affiliated to Capital Medical University 

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:

TRECKY2019-042 

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:

首都医科大学附属北京同仁医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Beijing Tongren Hospital affiliated to Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-11 

研究实施负责(组长)单位:

首都医科大学附属北京同仁医院针灸科 

Primary sponsor:

Department of Acupuncture-Moxibustion,Beijing Tongren Hospital Affiliated to Capital Medical University 

研究实施负责(组长)单位地址:

北京市东城区东交民巷1号 

Primary sponsor's address:

No. 1, Dongjiao Min Xiang, Dongcheng District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京同仁医院

具体地址:

北京市东城区东交民巷1号

Institution
hospital:

Beijing Tongren Hospital Affiliated to Capital Medical University

Address:

No. 1, Dongjiao Min Xiang, Dongcheng District, Beijing

经费或物资来源:

李新吾名老中医工作室 

Source(s) of funding:

Li Xinwu's Chinese Medicine Studio 

研究疾病:

紧张性头痛 

Target disease:

tension-type headache 

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:

I期临床试验 

Study phase:

Phase I 

研究目的:

本研究以紧张型头痛患者为研究对象,以火针针刺颈部扳机点为治疗方法,随机对照设计为研究方案,评价已证明能够缓解紧张型头痛患者颈项部肌肉紧张状态,有效减轻或消除头部疼痛的火针治疗方案对焦虑、抑郁等负性心理状态的影响,并验证以心理状态为指标预测紧张型头痛远期疗效的可行性,探讨积极的紧张型头痛非药物治疗方案对降低更难治愈的、对生活质量影响更大的药物性头痛患病率的意义,挖掘传统中医学“既病防变”理论的现代临床指导价值。 

Objectives of Study:

Taking tension—type headache patients as the research object, needling fire acupuncture in patients' neck trigger points, randomized controlled design as the research plan, this study will evaluate the fire needle treatment's effect ,which has proved that can relax neck muscles in tension headache patients and effectively reduce or eliminate head pain, on anxiety, depression and other negative psychological state, and verify the feasibility of mental state as the index to predict the long-term effect of tension headache. It is also will explored whether positive tension headache treatment can reduce drug-induced headache patients,as well as will illustrate traditional Chinese medicine's about "disease-preventing and anti-change" theory's guidance value to modern clinical. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1、符合频发性紧张型头痛和慢性紧张型头痛的诊断标准者; 2、年龄 18-65 岁; 3、触诊发现颈枕部肌肉存在压痛点; 4、没有严重的高血压、心、肝、肾、造血系统等严重疾病; 5、签署知情同意书者。 

Inclusion criteria

1, those who met the diagnostic criteria of frequent tension headache and chronic tension headache; 2, aged 18 ≤ 65 years old; 3, palpation found tenderness points in cervical and occipital muscles; 4, there were no serious diseases such as hypertension, heart, liver, kidney, hematopoietic system and so on; 5, signed informed consent. 

排除标准:

1、合并偏头痛、丛集性头痛、精神因素等其他原因所致的头痛; 2、颈源性头痛等继发头痛; 3、血压控制不理想者; 4、合并严重疾患及凝血功能障碍; 5、妊娠或哺乳期妇女。 

Exclusion criteria:

1. Headache caused by migraine, cluster headache, mental factors and other causes; 2, secondary headache such as cervicogenic headache; 3, unideal blood pressure control; 4, complicated with severe diseases and coagulation dysfunction; 5, pregnant or lactating women. 

研究实施时间:

Study execute time:

From2020-12-01To 2020-06-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

21

Group:

treatment group

Sample size:

干预措施:

火针和毫针针刺

干预措施代码:

Intervention:

fire acupuncture and acupuncture

Intervention code:

组别:

对照组

样本量:

21

Group:

Control group

Sample size:

干预措施:

毫针针刺

干预措施代码:

Intervention:

only acupuncture

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京同仁医院 

单位级别:

三级甲等综合医院 

Institution
hospital:

Beijing Tongren Hospital Affiliated to Capital Medical University  

Level of the institution:

3A Hospital 

测量指标:

Outcomes:

指标中文名:

焦虑自评量表评分

指标类型:

主要指标 

Outcome:

Self-rating anxiety scale score

Type:

Primary indicator 

指标中文名:

抑郁自评量表评分

指标类型:

主要指标 

Outcome:

Self-rating depression scale score

Type:

Primary indicator 

指标中文名:

肌肉压力痛阈值测定

指标类型:

主要指标 

Outcome:

Threshold of muscle pressure pain

Type:

Primary indicator 

指标中文名:

头痛日记

指标类型:

次要指标 

Outcome:

Headache diary

Type:

Secondary indicator 

指标中文名:

头痛影响测试量表

指标类型:

次要指标 

Outcome:

Headache effect test scale (HIT-6)

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

null

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

随机方法(请说明由何人用什么方法产生随机序列):

由不参与患者入组的独立工作人员采用SAS统计软件PROCPLAN过程语句产生随机机序列

性别:

男女均可

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

The independent staff enrolled in the non-participating patient developed a random random sequence using the SAS statistical software PROCPLAN procedure statement

Gender:

Both

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):

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

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):

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

创建人:

Creater Name:

 2019-12-23
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