"Seven-line point selection of neck" acupuncture combined with conventional treatment as salvage therapy for sudden deafness: a retrospective study

注册号:

Registration number:

ITMCTR2024000043

最近更新日期:

Date of Last Refreshed on:

2024-04-09

注册时间:

Date of Registration:

2024-04-09

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

“颈部七线取穴法”针刺联合常规治疗作为突发性聋的挽救疗法:回顾性研究

Public title:

"Seven-line point selection of neck" acupuncture combined with conventional treatment as salvage therapy for sudden deafness: a retrospective study

注册题目简写:

English Acronym:

研究课题的正式科学名称:

“颈部七线取穴法”针刺联合常规治疗作为突发性聋的挽救疗法:回顾性研究

Scientific title:

"Seven-line point selection of neck" acupuncture combined with conventional treatment as salvage therapy for sudden deafness: a retrospective study

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:

张重阳

研究负责人:

白鹏

Applicant:

Chongyang Zhang

Study leader:

Peng Bai

申请注册联系人电话:

Applicant telephone:

17812095895

研究负责人电话:

Study leader's telephone:

15810498777

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:

zhangcy3000@126.com

研究负责人电子邮件:

Study leader's E-mail:

baipeng202305@163.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:

北京市朝阳区北三环东路11号

研究负责人通讯地址:

北京市朝阳区安定门外小关街51号

Applicant address:

11 Beisanhuan Dong Lu, Chaoyang District, Beijing

Study leader's address:

51 Xiaoguan Street, Andingmenwai, Chaoyang 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:

北京中医药大学

Applicant's institution:

Beijing University of 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:

2024DZMEC-094-02

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

北京中医药大学东直门医院医学伦理委员会

Name of the ethic committee:

Ethics Committee of Dongzhimen Hospital Affiliated Beijing University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/3/14 0:00:00

伦理委员会联系人:

韩雪婷

Contact Name of the ethic committee:

Xueting Han

伦理委员会联系地址:

北京市东城区海运仓5号

Contact Address of the ethic committee:

No.5 Ocean Warehouse, Dongcheng District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-84012709

伦理委员会联系人邮箱:

Contact email of the ethic committee:

dzmyyec@126.com

研究实施负责(组长)单位:

北京中医药大学东直门医院

Primary sponsor:

Dongzhimen Hospital of Beijing University of Chinese Medicine

研究实施负责(组长)单位地址:

北京市东城区海运仓5号

Primary sponsor's address:

5 Haiyuncang Street, 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

市(区县):

Country:

China

Province:

BeiJing

City:

单位(医院):

北京中医药大学东直门医院

具体地址:

北京市东城区海运仓5号

Institution
hospital:

Dongzhimen Hospital of Beijing University of Chinese Medicine

Address:

5 Haiyuncang Street, Dongcheng District, Beijing

经费或物资来源:

Source(s) of funding:

No

研究疾病:

突发性聋

研究疾病代码:

Target disease:

Sudden deafness

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

队列研究

Cohort study

研究所处阶段:

Study phase:

II-III期临床试验

Phase II-III clinical trial

研究目的:

评价“颈部七线取穴法”针刺联合常规治疗作为挽救疗法,对于非急性期未痊愈的突发性聋患者的临床疗效。

Objectives of Study:

To evaluate the clinical effect of "seven-line point selection of neck" acupuncture combined with conventional treatment as salvage therapy for patients with sudden deafness in non-acute stage.

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)被诊断为突发性聋(国际疾病分类[ICD]-10编码为:H91.201),且为单侧发病; (2)年龄在18-80岁,性别不限; (3)病程≥15天。

Inclusion criteria

(1) Meet the above diagnostic criteria, and unilateral sudden deafness; (2) Age 18-80 years old, gender is not limited; (3) Patients with sudden deafness whose course of disease is ≥15 days and whose hearing has not returned to normal after initial treatment or without initial treatment. Failure to heal is defined as: the impaired frequency of hearing has not returned to normal, or the affected ear has not reached the level of healthy ear, or has not reached the level before the illness.

排除标准:

(1)其他原因导致的感音神经性聋,如:老年性聋、药物性聋、噪声性聋、外伤性聋、自身免疫性感音神经性聋、听神经瘤、梅尼埃病、特殊感染导致的听力下降等; (2)内耳畸形、蜗神经发育不良等先天发育异常; (3)孕妇及哺乳期妇女; (4)临床资料不完整的患者。

Exclusion criteria:

(1) sensorineural deafness caused by other causes, such as: senile deafness, drug deafness, noise deafness, traumatic deafness, autoimmune sensorineural deafness, acoustic neuroma, Meniere's disease, hearing loss caused by special infections, etc.; (2) congenital developmental abnormalities such as inner ear malformation and cochlear nerve dysplasia; (3) Pregnant and lactating women; (4) Patients with incomplete clinical data.

研究实施时间:

Study execute time:

From 2024-02-16

To      2024-06-30

征募观察对象时间:

Recruiting time:

From 2023-06-01

To      2023-11-30

干预措施:

Interventions:

组别:

“颈部七线取穴法”针刺联合常规治疗组

样本量:

75

Group:

"Seven-line point selection of neck" acupuncture combined with conventional treatment group

Sample size:

干预措施:

“颈部七线取穴法”针刺联合常规治疗

干预措施代码:

Intervention:

"Neck seven-line point selection method" acupuncture combined with conventional treatment

Intervention code:

组别:

普通针刺联合常规治疗组

样本量:

75

Group:

Ordinary acupuncture combined with conventional treatment group

Sample size:

干预措施:

普通针刺联合常规治疗

干预措施代码:

Intervention:

Ordinary acupuncture combined with conventional treatment

Intervention code:

组别:

常规治疗组

样本量:

75

Group:

Conventional treatment group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Conventional treatment

Intervention code:

样本总量 Total sample size : 225

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医药大学东直门医院

单位级别:

三级医院

Institution/hospital:

Dongzhimen Hospital of Beijing University of Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

治疗后纯音平均听阈较治疗前的变化

指标类型:

次要指标

Outcome:

The change of pure tone mean hearing threshold after treatment compared with before treatment

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

影响患者听力恢复的相关因素

指标类型:

次要指标

Outcome:

Related factors affecting patients' hearing recovery

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗后听力得到改善的患者的比例

指标类型:

次要指标

Outcome:

The proportion of patients whose hearing improved after treatment

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗后受损频率纯音平均听阈的最终阈值

指标类型:

主要指标

Outcome:

The change of pure tone mean hearing threshold of damaged frequency after treatment compared with before treatment

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:

组织:

Sample Name:

no

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:

结束

Completed

年龄范围:

最小 18
Min age years
最大 80
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):

依据突发性聋患者接受治疗的实际情况进行分组。

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

The patients with sudden deafness were grouped according to the actual treatment.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

Yes

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):

中国临床试验注册中心;http://www.medresman.org.cn

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

Chinese Clinical Trial Registry;http://www.medresman.org.cn

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:

通过纸质CRF表格记录元数据,再将数据录入到电子数据采集系统。数据管理由专人负责。

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

通过纸质CRF表格记录元数据,再将数据录入到电子数据采集系统。数据管理由专人负责。

数据管理委员会:

Data Managemen Committee:

No

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above