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Transcutaneous electrical stimulation at auricular acupoint innervated by auricular branch of vagus nerve pairing sound masking for tinnitus: a randomized controlled clinical trail
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注册号:

Registration number:

ChiCTR-TRC-14004940 

最近更新日期:

Date of Last Refreshed on:

2014-10-26 

注册时间:

Date of Registration:

2014-07-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

耳迷走神经分布区穴位电刺激配合声音掩蔽治疗耳鸣的临床研究 

Public title:

Transcutaneous electrical stimulation at auricular acupoint innervated by auricular branch of vagus nerve pairing sound masking for tinnitus: a randomized controlled clinical trail 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

从听觉中枢可塑性改善探讨耳针加声音掩蔽治疗耳鸣机制研究 

Scientific title:

Research on the effect of electrical stimulation of auricular vagus nerve pairing masking tone on tinnitus in light of auditory center 

研究课题代号(代码):

Study subject ID:

2013Z-Y10 

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:

U1111-1158-7062 

申请注册联系人:

李甜甜 

研究负责人:

梅志刚 

Applicant:

Tiantian Li 

Study leader:

Zhigang Mei 

申请注册联系人电话:

Applicant telephone:

+86 13972563796 

研究负责人电话:

Study leader's telephone:

+86 13997749153 

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:

919033846@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zhigangmei@139.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:

湖北省宜昌市大学路8号三峡大学医学院 

研究负责人通讯地址:

湖北省宜昌市大学路8号三峡大学科技处 

Applicant address:

Medical College of China Three Gorges University, No.8, University Avenue, Yichang, Hubei, China 

Study leader's address:

Science and Technology Department of China Three Gorges University, No.8, University Avenue, Yichang, Hubei, China 

申请注册联系人邮政编码:

Applicant postcode:

443002 

研究负责人邮政编码:

Study leader's postcode:

443002 

申请人所在单位:

三峡大学医学院 

Applicant's institution:

Medical College of China Three Gorges 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:

201407041 

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:

三峡大学中医临床医学院宜昌市中医医院伦理委员会 

Name of the ethic committee:

Ethic committee of Yichang Hospital of Traditional Chinese Medicine, Clinical Medical College of Traditional Chinese Medicine, China Three Gorges Univ 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-07-04 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

三峡大学医学院 

Primary sponsor:

Medical College of China Three Gorges University 

研究实施负责(组长)单位地址:

湖北省宜昌市大学路8号 

Primary sponsor's address:

No.8, University Avenue, Yichang, Hubei, 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):

湖北

市(区县):

Country:

China

Province:

Hubei

City:

单位(医院):

三峡大学中医临床医学院宜昌市中医医院

具体地址:

湖北省宜昌市胜利三路2号

Institution
hospital:

Yichang Hospital of Traditional Chinese Medicine,

Address:

No.2, Victory Three Road, Yichang, Hubei, China

经费或物资来源:

湖北省卫计委中医、中西医结合一般科研项目 

Source(s) of funding:

General scientific research project of traditional Chinese medicine approved by Health and Family Pl 

研究疾病:

耳鸣 

Target disease:

Tinnitus 

研究疾病代码:

ICD-10:H93.101 

Target disease code:

ICD-10:H93.101 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

评价耳迷走神经分布区穴位电刺激配合声音掩蔽治疗耳鸣的临床疗效,以期为临床治疗耳鸣提供根据。 

Objectives of Study:

To evaluate the effect of transcutaneous electrical stimulation at auricular acupoint innervated by auricular branch of vagus nerve pairing sound masking for tinnitus. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

①主观性耳鸣,且耳鸣属于单音调者;②耳鸣间歇性发作1月以上,或持续发作在5日以上;③能正常填写相关的量化表;④自愿签署知情同意书;⑤年龄在15-65岁,男女均可。 

Inclusion criteria

1. Single-tone subjective tinnitus; 2 Recurrent attacks for more than 1 month, or persist attack more than 5 days; 3 Having ability of filling the scale forms smoothly; 4 Voluntarily signed informed consent; 5. Age 15 to 65, either genders. 

排除标准:

(1)年龄<15岁,或>65岁;(2)排除由中耳、内耳或小脑桥角肿瘤引起的耳鸣,以及有梅尼埃病史的患者;(3)排除蜗后病变;(4)排除患有严重精神性疾病、糖尿病、高血压以及心血管疾病等患者;(5)因故不能配合填写相关量表者。 

Exclusion criteria:

1. Age younger than 15 years old or older than 65 years old; 2. Tinnitus induced by middle ear/inner ear/cerebellopontine angle tumours, or patients with Meniere disease; 3. post-cochlear lesion; 4. Patients with severe mental disease, diabetes, hypertension and cardiovascular disease; 5. Patients unable to fill scale forms. 

研究实施时间:

Study execute time:

From2014-09-21To 2014-12-31 

征募观察对象时间:

Recruiting time:

From2014-07-01To  

干预措施:

Interventions:

组别:

A

样本量:

30

Group:

Group A

Sample size:

干预措施:

体针电刺激,电刺激参数以受试者耐受为度。远近端配合取穴,刺激穴位有近端穴翳风、听会和远端穴侠溪、中渚。每次30分钟,隔日一次,共治疗8周。

干预措施代码:

Intervention:

This group will be treated with electro-acupuncture. All parameters of the electrical stimulation will be adjusted individually based on the tolerance of the patients. Local acupoints ( TE 17, GB 2) are combined with distal acupoints (GB 43, TE 3). Each treatment will last for 30 min and will be carried on every other day for 8 weeks.

Intervention code:

组别:

B

样本量:

30

Group:

Group B

Sample size:

干预措施:

将耳迷走神经电刺激仪耳夹戴在耳迷走神经分布区穴位处(如神门、胰胆、肝、肾),频率20Hz,波宽≤1ms,电流1-5mA,强度以受试者耐受为度。每次30分钟,隔日一次,共治疗8周

干预措施代码:

Intervention:

Wearing the ear clip producing frequency at 20Hz with less than 1ms' wave width and 1-5mA current at regions innervated by auricular branch of vagus nerve (mainly TF4, CO11,CO10 and CO12). The intensity is set according to durability. Each treatment will last for 30 min and will be carried on every other day. Treatment course is 8 weeks.

Intervention code:

组别:

C

样本量:

30

Group:

Group C

Sample size:

干预措施:

将耳迷走神经电刺激仪耳夹夹在耳迷走神经分布区穴位处,穴位和刺激参数均同耳迷走神经分布区穴位电刺激组,同时进行声音掩蔽,采用声音掩蔽软件(Tinnitus measurer)选择除了患者耳鸣主频率的纯音进行掩蔽治疗,并不断地更换频率,强度以耐受为度。每次30分钟,隔日一次,共治疗8周

干预措施代码:

Intervention:

Wearing the ear clip on the region innervated by auricular branch of vagus nerve. The stimulation parameters and acupoints will be the same as those for treatment group B. Meanwhile, sound stimulus will be delivered by the Tinnitus measurer at a comfortable listening level. Randomly interleaved pure tones that span the hearing range but exclude the tinnitus tone will be selected. Each treatment will last for 30 min and is carried on every other day. Treatment course is 8 weeks.

Intervention code:

组别:

D

样本量:

30

Group:

Group D

Sample size:

干预措施:

将耳迷走神经电刺激仪耳夹夹在耳大神经分布区,同时配合声音刺激。刺激参数及声音掩蔽形式同耳迷走神经分布区穴位电刺激配合声音掩蔽组。每次30分钟,隔日一次,共治疗8周

干预措施代码:

Intervention:

Wearing the ear clip on where great auricular nerve distribute. The stimulation format and sound stimulus will be the same as Group C. Each treatment will last for 30 min and will be carried on every other day. Treatment course is 8 weeks

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

三峡大学中医临床医学院宜昌市中医医院 

单位级别:

三级甲等 

Institution
hospital:

Yichang Hospital of Traditional Chinese Medicine,  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

耳鸣残疾度量化表

指标类型:

主要指标 

Outcome:

Tinnitus Handicap Inventory (THI)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视觉模拟评分法

指标类型:

主要指标 

Outcome:

Visual Analogue Scale (VAS)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

医院焦虑抑郁量化表

指标类型:

主要指标 

Outcome:

Hospital Anxiety and Depression Scale (HADS

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:

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 15 years
最大 Max age 65 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

SPSS 15.0 软件

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

SPSS 15.0 software

盲法:

患者是单盲法

Blinding:

single-blind

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

三峡大学医学院;三峡大学中医临床医学院宜昌市中医医院

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

Medical College of China Three Gorges University;Yichang Hospital of Traditional Chinese Medicine, Clinical Medical College of Traditional Chinese Medicine, China Three Gorges University

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:

三峡大学医学院

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

Medical College of China Three Gorges University

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-07-08
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