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Electroacupuncture and Wrist Splinting for Carpal Tunnel Syndrome: A Randomized Trial in Primary Care Setting
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注册号：

Registration number：

 ChiCTR-TRC-11001655 

最近更新日期：

Date of Last Refreshed on：

 2015-08-19 

注册时间：

Date of Registration：

2011-11-04 

注册号状态：

预注册  

Registration Status：

Prospective registration  

注册题目：

Electroacupuncture and Wrist Splinting for Carpal Tunnel Syndrome: A Randomized Trial in Primary Care Setting 

Public title：

Electroacupuncture and Wrist Splinting for Carpal Tunnel Syndrome: A Randomized Trial in Primary Care Setting 

注册题目简写：

 

English Acronym：

 

研究课题的正式科学名称：

Electroacupuncture and Wrist Splinting for Carpal Tunnel Syndrome: A Randomized Trial in Primary Care Setting 

Scientific title：

Electroacupuncture and Wrist Splinting for Carpal Tunnel Syndrome: A Randomized Trial in Primary Care Setting 

研究课题代号(代码)：

Study subject ID：

09100681 

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：

CUHK_CCT00297 

申请注册联系人：

Vincent Chi Ho, Chung 

研究负责人：

Vincent Chi Ho, Chung 

Applicant：

Vincent Chi Ho, Chung 

Study leader：

Vincent Chi Ho, Chung 

申请注册联系人电话：

Applicant telephone：

+852 22528759 

研究负责人电话：

Study leader's telephone：

+852 22528759 

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：

vchung@cuhk.edu.hk 

研究负责人电子邮件：

Study leader's E-mail：

vchung@cuhk.edu.hk 

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00297 

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00297 

申请注册联系人通讯地址：

4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, Hong Kong 

研究负责人通讯地址：

4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, Hong Kong 

Applicant address：

4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, Hong Kong 

Study leader's address：

4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, Hong Kong 

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：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong 

Applicant's institution：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong 

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：

N/A 

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：

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee 

Name of the ethic committee：

The Chinese University of Hong Kong 

伦理委员会批准日期：

Date of approved by ethic committee：

2010-09-14 

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：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong 

Primary sponsor：

JC School of Public Health and Primary Care, The Chinese University of Hong Kong 

研究实施负责（组长）单位地址：

4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, Hong Kong 

Primary sponsor's address：

4/F, School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, Hong Kong 

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

Lek Yuen Health Center, Shatin, Hong Kong

具体地址：

Lek Yuen Health Center, Shatin, Hong Kong

Institution
hospital：

Lek Yuen General Out-Patient Clinic

Address：

Lek Yuen General Out-Patient Clinic

经费或物资来源：

Health and Health Service Research Fund (HHSRF) 

Source(s) of funding：

Health and Health Service Research Fund (HHSRF) 

研究疾病：

Carpal Tunnel Syndrome 

Target disease：

Carpal Tunnel Syndrome 

研究疾病代码：

 

Target disease code：

 

研究类型：

干预性研究 

Study type：

Interventional study 

研究所处阶段：

III期临床试验 

Study phase：

3 

研究目的：

N 

Objectives of Study：

/ 

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

Electroacupuncture and Wrist Splinting 

研究设计：

随机平行对照 

Study design：

Parallel 

纳入标准：

Patients aged 18-70 and fulfilling the Katz CTS hand diagram criteria of (1) Classic / Probable Symptoms or (2) Possible Symptoms. Eligible patients should also (3) have the ability to read and speak Chinese (Cantonese), and (4) agree to sign the Informed consent and (5) are willing to attend follow up and / or electroacupuncture sessions. 

Inclusion criteria

Patients aged 18-70 and fulfilling the Katz CTS hand diagram criteria of (1) Classic / Probable Symptoms or (2) Possible Symptoms. Eligible patients should also (3) have the ability to read and speak Chinese (Cantonese), and (4) agree to sign the Informed consent and (5) are willing to attend follow up and / or electroacupuncture sessions. 

排除标准：

Patients with symptoms and signs of axonal loss and evident median nerve denervation, including (1) constant numbness, (2) loss of sensibility, and (3) thenar muscular atrophy or weakness will be excluded. Patients with secondary CTS caused by inflammatory arthropathy, coexisting cervical radical radiculopathy, polyneuropathy, diabetes mellitus, pregnancy, malignancy, hypothyroidism, alcoholism, rheumatoid arthritis, space-occupying lesions (tumours, hypertrophic synovial tissue, fracture callus, and osteophytes), infections, and familial neuropathy will also be excluded. In particular, cervical radiculopathy will be actively ruled out by assessing the existence of related symptoms and signs, including neck pain, reduced reflexes, less well demarcated dermatomal involvement, and positive Spurling's test. Patients who received previous carpal tunnel release surgery, or have used warfarin, oral steroid, local steroid injection, night splint or acupuncture for CTS in the past 6 months, or other serious illnesses will be considered as ineligible. 

Exclusion criteria：

Patients with symptoms and signs of axonal loss and evident median nerve denervation, including 1. constant numbness; 2. loss of sensibility, and 3. thenar muscular atrophy or weakness will be excluded. Patients with secondary CTS caused by inflammatory arthropathy, coexisting cervical radical radiculopathy, polyneuropathy, diabetes mellitus, pregnancy, malignancy, hypothyroidism, alcoholism, rheumatoid arthritis, space-occupying lesions (tumours, hypertrophic synovial tissue, fracture callus, and osteophytes), infections, and familial neuropathy will also be excluded. In particular, cervical radiculopathy will be actively ruled out by assessing the existence of related symptoms and signs, including neck pain, reduced reflexes, less well demarcated dermatomal involvement, and positive Spurling's test. Patients who received previous carpal tunnel release surgery, or have used warfarin, oral steroid, local steroid injection, night splint or acupuncture for CTS in the past 6 months, or other serious illnesses will be considered as ineligible. 

研究实施时间：

Study execute time：

从From2012-04-01至To  

征募观察对象时间：

Recruiting time：

从From2012-04-01至To  

干预措施：

Interventions：

组别：

Two groups

样本量：

 182

Group：

Two groups

Sample size：

干预措施：

Electroacupuncture and Wrist Splinting, Night Splinting Plus Electroacupuncture versus Night Splinting Plus Waiting List, duration: 17 weeks

干预措施代码：

Intervention：

Group 1: Night Splinting Plus Electroacupuncture” ; Group 2: Night Splinting Plus Waiting List. Access the partner registry to get the detail discription. Duration: 17 weeks

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

  

省(直辖市)：

  

市(区县)：

  

Country：

 China 

Province：

 Hong Kong SAR 

City：

  

单位(医院)：

  

单位级别：

  

Institution
hospital：

 School of Public Health and Primary Care The Chinese University of Hong Kong  

Level of the institution：

 School of Public Health and Primary Care The Chinese University of Hong Kong 

测量指标：

Outcomes：

指标中文名：

Boston Carpal Tunnel Questionnaire Scoring at 1,2,5 and 17 weeks

指标类型：

主要指标 

Outcome：

Boston Carpal Tunnel Questionnaire Scoring at 1, 2, 5 and 17 weeks

Type：

Primary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

1. Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire 2. A 0 to 10 point numerical rating scale to measure pain intensity. 3. Tip pinch strength (TPS) 4. Semmes-Weinstein monofilament testing (SWMT) 5. Dellon-modified Moberg pick-up test (DMMPUT)

指标类型：

次要指标 

Outcome：

1. Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire

Type：

Secondary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标 

Outcome：

2. A 0 to 10 point numerical rating scale to measure pain intensity.

Type：

Secondary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标 

Outcome：

3. Tip pinch strength (TPS)

Type：

Secondary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标 

Outcome：

4. Semmes-Weinstein monofilament testing (SWMT)

Type：

Secondary indicator 

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标 

Outcome：

5. Dellon-modified Moberg pick-up test (DMMPUT)

Type：

Secondary 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：

结束

Completed

年龄范围：

Participant age：

最小 Min age 18 岁 years
最大 Max age 70 岁 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）：

Randomized

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

Block randomization was applied to allocate patients to the two groups at 1:1 ratio, with random block sizes. The Random Allocation Software was used to generate the sequence.

盲法：

单盲

Blinding：

Single blinding

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）：

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

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：

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

数据管理委员会：

Data Managemen Committee：

暂未确定/Not yet

注册人：

Name of Registration：

 2011-11-04
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