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: |
|
||||||||||||||||||||||
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: |
|
研究实施地点: Countries of recruitment and research settings: |
|
测量指标: Outcomes: |
|