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Efficacy of Abdominal Acupuncture for Neck Pain: A Randomized Controlled Trial
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注册号:

Registration number:

ChiCTR-TRC-14004932 

最近更新日期:

Date of Last Refreshed on:

2017-09-03 

注册时间:

Date of Registration:

2014-07-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

腹針治療頸痛的臨床隨機對照研究 

Public title:

Efficacy of Abdominal Acupuncture for Neck Pain: A Randomized Controlled Trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

腹針治療頸痛的臨床隨機對照研究 

Scientific title:

Efficacy of Abdominal Acupuncture for Neck Pain: A Randomized Controlled Trial 

研究课题代号(代码):

Study subject ID:

CRE-2013.627-T 

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_CCT00422 

申请注册联系人:

Professor Yuanqi GUO 

研究负责人:

Professor Yuanqi GUO 

Applicant:

Professor Yuanqi GUO 

Study leader:

Professor Yuanqi GUO 

申请注册联系人电话:

Applicant telephone:

+852 3943 8131 

研究负责人电话:

Study leader's telephone:

+852 3943 8131 

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:

cuguoyq@yahoo.com.hk 

研究负责人电子邮件:

Study leader's E-mail:

cuguoyq@yahoo.com.hk 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/261 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/261 

申请注册联系人通讯地址:

School of Chinese Medicine, 1/F Sino Building, The Chinese University of Hong Kong, N.T., Hong Kong 

研究负责人通讯地址:

School of Chinese Medicine, 1/F Sino Building, The Chinese University of Hong Kong, N.T., Hong Kong 

Applicant address:

School of Chinese Medicine, 1/F Sino Building, The Chinese University of Hong Kong, N.T., Hong Kong 

Study leader's address:

School of Chinese Medicine, 1/F Sino Building, The Chinese University of Hong Kong, N.T., 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:

The Chinese University of Hong Kong 

Applicant's institution:

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:

CRE-2013.627-T 

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:

Joint CUHK-NTEC Clinical Research Ethics Committee 

Name of the ethic committee:

Joint CUHK-NTEC Clinical Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-01-21 

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:

School of Chinese Medicine, 1/F Sino Building, The Chinese University of Hong Kong, N.T., Hong Kong 

Primary sponsor:

School of Chinese Medicine, The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

School of Chinese Medicine, 1/F Sino Building, The Chinese University of Hong Kong, N.T., Hong Kong 

Primary sponsor's address:

School of Chinese Medicine, The Chinese University of 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:

Pok Oi Hospital - The Chinese University of Hong Kong Chinese Medicine Centre for Training and Research (Shatin) 

Source(s) of funding:

Pok Oi Hospital - The Chinese University of Hong Kong Chinese Medicine Centre for Training and Research (Shatin) 

研究疾病:

Neck pain 

Target disease:

Neck pain 

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:

IV期临床试验 

Study phase:

研究目的:

Abdominal acupuncture treatment under the guidance of traditional Chinese medicine acupuncture meridian theory and new concepts developed by Dr Ziyun Bo. 

Objectives of Study:

Abdominal acupuncture treatment under the guidance of traditional Chinese medicine acupuncture meridian theory and new concepts developed by Dr Ziyun Bo. 

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. Between 18 and 65 years of age with the ability to speak and understand Cantonese; 2. Neck complaints on: (1) pain, stiffness or tenderness, with or without musculoskeletal signs including decreased range of motion and point tenderness; (2) pain felt in the neck with radiation to the occiput or towards the shoulders, or both with limitation of neck motion; and (3) neck pain with degenerative joint disease or cervical spondylosis, or both; 3. 3 points or more on a 10-cm visual analogue scale for neck pain at the time of screening; 4. No previous treatment with abdominal acupuncture for any reason; 5. Agreed to be randomized; and 6. Agreed to sign the informed consent form. 

Inclusion criteria

1. Between 18 and 65 years of age with the ability to speak and understand Cantonese; 2. Neck complaints on: (1) pain, stiffness or tenderness, with or without musculoskeletal signs including decreased range of motion and point tenderness; (2) pain felt in the neck with radiation to the occiput or towards the shoulders, or both with limitation of neck motion; and (3) neck pain with degenerative joint disease or cervical spondylosis, or both; 3. 3 points or more on a 10-cm visual analogue scale for neck pain at the time of screening; 4. No previous treatment with abdominal acupuncture for any reason; 5. Agreed to be randomized; and 6. Agreed to sign the informed consent form. 

排除标准:

1. Visceral pain in the neck, including carcinoma of thyroid or larynx and tuberculosis of larynx; 2. Serious spinal disorders, including malignancy, vertebral fracture, spinal infection and inflammatory spondylitis; 3. Patients who previously had neck surgery or are scheduled to have one during the study; 4. Other chronic diseases that could interfere with abdominal acupuncture treatment effects, including cardiovascular disease, diabetic neuropathy, active hepatitis, fibromyalgia, rheumatoid arthritis, dementia and epilepsy; 5. Diagnosis of cancer of any nature; 6. Chief musculoskeletal pain other than neck pain; 7. Conditions that abdominal acupuncture might not be safe, including clotting disorders, administration of an anticoagulant agent, acute abdominal disorders, venous dilation of the naval, celiac tumor and pregnant women; 8. Possess abdominal scar which will affect the proper selection of acupuncture points for abdominal acupuncture; 9. Severe psychiatric or psychological disorder; 10. Acupuncture treatment for neck pain during the previous month; 11. Conflicting or ongoing co-interventions (drugs or alternative treatments, or both); 12. Engage in any other clinical trial during the study period; 13. Pending neck-related litigation or disability claims; 14. Incapacity to complete the questionnaires or to answer the questions of the assessor in the study; and 15. Pregnant and breast feeding women. 

Exclusion criteria:

1. Visceral pain in the neck, including carcinoma of thyroid or larynx and tuberculosis of larynx; 2. Serious spinal disorders, including malignancy, vertebral fracture, spinal infection and inflammatory spondylitis; 3. Patients who previously had neck surgery or are scheduled to have one during the study; 4. Other chronic diseases that could interfere with abdominal acupuncture treatment effects, including cardiovascular disease, diabetic neuropathy, active hepatitis, fibromyalgia, rheumatoid arthritis, dementia and epilepsy; 5. Diagnosis of cancer of any nature; 6. Chief musculoskeletal pain other than neck pain; 7. Conditions that abdominal acupuncture might not be safe, including clotting disorders, administration of an anticoagulant agent, acute abdominal disorders, venous dilation of the naval, celiac tumor and pregnant women; 8. Possess abdominal scar which will affect the proper selection of acupuncture points for abdominal acupuncture; 9. Severe psychiatric or psychological disorder; 10. Acupuncture treatment for neck pain during the previous month; 11. Conflicting or ongoing co-interventions (drugs or alternative treatments, or both); 12. Engage in any other clinical trial during the study period; 13. Pending neck-related litigation or disability claims; 14. Incapacity to complete the questionnaires or to answer the questions of the assessor in the study; and 15. Pregnant and breast feeding women. 

研究实施时间:

Study execute time:

From2014-09-01To  

征募观察对象时间:

Recruiting time:

From2014-09-01To  

干预措施:

Interventions:

组别:

Two groups

样本量:

154

Group:

Two groups

Sample size:

干预措施:

Abdominal Acupuncture three times a week for two weeks versus Sham abdominal acupuncture treatment

干预措施代码:

Intervention:

Abdominal Acupuncture three times a week for two weeks versus Sham abdominal acupuncture treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

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):

Chinese University of Hong Kong 

单位级别:

Chinese University of Hong Kong 

Institution
hospital:

Chinese University of Hong Kong  

Level of the institution:

Chinese University of Hong Kong 

测量指标:

Outcomes:

指标中文名:

Northwick Park Neck Pain Questionnaire

指标类型:

主要指标 

Outcome:

Northwick Park Neck Pain Questionnaire

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

VAS for pain intensity

指标类型:

次要指标 

Outcome:

VAS for 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:

SF-36-v2 Health Survey

指标类型:

次要指标 

Outcome:

SF-36-v2 Health Survey

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Credibility test

指标类型:

次要指标 

Outcome:

Credibility test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Satisfaction with treatment

指标类型:

次要指标 

Outcome:

Satisfaction with 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:

Blinding assessment

指标类型:

次要指标 

Outcome:

Blinding assessment

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 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):

Random

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

Random

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

No

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据与安全监察委员会:

Data and Safety Monitoring Committee:

注册人:

Name of Registration:

 2014-07-11
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