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Electro-acupuncture plus warm needling therapy for heel pain
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注册号：

Registration number：

 ChiCTR1800014906 

最近更新日期：

Date of Last Refreshed on：

 2018-07-29 

注册时间：

Date of Registration：

2018-02-12 

注册号状态：

预注册  

Registration Status：

Prospective registration  

注册题目：

電針配合溫針灸治療跟痛症的臨床隨機對照研究 

Public title：

Electro-acupuncture plus warm needling therapy for heel pain 

注册题目简写：

 

English Acronym：

 

研究课题的正式科学名称：

電針配合溫針灸治療跟痛症的臨床隨機對照研究 

Scientific title：

Electro-acupuncture plus warm needling therapy for heel pain: a randomized controlled tria 

研究课题代号(代码)：

Study subject ID：

2017.600-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_CCRB00586 

申请注册联系人：

HO Lai Fun 

研究负责人：

LIN Zhixiu 

Applicant：

HO Lai Fun 

Study leader：

LIN Zhixiu 

申请注册联系人电话：

Applicant telephone：

+852 24792126 

研究负责人电话：

Study leader's telephone：

+852 28733252 

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：

cmpst@pokoi.org.hk 

研究负责人电子邮件：

Study leader's E-mail：

linzx@cuhk.edu.hk 

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

https://www2.ccrb.cuhk.edu.hk/registry/public/523 

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/523 

申请注册联系人通讯地址：

G/F, Shatin (Taiwai) Clinic, 2 Man Lai Road, Taiwai, Shatin, NT., Hong Kong, China 

研究负责人通讯地址：

4L, Integrative Medical Centre, 4/F, Day Treatment Block, Prince of Wales Hospital, Hong Kong, China 

Applicant address：

G/F, Shatin (Taiwai) Clinic, 2 Man Lai Road, Taiwai, Shatin, NT., Hong Kong, China 

Study leader's address：

4L, Integrative Medical Centre, 4/F, Day Treatment Block, Prince of Wales Hospital, Hong Kong, China 

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：

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

Applicant's institution：

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

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：

2017.600-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：

2018-01-27 

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：

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

Primary sponsor：

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

研究实施负责（组长）单位地址：

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

Primary sponsor's address：

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

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Chinese Medicine Department, Hospital Authority, Hong Kong 

Source(s) of funding：

Chinese Medicine Department, Hospital Authority, Hong Kong 

研究疾病：

跟痛症 

Target disease：

Heel 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：

I期临床试验 

Study phase：

1 

研究目的：

電針配合溫針灸治療跟痛症 

Objectives of Study：

Electro-acupuncture plus warm needling therapy for heel pain 

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

研究设计：

横断面 

Study design：

Cross-sectional 

纳入标准：

1. males and females aged 50 to 80 years; 2. heel pain characterized by the pain worsened when standing or walking after getting up in the morning. The pain gets relieved after a while of walking, and worsened after a long period of walking; 3. heel pain with marked tenderness at the plantar aspect and lateral aspect of the calcaneal tuberosity; 4. either unilateral or bilateral heel pain; 5. acute or chronic pain in nature with degree of heel pain experienced upon taking the first few steps rating 50 mm or more on a 0-100 mm visual analogue scale at the time of recruitment; and 6. agreed to sign the informed consent form. 

Inclusion criteria

1. males and females aged 50 to 80 years; 2. heel pain characterized by the pain worsened when standing or walking after getting up in the morning. The pain gets relieved after a while of walking, and worsened after a long period of walking; 3. heel pain with marked tenderness at the plantar aspect and lateral aspect of the calcaneal tuberosity; 4. either unilateral or bilateral heel pain; 5. acute or chronic pain in nature with degree of heel pain experienced upon taking the first few steps rating 50 mm or more on a 0-100 mm visual analogue scale at the time of recruitment; and 6. agreed to sign the informed consent form. 

排除标准：

1. suffering from pain in another area that is severe than heel pain; 2. loss of plantar foot sensation; 3. open wounds or tumors, skin ulceration on the painful heel(s) and surrounding area; 4. documentation of fracture or abnormalities at the painful heel(s) within 4 weeks that are not suitable for the study treatments; 5. acupuncture and/ or moxibustion treatment for the same heel pain during the previous month; 6. expected ongoing co-interventions (medication or alternative treatments, or both) during study period; 7. previous surgery to the painful heel(s) or scheduled to have one during the study period; 8. severe needle phobia; 9. known hypersensitive reaction after acupuncture and moxibustion treatment or an inability to cooperate with the acupuncture and moxibustion procedure; 10. diagnosis of cancer of any nature within 5 years; 11. known severe disease of the heart, brain, lung, liver, kidney, or hematopoietic system; 12. currently on cardiac pacemaker; 13. pregnant, breast feeding or expecting a pregnancy during the study period; 14. known severe psychiatric or psychological disorder; 15. other factors that have been deemed unsuitable for participation assessed by investigators; 16. engage in any other clinical trial during the study period; 17. pending foot-related litigation or disability claims; and 18. incapable to understand and answer the questions of the assessors in the study. 

Exclusion criteria：

1. suffering from pain in another area that is severe than heel pain; 2. loss of plantar foot sensation; 3. open wounds or tumors, skin ulceration on the painful heel(s) and surrounding area; 4. documentation of fracture or abnormalities at the painful heel(s) within 4 weeks that are not suitable for the study treatments; 5. acupuncture and/ or moxibustion treatment for the same heel pain during the previous month; 6. expected ongoing co-interventions (medication or alternative treatments, or both) during study period; 7. previous surgery to the painful heel(s) or scheduled to have one during the study period; 8. severe needle phobia; 9. known hypersensitive reaction after acupuncture and moxibustion treatment or an inability to cooperate with the acupuncture and moxibustion procedure; 10. diagnosis of cancer of any nature within 5 years; 11. known severe disease of the heart, brain, lung, liver, kidney, or hematopoietic system; 12. currently on cardiac pacemaker; 13. pregnant, breast feeding or expecting a pregnancy during the study period; 14. known severe psychiatric or psychological disorder; 15. other factors that have been deemed unsuitable for participation assessed by investigators; 16. engage in any other clinical trial during the study period; 17. pending foot-related litigation or disability claims; and 18. incapable to understand and answer the questions of the assessors in the study. 

研究实施时间：

Study execute time：

从From至To  

征募观察对象时间：

Recruiting time：

从From2018-03-19至To  

干预措施：

Interventions：

组别：

Two groups

样本量：

 80

Group：

Two groups

Sample size：

干预措施：

Electro-acupuncture and warm needling therapy (acupuncture and moxibustion) used in this study are based on traditional Chinese medicine theory and review of literature, for four weeks, Six treatment sessions over a 4-week period on a regular basis. Versus waiting list.

干预措施代码：

Intervention：

Electro-acupuncture and warm needling therapy (acupuncture and moxibustion) used in this study are based on traditional Chinese medicine theory and review of literature, for four weeks, Six treatment sessions over a 4-week period on a regular basis. Versus waiting list.

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 Medicine Department, Hospital Authority 

单位级别：

 Chinese Medicine Department, Hospital Authority 

Institution
hospital：

 Chinese Medicine Department, Hospital Authority  

Level of the institution：

 Chinese Medicine Department, Hospital Authority 

测量指标：

Outcomes：

指标中文名：

First step pain VAS

指标类型：

主要指标 

Outcome：

First step pain VAS

Type：

Primary indicator 

测量时间点：

4-week (end of treatment)

测量方法：

Questionnaire

Measure time point of outcome：

4-week (end of treatment)

Measure method：

Questionnaire

指标中文名：

Foot Function Index

指标类型：

次要指标 

Outcome：

Foot Function Index

Type：

Secondary indicator 

测量时间点：

2-week, 4-week (end of treatment), 8-week (for intervention group)

测量方法：

Questionnaire

Measure time point of outcome：

2-week, 4-week (end of treatment), 8-week (for intervention group)

Measure method：

Questionnaire

指标中文名：

Global rating of change (GRC) scale

指标类型：

次要指标 

Outcome：

Global rating of change (GRC) scale

Type：

Secondary indicator 

测量时间点：

4-week (end of treatment)

测量方法：

Questionnaire

Measure time point of outcome：

4-week (end of treatment)

Measure method：

Questionnaire

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 50 岁 years
最大 Max age 80 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）：

Random allocation is performed by a computer software

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

Random allocation is performed by a computer software

盲法：

Not stated

Blinding：

Not stated

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：

有/Yes

注册人：

Name of Registration：

 2018-02-12
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