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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:

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:

FromTo  

征募观察对象时间:

Recruiting time:

From2018-03-19To  

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 years
最大 Max age 80 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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