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Effectiveness of dextrose prolotherapy in the treatment of knee osteoarthritis: a randomized controlled trial
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注册号:

Registration number:

ChiCTR-IPC-15006617 

最近更新日期:

Date of Last Refreshed on:

2017-08-04 

注册时间:

Date of Registration:

2015-06-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

葡萄糖注射治療對退化性膝關節炎的效用 

Public title:

Effectiveness of dextrose prolotherapy in the treatment of knee osteoarthritis: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

葡萄糖注射治療對退化性膝關節炎的效用 

Scientific title:

Effectiveness of dextrose prolotherapy in the treatment of knee osteoarthritis: a randomized controlled trial 

研究课题代号(代码):

Study subject ID:

CREC 2014.059-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_CCT00456 

申请注册联系人:

Wing Yin TAM 

研究负责人:

Professor Regina Wing Shan SIT 

Applicant:

Wing Yin TAM 

Study leader:

Professor Regina Wing Shan SIT 

申请注册联系人电话:

Applicant telephone:

+852 25039053 

研究负责人电话:

Study leader's telephone:

+852 25039053 

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:

wingyintam@cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

reginasit@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/295 

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/295 

申请注册联系人通讯地址:

Room 04, 4/F, Lek Yuen Health Centre, 9 Lek Yuen Street, Shatin, N.T., Hong Kong 

研究负责人通讯地址:

Room 17A, 4/F, Lek Yuen Health Centre, 9 Lek Yuen Street, Shatin, N.T., Hong Kong 

Applicant address:

Room 04, 4/F, Lek Yuen Health Centre, 9 Lek Yuen Street, Shatin, N.T., Hong Kong 

Study leader's address:

Room 17A, 4/F, Lek Yuen Health Centre, 9 Lek Yuen Street, Shatin, 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:

Division of Family Medicine and Primary Health Care, The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong 

Applicant's institution:

Division of Family Medicine and Primary Health Care, The Jockey Club 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:

2014.059-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:

2014-06-25 

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:

Professor Regina Wing Shan SIT 

Primary sponsor:

Professor Regina Wing Shan SIT 

研究实施负责(组长)单位地址:

Room 17A, 4/F, Lek Yuen Health Centre, 9 Lek Yuen Street, Shatin, N.T., Hong Kong 

Primary sponsor's address:

Room 17A, 4/F, Lek Yuen Health Centre, 9 Lek Yuen Street, Shatin, N.T., 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:

Division of Family Medicine and Primary Health Care, The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong 

Source(s) of funding:

Division of Family Medicine and Primary Health Care, The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong 

研究疾病:

knee osteoarthritis 

Target disease:

knee osteoarthritis 

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:

其它 

Study phase:

N/A 

研究目的:

葡萄糖注射治療對退化性膝關節炎的效用 

Objectives of Study:

Effectiveness of dextrose prolotherapy in the treatment of knee osteoarthritis: a randomized controlled trial 

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. To be aged from 45 to 75 years old; 2. Diagnosis of knee OA based on clinical criteria as defined by the American Rheumatology Association; 3. Have experienced moderate to severe anterior knee pain for at least 3 months, defined as a score of 3 or more (0-6 ordinal response scale) on the question "What is the average level of your left/right knee pain?" 4. Failed 6 months of usual care. 

Inclusion criteria

1. To be aged from 45 to 75 years old; 2. Diagnosis of knee OA based on clinical criteria as defined by the American Rheumatology Association; 3. Have experienced moderate to severe anterior knee pain for at least 3 months, defined as a score of 3 or more (0-6 ordinal response scale) on the question "What is the average level of your left/right knee pain?" 4. Failed 6 months of usual care. 

排除标准:

1. History of corn allergy; 2. Previous operation either open or arthroscopic, on the referring knee; 3. Pregnancy; 4. Body mass index >=35 kg/m2; 5. Patients on anti-coagulant therapy; 6. Prior knee prolotherapy; 7. Any knee injections within 3 months; 8. Inflammatory or post-infectious knee arthritis; 9. Significant effusion as defined by a balotteable patella; 10. Co-morbidity severe enough to prevent participation in the study protocol like attendance at scheduled injection appointments. 

Exclusion criteria:

1. History of corn allergy; 2. Previous operation either open or arthroscopic, on the referring knee; 3. Pregnancy; 4. Body mass index >=35 kg/m2; 5. Patients on anti-coagulant therapy; 6. Prior knee prolotherapy; 7. Any knee injections within 3 months; 8. Inflammatory or post-infectious knee arthritis; 9. Significant effusion as defined by a balotteable patella; 10. Co-morbidity severe enough to prevent participation in the study protocol like attendance at scheduled injection appointments. 

研究实施时间:

Study execute time:

From2015-06-30To  

征募观察对象时间:

Recruiting time:

From2015-06-30To  

干预措施:

Interventions:

组别:

Group 1

样本量:

38

Group:

Group 1

Sample size:

干预措施:

Intra-articular dextrose injection 16 weeks

干预措施代码:

Intervention:

Intra-articular dextrose injection 16 weeks

Intervention code:

组别:

Group 2

样本量:

38

Group:

Group 2

Sample size:

干预措施:

Intra-articular normal saline injection 16 weeks

干预措施代码:

Intervention:

Intra-articular normal saline injection 16 weeks

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):

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

单位级别:

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

Institution
hospital:

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

Level of the institution:

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

测量指标:

Outcomes:

指标中文名:

(1) WOMAC score of both intervention and control group

指标类型:

主要指标 

Outcome:

(1) WOMAC score of both intervention and control group

Type:

Primary indicator 

测量时间点:

At baseline, week 16, week 24 and 52

测量方法:

Measure time point of outcome:

At baseline, week 16, week 24 and 52

Measure method:

指标中文名:

(2) VAS 0-100 mm

指标类型:

次要指标 

Outcome:

(2) VAS 0-100 mm

Type:

Secondary indicator 

测量时间点:

At week 0, 16, 24 and 52.

测量方法:

Measure time point of outcome:

At week 0, 16, 24 and 52.

Measure method:

指标中文名:

(3) 30 second chair stand performance test

指标类型:

次要指标 

Outcome:

(3) 30 second chair stand performance test

Type:

Secondary indicator 

测量时间点:

At week 0, 16, 24 and 52

测量方法:

Measure time point of outcome:

At week 0, 16, 24 and 52

Measure method:

指标中文名:

(4) timed up and go test

指标类型:

次要指标 

Outcome:

(4) timed up and go test

Type:

Secondary indicator 

测量时间点:

At week 0, 16, 24 and 52

测量方法:

Measure time point of outcome:

At week 0, 16, 24 and 52

Measure method:

指标中文名:

(5) EQ5

指标类型:

次要指标 

Outcome:

(5) EQ5

Type:

Secondary indicator 

测量时间点:

At week 0, 24 and 52

测量方法:

Measure time point of outcome:

At week 0, 24 and 52

Measure method:

指标中文名:

(6) the pattern of analgesic consumption with the statement "I take analgesic drugs like (name of analgesics) daily, as needed, none at all."

指标类型:

次要指标 

Outcome:

(6) the pattern of analgesic consumption with the statement "I take analgesic drugs like (name of analgesics) daily, as needed, none at all."

Type:

Secondary indicator 

测量时间点:

At week 0, 16, 24 and 52

测量方法:

Measure time point of outcome:

At week 0, 16, 24 and 52

Measure method:

指标中文名:

(7) treatment satisfaction will be assessed at 24 weeks with the question “Will you recommend the therapy to others with knee OA like yours? (yes/no)”.

指标类型:

次要指标 

Outcome:

(7) treatment satisfaction will be assessed at 52 weeks with the question “Will you recommend the therapy to others with knee OA like yours? (yes/no)”.

Type:

Secondary indicator 

测量时间点:

At week 52

测量方法:

Measure time point of outcome:

At week 52

Measure method:

指标中文名:

(8) Adverse events will be assessed in terms of incidence of knee infection, allergy to medications, nerve or vessel injuries, and any adverse responses as reported by participants.

指标类型:

副作用指标 

Outcome:

(8) Adverse events will be assessed in terms of incidence of knee infection, allergy to medications, nerve or vessel injuries, and any adverse responses as reported by participants.

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

40 meter fast-paced walk test

指标类型:

次要指标 

Outcome:

40 meter fast-paced walk test

Type:

Secondary indicator 

测量时间点:

at week 0, 16, 24 and 52

测量方法:

Measure time point of outcome:

at week 0, 16, 24 and 52

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 45 years
最大 Max age 75 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):

Randomized

盲法:

Double-blind

Blinding:

Double-blind

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):

NA

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

NA

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:

NA

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

NA

数据管理委员会:

Data Managemen Committee:

注册人:

Name of Registration:

 2015-06-17
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