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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：

从From2015-06-30至To  

征募观察对象时间：

Recruiting time：

从From2015-06-30至To  

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 岁 years
最大 Max age 75 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）：

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)：

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）：

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

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

 2015-06-17
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