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: |
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English Acronym: |
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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: |
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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: |
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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 |
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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 |
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Approved by ethic committee: |
Yes |
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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: |
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批准本研究的伦理委员会名称: |
Joint CUHK-NTEC Clinical Research Ethics Committee |
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Name of the ethic committee: |
Joint CUHK-NTEC Clinical Research Ethics Committee |
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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: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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: |
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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: |
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Target disease code: |
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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: |
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Description for medicine or protocol of treatment in detail: |
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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: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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