|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ChiCTR |
|
Last refreshed on:
|
2 October 2017 |
|
Main ID: |
ChiCTR-IOR-17012628 |
|
Date of registration:
|
2017-09-10 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The evaluation of the clinical efficacy of the moxibustion of different storage time in the treatment of severe primary knee osteoarthritis
|
|
Scientific title:
|
The evaluation of the clinical efficacy of the moxibustion of different storage time in the treatment of severe primary knee osteoarthritis |
|
Date of first enrolment:
|
2017-09-01 |
|
Target sample size:
|
Storage 1 years moxa:88;storage 3years moxa:88; |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=21549 |
|
Study type:
|
Interventional study |
|
Study design:
|
Randomized parallel controlled trial
|
|
Phase:
|
Other
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
HONG ZHAO
|
|
Address:
|
16 Nanxiao Street, Dongzhimen, Dongcheng District, Beijing, China
|
|
Telephone:
|
+86 13911132103 |
|
Email:
|
hongzhao2005@aliyun.com |
|
Affiliation:
|
Institute of Acupuncture and Moxibustion China Academy of Chinese Medical Sciences |
|
|
Name:
|
HONG ZHAO
|
|
Address:
|
16 Nanxiao Street, Dongzhimen, Dongcheng District, Beijing, China
|
|
Telephone:
|
+86 13911132103 |
|
Email:
|
hongzhao2005@aliyun.com |
|
Affiliation:
|
Institute of Acupuncture and Moxibustion China Academy of Chinese Medical Sciences |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: (1) aged 38 to 70 years;
(2) meet the diagnostic criteria of primary knee osteoarthritis;
(3) drug (non-steroidal anti-inflammatory drugs, pain relievers, traditional Chinese medicine and Chinese patent medicine) for knee osteoarthritis elution after 7 days, WOMAC96 joint index scores between > 48 to 72 or less, the grading for moderate to severe knee osteoarthritis disease;
(4) the Kellgren and Lawrecne osteoarthritis class for II or III radiology.
Exclusion criteria: (1) non-primary knee osteoarthritis (such as secondary knee osteoarthritis; Inflammatory or other rheumatic diseases; Symptomatic hip arthritis or patella osteoarthritis in the same side of the target knee
(2) the target knee injury in nearly a year (such as acute injury of knee joint meniscus, or acute knee ligament damage/around fracture, etc.) or a history of surgery, or severe joint deformities (varus or valgus 8 degree or higher); Or peripheral tumor, tuberculosis or idiopathic bone necrosis;
(3) the target knee joint was injected with glucocorticoid in the joint cavity for nearly three months, or injection of sodium hyaluronate in the joint cavity within 2 weeks;
(4) patients with acetaminophen, non-steroidal anti-inflammatory drugs or analgesics for other diseases;
(5) uncontrolled hypertension or diabetes, severe cardiovascular and cerebrovascular, pulmonary, liver, spleen, kidney and hematopoietic system disease, tumor, hemorrhagic disease and mental illness;
(6) scar or skin sensation;
(7) pregnant or lactating women;
(8) refusal to sign informed consent.
Age minimum:
38
Age maximum:
70
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
knee osteoarthritis
|
|
Intervention(s)
|
|
Storage 1 years moxa:moxibustion;storage 3years moxa:moxibustion;
|
|
Primary Outcome(s)
|
|
WOMAC osteoarthritis index pain project score;visual analogue scale, VAS;
|
|
Secondary Outcome(s)
|
|
WOMAC osteoarthritis index score, rigid project score and joint function project score;Overall assessment of patients;
|
|
Secondary ID(s)
|
|
AMCTR-IOR-17000100
|
|
Source(s) of Monetary Support
|
|
National key basic research and development plan (project 973)
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|