Unique ID issued by UMIN | UMIN000012683 |
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Receipt number | R000014670 |
Scientific Title | JAPAN Multicenter, Randomized, Open-label, Parallel-Group Comparison Study on Clinical Efficacy and Responders to Acupuncture for Osteoarthritis of the Knee |
Date of disclosure of the study information | 2013/12/25 |
Last modified on | 2023/12/05 17:58:37 |
JAPAN Multicenter, Randomized, Open-label, Parallel-Group Comparison Study on Clinical Efficacy and Responders to Acupuncture for Osteoarthritis of the Knee
JEAK study
JAPAN Multicenter, Randomized, Open-label, Parallel-Group Comparison Study on Clinical Efficacy and Responders to Acupuncture for Osteoarthritis of the Knee
JEAK study
Japan |
osteoarthritis of the knee
Orthopedics |
Others
NO
A meta analysis has found that patients with osteoarthritis of the knee treated with acupuncture show better clinical improvement than patients treated with ordinary therapies such as NSAIDs or NSAIDs + exercise when compared in a short period of time. The analysis has also indicated that acupuncture is more effective than sham procedures, although the difference is not statistically significant.
Yet, many unresolved questions there still remain regarding how much stimulus on the affected sites can induce a response to acupuncture therapy and from what types of patients.
The purpose of this study is, together working with an orthopedist, to elucidate what makes a patient with osteoarthritis of the knee a responder or non-responder to treatment with acupuncture.
Safety,Efficacy
Confirmatory
Explanatory
Phase I,II
VAS
WOMAC SF-36
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is considered as a block.
YES
Central registration
3
Treatment
Maneuver |
Thumb Tack Needles
sham
acupuncture
45 | years-old | <= |
85 | years-old | > |
Male and Female
1)Kellgren and Lawrence grade 2 or lower
2)No intra-articular injection within 4weeks prior to enrollment
3)No history of acupuncture therapy within 6 months prior to enrollment
4)No evident disease in hip joints and lumbar spine parts impairing walking
5)No evident trauma, arthritis not caused by age related alteration such as septic arthritis, and history of surgery
6)Patients must have oral communication ability; can provide written informed consent signed by him/her or from a family member under their free will after receiving full explanation of the study.
1)Patients who do not consent to the nature of the study
2)Patients who are currently participating in other study(ies)
3)Patients who have any change in their current treatment drugs, exercise therapy or orthosis for knee pain during the study period
4)Patients with internal derangement of the knee joint such as a meniscal tear detected using MRI.
40
1st name | Satoru |
Middle name | |
Last name | Yamaguchi |
Saitama Medical University
The Center for Oriental and Integrated Medicine,Saitama Medical University, Saitama, Japan.
049-276-1193
38,Morohongo,Moroyamamachi,Iruma-gun,Saitama
049-276-1193
sayama@saitama-med.ac.jp
1st name | satoru |
Middle name | |
Last name | Yamaguchi |
Saitama Medical University
The Center for Oriental and Integrated Medicine,Saitama Medical University, Saitama, Japan.
3500845
38,Morohongo,Moroyamamachi,Iruma-gun,Saitama
049-276-1193
sayama@saitama-med.ac.jp
Saitama Medical University
The Japan Society of Acupuncture and Moxibustion
Other
Japanese Red Cross Ogawa Hospital
The Center for Oriental and lntegrated Medicine Saitama Medical University
38 Morohongo, Moroyama-machi, Saitama Prefecture
049-276-1193
sayama@saitama-med.ac.jp
NO
2013 | Year | 12 | Month | 25 | Day |
Unpublished
Completed
2013 | Year | 11 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 01 | Month | 06 | Day |
2015 | Year | 03 | Month | 31 | Day |
2013 | Year | 12 | Month | 25 | Day |
2023 | Year | 12 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014670
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