UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007773 |
|---|---|
| Receipt number | R000009088 |
| Scientific Title | The Clinical Effects of Acupuncture in Patients with Parkinson's Disease: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2012/04/16 |
| Last modified on | 2013/02/18 18:01:40 |
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Basic information
Public title
The Clinical Effects of Acupuncture in Patients with Parkinson's Disease:
A Randomized Controlled Trial
Acronym
Effectiveness of acupuncture for Parkinson's Disease.
Scientific Title
The Clinical Effects of Acupuncture in Patients with Parkinson's Disease:
A Randomized Controlled Trial
Scientific Title:Acronym
Effectiveness of acupuncture for Parkinson's Disease.
Region
| Japan |
Condition
Condition
Parkinson's Disease
Classification by specialty
| Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the clinical effects of acupuncture in patients with Parkinson's disease and to investigate whether acupuncture affects the spinal anterior horn motor cells or the cerebral cortex and the basal ganglia, using F wave and Long Latency Reflex of the EMG.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
PDRS(Unified Parkinson's Disease Rating Scale), F wave, Long Loop Reflex
Key secondary outcomes
Timed Up and Go test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
standard acupuncture
Interventions/Control_2
low frequency acupuncture
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Parkinson disease patients who are in stage 1 to 3 (HY) at the on period.
2)Not change taking medications within 3 months before starting this study.
3) Subjects who gave the written informed consent.
Key exclusion criteria
1)PD-related disorders and other neurodegenrative diseases.
2) The change of medications in this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Namura |
Organization
Meiji University of Integrative Medicine
Division name
Department of Internal Medicine
Zip code
Address
Hioshi-cho, Nantan-shi, Kyoto 629-0392, Japan
TEL
0771-72-1221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Egawa |
Organization
Meiji University of Integrative Medicine
Division name
Department of Geriatric Acupuncture and Moxibustion
Zip code
Address
TEL
Homepage URL
m_egawa@meiji-u.ac.jp
Sponsor or person
Institute
Meiji University of Integrative Medicine
Institute
Department
Personal name
Funding Source
Organization
Meiji University of Integrative Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
明治国際医療大学附属病院（京都府）、明治国際医療大学附属京都駅前鍼灸センター（京都府）、明治国際医療大学附属鍼灸センター（京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
There were no difference, between both acupuncture groups in all outcomes of this study. Both acupuncture groups showed significant improvements in total scores of UPDRS and TUG by acupuncture treatment. The standard acupuncture group showed significant increase in FRT indicating improvement of complexed motor functions and significant decrease in the occurrence rate of F wave indicating decrease of excitability of the spinal anterior horn motor cells.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 16 | Day |
Last modified on
| 2013 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009088
