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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007773
Receipt No. 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

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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
Email

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
Email m_egawa@meiji-u.ac.jp

Sponsor
Institute Meiji University of Integrative Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009088

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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