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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009099
Receipt No. R000010673
Scientific Title The effect of lidocaine injection into the external oblique in Parkinson's disease patients with upper camptorcormia
Date of disclosure of the study information 2012/10/12
Last modified on 2014/10/14

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Basic information
Public title The effect of lidocaine injection into the external oblique in Parkinson's disease patients with upper camptorcormia
Acronym The effect of lidocaine injection in Parkinson's disease patients with camptorcormia
Scientific Title The effect of lidocaine injection into the external oblique in Parkinson's disease patients with upper camptorcormia
Scientific Title:Acronym The effect of lidocaine injection in Parkinson's disease patients with camptorcormia
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effect of lidocaine injection into the external oblique in Parkinson's disease patients with upper camptocormia through double blind randomized control study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Flexion angle of trunk
Key secondary outcomes UPRDS, Center of position, visual analoue scale, Roland Morris Score

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 lidocaine injection into the external oblique
Interventions/Control_2 normal saline injection into the external oblique
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Parkinson's disease patients with upper camptocormia (flexion angle >40&ordm;) are included. Upper camptocormia is defined as abnormal truncal flexion at a point between the lower thoracic and upper lumbar vertebrae. Patients are diagnosed with PD according to the United Kingdom Parkinson Disease Society Brain Bank criteria.
Key exclusion criteria Patients with severe spondylosis associated with kyphosis or other similar conditions arising from truncal muscle weakness, moderate or severe atrophy in parapsinal muslce are excluded in this study. Patients with dementia, arrhythmia, allergy to lidocaine or local anethesia are also excluded. Pregnant patients are also excluded
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Furusawa
Organization National Center Hospital, National Center of Neurology and Psychiatry
Division name Neurology
Zip code
Address 4-1-1 Ogawa-higashi-cho, Kodaira, Tokyo, 187-8551, Japan
TEL 042-342-2711
Email yfuru@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiko Furusawa
Organization National Center Hospital, National Center of Neurology and Psychiatry
Division name Neurology
Zip code
Address 4-1-1 Ogawa-higashi-cho, Kodaira, Tokyo, 187-8551, Japan
TEL 042-341-2711
Homepage URL
Email yfuru@ncnp.go.jp

Sponsor
Institute Parkinson's disease and Movement Disorder Center
Institute
Department

Funding Source
Organization Grants-in-Aid from the Research Committee of CNS Degenerative Disease, the Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 国立精神・神経医療研究センター病院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 12 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
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 Open public recruiting
Date of protocol fixation
2012 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 01 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
2013 Year 12 Month 31 Day
Date trial data considered complete
2013 Year 12 Month 31 Day
Date analysis concluded
2013 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 10 Month 12 Day
Last modified on
2014 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010673

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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