UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009099 |
|---|---|
| Receipt number | 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 15:10:31 |
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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 >40º) 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
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
yfuru@ncnp.go.jp
Sponsor or person
Institute
Parkinson's disease and Movement Disorder Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010673
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
