UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044119 |
|---|---|
| Receipt number | R000050373 |
| Scientific Title | Pathological mechanism analysis of respectively phenotype in post stroke pain |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2021/05/06 17:35:21 |
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Basic information
Public title
Pathological mechanism analysis of respectively phenotype in post stroke pain
Acronym
Pathological analysis of post stroke pain
Scientific Title
Pathological mechanism analysis of respectively phenotype in post stroke pain
Scientific Title:Acronym
Pathological analysis of post stroke pain
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Anesthesiology | Neurosurgery |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the structure of pathological characteristics in post-stroke pain by analyzing the factors of pain phenotype, abnormal sensory pattern, other related factor.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sensory data in Bed-side Quantitative sensory testing
Key secondary outcomes
Neuropathic pain symptom inventory
Short form McGill pain questionnaire
other pain questionnaire
motor function and physical findings
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pain have post-stroke patient and non pain post-stroke patient
Key exclusion criteria
Transient ischemic attack, subarachnoid hemorrhage, communication problem(e.g. severe aphasia or dysarthria), sever dementia, psychological problem, other nociception and neuropathic pain have patient.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Igawa |
Organization
Kio university graduate school
Division name
Graduate School of Health Science
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
kgsm.1ga@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Igawa |
Organization
Kio university graduate school
Division name
Graduate School of Health Science
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
Homepage URL
kgsm.1ga@gmail.com
Sponsor or person
Institute
Kio university graduate school
Institute
Department
Personal name
Funding Source
Organization
Kio university graduate school
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
Kio university graduate school
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
Tel
0745-54-1601
kgsm.1ga@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multicenter study
Management information
Registered date
| 2021 | Year | 05 | Month | 06 | Day |
Last modified on
| 2021 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050373
