UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045774 |
|---|---|
| Receipt number | R000052258 |
| Scientific Title | Analysis of the pathological mechanism of each phenotype in post-stroke pain |
| Date of disclosure of the study information | 2021/10/16 |
| Last modified on | 2026/04/19 19:09:38 |
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Basic information
Public title
Analysis of the pathological mechanism of each phenotype in post-stroke pain
Acronym
Analysis of the pathological mechanism of each phenotype in post-stroke pain
Scientific Title
Analysis of the pathological mechanism of each phenotype in post-stroke pain
Scientific Title:Acronym
Analysis of the pathological mechanism of each phenotype in post-stroke pain
Region
| Japan |
Condition
Condition
Stroke patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the pathological mechanism of each symptom by analyzing the relationship between each pain phenotype and the area of brain damage in post-stroke pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative sensory testing
Questionnaire on pain and psychological aspects
Assessment of physical function
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stroke patients without pain
Stroke patients with pain
Key exclusion criteria
Patients with transient ischemic attack (TIA), subarachnoid hemorrhage, speech problems (severe aphasia or dysarthria), severe dementia, mental disorders, nociceptive and neuropathic pain from other diseases
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Iki |
Organization
Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
rehabilitation department
Zip code
5730086
Address
9-25-202, Kourien-cho, Hirakata-shi, Osaka
TEL
0728351010
kawaguchi.ns.reha@gmail.com
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Iki |
Organization
Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
rehabilitation department
Zip code
5730086
Address
9-25-202, Kourien-cho, Hirakata-shi, Osaka
TEL
0728351010
Homepage URL
kawaguchi.ns.reha@gmail.com
Sponsor or person
Institute
Kawaguchi Neurosurgery Rehabilitation Clinic
Institute
Department
Personal name
Funding Source
Organization
None
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
Kawaguchi Neurosurgery Rehabilitation Clinic
Address
9-25-202, Kourien-cho, Hirakata-shi, Osaka
Tel
0728351010
kawaguchi.ns.reha@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
R3-07
Org. issuing International ID_1
Kio University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 16 | Day |
Related information
URL releasing protocol
https://pmc.ncbi.nlm.nih.gov/articles/PMC12042915/
Publication of results
Published
Result
URL related to results and publications
https://pmc.ncbi.nlm.nih.gov/articles/PMC12042915/
Number of participants that the trial has enrolled
70
Results
Central post stroke pain was associated with cold hypoesthesia at 8C, cold hyperalgesia at 8C and higher Neuropathic Pain Symptom Inventory scores, whereas non central post stroke pain was associated with joint pain and lower Neuropathic Pain Symptom Inventory scores. In the voxel based lesion symptom mapping, the extracted lesion areas indicated mainly voxels significantly associated with cold hyperalgesia, allodynia at 8C and 22C and heat hypoesthesia at 45C.
Results date posted
| 2026 | Year | 04 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This cross-sectional study was performed on stroke patients in subacute or chronic phases. Patients participated in this study as outpatients or while hospitalized in one of four affiliated institutions. Participants with ischaemic or haemorrhagic stroke confirmed by imaging (CT or MRI) were enrolled in this study. In addition, three patients with a history of a previous stroke were also included in this study. They had an injury on one side only, as seen by the small lacunar infarctions, which had no symptoms before the current onset (the contralateral areas were unremarkable).
Participant flow
Fifty PSP patients were divided into two groups. The CPSP group was defined according to the Neuropathic Pain Grading System (NeuPSIG) and diagnostic criteria identified in previous studies. The non-CPSP group included participants without neuropathic pain, as determined by the Neuropathic Pain Grading System. Assessments were conducted, including pain-related interviews, physical examinations, bedside QST, and brain imaging.
Adverse events
None
Outcome measures
Pain related interview, Pain questionnaires, Physical examination,Bed side-QOT, Brain image
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 10 | Month | 16 | Day |
Last modified on
| 2026 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052258
