UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044153 |
|---|---|
| Receipt number | R000050417 |
| Scientific Title | n of Warmth and Pain in Patients with Central Post-stroke Pain: Verification Using the Thermal Grill Illusion |
| Date of disclosure of the study information | 2021/05/09 |
| Last modified on | 2023/11/12 18:13:58 |
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Basic information
Public title
Functional Abnormalities in the Integration of Warmth and Pain in Patients with Central Post-stroke Pain: Verification Using the Thermal Grill Illusion
Acronym
Effects of Thermal Grill Illusion on Patients with Central Post-stroke Pain
Scientific Title
n of Warmth and Pain in Patients with Central Post-stroke Pain: Verification Using the Thermal Grill Illusion
Scientific Title:Acronym
Effects of Thermal Grill Illusion on Patients with Central Post-stroke Pain
Region
| Japan |
Condition
Condition
Post-stroke patients
Classification by specialty
| Neurosurgery | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of pain mechanisms related to temperature sensation such as burning pain in central post-stroke pain patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment using questionnaires on pain intensity and pain (e.g., catastrophizing and depression)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Subjects with post-stroke pain will be given warm and cold stimuli at the same time to induce the thermal grill illusion. This is performed once on the healthy side and once on the affected side for a maximum of 30 seconds each.
Interventions/Control_2
Thermal grill illusion is induced by simultaneous application of warm and cold stimuli to a person without pain after a stroke. This will be performed once on the healthy side and once on the affected side for a maximum of 30 seconds each.
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
People with pain after stroke
Key exclusion criteria
People with neurological diseases or dementia. Those who have higher brain dysfunction and have difficulty in answering the questionnaire. Those who have orthopedic disease or central nervous system disease in their medical history and have left-right differences in physical function.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | matsuda |
| Middle name | |
| Last name | soichiro |
Organization
Kio university
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2 Umaminaka, Hiroryo-cho, Kitatsukagi-gun, Nara Prefecture
TEL
0745-54-1601
chocobaby.0802.26@gmail.com
Public contact
Name of contact person
| 1st name | Osumi |
| Middle name | |
| Last name | Michihiro |
Organization
Kio university
Division name
Graduate School of Health Science
Zip code
635-0832
Address
4-2-2 Umaminaka, Hiroryo-cho, Kitatsukagi-gun, Nara Prefecture
TEL
0745-54-1601
Homepage URL
m.ohsumi@kio.ac.jp
Sponsor or person
Institute
KIo university
Institute
Department
Personal name
Funding Source
Organization
KIo university
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
Address
4-2-2 Umaminaka, Hiroryo-cho, Kitatsukagi-gun, Nara Prefecture
Tel
0745-54-1601
chocobaby.0802.26@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
| 2021 | Year | 05 | Month | 09 | 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
20
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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 09 | 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
Management information
Registered date
| 2021 | Year | 05 | Month | 09 | Day |
Last modified on
| 2023 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050417
| 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 |
