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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044153
Receipt No. 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 2021/05/09

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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
Email 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
Email m.ohsumi@kio.ac.jp

Sponsor
Institute KIo university
Institute
Department

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
Email 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
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 05 Month 09 Day
Date of IRB
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
2021 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050417

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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