UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000045213 |
|---|---|
| Receipt number | R000045660 |
| Scientific Title | Investigating frequency-dependent current thermal pain threshold |
| Date of disclosure of the study information | 2021/08/21 |
| Last modified on | 2021/08/21 08:21:21 |
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Basic information
Public title
Investigating frequency-dependent current thermal pain threshold
Acronym
Investigating frequency-dependent current thermal pain threshold
Scientific Title
Investigating frequency-dependent current thermal pain threshold
Scientific Title:Acronym
Investigating frequency-dependent current thermal pain threshold
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the thermal effect on the human body and the perceptual threshold by the middle- to high-frequency electrical current.
Basic objectives2
Others
Basic objectives -Others
The perceptual threshold at each electrical frequency
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The perceptual threshold at each electrical frequency
Key secondary outcomes
Characteristics of the perception threshold by age, gender, etc.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Electrical current stimulation to a fingertip in contact or non-contact manner
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
a. No past history of brain, neurologic/muscular diseases, mental illness, or diabetes, etc.
b. Consent to participate in the study.
Key exclusion criteria
a. Past history of brain, neurologic/muscular diseases, mental illness, or diabetes, etc. that may affect the sensation or perception.
b. Currently taking treatment for the above diseases.
c. Having cardiac pacemakers.
d. Having eczema or rough skin on the hands.
e. Pregnancy.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine I, School of Medicine,
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan
TEL
0562-93-2167
yootaka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Uehara |
Organization
Fujita Health University
Division name
Faculty of Rehabilitation, School of Health Sciences
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-9000
Homepage URL
suehara@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Internal Affairs and Communications
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya Institute of Technology
Utsunomiya University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.ac.jp
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
藤田医科大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 08 | 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
Management information
Registered date
| 2021 | Year | 08 | Month | 21 | Day |
Last modified on
| 2021 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045660
| 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 |
