UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059682 |
|---|---|
| Receipt number | R000068261 |
| Scientific Title | Investigation of the mechanism of pain suppression by focal mechanical vibration |
| Date of disclosure of the study information | 2025/11/07 |
| Last modified on | 2025/11/07 12:23:24 |
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Basic information
Public title
Investigation of the mechanism of pain suppression by focal mechanical vibration
Acronym
Investigation of the mechanism of pain suppression by focal mechanical vibration
Scientific Title
Investigation of the mechanism of pain suppression by focal mechanical vibration
Scientific Title:Acronym
The mechanism of pain suppression by focal mechanical vibration
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the pain suppression mechanism of FMV by investigating the effects of focal mechanical vibration (FMV) on the current perceptions thresholds (CPTs) of A beta, A delta, and C fibers at the stimulated spinal segment, adjacent segments, and the contralateral side.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Current perception threshold during vibratory stimulation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
focal mechanical vibration
Interventions/Control_2
sham
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals aged 18 years or older who are capable of communicating in Japanese
Key exclusion criteria
Individuals with lacerations on the wrist or palm
Individuals with neurological symptoms such as numbness in the upper limbs
Individuals with chronic pain who are receiving treatment such as oral medication
Individuals who are pregnant
Individuals who have difficulty communicating in Japanese
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Shimo |
Organization
Kobe Gakuin University
Division name
Faculty of Rehabilitation
Zip code
651-2180
Address
Arise 518, Ikawadani-cho, Nishi-ku, Kobe, Hyogo
TEL
078(974)1551
shimo@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Shimo |
Organization
Kobe Gakuin University
Division name
Faculty of Rehabilitation
Zip code
651-2180
Address
Arise 518, Ikawadani-cho, Nishi-ku, Kobe, Hyogo
TEL
078(974)1551
Homepage URL
shimo@reha.kobegakuin.ac.jp
Sponsor or person
Institute
Kobe Gakuin University
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe Gakuin University
Address
Arise 518, Ikawadani-cho, nishi-ku, Kobe, Hyogo
Tel
078(974)1551
ethic@reha.kobegakuin.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 07 | 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
| 2025 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068261
