UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060524 |
|---|---|
| Receipt number | R000069238 |
| Scientific Title | Hypoalgesic effects and underlying mechanisms of belt electrode skeletal muscle electrical stimulation-induced muscle contractions |
| Date of disclosure of the study information | 2026/01/30 |
| Last modified on | 2026/01/30 16:21:36 |
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Basic information
Public title
Hypoalgesic effects of belt electrode skeletal muscle electrical stimulation-induced muscle contractions in healthy young adults
Acronym
Hypoalgesic effects of belt electrode skeletal muscle electrical stimulation
Scientific Title
Hypoalgesic effects and underlying mechanisms of belt electrode skeletal muscle electrical stimulation-induced muscle contractions
Scientific Title:Acronym
Hypoalgesic effects of belt electrode skeletal muscle electrical stimulation-induced muscle contractions
Region
| Japan |
Condition
Condition
Healthy young volunteers
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the hypoalgesic effects of belt electrode skeletal muscle electrical stimulation (B-SES)-induced muscle contractions and to explore the underlying mechanisms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Pressure pain threshold
Key secondary outcomes
Conditioned pain modulation, skeletal muscle mass index
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
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Belt electrode skeletal muscle electrical stimulation (B-SES) condition
Interventions/Control_2
Electrical muscular stimulation (EMS) condition
Interventions/Control_3
Sham condition
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
| 23 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pain-free individuals aged 18 to 23 years
Key exclusion criteria
Acute or chronic pain; current use of any analgesic medication; pregnancy; and any neurological, cardiovascular, respiratory, or metabolic disorder
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Ohga |
Organization
Kobe Gakuin University
Division name
Faculty of Rehabilitation
Zip code
651-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe, JAPAN
TEL
078-974-2446
ohga@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Ohga |
Organization
Kobe Gakuin University
Division name
Faculty of Rehabilitation
Zip code
651-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe, JAPAN
TEL
078-974-2446
Homepage URL
ohga@reha.kobegakuin.ac.jp
Sponsor or person
Institute
Kobe Gakuin University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe Gakuin University
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe, JAPAN
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
神戸学院大学（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 30 | 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
| 2026 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2026 | Year | 01 | Month | 30 | Day |
Last modified on
| 2026 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069238
