UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051951 |
|---|---|
| Receipt number | R000059290 |
| Scientific Title | Hypoalgesic effects of electrical muscular stimulation-induced muscle contraction in healthy young adults |
| Date of disclosure of the study information | 2023/08/19 |
| Last modified on | 2024/02/19 08:57:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Hypoalgesic effects of electrical muscular stimulation in healthy young adults
Acronym
Hypoalgesic effects of electrical muscular stimulation
Scientific Title
Hypoalgesic effects of electrical muscular stimulation-induced muscle contraction in healthy young adults
Scientific Title:Acronym
Hypoalgesic effects of electrical muscular stimulation-induced muscle contraction
Region
| Japan |
Condition
Condition
Healthy young volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine whether hypoalgesic effect is caused by electrical muscular stimulation-induced muscle contraction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pressure pain threshold
Key secondary outcomes
Skeletal muscle mass index, conditioned pain modulation
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
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Electrical muscular stimulation condition
Interventions/Control_2
Sham condition
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
| 23 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pain-free individuals aged 18 to 23 years
Key exclusion criteria
Neurological, cardiovascular, or psychological disorders; pregnancy; acute or chronic pain conditions; and use of any pain medication
Target sample size
27
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 651-2180, JAPAN
TEL
078-974-2461
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 651-2180, JAPAN
TEL
078-974-2461
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 651-2180, 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
| 2023 | Year | 08 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 10 | 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
| 2023 | Year | 08 | Month | 19 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059290
