UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063422 |
|---|---|
| Receipt number | R000072501 |
| Scientific Title | Effects of transcutaneous electrical nerve stimulation to the same dermatome of the limb contralateral to the assumed pain site |
| Date of disclosure of the study information | 2026/10/26 |
| Last modified on | 2026/10/26 16:03:27 |
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Basic information
Public title
The effects of electrical stimulation applied to the same nerve region in the limb contralateral to the site where pain is assumed to be present
Acronym
Electrical stimulation of the corresponding neural region on the opposite side
Scientific Title
Effects of transcutaneous electrical nerve stimulation to the same dermatome of the limb contralateral to the assumed pain site
Scientific Title:Acronym
Study on the Effects of TENS Applied to the Same Dermatome of the Contralateral Limb on Pain
Region
| Japan |
Condition
Condition
healthy adults without neurological or orthopedic diseases of the limbs or trunk
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to identify the effects of transcutaneous electrical nerve stimulation to the same dermatome contralateral to the assumed pain site based on the thermal pain threshold and autonomic nervous system changes, and to elucidate whether the contralateral dermatome can be used as an alternate site of choice for analgesic treatment.
Basic objectives2
Others
Basic objectives -Others
To elucidate whether the contralateral dermatome can be used as an alternate site of choice for analgesic treatment.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Thermal pain threshold
Key secondary outcomes
Heart rate variability
Low frequency components, an indicator of sympathetic nerve activity
High frequency components, an indicator of parasympathetic nerve function
The ratio of low frequency components to high frequency components, which reflects sympathetic and parasympathetic branches of the autonomic nervous system balance
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Transcutaneous Electrical Nerve Stimulation to the contralateral limb
Duration per Session 30 minutes
Frequency once a day
Duration 2 months
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
| 18 | years-old | <= |
Age-upper limit
| 26 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy adults without neurological or orthopedic diseases of the limbs or trunk
Key exclusion criteria
healthy adults with neurological or orthopedic diseases of the limbs or trunk
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Hirobumi |
| Middle name | |
| Last name | Kawamura |
Organization
University of Kochi Health Sciences
Division name
Division of Physical Therapy, Department of Rehabilitation Sciences, Faculty of Health Sciences
Zip code
781-5103
Address
2500-2 Otsu, Ohtsu, Kochi-City, Kochi
TEL
09075700670
kawamura@ko-ken-k3.ac.jp
Public contact
Name of contact person
| 1st name | Hirobumi |
| Middle name | |
| Last name | Kawamura |
Organization
University of Kochi Health Sciences
Division name
Division of Physical Therapy, Department of Rehabilitation Sciences, Faculty of Health Sciences
Zip code
781-5103
Address
2500-2 Otsu, Ohtsu, Kochi-City, Kochi
TEL
09075700670
Homepage URL
kawamura@ko-ken-k3.ac.jp
Sponsor or person
Institute
University of Kochi Health Sciences
Institute
Department
Personal name
Funding Source
Organization
others
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
The Research Ethics Committee of University of Kochi Health Sciences
Address
2500-2 Otsu, Ohtsu, Kochi-City, Kochi
Tel
0888666119
kokendai@ko-ken-k3.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
高知健康科学大学（高知県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 26 | Day |
Related information
URL releasing protocol
https://doi.org/10.82161/8ca1-6r48
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.82161/8ca1-6r48
Number of participants that the trial has enrolled
24
Results
Compared with the control, the thermal pain threshold showed a significant increase 10 minutes after transcutaneous electrical nerve stimulation TENS started, and 5 and 10 minutes after TENS ended. No change was seen 5 minutes after TENS started, whereas an upward trend was observed 15 minutes after TENS started. No significant differences were seen in high frequency components, low frequency components, and the ratio of LF to HF compared with the control.
Results date posted
| 2026 | Year | 10 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
24 healthy adults
mean age 21 years
17 females 7 males
without neurological or orthopedic diseases of the limbs or trunk
Participant flow
The inclusion criteria were set at a total of 25 healthy individuals with no neurological or orthopedic disorders affecting the limbs or trunk. The information provided on the posted recruitment notice covered the following items: the research implementation structure; the research objectives; the voluntary nature of participation and the freedom to withdraw; research methods; the study period; expected benefits of participation; potential risks and disadvantages; remuneration; publication of research results; handling of personal information; methods for the storage and disposal of materials and information; funding sources; conflicts of interest; and contact information for inquiries regarding the research. A total of 29 people applied, and the study included 24 participants, excluding five individuals, one for whom data could not be measured and four for whom data were incomplete.
Adverse events
Not Applicable
Outcome measures
The thermal pain threshold was measured in degrees Celsius using a pain measurement device.
Changes in the Autonomic Nervous System Heart rate variability was measured, including the low frequency component an indicator of sympathetic nervous system activity the high frequency component an indicator of parasympathetic nervous system function and the ratio of low frequency component to high frequency component which reflects the balance of the autonomic nervous system.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 29 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 13 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 13 | Day |
Date analysis concluded
| 2024 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 26 | Day |
Last modified on
| 2026 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072501
