UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060584 |
|---|---|
| Receipt number | R000069298 |
| Scientific Title | An Investigation of the Effects of Photobiomodulation by LED Irradiation on Pain Thresholds and Tissue Temperature. |
| Date of disclosure of the study information | 2026/02/05 |
| Last modified on | 2026/02/05 10:02:46 |
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Basic information
Public title
An Investigation of the Effects of Photobiomodulation by LED Irradiation on Pain Thresholds and Tissue Temperature.
Acronym
An Investigation of the Effects of Photobiomodulation by LED Irradiation on Pain Thresholds and Tissue Temperature.
Scientific Title
An Investigation of the Effects of Photobiomodulation by LED Irradiation on Pain Thresholds and Tissue Temperature.
Scientific Title:Acronym
An Investigation of the Effects of Photobiomodulation by LED Irradiation on Pain Thresholds and Tissue Temperature.
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of photobiomodulation induced by LED irradiation on pain thresholds and tissue temperature.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain threshold of intraepidermal nerve terminal, electrical pain threshold, electrical perception threshold, pressure pain threshold, tissue temperature, subjective thermal sensation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
LED light irradiation, 5 minutes (Pain relief effects and tissue temperature changes will be examined through separate interventions)
Interventions/Control_2
sham irradiation (Pain relief effects and tissue temperature changes will be examined through separate interventions)
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
Healthy adults aged 18 years or older who provided informed consent / Not currently undergoing treatment for pain / Not taking any analgesics
Key exclusion criteria
Taking pain medication / Experiencing some form of pain / Unable to obtain consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Takeuchi |
Organization
Takasaki University of Health and Welfare
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
370-0033
Address
27 Nakadairumachi, Takasaki City, Gunma Prefecture, Japan
TEL
0273521291
ntakeuchi@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | nobuyuki |
| Middle name | |
| Last name | takeuchi |
Organization
Takasaki University of Health and Welfare
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
3700033
Address
27 Nakadairumachi, Takasaki City, Gunma Prefecture, Japan
TEL
09088759981
Homepage URL
takenobuyuki@yahoo.co.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Takasaki University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Honjo General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Honjo general hospital
Address
1780 Kitahori, Honjo City, Saitama Prefecture, Japan
Tel
0495-22-6111
soumu001@honjo-hp.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
| 2026 | Year | 02 | Month | 05 | 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
| 2025 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 05 | 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 | 02 | Month | 05 | Day |
Last modified on
| 2026 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069298
