UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056285 |
|---|---|
| Receipt number | R000064009 |
| Scientific Title | The effects of low level laser irradiation on the activity of A-delta fibers and C fibers |
| Date of disclosure of the study information | 2024/11/27 |
| Last modified on | 2026/02/04 23:04:57 |
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Basic information
Public title
The effects of low level laser irradiation on the activity of A-delta fibers and C fibers
Acronym
The effects of low level laser irradiation on the activity of A-delta fibers and C fibers
Scientific Title
The effects of low level laser irradiation on the activity of A-delta fibers and C fibers
Scientific Title:Acronym
The effects of low level laser irradiation on the activity of A-delta fibers and C fibers
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to examine foundational data on the pain-relieving effects of low-level laser irradiation. Specifically, the study aims to investigate the excitability of A-delta fibers and C fibers involved in pain perception in healthy adults.
Basic objectives2
Others
Basic objectives -Others
Investigate the effects of continuous 180mW laser irradiation and 10W pulsed laser irradiation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measured before and after laser irradiation.
Pain threshold of intraepidermal nerve terminal(PINT)
Electrical pain threshold
Electrical perception threshold
Pressure pain threshold(PPT)
Thermal pain threshold(TPT)
Temporal summation(TS)
Perception threshold
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Low-level laser irradiation
Continuous irradiation, 60 to 180mW / Pulsed irradiation, peak output 10W
Interventions/Control_2
Sham irradiation
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 without pain
Key exclusion criteria
Experiencing pain
Under treatment for some form of pain
Unable to obtain consent
Withdraws from the study
Target sample size
60
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
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
本庄総合病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 27 | Day |
Last modified on
| 2026 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064009
