UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061030 |
|---|---|
| Receipt number | R000069842 |
| Scientific Title | Effects of Middle Fingertip Point Stimulation Using a Stimulation Device on Microcirculatory Blood Flow |
| Date of disclosure of the study information | 2026/03/24 |
| Last modified on | 2026/03/26 15:18:43 |
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Basic information
Public title
Effects of Middle Fingertip Point Stimulation Using a Stimulation Device on Microcirculatory Blood Flow
Acronym
Effects of Middle Fingertip Point Stimulation Using a Stimulation Device on Microcirculatory Blood Flow
Scientific Title
Effects of Middle Fingertip Point Stimulation Using a Stimulation Device on Microcirculatory Blood Flow
Scientific Title:Acronym
Effects of Middle Fingertip Point Stimulation Using a Stimulation Device on Microcirculatory Blood Flow
Region
| Japan |
Condition
Condition
Healthy adults and older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate, using a crossover design, the effects of the middle fingertip point stimulation with a stimulation device on microcirculatory blood flow.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Capillary Blood Flow Velocity: comparison of active point stimulation and sham stimulation (no stimulation) in the middle fingertip, 11-minute measurement (1-minute rest, 10-minute intervention)
Key secondary outcomes
Standing forward flexion distance (cm): comparison of active point stimulation and sham stimulation (no stimulation) in the middle fingertip, assessed after the test.
Shoulder muscle stiffness: comparison of active point stimulation and sham stimulation (no stimulation) in the middle fingertip, assessed before and after the intervention (before the standing forward flexion test).
Subjective evaluation of ease of movement (questionnaire): comparison of active point stimulation and sham stimulation (no stimulation) in the middle fingertip, assessed after the test.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Active middle fingertip point stimulation - Washout - Sham middle fingertip point stimulation (no stimulation)
Interventions/Control_2
Sham middle fingertip point stimulation (no stimulation) - Washout - Active middle fingertip point stimulation
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy Japanese males and females who are aged 20 to under 90 years at the time of written informed consent.
2. Participants who have been fully informed the purpose and details of the study, have the ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study in writing.
3. Participants who can come to the facility on the designated test date and take the test.
4. Participants who are healthy enough to exercise.
Key exclusion criteria
1.Participants with chronic diseases associated with exercise restrictions, or those currently receiving treatment for any diseases.
2.Participants with a history or current diagnosis of chronic fatigue syndrome with exercise restrictions, psychiatric disorders, sleep disorders, hypertension, diabetes, dyslipidemia, or other serious diseases.
3.Participants with a history or current diagnosis of low back pain or spinal disorders (e.g., herniated disc, spinal canal stenosis).
4.Participants with a history or current diagnosis of severe cardiovascular, respiratory, hepatic, renal, hematologic, or gastrointestinal disorders that may adversely affect health during exercise.
5.Participants with severe anemia.
6.Participants who have continuously used medications (oral or topical) for disease treatment within the past month.
7.Participants with a body mass index (BMI) exceeding 30.
8.Participants with potential allergies to materials (e.g., plastic) used in the device.
9.Participants with irregular lifestyles due to shift work or night work.
10.Participants who are currently participating in another clinical trial, or who have participated in another clinical trial within the past three months.
11.Participants who are pregnant, breastfeeding, have the potential to become pregnant, or intend to become pregnant during the study period.
12.Participants who are judged as ineligible to participate in this study by the principal investigator.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hisayo |
| Middle name | |
| Last name | Sugao |
Organization
LEMON inc.
Division name
Research and Development Division, Headquarters
Zip code
100-0005
Address
Nippon Life Marunouchi Building 21F, 1-6-6 Marunouchi, Chiyoda-ku, Tokyo
TEL
080-2923-9987
sugaohisayo@lemonkk.co.jp
Public contact
Name of contact person
| 1st name | Hisayo |
| Middle name | |
| Last name | Sugao |
Organization
LEMON inc.
Division name
Research and Development Division, Headquarters
Zip code
100-0005
Address
Nippon Life Marunouchi Building 21, 1-6-6 Marunouchi, Chiyoda-ku, Tokyo
TEL
080-2923-9987
Homepage URL
sugaohisayo@lemonkk.co.jp
Sponsor or person
Institute
LEMON inc.
Institute
Department
Personal name
Funding Source
Organization
LEMON inc.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
03-6240-1162
info@ueno-asagao.clinic
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 | 03 | Month | 24 | 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
| 2025 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | 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 | 03 | Month | 24 | Day |
Last modified on
| 2026 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069842
