UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045979 |
|---|---|
| Receipt number | R000052483 |
| Scientific Title | Changes in facial blood flow due to electroacupuncture stimulation to the trigeminal nerve area: A randomized crossover trial |
| Date of disclosure of the study information | 2021/11/08 |
| Last modified on | 2021/11/04 15:19:23 |
* 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
Changes in facial blood flow due to electroacupuncture stimulation to the trigeminal nerve area
Acronym
Changes in facial blood flow due to electroacupuncture stimulation to the trigeminal nerve area
Scientific Title
Changes in facial blood flow due to electroacupuncture stimulation to the trigeminal nerve area: A randomized crossover trial
Scientific Title:Acronym
Changes in facial blood flow due to electroacupuncture stimulation to the trigeminal nerve area: A randomized crossover trial
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine changes in facial cutaneous blood flow due to acupuncture stimulation to the trigeminal nerve region by comparing electro and manual acupuncture stimulation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Facial cutaneous blood flow
Key secondary outcomes
State-trait anxiety inventory (STAI)
The Japanese version of the Massachusetts General Hospital Acupuncture Sensation Scale (MASS)
Adverse event
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Acupuncture stimulation (manual)
Interventions/Control_2
electroacupuncture stimulation
Interventions/Control_3
no stimulation
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults who agreed to participate in the study
Key exclusion criteria
Cranial and facial underlying disorders
Under treatment for facial or dental symptoms
During menstruation or within 1 week of menstruation
Have a metal allergy / bleeding tendency
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuto |
| Middle name | |
| Last name | Matsuura |
Organization
Tokyo Ariake University of Medical and Health Sciences, Tokyo, Japan
Division name
Department of Acupuncture and Moxibustion
Zip code
135-0063
Address
2-9-1, Ariake, Koto-ku, Tokyo 135-0063, Japan
TEL
03-6703-7014
matsuuray@tau.ac.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Matsuura |
Organization
Tokyo Ariake University of Medical and Health Sciences, Tokyo, Japan
Division name
Department of Acupuncture and Moxibustion
Zip code
135-0063
Address
2-9-1, Ariake, Koto-ku, Tokyo 135-0063, Japan
TEL
03-6703-7014
Homepage URL
matsuuray@tau.ac.jp
Sponsor or person
Institute
Tokyo Ariake University of Medical and Health Sciences, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
Tokyo Ariake University of Medical and Health Sciences, Tokyo, Japan
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
Tokyo Ariake University of Medical and Health Sciences, Tokyo, Japan
Address
2-9-1, Ariake, Koto-ku, Tokyo 135-0063, Japan
Tel
03-6703-7000
akiyama@tau.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 08 | 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
| 2021 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2021 | Year | 11 | Month | 04 | Day |
Last modified on
| 2021 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052483
