UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017983 |
|---|---|
| Receipt number | R000020834 |
| Scientific Title | The effect of acupuncture stimulation on orofacial sensory threshold and autonomic nervous system |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2022/03/16 15:27:02 |
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Basic information
Public title
The effect of acupuncture stimulation on orofacial sensory threshold and autonomic nervous system
Acronym
The effect of acupuncture stimulation on orofacial sensory threshold and autonomic nervous system
Scientific Title
The effect of acupuncture stimulation on orofacial sensory threshold and autonomic nervous system
Scientific Title:Acronym
The effect of acupuncture stimulation on orofacial sensory threshold and autonomic nervous system
Region
| Japan |
Condition
Condition
Neuropathic pain
Classification by specialty
| Oral surgery | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the perception threshold m after the acupuncture stimulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Current perception threshold
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
acupuncture stimulation
Interventions/Control_2
electro acupuncture 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult
Key exclusion criteria
1. History of acupuncture
2. Inferior alveolar nerve injury
3. Skin disorders of the left mental region or LI4/LI1
4. Paresthesia
5. Bleeding diathesis
6. Pregnancy
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Niwa |
Organization
Osaka University Graduate School of Dentistry
Division name
Dept. of Dental Anesthesiology
Zip code
Address
1-8 Yamada-oka, Suita, 565-0871, Japan
TEL
06-6879-2972
niwa@dent.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aiko Oyamaguchi |
Organization
Osaka University Graduate School of Dentistry
Division name
Dept. of Dental Anesthesiology
Zip code
Address
1-8 Yamada-oka, Suita, 565-0871, Japan
TEL
06-6879-2972
Homepage URL
a-ohyama@dent.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Management Expenses Grants
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
Address
Tel
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
大阪大学歯学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | 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
| 2015 | Year | 06 | Month | 19 | Day |
Last modified on
| 2022 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020834
