UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052768 |
|---|---|
| Receipt number | R000060215 |
| Scientific Title | Effects of scalp electroacupuncture on pain thresholds in healthy adults |
| Date of disclosure of the study information | 2023/11/12 |
| Last modified on | 2023/11/11 23:52:44 |
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Basic information
Public title
Effects of scalp electroacupuncture on pain thresholds in healthy adults
Acronym
Effects of scalp electroacupuncture on pain thresholds in healthy adults
Scientific Title
Effects of scalp electroacupuncture on pain thresholds in healthy adults
Scientific Title:Acronym
Effects of scalp electroacupuncture on pain thresholds in healthy adults
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effectiveness of scalp electroacupuncture in healthy adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain threshold
Key secondary outcomes
TSP/CPM/OA
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Scalp electro acupuncture + two-limb electro acupuncture
Interventions/Control_2
two-limb electro acupuncture
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 over 18 years old
Key exclusion criteria
Those with a pain catastrophizing scale (PCS) score of 30 points or higher
Those with a score of 11 or higher in each depression and anxiety item of the Hospital Anxiety and Depression Scale (HADS)
Persons with mental illness or neurological disease
Subjects were considered to have taken any medication that may affect this study, such as analgesics, within the past 24 hours
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Itoh |
Organization
Meiji University of Integrative Medicine
Division name
Acupuncture and Moxibustion
Zip code
629-0301
Address
Nantan, Kyoto
TEL
0771-72-1181
k_itoh@meiji-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Itoh |
Organization
Meiji University of Integrative Medicine
Division name
Acupuncture and Moxibustion
Zip code
629-0301
Address
Nantan, Kyoto
TEL
0771-72-1181
Homepage URL
k_itoh@meiji-u.ac.jp
Sponsor or person
Institute
Meiji University of Integrative Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Meiji University of Integrative Medicine
Address
Nantan, Kyoto
Tel
0771721181
k_itoh@meiji-u.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
明治国際医療大学
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 11 | Month | 11 | Day |
Last modified on
| 2023 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060215
