UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028604 |
|---|---|
| Receipt number | R000032741 |
| Scientific Title | Effects of electrical-stimulation on frequencies (pain subjects) |
| Date of disclosure of the study information | 2017/08/15 |
| Last modified on | 2019/08/13 16:00:38 |
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Basic information
Public title
Effects of electrical-stimulation on frequencies (pain subjects)
Acronym
Effects of electrical-stimulation on frequencies
Scientific Title
Effects of electrical-stimulation on frequencies (pain subjects)
Scientific Title:Acronym
Effects of electrical-stimulation on frequencies
Region
| Japan |
Condition
Condition
chronic low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Inspection of the anesthetic effect on electrical-stimulations
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neuro meter
VAS
RDQ
Key secondary outcomes
Painful sense question
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
acupuncture
Interventions/Control_2
electrical-stemulation of 1Hz
Interventions/Control_3
electrical-stemulation of 20Hz
Interventions/Control_4
electrical-stemulation of 100Hz
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1
Key exclusion criteria
1
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Itoh |
Organization
Meiji University of Integrative Medicine
Division name
Acupuncture and Moxibustion
Zip code
Address
Nantan, Kyoto
TEL
0771-72-1181
k_itoh@meiji-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Itoh |
Organization
Meiji University of Integrative Medicine
Division name
Acupuncture and Moxibustion
Zip code
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
Omron
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
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
明治国際医療大学
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 15 | 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
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 09 | Day |
Last modified on
| 2019 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032741
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
