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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028604
Receipt No. 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

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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
Email 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
Email k_itoh@meiji-u.ac.jp

Sponsor
Institute Meiji University of Integrative Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032741

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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