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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027986
Receipt No. R000032050
Scientific Title Effects of Contralateral Segmental Transcutaneous Electrical Nerve Stimulation on Nociceptive Flexion Reflex in Healthy Participants
Date of disclosure of the study information 2017/06/30
Last modified on 2017/06/28

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Basic information
Public title Effects of Contralateral Segmental Transcutaneous Electrical Nerve Stimulation on Nociceptive Flexion Reflex in Healthy Participants
Acronym Effects of Contralateral Segmental Transcutaneous Electrical Nerve Stimulation
Scientific Title Effects of Contralateral Segmental Transcutaneous Electrical Nerve Stimulation on Nociceptive Flexion Reflex in Healthy Participants
Scientific Title:Acronym Effects of Contralateral Segmental Transcutaneous Electrical Nerve Stimulation
Region
Japan

Condition
Condition Healthy Participants
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to compare the analgesic effects of segmental and extrasegmental contralateral transcutaneous electrical nerve stimulation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual Analogue Scale
Nociceptive Flexion Reflex Threshold
Amplitude of Nociceptive Flexion Reflex by the 1.2 times intensity of threshold
Key secondary outcomes State-trait Anxiety Inventory
Expectation of Analgesia

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Contralateral Segmental Transcutaneous Electrical Nerve Stimulation for 30 Minutes
Interventions/Control_2 Contralateral Extrasegmental Transcutaneous Electrical Nerve Stimulation for 30 Minutes
Interventions/Control_3 Contralateral Segmental Sham Stimulation for 30 Minutes
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
40 years-old >=
Gender Male and Female
Key inclusion criteria Men and women between 18 and 40 age
Key exclusion criteria Volunteers with Cardiac Pacemakers
Tumors
Diabetes Mellitus
Local Skin Infection
Pain Condition in the Lower Limbs
Analgesic administration
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiro Takiguchi
Organization Gakkentoshi Hospital
Division name Department of Rehabilitation
Zip code
Address 7-4-1, Seikadai, Seikacho, Sourakugun, Kyoto, 619-0238, Japan.
TEL 0774-98-2123
Email b4771325@kio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuhiro Takiguchi
Organization Graduate School of Kio University
Division name Graduate School of Health Sciences
Zip code
Address 4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, 635-0832, Japan.
TEL +81-745-54-1601
Homepage URL
Email b4771325@kio.ac.jp

Sponsor
Institute Kio University
Institute
Department

Funding Source
Organization Kio University
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 30 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
2017 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 28 Day
Last modified on
2017 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032050

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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