UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027986 |
|---|---|
| Receipt number | 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 | 2023/01/06 14:13:53 |
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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 | Nobuhiro |
| Middle name | |
| Last name | Takiguchi |
Organization
Gakkentoshi Hospital
Division name
Department of Rehabilitation
Zip code
619-0238
Address
7-4-1, Seikadai, Seikacho, Sourakugun, Kyoto, 619-0238, Japan.
TEL
0774-98-2123
b4771325@kio.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Takiguchi |
Organization
Graduate School of Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, 635-0832, Japan.
TEL
+81-745-54-1601
Homepage URL
b4771325@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
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
Kio University Ethical Committee
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, 635-0832, Japan.
Tel
+81-745-54-1601
soumu@kio.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
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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 10 | Day |
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
| 2023 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032050
