UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000045213
Receipt number R000045660
Scientific Title Investigating frequency-dependent current thermal pain threshold
Date of disclosure of the study information 2021/08/21
Last modified on 2021/08/21 08:21:21

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Basic information

Public title

Investigating frequency-dependent current thermal pain threshold

Acronym

Investigating frequency-dependent current thermal pain threshold

Scientific Title

Investigating frequency-dependent current thermal pain threshold

Scientific Title:Acronym

Investigating frequency-dependent current thermal pain threshold

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the thermal effect on the human body and the perceptual threshold by the middle- to high-frequency electrical current.

Basic objectives2

Others

Basic objectives -Others

The perceptual threshold at each electrical frequency

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The perceptual threshold at each electrical frequency

Key secondary outcomes

Characteristics of the perception threshold by age, gender, etc.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

YES

Dynamic allocation


Institution consideration


Blocking

NO

Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Electrical current stimulation to a fingertip in contact or non-contact manner

Interventions/Control_2


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

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

a. No past history of brain, neurologic/muscular diseases, mental illness, or diabetes, etc.
b. Consent to participate in the study.

Key exclusion criteria

a. Past history of brain, neurologic/muscular diseases, mental illness, or diabetes, etc. that may affect the sensation or perception.
b. Currently taking treatment for the above diseases.
c. Having cardiac pacemakers.
d. Having eczema or rough skin on the hands.
e. Pregnancy.

Target sample size

180


Research contact person

Name of lead principal investigator

1st name Yohei
Middle name
Last name Otaka

Organization

Fujita Health University

Division name

Department of Rehabilitation Medicine I, School of Medicine,

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan

TEL

0562-93-2167

Email

yootaka@fujita-hu.ac.jp


Public contact

Name of contact person

1st name Shintaro
Middle name
Last name Uehara

Organization

Fujita Health University

Division name

Faculty of Rehabilitation, School of Health Sciences

Zip code

470-1192

Address

1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan

TEL

0562-93-9000

Homepage URL


Email

suehara@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Internal Affairs and Communications

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nagoya Institute of Technology
Utsunomiya University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Fujita Health University

Address

1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan

Tel

0562-93-2865

Email

f-irb@fujita-hu.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

藤田医科大学(愛知県)


Other administrative information

Date of disclosure of the study information

2021 Year 08 Month 21 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

Enrolling by invitation

Date of protocol fixation

2020 Year 03 Month 13 Day

Date of IRB

2020 Year 03 Month 13 Day

Anticipated trial start date

2020 Year 12 Month 08 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

2021 Year 08 Month 21 Day

Last modified on

2021 Year 08 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045660


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name