UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042479
Receipt number R000048492
Scientific Title Effect of preference conditioning stimulation for Conditioned Pain Modulation.
Date of disclosure of the study information 2020/11/18
Last modified on 2020/11/17 15:13:29

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Basic information

Public title

Effect of preference conditioning stimulation for analgesia.

Acronym

Effect of preference pain for analgesic effect.

Scientific Title

Effect of preference conditioning stimulation for Conditioned Pain Modulation.

Scientific Title:Acronym

Preference conditioning stimulation and analgesia.

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine whether differences in preference for conditioning stimulation affect the function of pain inhibitory.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of Pain pressure threshold by conditioned pain modulation.

Key secondary outcomes

Preference for conditioning stimulation
Sensation and pain rating scale
Beck depression inventory
State trait anxiety inventory
Pain catastrophizing scale


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

60 years-old >

Gender

Male and Female

Key inclusion criteria

Without person pain that lasts more than 3 months, dysesthesia, cardiovascular disease, state of affecting the autonomic nervous system.

Key exclusion criteria

Person have pain that lasts more than 3 months, dysesthesia, cardiovascular disease, state of affecting the autonomic nervous system.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yuta
Middle name
Last name Terasawa

Organization

Kio University Graduate School

Division name

Kio University Graduate School Neuro Rehabilitation research center

Zip code

6540832

Address

4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara Prefecture

TEL

09016491857

Email

16r0060@gmail.com


Public contact

Name of contact person

1st name Yuta
Middle name
Last name Terasawa

Organization

Kio University Graduate School

Division name

Kio University Graduate School Neuro Rehabilitation research center

Zip code

6540832

Address

4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara Prefecture

TEL

09016491857

Homepage URL


Email

16r0060@gmail.com


Sponsor or person

Institute

Kio University Graduate School

Institute

Department

Personal name



Funding Source

Organization

Kio University Graduate School

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 Graduate School

Address

4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara Prefecture

Tel

09016491857

Email

16r0060@gmail.com


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

2020 Year 11 Month 18 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

Preinitiation

Date of protocol fixation

2020 Year 11 Month 12 Day

Date of IRB


Anticipated trial start date

2020 Year 11 Month 18 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This in before the start of research, and there are no items to be described.


Management information

Registered date

2020 Year 11 Month 17 Day

Last modified on

2020 Year 11 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048492


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name