UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037337
Receipt number R000042565
Scientific Title Elucidation of the brain mechanisms underlying the pain modulation by psychological factors in patients with chronic pain
Date of disclosure of the study information 2019/07/12
Last modified on 2019/07/11 14:50:03

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Basic information

Public title

Elucidation of the brain mechanisms underlying the pain modulation by psychological factors in patients with chronic pain

Acronym

Elucidation of the brain mechanisms underlying the pain modulation by psychological factors in patients with chronic pain

Scientific Title

Elucidation of the brain mechanisms underlying the pain modulation by psychological factors in patients with chronic pain

Scientific Title:Acronym

Elucidation of the brain mechanisms underlying the pain modulation by psychological factors in patients with chronic pain

Region

Japan


Condition

Condition

Chronic pain

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to elucidate the brain mechanisms underlying the pain modulation by psychological factors in patients with chronic pain.
We investigate the effects of cue-based expectations for pain in patients with chronic pain on cerebral hemodynamic responses using near-infrared spectroscopy(NIRS).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cerebral hemodynamics(Oxy-Hb, Deoxy-Hb, Total-Hb)

Key secondary outcomes

Visual Analog Scale(VAS)
Heart rate
Skin conductance


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment

Interventions/Control_1

Patients with chronic pain

Interventions/Control_2

Healthy controls

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

patients over 20 years old
patients who regularly go to the pain clinic

Key exclusion criteria

patients with a past history of heart disease

Pregnant female

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Mitsuaki
Middle name
Last name Yamazaki

Organization

University of Toyama

Division name

Department of anesthesiology

Zip code

930-0194

Address

2630, Sugitani, Toyama, Japan

TEL

076-434-7377

Email

myama@med.u-toyama.ac.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Hibi

Organization

University of Toyama

Division name

Department of anesthesiology

Zip code

930-0194

Address

2630, Sugitani, Toyama, Japan

TEL

076-434-7377

Homepage URL


Email

d1661011@ems.u-toyama.ac.jp


Sponsor or person

Institute

University of Toyama

Institute

Department

Personal name



Funding Source

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee, University of Toyama

Address

2630, Sugitani, Toyama, Japan

Tel

076-434-7681

Email

rinri@adm.u-toyama.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

2019 Year 07 Month 12 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

2018 Year 08 Month 10 Day

Date of IRB

2018 Year 04 Month 23 Day

Anticipated trial start date

2018 Year 08 Month 31 Day

Last follow-up date

2020 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

2019 Year 07 Month 11 Day

Last modified on

2019 Year 07 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042565


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name