UMIN-CTR Clinical Trial

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
Institute	University of Toyama
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042565