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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011253
Receipt No. R000013154
Scientific Title Magnetic resonance imaging study on the cerebral biomarkers of pain chronification
Date of disclosure of the study information 2013/07/23
Last modified on 2013/07/23

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Basic information
Public title Magnetic resonance imaging study on the cerebral biomarkers of pain chronification
Acronym Brain biomarkers of chronic pain
Scientific Title Magnetic resonance imaging study on the cerebral biomarkers of pain chronification
Scientific Title:Acronym Brain biomarkers of chronic pain
Region
Japan North America Europe

Condition
Condition chronic pain syndrome
Classification by specialty
Clinical immunology Psychiatry Orthopedics
Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify pathophysiologic changes in chronic pain patients using multiple modalities of magnetic resonance imaging. To establish brain biomarkers of chronic pain for its diagnosis and evaluation.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Psychophysics of pain
Pain-related cerebral activity
Connectivity of cerebral networks
Gray matter signal density
White matter axonal directions
Key secondary outcomes Correlations between psychophysical and imaging parameters

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
75 years-old >=
Gender Male and Female
Key inclusion criteria Complex regional pain syndrome
Chronic low back pain
Fibromyalgia
Other chronic pain syndromd
Healthy volunteer subjects
Key exclusion criteria Implanted metals or electric devices
Tatoo
Pregnancy
Claustrophobia
Dementia
Decreased level of awareness
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Jiro Kurata
Organization Tokyo Medical and Dental University Hospital of Medicine
Division name Department of Anesthesiology and Pain Clinic
Zip code
Address Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL 03-5803-5325
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Jiro Kurata
Organization Tokyo Medical and Dental University Hospital of Medicine
Division name Department of Anesthesiology and Pain Clinic
Zip code
Address Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL 03-5803-5325
Homepage URL
Email jkmane@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University Hospital of Medicine
Institute
Department

Funding Source
Organization The Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 東京医科歯科大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 23 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 Open public recruiting
Date of protocol fixation
2013 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will examine the relationships between the psychophysical and MRI parameters, and will establish the cerebral biomarkers of pain chronification.

Management information
Registered date
2013 Year 07 Month 23 Day
Last modified on
2013 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013154

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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