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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011262
Receipt No. R000013119
Scientific Title A study to elucidate pathologic specificity in the patients with chronic pain using MRI
Date of disclosure of the study information 2013/07/25
Last modified on 2017/07/27

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Basic information
Public title A study to elucidate pathologic specificity in the patients with chronic pain using MRI
Acronym Chronic pain and MRI
Scientific Title A study to elucidate pathologic specificity in the patients with chronic pain using MRI
Scientific Title:Acronym Chronic pain and MRI
Region
Japan

Condition
Condition Fibromyalgia, low back pain or postherpetic neuralgia (PHN)
Classification by specialty
Neurology Clinical immunology Orthopedics
Anesthesiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate central nervous sysytem connectivity using fMRI in the patients with chronic pain.
Basic objectives2 Others
Basic objectives -Others central nervous sysytem connectivity
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes connectivity
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 MRI
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
70 years-old >=
Gender Male and Female
Key inclusion criteria chronic pain (fibromyalgia, low back pain, PHN)
Key exclusion criteria CNS dysfunction
Target sample size 120

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shinichi Inomata
Organization Faculty of Medicine, University of Tsukuba
Division name Department of Anesthesiology
Zip code
Address Tennnoudai 1-1-1, Tsukuba City, Ibaraki, Japan
TEL 029-853-3525
Email inomatas@md.tsukuba.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shinichi Inomata
Organization Faculty of Medicine, University of Tsukuba
Division name Department of Anesthesiology
Zip code
Address Tennnoudai 1-1-1, Tsukuba City, Ibaraki, Japan
TEL 029-853-3525
Homepage URL
Email inomatas@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization none
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
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 筑波大学附属病院

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 25 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 Completed
Date of protocol fixation
2013 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 24 Day
Last modified on
2017 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013119

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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