UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011262 |
|---|---|
| Receipt number | 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 09:44:16 |
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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
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
inomatas@md.tsukuba.ac.jp
Public contact
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
inomatas@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013119
