UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011253 |
|---|---|
| Receipt number | 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 | 2020/03/26 16:47:34 |
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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
Name of lead principal investigator
| 1st name | Jiro |
| Middle name | |
| Last name | Kurata |
Organization
The Jikei University School of Medicine
Division name
Department of Anesthesiology
Zip code
105-8461
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
jkurata@plum.plala.or.jp
Public contact
Name of contact person
| 1st name | Jiro |
| Middle name | |
| Last name | Kurata |
Organization
The Jikei University School of Medicine
Division name
Department of Anesthesiology
Zip code
105-8461
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
jkurata@plum.plala.or.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Medical and Dental University
Fukushima Medical University
Hamamatsu Medical University
Kyoto University Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics committee of The Jikei University School of Medicine for Biomedical Research
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo
Tel
03-3433-1111
rinri@jikei.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
東京慈恵会医科大学（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
| 2013 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
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
| 2020 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013154
