UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029226 |
|---|---|
| Receipt number | R000033406 |
| Scientific Title | Longitudinal and observational study for persistent idiopathic facial pain: PIFP, using magnetic resonance imaging analysis |
| Date of disclosure of the study information | 2017/10/12 |
| Last modified on | 2022/03/28 16:32:12 |
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Basic information
Public title
Longitudinal and observational study for persistent idiopathic facial pain: PIFP, using magnetic resonance imaging analysis
Acronym
Longitudinal and observational study for PIFP: MRI study
Scientific Title
Longitudinal and observational study for persistent idiopathic facial pain: PIFP, using magnetic resonance imaging analysis
Scientific Title:Acronym
Longitudinal and observational study for PIFP: MRI study
Region
| Japan |
Condition
Condition
persistent idiopathic facial pain: PIFP
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To make clear the central neural changes and pathogenesis of persistent idiopathic facial pain: PIFP, we take head MRI (magnetic resonance imaging) of the PIFP patients at the timing of before and after high-dose Amitriptyline therapy, using brain imaging analysis techniques.
Basic objectives2
Others
Basic objectives -Others
To prove observational evidence by brain imaging for empirical effective therapeutic method.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
VBM (voxel-based morphometry), DTI (diffusion tensor imaging), RS-fMRI (resting state functional MRI) data analysis
Key secondary outcomes
Some subjective questionaries.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed as PIFP at the special outpatient for PIFP
2. Endurable for relatively big noise (MRI noise)
3. The men and women who have own willing to participate the current research, well-Informed, and have consent.
Key exclusion criteria
1. Heart failure, renal failure, liver failure, respiratory failure and so on.
2. Severe psychosis.
3. Closed-phobia and dark-phoibia (for MRI acquisition circumstances)
4. having metal in their body inside (for MRI acquisition)
5. pregnancy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Ogino |
Organization
Gunma University Graduate School of Medicine
Division name
Anesthesiology
Zip code
371-8511
Address
3-39-22 Showamachi, Maebashi 371-8511, Japan
TEL
027-220-8454
oginoyuichi@me.com
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Ikawa |
Organization
Shizuoka city Shimizu Hospital
Division name
Oral maxillofacial surgery
Zip code
424-0911
Address
1231 Miyakami Shimizu-ku Shizuoka-city, Japan
TEL
054-336-1111
Homepage URL
https://www.shimizuhospital.com/healthcareservice/oral-maxillofacial/
ofpikawa@gmail.com
Sponsor or person
Institute
Shimizu hospital
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimizu Hospital
Address
1231 Miyakazou Shimizu-ku Shizuolka
Tel
054-336-1111
ofpikawa@gmail.com
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
静岡市立清水病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | 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
24
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
| 2017 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At the timeing of first visit and approximately 3 months after of the PIFP special outpatient, patients take subjective questionaries and head MRI under their own willing and consent for the research. MRI analysis would be done by following three: VBM, DTI and rs-fMRI.
Management information
Registered date
| 2017 | Year | 09 | Month | 21 | Day |
Last modified on
| 2022 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033406
