UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029226
Receipt No. 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 2019/09/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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/
Email ofpikawa@gmail.com

Sponsor
Institute Shimizu hospital
Institute
Department

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
Email 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
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
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
2023 Year 12 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
2019 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033406

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.