UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033406