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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002548
Receipt No. R000003115
Scientific Title Regional cerebral blood flow in patients with orally localized somatoform pain disorder: A single photon emission computed tomography study
Date of disclosure of the study information 2009/09/25
Last modified on 2009/09/25

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Basic information
Public title Regional cerebral blood flow in patients with orally localized somatoform pain disorder: A single photon emission computed tomography study
Acronym Cerebral blood flow in oral pain disorder
Scientific Title Regional cerebral blood flow in patients with orally localized somatoform pain disorder: A single photon emission computed tomography study
Scientific Title:Acronym Cerebral blood flow in oral pain disorder
Region
Japan

Condition
Condition Somatoform pain disorder
Classification by specialty
Psychiatry Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the pathological features of somatoform pain disorder localized to the oral region by single photon emission computed tomography (SPECT)
Basic objectives2 Others
Basic objectives -Others Pathological features of patients with orally localized somatoform pain disorder
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Regional cerebral blood flow assessed by three-dimensional stereotactic surface projections
Key secondary outcomes Pain intensity (numeric rating scale)

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with orally localized somatoform pain disorder diagnosed by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR).
Key exclusion criteria Patients who were diagnosed with neuropathic pain, those with intentionally created or fabricated pain, or those having other mental disorders causing somatic symptoms.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Karibe
Organization Nippon Dental University
Division name Department of Pediatric Dentistry
Zip code
Address 1-9-20 Fujimi Chiyoda-ku, 102-8159 Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nippon Dental University
Division name Department of Pediatric Dentistry
Zip code
Address 1-9-20 Fujimi Chiyoda-ku, 102-8159 Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Nippon Dental University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Nippon Medical School
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 日本医科大学付属病院(東京都)

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 25 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
A preliminary report was presented at the Congress of the International Association for Disability and Oral Health in Santos, Brazil, on October 28-31, 2008 (Journal of Disability and Oral Health 9(4)[Spec Iss]:220[abstract]).
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
2005 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 08 Month 01 Day
Last follow-up date
2008 Year 09 Month 01 Day
Date of closure to data entry
2008 Year 10 Month 01 Day
Date trial data considered complete
2008 Year 12 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information Cross-sectional study
Consecutive sampling

Management information
Registered date
2009 Year 09 Month 25 Day
Last modified on
2009 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003115

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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