UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002548 |
|---|---|
| Receipt number | 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 | 2023/09/16 12:06:29 |
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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 | Hiroyuki |
| Middle name | |
| Last name | Karibe |
Organization
Nippon Dental University
Division name
Department of Pediatric Dentistry
Zip code
1028159
Address
1-9-20 Fujimi Chiyoda-ku, 102-8159 Tokyo
TEL
0332616524
h-karibe@tky.ndu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Karibe |
Organization
Nippon Dental University
Division name
Department of Pediatric Dentistry
Zip code
1028159
Address
1-9-20 Fujimi Chiyoda-ku, 102-8159 Tokyo
TEL
0332616524
Homepage URL
h-karibe@tky.ndu.ac.jp
Sponsor or person
Institute
Nippon Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nippon Medical School
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Nippon Dental University, School of Life Dentistry
Address
1-9-20 Fujimi Chiyoda Tokyo
Tel
0332610924
ndu-rinri@tky.ndu.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
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
https://pubmed.ncbi.nlm.nih.gov/20727111/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/20727111/
Number of participants that the trial has enrolled
22
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
| 2023 | Year | 09 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Ten patients (nine females and one male; average age 55.0 years) having somatoform pain disorder with oral symptoms participated.
We also selected 12 healthy individuals (seven females and five males; average age 61.8 years) to act as controls.
Participant flow
This study included 10 patients with somatoform pain disorder of the oral region (nine females and one male; average age 55.0 years). All patients attended the Clinical Center of Psychosomatic Dentistry, Nippon Dental University Hospital. The controls were 12 healthy individuals (seven females and five males; average age 61.8 years) selected from a database maintained by the Department of Neuropsychiatry, Nippon Medical School Hospital.
Adverse events
None
Outcome measures
SPECT was performed using N-isopropyl-4-[123I] iodoamphetamine intravenous injections, and regional cerebral blood flow (rCBF) was assessed by three-dimensional stereotactic surface projections.
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
| 2006 | Year | 06 | Month | 07 | Day |
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
| 2023 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003115
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