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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010344
Receipt No. R000012111
Scientific Title A study of therapeutic effects and neuroimaging for somatoform pain disorder.
Date of disclosure of the study information 2013/03/30
Last modified on 2020/01/25

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Basic information
Public title A study of therapeutic effects and neuroimaging for somatoform pain disorder.
Acronym A study of therapeutic effects and neuroimaging for somatoform pain disorder.
Scientific Title A study of therapeutic effects and neuroimaging for somatoform pain disorder.
Scientific Title:Acronym A study of therapeutic effects and neuroimaging for somatoform pain disorder.
Region
Japan

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

Objectives
Narrative objectives1 We practice a psychotherapy for the patients with pain disorder, and we examine the effects by psychosocial scales and brain functional imaging.
Basic objectives2 Others
Basic objectives -Others We research a treatment mechanisms about the relationship between pain, emotion, and pain catastrophizing.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The changes of pain intensity after a therapy
Key secondary outcomes The changes of depression (BDI-II), anxiety (STAI), pain catastrophizing (PCS), QOL (SF-36) and intensity of emotion after a therapy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 A psychotherapy during 3 months.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. The patients treated in Hiroshima University Hospital.
2. 20 years and up.
3. The patients diagnosed as being pain disorder by DSM-IV.
4. Accepted informed consent.
Key exclusion criteria 1. Difficulty to understand the purpose of study (e.g. dementia, delirium, psychosis).
2. Severe physical disease.
3. Brain organic disorder (e.g. cerebral hemorrhage, brain infarction).
4. The patients prescribed opioid as a treatment.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeto Yamawaki
Organization Hiroshima University
Division name Department of Psychiatry and Neuroscience
Zip code
Address Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL 082-257-5207
Email yoshino@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuo Yoshino
Organization Hiroshima University
Division name Department of Psychiatry and Neuroscience
Zip code
Address Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL 082-257-5207
Homepage URL
Email yoshino@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University, Department of Psychiatry
Institute
Department

Funding Source
Organization Scientific Research on Priority Areas from the Ministry of Education, Culture, Sports, Science and Technology of Japan.
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
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

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications https://onlinelibrary.wiley.com/doi/full/10.1111/pcn.12330
Number of participants that the trial has enrolled
Results
We published a preliminary result that pain, depression, anxiety, and QOL in 32 patients with chronic pain significantly improved by CBT.
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
2009 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We also published the neuroimaging study about the treatment effects of CBT.
https://www.cambridge.org/core/journals/psychological-medicine/article/changes-in-restingstate-brain-networks-after-cognitivebehavioral-therapy-for-chronic-pain/BE156D302FB88B1DB06A7E49E168443B

Management information
Registered date
2013 Year 03 Month 28 Day
Last modified on
2020 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012111

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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