UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010344
Receipt number 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 05:58:08

* 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

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 or person

Institute

Hiroshima University, Department of Psychiatry

Institute

Department

Personal name



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

Value
https://center6.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