UMIN-CTR Clinical Trial

Basic information
Public title	The effect of psycho-social approach for chronic pain patients
Acronym	The effect of psycho-social approach for chronic pain patients
Scientific Title	The effect of psycho-social approach for chronic pain patients
Scientific Title:Acronym	The effect of psycho-social approach for chronic pain patients
Region	Japan

Condition
Condition	Chronic pain
Classification by specialty	Neurology Orthopedics Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the efficacy of the psycho-social approach for patients with chronic pain through comparing treatment as usual(TAU)group and TAU+psycho-social group on pain intensity and psycho social factors(ex. degree of pain related difficulty on daily life, depression, anxiety, insomnia, self-efficacy, QOL, etc..). This study also examines how psychological factors at baseline would affect pain related difficulty.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Participants complete following questionnaires at baseline and 1, 3, 6months. 1.Pain Disability Assessment Scale(PDAS) 2.Hospital Anxiety and Depression Scale(HADS) 3.Pain Catastrophizing Scale(PCS) 4.Pain Self-Efficacy Questionnaire(PSEQ)
Key secondary outcomes	Participants complete following questionnaires at baseline(1-6)and 1, 3, 6months(1-5). 1.Brief Pain Inventory(BPI) 2.Athens Insomnia Scale(AIS) 3.EuroQol 5 Dimension(EQ5D) 4.Locomo25 5.The short of the Japanese version of the Zarit Caregiver Burden Interview 6.Demographic Data:disease name, age, sex, medication, height and weight, employment status etc

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Treatment as usual condition implementation period:2015/8-2017/3 intervention:standard medical care from the doctor
Interventions/Control_2	treatment as usual and cognitive behavioral approach condition implementation period:2015/8-2017/3 intervention:standard medical care from the doctor and tailor made cognitive behavioral approach from psychotherapist
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
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Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	existence of daily-life difficulty caused by pain experiencing pain for at least 3 months score of DIT(distress and impact thermometer) is over cut-off points who have written consent to participate in this research
Key exclusion criteria	to be judged inappropriate to this research by attending physician patients who refuse to participate in this study patients who have diagnosed Mental retardation, Developmental disorder patients who have language disorder who have substance abuse patients who require surgical intervention patients whose pain is because of inflammation
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toshihiro Yorozuya
Organization	Ehime University School of Medicine & Ehime University Hospital
Division name	Anesthesiology and Resuscitology
Zip code
Address	454, Shitsukawa,Toon,791-0295 Japan
TEL	089-960-5575
Email	yorozuya@m.ehime-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Toshihiro Yorozuya
Organization	Ehime University School of Medicine & Ehime University Hospital
Division name	Anesthesiology and Resuscitology
Zip code
Address	454 Shitsukawa,Toon,791-0295 Japan
TEL	089-960-5575
Homepage URL
Email	yorozuya@m.ehime-u.ac.jp

Sponsor
Institute	Ehime University School of Medicine & Ehime University Hospital
Institute
Department

Funding Source
Organization	Health and Labour Sciences Research Grant
Organization
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Other related organizations
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IRB Contact (For public release)
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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	2015 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
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Results
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Results Delayed
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Baseline Characteristics
Participant flow
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Outcome measures
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IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
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Other
Other related information

Management information
Registered date	2015 Year 07 Month 31 Day
Last modified on	2015 Year 08 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021414

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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