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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019240
Receipt No. R000022228
Scientific Title The effect of psycho-social approach for chronic pain patients.
Date of disclosure of the study information 2015/10/05
Last modified on 2019/05/14

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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, 6 months.

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, 6 months(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 Randomized
Randomization unit Individual
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:2015/10-2017/3
intervention :standard medical care from the doctor
Interventions/Control_2 treatment as usual and cognitive behavioral approach condition
implementation period:2015/10-2017/3
interventions: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
Interventions/Control_8
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 Yorozuya
Middle name
Last name Toshihiro
Organization Ehime University School of Medicine & Ehime University Hospital
Division name Anesthesiology and Resuscitology
Zip code 791-0295
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 Kotegawa
Middle name
Last name Yuichi
Organization Ehime University School of Medicine & Ehime University Hospital
Division name Total medical support center
Zip code 791-0295
Address 454 Shitsukawa,Toon,791-0295 Japan
TEL 089-960-5917
Homepage URL
Email kotegawa@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
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 Ehime University School of Medicine & Ehime University Hospital
Address 454 Shitsukawa,Toon,791-0295 Japan
Tel 089-960-5575
Email yorozuya@m.ehime-u.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

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 05 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Enrolling by invitation
Date of protocol fixation
2015 Year 10 Month 05 Day
Date of IRB
2015 Year 09 Month 28 Day
Anticipated trial start date
2015 Year 10 Month 05 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 05 Day
Last modified on
2019 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022228

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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