UMIN-CTR Clinical Trial

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

Chronic pain

Classification by specialty

Neurology	Orthopedics	Anesthesiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

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

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

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

Institute

Ehime University School of Medicine & Ehime University Hospital

Institute

Department

Personal name

Organization

Health and Labour Sciences Research Grant

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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

Date analysis concluded

Other related information

Registered date

2015

Year

07

Month

31

Day

Last modified on

2015

Year

08

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021414