UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033214
Receipt number R000037872
Scientific Title Reliability and validity study of the Japanese version of Chronic Pain Acceptance Questionnaire (CPAQ-J)
Date of disclosure of the study information 2018/06/30
Last modified on 2020/09/27 17:58:32

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Basic information

Public title

Reliability and validity study of the Japanese version of Chronic Pain Acceptance Questionnaire (CPAQ-J)

Acronym

Reliability and validity study of the Japanese version of Chronic Pain Acceptance Questionnaire (CPAQ-J)

Scientific Title

Reliability and validity study of the Japanese version of Chronic Pain Acceptance Questionnaire (CPAQ-J)

Scientific Title:Acronym

Reliability and validity study of the Japanese version of Chronic Pain Acceptance Questionnaire (CPAQ-J)

Region

Japan


Condition

Condition

chronic pain

Classification by specialty

Psychosomatic Internal Medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Development of the Japanese version of the Chronic Pain Acceptance Questionnaire (CPAQ-J), and Validity study of CPAQ-J

Basic objectives2

Others

Basic objectives -Others

development of a questionnaire

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cronbach's alpha
test-retest correlation
correlation between the CPAQ-J score and pain-related variables

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1)Patients with non-malignant pain (at least 3 months duration), treated at the department of Psychosomatic medicine, Kyushu University Hospital
2)Paitents who consented to participate in this study

Key exclusion criteria

1)Patients who suffer from severe cognitive problems such as severe mood disorders, psychosis, mental retardation, dementia, high-order brain dysfunction, substance related disorders
2)Patients who can not complete questionnaires by themselves

Target sample size

220


Research contact person

Name of lead principal investigator

1st name Nobuyuki
Middle name
Last name Sudo

Organization

Graduate School of Medical Sciences., Kyushu University

Division name

Deptartment of Psychosomatic Medicine

Zip code

812-8582

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka City, Japan

TEL

092-642-5318

Email

nobuyuki@med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Kozo
Middle name
Last name Anno

Organization

Kyushu University Hospital

Division name

Deptartment of Psychosomatic Medicine

Zip code

812-8582

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka City, Japan

TEL

092-642-5320

Homepage URL


Email

annok@cephal.med.kyushu-u.ac.jp


Sponsor or person

Institute

Kyushu University hospital

Institute

Department

Personal name



Funding Source

Organization

Kyushu University hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyushu University Institutional Review Board for Clinical Research

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka City, Japan

Tel

092-642-5774

Email

bynintei@jimu.kyushu-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

2018 Year 06 Month 30 Day


Related information

URL releasing protocol

http://www.cephal.med.kyushu-u.ac.jp/

Publication of results

Unpublished


Result

URL related to results and publications

http://www.cephal.med.kyushu-u.ac.jp/

Number of participants that the trial has enrolled

216

Results

chronic pain acceptance questionnaire-J
mean score 47.4 (SD 16.7)

<reliability>
Cronbach's alpha = 0.82
test-retest reliability r = 0.94

<correlation analysis>
pain intensity (BPI) -0.27 (P<0.01)
disability (PDAS) -0.38 (P<0.01)
depression (HADS-D) -0.40 (P<0.01)
anxiety (HADS-A) -0.51 (P<0.01)
pain catastrophizing (PCS) -0.63 (P<0.0)
life satisfaction (VAS) 0.48 (P<0.01)

Results date posted

2020 Year 09 Month 27 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

mean age (years) 48.4 (SD 16.0)
female 78,7%
median pain duration (months) 35 (IQ 12-99)

Participant flow

complete

Adverse events

non

Outcome measures

<questionnaires>
Chronic pain acceptance questionnaire
Brief pain inventory
Pain disability assessment scale
pain catastrophizing scale
Hospital anxiety and depression scale
life satisfaction (visual analogue scale)

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 08 Month 29 Day

Date of IRB

2014 Year 08 Month 26 Day

Anticipated trial start date

2014 Year 08 Month 29 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2018 Year 06 Month 30 Day

Last modified on

2020 Year 09 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037872


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name