UMIN-CTR Clinical Trial

Public title

Japanese validation study of the Pain Stage of Change Questionnaire

Acronym

PSOCQ-J

Scientific Title

Japanese validation study of the Pain Stage of Change Questionnaire

Scientific Title:Acronym

PSOCQ-J

Region

Japan

Condition

Chronic Pain

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The present study aims to develop the Japanese version of the Pain Stage of Change Questionnaire (PSOCQ-J) and to evaluate its reliability and validity.

Basic objectives2

Others

Basic objectives -Others

Confirmation of the psychometric properties of the Japanese version of the Pain Stage of Change Questionnaire

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

the Japanese version of the Pain Stage of Change Questionnaire

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. history of pain for 3 months and more
2. age 20 years and older
3. adequate ability to read and write Japanese
4. willingness to participate in the present study shown by an authentic signature.

Key exclusion criteria

cognitive impairment disturbing responses to the questionnaires

Target sample size

210

Name of lead principal investigator

1st name
Middle name
Last name	Sei Fukui

Organization

Shiga University of Medical Science

Division name

Pain Management Clinic, Shiga University of Medical Science Hospital

Zip code

Address

ZIP: 520-2192, Seta Tsukinowa-cho, Otsu, Shiga, JAPAN

TEL

077-548-2281

Email

sei@belle.shiga-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Tomonori Adachi

Organization

Shiga University of Medical Science

Division name

Pain Management Clinic, Shiga University of Medical Science Hospital

Zip code

Address

ZIP: 520-2192, Seta Tsukinowa-cho, Otsu, Shiga, JAPAN

TEL

077-548-2281

Homepage URL

Email

atom8567@belle.shiga-med.ac.jp

Institute

Shiga University of Medical Science

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2016

Year

09

Month

26

Day

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027752

Publication of results

Published

URL related to results and publications

https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027752

Number of participants that the trial has enrolled

201

Results

The results supported a 4-factor structure of the PSOCQ-J. We also found good to excellent internal consistencies and good test-retest reliabilities for the 4 scales. The findings generally supported hypothesized associations with criterion pain-related measures.

Results date posted

2019

Year

03

Month

24

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Mixed pain conditions. We recruited individuals with pain lasting at least 3 months. A part of the study participants was asked to complete the Japanese version of the Pain Stage of Change Questionnaire again to assess test-retest reliability.

Participant flow

Study participants were recruited from five clinics.

Adverse events

nothing

Outcome measures

The Japanese version of the Pain Stage of Change Questionnaire,
Numerical Rating Scale,
Brief Pain Inventory Pain Interference Scale,
Pain Catastrophizing Scale,
Pain Self-Efficacy Questionnaire,
Chronic Pain Coping Inventory

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

09

Month

15

Day

Date of IRB

2016

Year

09

Month

15

Day

Anticipated trial start date

2016

Year

10

Month

01

Day

Last follow-up date

2017

Year

07

Month

18

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Design: Cross-sectional
Method of Recruitment: Patients who satisfy selection criteria, and attend facilities conducting the present study from October, 2016 to March, 2019
Study Measure: Participant's historical information, Japanese Pain Stage of Change Questionnaire, Brief Pain Inventory, Pain Catastrophizing Scale, Pain Self-Efficacy Questionnaire, Chronic Pain Coping Inventory, the patient's global impression of change

Registered date

2016

Year

09

Month

20

Day

Last modified on

2019

Year

03

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027752