UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000024107
Receipt No. R000027752
Scientific Title Japanese validation study of the Pain Stage of Change Questionnaire
Date of disclosure of the study information 2016/09/26
Last modified on 2019/03/24 (Ver. 5)

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Basic information
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
Condition Chronic Pain
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes the Japanese version of the Pain Stage of Change Questionnaire
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

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

Research contact person
Last 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

Public contact
1st 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

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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
Address
Tel
Email

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
2016 Year 09 Month 26 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027752
Publication of results Published

Result
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

Progress
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
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

Management information
Registered date
2016 Year 09 Month 20 Day
Last modified on
2019 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027752