UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027473 |
|---|---|
| Receipt number | R000031472 |
| Scientific Title | Development and Validation of a Japanese version of the Short-Form Arthritis Self-Efficacy Scale in patients with knee osteoarthritis |
| Date of disclosure of the study information | 2017/05/24 |
| Last modified on | 2024/01/11 16:08:24 |
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Basic information
Public title
Development and Validation of a Japanese version of the Short-Form Arthritis Self-Efficacy Scale in patients with knee osteoarthritis
Acronym
Development of a Japanese version of the Short-Form Arthritis Self-Efficacy Scale
Scientific Title
Development and Validation of a Japanese version of the Short-Form Arthritis Self-Efficacy Scale in patients with knee osteoarthritis
Scientific Title:Acronym
Development of a Japanese version of the Short-Form Arthritis Self-Efficacy Scale
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop a Japanese version of the Short-Form Arthritis Self-Efficacy Scale and investigate its validity in people with knee osteoarthritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-Efficacy
Key secondary outcomes
pain, physical function, depression, coping
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Kellgren-Lawrence grade is more than 2
Knee pain on most days of the past month
Key exclusion criteria
History of knee joint replacement on study knee.
Any other condition affecting lower limb function to a greater extent than their knee pain.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Uritani |
Organization
Kio University
Division name
Fuculty of Health Science
Zip code
6350832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragi-gun Nara
TEL
0745541601
d.uritani@kio.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Uritani |
Organization
Kio University
Division name
Faculty of Health Science
Zip code
6350832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragi-gun Nara
TEL
0745541601
Homepage URL
d.uritani@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
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
Kio University
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
Tel
0745541601
soumu@kio.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
| 2017 | Year | 05 | Month | 24 | Day |
Related information
URL releasing protocol
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0292426
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0292426
Number of participants that the trial has enrolled
179
Results
The Japanese 8-item Short-Form Arthritis Self-Efficacy Scale (ASES-8J) is a valid and reliable tool for assessing self-efficacy in Japanese patients with knee osteoarthritis (OA).
Results date posted
| 2024 | Year | 01 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were 179 individuals (52 male and 127 female participants; mean age: 70.1 years) with knee OA (KL grade; 2=60, 3=67, 4=52).
Participant flow
The participants were Japanese patients with painful knee OA recruited from five clinics and hospitals in different regions of Japan.
Participants completed the ASES-8J again within 2 weeks, which was the next visit from the first assessment of the ASES-8J.
Adverse events
None
Outcome measures
ASES-8J
Pain Self-Efficacy Questionnaire (PSEQ)
the problem-solving and positive thinking subscales of Brief Coping Orientation to Problems Experienced (Brief COPE)
Short-form version of Depression, Anxiety, and Stress Scale-21 (DASS-21)
Brief Fear of Movement Scale for Osteoarthritis (BFOMSO)
Pain Catastrophizing Scale (PCS)
Physical function subscale of Western Ontario and McMaster Arthritis Index (WOMAC)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study using questionnaires
Management information
Registered date
| 2017 | Year | 05 | Month | 24 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031472
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