UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041190 |
|---|---|
| Receipt number | R000046762 |
| Scientific Title | Examination of factors affecting pain on walking and pain at rest in patients with knee osteoarthritis |
| Date of disclosure of the study information | 2020/07/22 |
| Last modified on | 2022/07/25 09:56:52 |
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Basic information
Public title
Examination of factors affecting pain on walking and pain at rest in patients with knee osteoarthritis
Acronym
Examination of factors affecting pain on walking and pain at rest in patients with knee osteoarthritis
Scientific Title
Examination of factors affecting pain on walking and pain at rest in patients with knee osteoarthritis
Scientific Title:Acronym
Examination of factors affecting pain on walking and pain at rest in patients with knee osteoarthritis
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the factors affecting each of pain on walking and pain at rest in patients with knee osteoarthritis
Basic objectives2
Others
Basic objectives -Others
To clarify the difference between the factors that affect pain on walking and pain at rest
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between pain intensity during walking and rest, and image data and pressure pain threshold
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
Knee Osteoarthritis (Kellgren Lawrence grade >=2)
Key exclusion criteria
1)History of surgery on ipsilateral knee
2)Systemic inflammatory arthritis (RA etc.)
3)Cognitive decline due to psychiatric disorders
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Satake |
Organization
Kochi Medical School, Kochi University
Division name
Department of Orthopaedic Surgery
Zip code
783-8505
Address
Kohasu, Okoh-cho, Nankoku-City, Kochi, JAPAN
TEL
088-880-2387
im35@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Taniuchi |
Organization
Kochi Medical School, Kochi University
Division name
Department of Orthopaedic Surgery
Zip code
783-8505
Address
Kohasu, Okoh-cho, Nankoku-City, Kochi, JAPAN
TEL
088-880-2387
Homepage URL
im35@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Kochi Medical School
Address
Kohasu, Okoh-cho, Nankoku-City, Kochi, JAPAN
Tel
088-880-2180
is21@kochi-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
| 2020 | Year | 07 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.dovepress.com/comparison-of-predisposing-factors-between-pain-on-walking-and-pain-at-pee
Number of participants that the trial has enrolled
93
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
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 20 | 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
We analyze the factors affecting knee pain in patients with knee osteoarthritis. The object variables are VAS on walking and at rest. We perform multivariate analysis using basic data such as age and sex, radiograph severity, MRI scoring, and knee pressure pain threshold as explanatory variables.
Management information
Registered date
| 2020 | Year | 07 | Month | 22 | Day |
Last modified on
| 2022 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046762
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
