UMIN-CTR Clinical Trial

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
Email	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
Email	im35@kochi-u.ac.jp

Sponsor
Institute	Kochi Medical School, Kochi University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046762