UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045972
Receipt No. R000052474
Scientific Title Relationship between motion variability of knee and pain intensity during stepping movement in patients with knee osteoarthritis
Date of disclosure of the study information 2021/12/01
Last modified on 2021/11/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Relationship between motion variability of knee and pain intensity during stepping movement in patients with knee osteoarthritis
Acronym Relationship between motion variability of knee and pain intensity during stepping movement in patients with knee osteoarthritis
Scientific Title Relationship between motion variability of knee and pain intensity during stepping movement in patients with knee osteoarthritis
Scientific Title:Acronym Relationship between motion variability of knee and pain intensity during stepping movement 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 clarify the relationship between the "variability" of the knee joint inversion angle during the stepping movement and the intensity of knee joint pain, knee extension muscle strength, and the severity of knee deformity in patients with knee osteoarthritis.
Basic objectives2 Others
Basic objectives -Others To investigate the relationship between the degree of deformity progression and the angle of knee inversion and the angle of lateral tilt of the lower leg when stepping movement.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Variability of knee joint inversion angle during stepping movement.
Key secondary outcomes Intensity of knee joint pain during weight bearing

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
40 years-old <
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria The patient with 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 50

Research contact person
Name of lead principal investigator
1st name shigeki
Middle name
Last name yokoyama
Organization Kyoto Tachibana University
Division name Faculty of Health Science
Zip code 6078175
Address 34 Yamada-cho Oyake Yamashina-ku, Kyoto
TEL 0755711111
Email yokoyama-s@tachibana-u.ac.jp

Public contact
Name of contact person
1st name shigeki
Middle name
Last name yokoyama
Organization Kyoto Tachibana University
Division name Faculty of Health Science
Zip code 6078175
Address 34 Yamada-cho Oyake Yamashina-ku, Kyoto
TEL 0755711111
Homepage URL
Email yokoyama-s@tachibana-u.ac.jp

Sponsor
Institute Kyoto Tachibana University
Institute
Department

Funding Source
Organization Kyoto Tachibana University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Suginoshita Orthopeadics Clinic
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Ethical Review Board of Kyoto Tachibana University
Address 34 Yamada-cho Oyake Yamashina-ku, Kyoto
Tel 0755744186
Email tuho@tachibana-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
2021 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Preinitiation
Date of protocol fixation
2021 Year 06 Month 01 Day
Date of IRB
2021 Year 06 Month 24 Day
Anticipated trial start date
2021 Year 12 Month 01 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To investigate the factors affecting knee pain in patients with knee osteoarthritis during stepping movement.
The object variables are VAS on stepping movement.
We perform multivariate analysis using basic data such as radiograph severity, motion analysis of knee and hip.

Management information
Registered date
2021 Year 11 Month 03 Day
Last modified on
2021 Year 11 Month 03 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052474

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.