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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035774
Receipt No. R000040749
Scientific Title Noncoding RNA related to pain of osteoarthritis: Does miR-21 relate to osteoarthritic pain?
Date of disclosure of the study information 2019/02/04
Last modified on 2019/04/10

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Basic information
Public title Noncoding RNA related to pain of osteoarthritis: Does miR-21 relate to osteoarthritic pain?
Acronym Involvement of miR-21 in osteoarthritic pain
Scientific Title Noncoding RNA related to pain of osteoarthritis: Does miR-21 relate to osteoarthritic pain?
Scientific Title:Acronym Involvement of miR-21 in osteoarthritic pain
Region
Japan

Condition
Condition Osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A purpose is development of a new therapeutic agent of osteoarthritis (OA) by identification of noncoding RNA related to OA pain.
Basic objectives2 Others
Basic objectives -Others Mechanisms of disease
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation of miR-21 expression in synovium and synovial fluid of OA patients and Knee Injury and Osteoarthritis Outcome Score(KOOS) Pain Score
Key secondary outcomes (1) Correlation of miR-21 expression in synovium and synovial fluid of OA patients and Pain VAS score
(2) miR-21 expression of each group

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 Patients who visited the department of orthopaedic surgery of Nippon Medical School are considered for trial recruitment.
Eligibility criteria also includes an age of at least 20 years and any of following criteria.
(1) Patients with Kellgren-Lawrence classifications III-IV knee OA who take arthrocentesis of knee in outpatient clinic and whose pain VAS score is less than 50mm
(2) Patients without knee OA who take arthroscopic surgery and whose pain VAS score is less than 50mm
(3) Patients with knee OA who take knee replacement
Key exclusion criteria (1) Patients who do not consent for this research
(2) Patients who have psychiatric disorder
(3) Patients who can not answer questionnaire for pain due to dementia and others
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoya Hoshikawa
Organization Nippon Medical School
Division name Department of Orthopaedic Surgery
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8602, Japan
TEL +81-3-3822-2131
Email hoshikawa-nms@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoya Hoshikawa
Organization Nippon Medical School
Division name Department of Orthopaedic Surgery
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8602, Japan
TEL +81-3-3822-2131
Homepage URL
Email hoshikawa-nms@umin.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization Nippon Medical School
Organization
Division
Category of Funding Organization Self funding
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
2019 Year 02 Month 04 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 Open public recruiting
Date of protocol fixation
2019 Year 02 Month 04 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Confirmatory sudy

Patients who visit our department from February 4, 2019 to January 31, 2021 and meet the inclusion criteria are adopted.

Pain VAS score and KOOS score are recorded.
miR-21 expression in synovium and synovial fluid are measured by quantitative Polymerase Chain Reaction (PCR).

Management information
Registered date
2019 Year 02 Month 04 Day
Last modified on
2019 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040749

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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