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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024693
Receipt No. R000028411
Scientific Title The analysis of usefulness of LOQOA tape for osteoarthritis of the knee
Date of disclosure of the study information 2016/12/01
Last modified on 2018/05/07

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Basic information
Public title The analysis of usefulness of LOQOA tape for osteoarthritis of the knee
Acronym The analysis of usefulness of LOQOA tape for osteoarthritis of the knee
Scientific Title The analysis of usefulness of LOQOA tape for osteoarthritis of the knee
Scientific Title:Acronym The analysis of usefulness of LOQOA tape for osteoarthritis of the knee
Region
Japan

Condition
Condition Osteoarthritis of the knee
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare efficacy between the LOQOA tape and NSAIDs internally combined with existing poultices for knee osteoarthritis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Knee Injury and Osteoarthritis Outcome Score pain scale

Key secondary outcomes Visual Analog Scale (VAS)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 LOQOA tape is put for four weeks.
Interventions/Control_2 NSAIDs are administered in addition to putting existing poultices for four weeks.
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 Inclusion criteria are the patients diagnosed as knee osteoarthritis by X-ray examination, who have not receive a treatment previously.
Key exclusion criteria Exclusion criteria are the patients with severe osteoarthritis, collagen disease as underlying disease, and the patients with previous knee surgery.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuya Naraoka
Organization Hirosaki University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 5 Zaifu-cho, Hirosaki, Aomori 036-8562, Japan
TEL 0172-36-3826
Email takuya5@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuya Naraoka
Organization Hirosaki University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 5 Zaifu-cho, Hirosaki, Aomori 036-8562, Japan
TEL 0172-39-5083
Homepage URL
Email takuya5@hirosaki-u.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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
2016 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
2016 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 02 Day
Last modified on
2018 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028411

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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