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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000026405
Receipt No. R000030336
Scientific Title Effectiveness of far-infrared radiation seat for treatment of the knee osteoarthritis
Date of disclosure of the study information 2017/03/05
Last modified on 2017/03/05

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Basic information
Public title Effectiveness of far-infrared radiation seat for treatment of the knee osteoarthritis
Acronym far-infrared radiation seat
Scientific Title Effectiveness of far-infrared radiation seat for treatment of the knee osteoarthritis
Scientific Title:Acronym far-infrared radiation seat
Region
Japan

Condition
Condition Knee OA
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effectiveness of far-infrared radiation seat for treatment of the knee osteoarthritis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical symptom
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 far-infrared radiation seat
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) more than 50-year-old, knee OA.
2) Lysholm Knee Score is less than 64.
3) the person who could get the consent which is study participation by a document.
Key exclusion criteria 1) person with the medical history of the skin disease
2) person with the medical history of the medicine hyperesthesia
3) person with a severe liver, a kidney, a heart disease and gastrointestinal dysfunction
4) diabetes and a diffuse collagen disease, person with during treatment or the medical history
5) additionally a study person in charge or a study allotment person is the person who judged study participation to be unsuitable.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Uchio
Organization Shimane University
Division name Department of Orthopaedic Surgery
Zip code
Address 89-1 Enyasgo Izumo Shimane
TEL 0853202240
Email uchio@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Uchio
Organization Shimane University
Division name Department of Orthopaedic Surgery
Zip code
Address 89-1 Enyasgo Izumo Shimane
TEL 0853202240
Homepage URL
Email uchio@med.shimane-u.ac.jp

Sponsor
Institute Shimane University
Institute
Department

Funding Source
Organization Shimane University
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
2017 Year 03 Month 05 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
Date of protocol fixation
2015 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 05 Day
Last modified on
2017 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030336

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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