UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of far-infrared radiation seat for treatment of the knee osteoarthritis
Title of the study (Brief title)	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	Yuji Uchio
Organization	Shimane University
Division name	Department of Orthopaedic Surgery
Address	89-1 Enyasgo Izumo Shimane
TEL	0853202240
Email	uchio@med.shimane-u.ac.jp

Public contact
Name of contact person	Yuji Uchio
Organization	Shimane University
Division name	Department of Orthopaedic Surgery
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 11 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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