UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026405 |
|---|---|
| Receipt number | 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 16:13:04 |
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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
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
uchio@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030336
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
