UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037328 |
|---|---|
| Receipt number | R000042496 |
| Scientific Title | Development of a screening method for arthritis using a radiation thermometer in patients with inflammatory joint disease |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2021/01/12 22:07:46 |
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Basic information
Public title
Development of a screening method for arthritis using a radiation thermometer in patients with inflammatory joint disease
Acronym
Development of a screening method for arthritis using a radiation thermometer
Scientific Title
Development of a screening method for arthritis using a radiation thermometer in patients with inflammatory joint disease
Scientific Title:Acronym
Development of a screening method for arthritis using a radiation thermometer
Region
| Japan |
Condition
Condition
Inflammatory joint disease (Rheumatoid Arthritis, Spondyloarthritis, etc)
Classification by specialty
| Clinical immunology | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of our research is to develop a low-cost, simple and safe screening method for arthritis using a radiation thermometer for patients with inflammatory joint disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Surface temperature of the upper limb joints
Key secondary outcomes
swelling and pain of the joints
presence of joint inflammation on enhanced MRI
CRP (mg/dl)
Composite measure (Simplified Disease Activity Index(SDAI), Clinical Disease Activity Index (CDAI), Disease Activity Score(DAS))
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Using a radiation thermometer (IT-480S), measure the joint surface temperature of a patient with inflammatory joint disease such as rheumatoid arthritis, and compare the surface temperature of the area with and without arthritis. Observe the change of surface temperature of inflamed joints over time. (Observation point: Day0, 1-2M, 2-4M)
Using a radiation thermometer (IT-480S), we measure and compare the joint surface temperature of patients with inflammatory joint disease or patients without inflammatory joint disease.
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 in hospital or outpatient of hospital of Kyoto Prefectural University of Medicine
Patients who consent to study participation with the document by free will
Patients aged 20 and over at the time of consent acquisition
Gender does not matter
Case group: Patients with inflammatory joint disease or suspicion such as rheumatoid arthritis
Control group: Patients without inflammatory joint disease
Key exclusion criteria
Patients with severe higher brain dysfunction
Patients with the following contraindications; heart disease, pacemaker user, infection, blood pressure abnormality, skin disease on applicable site, possibility of blood flow disorder
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Mikami |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
602-8566
Address
465, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan
TEL
075-251-5111
mikami@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Suzuyo |
| Middle name | |
| Last name | Ohashi |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
602-8566
Address
465, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan
TEL
075-251-5111
Homepage URL
s-ohashi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
HORIBA, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine, Clinical Research Review Board
Address
465, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan
Tel
075-251-5111
rinri@koto.kpu-m.ac.jp
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 | 08 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 10 | Day |
Last modified on
| 2021 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042496
