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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037328
Receipt No. 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 2020/01/31

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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
Email 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
Email s-ohashi@koto.kpu-m.ac.jp

Sponsor
Institute Department of Rehabilitation Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department

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
Email 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
2021 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
2020 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042496

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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