UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042496