UMIN-CTR Clinical Trial

Basic information
Public title	Examination on the effects of magnetic field irradiation on elderly with arthralgia
Acronym	Effects of magnetic field irradiation on elderly with arthralgia
Scientific Title	Examination on the effects of magnetic field irradiation on elderly with arthralgia
Scientific Title:Acronym	Effects of magnetic field irradiation on elderly with arthralgia
Region	Japan

Condition
Condition	Arthropathy
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of arthralgia due to arthropathy in the elderly using a magnetic field irradiation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual Analog Scale (Evaluation up to 6 weeks before equipment start, every 1 week after starting)
Key secondary outcomes	vital signs Radiation part skin temperature Range of motion test Health related QOL scale (SF-8 Health Survey) (Evaluation up to 6 weeks before equipment start, every 1 week after starting)

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	Apply the magnetic field generator to the joint pain site. Twice a day (AM and PM), use the equipment once for 30 minutes. The magnetic field is not generated for two weeks from the start, and the magnetic field is generated for the following four weeks.
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	65 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with chronic lumbago or limb joint pain who explained the research sufficiently in the document and obtained consent.
Key exclusion criteria	Patients after pacemaker implantation Those containing metal in the body Dementia patients Patients undergoing oral treatment for arthralgia Patients who are using external medicine for arthralgia
Target sample size	18

Research contact person
Last name of lead principal investigator	1st name Tomoko Middle name Last name Ohkusa
Organization	Ube Frontier University
Division name	Faculty of Health Sciences
Zip code	755-0805
Address	2-1-1, Bunkyodai, Ube, Yamaguchi
TEL	0836-38-0500
Email	ohkusa@frontier-u.jp

Public contact
1st name of contact person	1st name Tomoko Middle name Last name Ohkusa
Organization	Ube Frontier University
Division name	Faculty of Health Sciences
Zip code	755-0805
Address	2-1-1, Bunkyodai, Ube, Yamaguchi
TEL	0836-38-0500
Homepage URL
Email	ohkusa@frontier-u.jp

Sponsor
Institute	Ube Frontier University, Faculty of Health Sciences
Institute
Department

Funding Source
Organization	General Foundation corporation, Yamaguchi old age Research Institute
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ube Frontier University and Ube Frontier University Junior College Research Ethics Committee
Address	2-1-1, Bunkyodai, Ube, Yamaguchi
Tel	0836-38-0500
Email	soumu@frontier-u.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	2018 Year 07 Month 23 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	14
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	Completed
Date of protocol fixation	2018 Year 07 Month 10 Day
Date of IRB	2018 Year 07 Month 10 Day
Anticipated trial start date	2018 Year 07 Month 23 Day
Last follow-up date	2018 Year 09 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 10 Month 05 Day

Other
Other related information

Management information
Registered date	2018 Year 07 Month 20 Day
Last modified on	2019 Year 03 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038148