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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033455
Receipt No. R000038148
Scientific Title Examination on the effects of magnetic field irradiation on elderly with arthralgia
Date of disclosure of the study information 2018/07/23
Last modified on 2019/03/28

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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
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
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

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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