UMIN-CTR Clinical Trial

Basic information
Public title	Effect of frequency-modulated electromagnetic therapy for increasing the lower extremity deep-vein blood flow, and improving edema: a randomized, placebo controlled trial
Acronym	Effect of frequency-modulated electromagnetic therapy on deep-vein blood flow and edema
Scientific Title	Effect of frequency-modulated electromagnetic therapy for increasing the lower extremity deep-vein blood flow, and improving edema: a randomized, placebo controlled trial
Scientific Title:Acronym	Effect of frequency-modulated electromagnetic therapy on deep-vein blood flow and edema
Region	Japan

Condition
Condition	edema, peripheral vascular disease
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The current study is to: 1) compare the before-after change of the lower extremity deep-vein blood flow, muscle hardness, and leg volume; and 2) compare the changes of aforementioned parameters among groups with the intervention of an electromagnetic therapy machine, a placebo machine, or without intervention.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Difference of the speed of the leg deep-vein blood flow Change rate of the speed of the leg deep-vein blood flow
Key secondary outcomes	Difference of the gastrocnemius muscle hardness Difference of the calf circumference Difference of the calf volume Difference of subjective estimative index with questionnaire

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	6
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	frequency-modulated electromagnetic therapy (electromagnetic therapy) -> an over 24h washout period (WO) -> dummy machine (placebo) -> WO -> without intervention
Interventions/Control_2	electromagnetic therapy -> WO -> without intervention -> WO -> placebo
Interventions/Control_3	placebo -> WO -> electromagnetic therapy -> WO -> without intervention
Interventions/Control_4	placebo -> WO -> without intervention -> WO -> electromagnetic therapy
Interventions/Control_5	without intervention-> WO -> electromagnetic therapy -> WO -> placebo
Interventions/Control_6	without intervention -> WO -> placebo -> WO -> electromagnetic therapy
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Outpatients of Seisen Clinic Orthopedics in Sizuoka, Males and females aged over 18 years, Without history of venous thrombosis, Without history of lower extremity surgery, Without history of diabetes, cardiac disease or respiratory disease, Without communication problem.
Key exclusion criteria	Patients underwent injury treatment, Patients with lower extremity deisease or underwent leg rehabilitates, Patients with nerve disease, Patients who was judged ineligible to be recruited by the principal investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Keika HOSHI
Organization	Kitasato University, School of Medicine
Division name	Department of Preventive Medicine
Zip code
Address	1-15-1 Kitasato, Minami-ku, Sagamihara 252-0374 Kanagawa, Japan
TEL	0427788111
Email	kcrcinfo@med.kitasato-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yasutoshi SAKAMOTO
Organization	Kitasato University, School of Medicine
Division name	Kitasato Clinical Research Center
Zip code
Address	1-15-1 Kitasato, Minami-ku, Sagamihara 252-0374 Kanagawa, Japan
TEL	+81-(0)42-777-6308
Homepage URL
Email	kcrcinfo@med.kitasato-u.ac.jp

Sponsor
Institute	Kitasato Clinical Research Center
Institute
Department

Funding Source
Organization	NIKKEN Inc
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	清泉クリニック整形外科（静岡）　Seisen Clinic Orthopedics

Other administrative information
Date of disclosure of the study information	2012 Year 11 Month 09 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	Completed
Date of protocol fixation	2012 Year 09 Month 12 Day
Date of IRB	2012 Year 09 Month 12 Day
Anticipated trial start date	2012 Year 11 Month 07 Day
Last follow-up date	2013 Year 01 Month 31 Day
Date of closure to data entry	2013 Year 03 Month 31 Day
Date trial data considered complete	2013 Year 03 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2012 Year 11 Month 09 Day
Last modified on	2020 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010907