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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009299
Receipt No. R000010907
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
Date of disclosure of the study information 2012/11/09
Last modified on 2014/05/23

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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 No longer recruiting
Date of protocol fixation
2012 Year 09 Month 12 Day
Date of IRB
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
2014 Year 05 Month 23 Day


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

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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