UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009299 |
|---|---|
| Receipt number | 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 | 2020/05/25 16:41:46 |
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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
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
kcrcinfo@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato Clinical Research Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010907
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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