UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048074 |
|---|---|
| Receipt number | R000054688 |
| Scientific Title | Application of Electrical Muscle Stimulation as a treatment for lymphedema |
| Date of disclosure of the study information | 2022/06/16 |
| Last modified on | 2022/06/16 15:21:27 |
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Basic information
Public title
Application of Electrical Muscle Stimulation as a treatment for lymphedema
Acronym
Application of EMS as a treatment for lymphedema
Scientific Title
Application of Electrical Muscle Stimulation as a treatment for lymphedema
Scientific Title:Acronym
Application of EMS as a treatment for lymphedema
Region
| Japan |
Condition
Condition
Secondary lymphedema
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the efficacy and safety of EMS in patients with secondary lymphedema of the lower extremities by examining the effects of lower extremity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decrease in lower extremity circumference
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
With exercise using EMS
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
| 18 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient treated for lymphedema of the lower extremities at the Department of Plastic Surgery, Osaka Medical and Pharmaceutical University
Key exclusion criteria
History of any of the following
Primary lymphedema
Patients with pacemaker implantation
Cardiac disease or suspected cardiac disease
Patients whose physicians forbid exercise or the use of EMS equipment
Patients with venous thrombosis
Patients with metal implants such as bolts in the legs
Patients with scars on the sole of the foot
Patients who are pregnant or have just given birth
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | TAKASHI |
| Middle name | |
| Last name | NURI |
Organization
Osaka Medical and Pharmaceutical University
Division name
Plastic and Reconstructive Surgery
Zip code
569-8686
Address
2-7, Daigakumachi Takatsuki, Osaka
TEL
072-683-1221
takashi.nuri@ompu.ac.jp
Public contact
Name of contact person
| 1st name | TAKASHI |
| Middle name | |
| Last name | NURI |
Organization
Osaka Medical and Pharmaceutical University
Division name
Plastic and Reconstructive Surgery
Zip code
569-8686
Address
2-7, Daigakumachi Takatsuki, Osaka
TEL
072-683-1221
Homepage URL
takashi.nuri@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University
Address
2-7, Daigakumachi Takatsuki, Osaka
Tel
072-683-1221
takashi.nuri@ompu.ac.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
| 2022 | Year | 06 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 16 | Day |
Last modified on
| 2022 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054688
