UMIN-CTR Clinical Trial

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
Email	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
Email	takashi.nuri@ompu.ac.jp

Sponsor
Institute	Osaka Medical and Pharmaceutical University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054688

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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