UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048074
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.