![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | ||
Condition | Secondary lymphedema | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 |