UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009518 |
|---|---|
| Receipt number | R000011127 |
| Scientific Title | The effect of microcurrent electrical neuromuscular stimulation after total knee arthroplasty. |
| Date of disclosure of the study information | 2012/12/12 |
| Last modified on | 2017/12/14 12:21:24 |
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Basic information
Public title
The effect of microcurrent electrical neuromuscular stimulation after total knee arthroplasty.
Acronym
The effect of microcurrent electrical neuromuscular stimulation after total knee arthroplasty.
Scientific Title
The effect of microcurrent electrical neuromuscular stimulation after total knee arthroplasty.
Scientific Title:Acronym
The effect of microcurrent electrical neuromuscular stimulation after total knee arthroplasty.
Region
| Japan |
Condition
Condition
Patients with knee joint osteoarthritis scheduled elective unilateral total knee arthroplasty.
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate whether MENS recover strength of knee joint, range of motion, circumference of thigh, abilities of daily living, health related quality of life, anxiety and depression after TKA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain, strength of knee joint, range of motion and circumference of thigh
Key secondary outcomes
Activities of daily living, health related quality life, anxiety, depression, days of ambulation with a cane and days of discharge.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Group MENS
We stimulate patients during 12 hours per day, 5 times per a week still discharge.
Interventions/Control_2
Group placebo
We set MENS machine to patients during 12 hours per a day, 5 times per a week still discharge but we don't stimulate patients.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Patients with knee joint osteoarthritis scheduled elective unilateral total knee arthroplasty at Hyogo college of medicine hospital.
2. Adults(>20 years)
3. Participants were scheduled for unilateral TKA for osteoarthritis.
4. Written informed consent is provided
Key exclusion criteria
1. Inability to communicate lucidly
2. Bilateral TKA concurrently
3. Revision knee arthroplasty
4. Under 20 years
5. Participants with functional electric stimulation systems.
6. Women with pregnancy, possibility of pregnancy or breast-feeding.
7. Participants with fragile skin
8. Doctors decided exclusion
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Domen |
Organization
Hyogo college of medicine
Division name
Department of rehabilitation
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichiro Sota |
Organization
Hyogo college of medicine hospital
Division name
Department of rehabilitation
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo, Japan
TEL
0798-45-6358
Homepage URL
ksota-hyomed@umin.ac.jp
Sponsor or person
Institute
Department of rehabilitation, Hyogo college of medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Physical Therapy Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 12 | 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 | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 12 | Day |
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
| 2012 | Year | 12 | Month | 11 | Day |
Last modified on
| 2017 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011127
