UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of microcurrent electrical neuromuscular stimulation after total knee arthroplasty.
Title of the study (Brief title)	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	Kazuhisa Domen
Organization	Hyogo college of medicine
Division name	Department of rehabilitation
Address	1-1 Mukogawa-cho, Nishinomiya City, Hyogo, Japan
TEL
Email

Public contact
Name of contact person	Koichiro Sota
Organization	Hyogo college of medicine hospital
Division name	Department of rehabilitation
Address	1-1 Mukogawa-cho, Nishinomiya City, Hyogo, Japan
TEL	0798-45-6358
Homepage URL
Email	ksota-hyomed@umin.ac.jp

Sponsor
Institute	Department of rehabilitation, Hyogo college of medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011127