UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of early neuromuscular electrical stimulation on quadriceps muscle after total knee Arthroplasty.
Title of the study (Brief title)	Effect of early NMES on quadriceps muscle after TKA
Region	Japan

Condition
Condition	Osteoarthritis of the knee
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examine the effect of neuromuscular electrical stimulation on the quadriceps muscle performed from 2 days after total replacement surgery until 2 weeks after total knee replacement surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Quadriceps muscle strength
Key secondary outcomes	Resting pain, quadriceps maximal contraction pain, knee flexion movement range, knee joint extension range, quadriceps muscle cross sectional area (and IMAT), patellar upper extreme level circumference, patellar superior proximal level circumference Diameter, TUG, SCT

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Neuromuscular electrical stimulation to the quadriceps femoris(Ten times in total for 30 minutes, between 2 days and 14 days after surgery)
Interventions/Control_2	Non-intervention
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	60 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients scheduled to undergo total knee arthroplasty for osteoarthritis
Key exclusion criteria	patients with bilateral TKA, patients with orthopedic disease with strong pain on the other side, patients with infection, neurological symptoms (paralysis of lower limbs etc.) Patients with dementia, skin hyperresponsiveness or skin trouble
Target sample size	80

Research contact person
Name of lead principal investigator	Takashi Hisano
Organization	Shiraniwa hospital
Division name	Department of Rehabilitation
Address	6-10-1, Shiraniwadai, Ikoma-shi, Nara, 630-0136, Japan
TEL	0743-70-0022
Email	takashi807@gmail.com

Public contact
Name of contact person	Takashi Hisano
Organization	Elixir
Division name	Nursing home care
Address	4137, Kamimachi, Ikoma-shi, Nara, 630-0131, Japan
TEL	0743-70-0070
Homepage URL
Email	takashi807@gmail.com

Sponsor
Institute	Department of Rehabilitation Shiraniwa hospital
Institute
Department

Funding Source
Organization	Shiraniwa hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	医療法人社団松下会　白庭病院

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 12 Month 01 Day
Anticipated trial start date	2018 Year 01 Month 14 Day
Last follow-up date	2018 Year 10 Month 31 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2019 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 13 Day
Last modified on	2018 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035697