UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective comparison study on efficacy between physiotherapy and kinesitherapy for knee osteoarthritis in improvement of clinical symptoms and degeneration
Title of the study (Brief title)	Prospective comparison study on efficacy between the kinesitherapy combined with physiotherapy and single kinesitherapy for knee osteoarthritis
Region	Japan

Condition
Condition	Knee osteoarthritis
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare efficacy between the kinesitherapy combined with physiotherapy and single kinesitherapy for knee osteoarthritis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Clinical symptoms are assessed with the Japanese Knee Osteoarthritis Measure and Japanese Orthopaedic Association score for osteoarthritis knees before rehabilitation, 3 months and 1 year after the rehabilitation.
Key secondary outcomes	Knee range of motion, leg tightness are measured, and knee joint synovitis, joint edema, quadriceps muscle volume are evaluated using ultrasound device before rehabilitation, 3 months and 1 year after the rehabilitation. Knee X-rays are performed before rehabilitation and 1 year after the rehabilitation to evaluate osteoarthritis grade.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment Behavior,custom
Interventions/Control_1	Kinesitherapy includes legs stretching and strength training, which are instructed by a physical therapist within the first month. After that, the exercises are performed by patients themselves 3 times one week during 1 year.
Interventions/Control_2	In addition to the kinesitherapy, ultrasound therapy is performed 20 minutes once a week during the first 3 months for their both knees.
Interventions/Control_3	In addition to the kinesitherapy, hot pack therapy is performed 20 minutes once a week during the first 3 months for their both knees.
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	Inclusion criteria are the patients diagnosed as knee osteoarthritis by X-ray examination, who are able to walk completely on their own two feet.
Key exclusion criteria	Exclusion criteria are the patients with goat or collagen disease as underlying disease, and the patients with bone fracture, acute knee joint edema, or surgery such as knee arthroplasty.
Target sample size	90

Research contact person
Name of lead principal investigator	Koun Yamauchi
Organization	Akita hospital
Division name	Department of orthopedic surgery
Address	2-6-12 Takara, Chiryu City, Aichi, Japan
TEL	0566-81-2763
Email	koun_mail_world@yahoo.co.jp

Public contact
Name of contact person	Daisuke Yamada
Organization	Akita hospital
Division name	Research support division
Address	2-6-12 Takara, Chiryu City, Aichi, Japan
TEL	0566-81-2763
Homepage URL
Email	sougo@akitahospital.or.jp

Sponsor
Institute	Akita hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	秋田病院（愛知県）/Akita hospital(Aichi)

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 25 Day
Last follow-up date	2017 Year 08 Month 31 Day
Date of closure to data entry	2017 Year 09 Month 07 Day
Date trial data considered complete	2017 Year 09 Month 12 Day
Date analysis concluded	2017 Year 09 Month 17 Day

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

Management information
Registered date	2016 Year 04 Month 25 Day
Last modified on	2017 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025411