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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022060
Receipt No. R000025411
Scientific Title Prospective comparison study on efficacy between physiotherapy and kinesitherapy for knee osteoarthritis in improvement of clinical symptoms and degeneration
Date of disclosure of the study information 2016/04/25
Last modified on 2017/09/13

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Basic information
Public title Prospective comparison study on efficacy between physiotherapy and kinesitherapy for knee osteoarthritis in improvement of clinical symptoms and degeneration
Acronym Prospective comparison study on efficacy between the kinesitherapy combined with physiotherapy and single kinesitherapy for knee osteoarthritis
Scientific Title Prospective comparison study on efficacy between physiotherapy and kinesitherapy for knee osteoarthritis in improvement of clinical symptoms and degeneration
Scientific Title:Acronym 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
1st name
Middle name
Last name Koun Yamauchi
Organization Akita hospital
Division name Department of orthopedic surgery
Zip code
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
1st name
Middle name
Last name Daisuke Yamada
Organization Akita hospital
Division name Research support division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2016 Year 04 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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