UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022060 |
|---|---|
| Receipt number | 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 08:01:38 |
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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
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
sougo@akitahospital.or.jp
Sponsor or person
Institute
Akita hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025411
