UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039579 |
|---|---|
| Receipt number | R000045138 |
| Scientific Title | Randomized controlled study on efficacy of kinesitherapy using therapeutic modality in knee osteoarthritis |
| Date of disclosure of the study information | 2020/02/25 |
| Last modified on | 2024/02/27 11:46:02 |
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Basic information
Public title
Randomized controlled study on efficacy of kinesitherapy using therapeutic modality in patients with knee osteoarthritis
Acronym
Randomized controlled study on efficacy of kinesitherapy using therapeutic modality in knee osteoarthritis
Scientific Title
Randomized controlled study on efficacy of kinesitherapy using therapeutic modality in knee osteoarthritis
Scientific Title:Acronym
Randomized controlled study on efficacy of kinesitherapy using therapeutic modality in 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 kinesitherapy with and without therapeutic modality for knee osteoarthritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical symptoms are scored by self reported measurement outcomes using the Japanese Knee Osteoarthritis Measure before rehabilitation, 3 months and 6 months 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 6 months after rehabilitation.
Knee radiography are evaluated before rehabilitation to measure knee osteoarthritis grade and leg alignment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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 knee range of motion exercise, stretching, and strengthening, which are instructed by a physical therapist once a week during 3 months
Interventions/Control_2
In addition to the kinesitherapy, ultrasound therapy is performed once a week during 3 months for their both knees.
Interventions/Control_3
In addition to the kinesitherapy, NMES is performed once a week during 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
| 80 | 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 without any walker aids.
Key exclusion criteria
Exclusion criteria are the patients with goat or collagen disease as underlying disease, and the patients with bone necrosis, bone fracture, acute knee joint edema, or surgery such as knee arthroplasty.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Koun |
| Middle name | |
| Last name | Yamauchi |
Organization
Akita hospital
Division name
Department of orthopedic surgery
Zip code
4720056
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 | Yamada |
| Middle name | |
| Last name | Daisuke |
Organization
Akita hospital
Division name
Research support division
Zip code
4720056
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
No funding.
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
Akita hospital(Aichi)
Address
2-6-12 Takara, Chiryu City, Aichi, Japan
Tel
0566-81-2763
sougo@akitahospital.or.jp
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）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 25 | Day |
Related information
URL releasing protocol
No
Publication of results
Unpublished
Result
URL related to results and publications
Not completed
Number of participants that the trial has enrolled
93
Results
Analysing
Results date posted
| 2024 | Year | 02 | Month | 27 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Analysing
Date of the first journal publication of results
Baseline Characteristics
Knee osteoarthritis (OA) is a common disease in worldwide and leads to pain and instability of the knee. Therapeutic exercise, particularly including combining exercises to increase muscle strength and flexibility, and aerobic capacity, can improve these knee symptoms, and secondarily increase physical function and participation in social and recreational activities for patients with knee OA (Uthman ). The evidence of therapeutic exercise efficacy in patients with knee OA has been strongly confirmed (Uthman ); however, therapeutic exercise was not effective for all of patients with knee OA and the effective rate was 74% (Skou ). Although some authors have reported that therapeutic exercise efficacy on knee pain relief was affected by age (Goh et al.) and by varus knee alignment (Lim BW ), the other possible potential determinants of therapeutic exercise efficacy in patients with knee OA have been unknown.
Participant flow
This prospective cohort study was conducted between 2016 and 2023 in a hospital at the department of orthopedic surgery examination of outpatients. A total of 93 patients, aged 60 to 80 years, who complained of knee pain lasting for 3 months in one or both knees, were able to walk without using a cane, and who were diagnosed as medial knee OA by the first author (17 years of experience), based on the Kellgren Lawrence classification using radiography, were registered into the study. Of 93 patients, 87 were followed up for 3 months.
Adverse events
No
Outcome measures
Measurements of lower extremity and patella alignments
Measurements of subcutaneous fat thickness, individual QM thicknesses, power-Doppler (P/D) scores and joint effusion in the knee
Evaluation for knee function and self-reported score on knee pain and ADL
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 24 | Day |
Last modified on
| 2024 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045138
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