UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062100 |
|---|---|
| Receipt number | R000071055 |
| Scientific Title | Effects of an Eight-Week Neuromuscular Electrical Stimulation Program Targeting the Vastus Medialis on Muscle Echo Intensity and Knee Extension Strength in Patients with Knee Osteoarthritis: An Assessor-Blinded Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/07/10 |
| Last modified on | 2026/06/30 14:11:46 |
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Basic information
Public title
Effects of Electrical Stimulation of the Vastus Medialis in Patients with Knee Osteoarthritis
Acronym
KOA-NMES Trial
Scientific Title
Effects of an Eight-Week Neuromuscular Electrical Stimulation Program Targeting the Vastus Medialis on Muscle Echo Intensity and Knee Extension Strength in Patients with Knee Osteoarthritis: An Assessor-Blinded Randomized Controlled Trial
Scientific Title:Acronym
VM-NMES-KOA RCT
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of neuromuscular electrical stimulation (NMES) targeting the vastus medialis on muscle echo intensity, knee extension strength, and physical function in patients with knee osteoarthritis compared with conventional physical therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Vastus medialis echo intensity assessed by ultrasonography at baseline and after the 8-week intervention. Between-group differences in change from baseline will be analyzed.
Key secondary outcomes
Knee extension strength, vastus medialis muscle thickness, Knee Injury and Osteoarthritis Outcome Score, Timed Up and Go Test, and 30-Second Chair Stand Test, assessed at baseline and after the 8-week intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Participants will receive 20 minutes of exercise therapy followed by 20 minutes of neuromuscular electrical stimulation applied to the vastus medialis muscle, three times per week for 8 weeks (24 sessions).
Interventions/Control_2
Participants will receive 40 minutes of conventional physical therapy three times per week for 8 weeks (24 sessions).
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
| 85 | years-old | > |
Gender
Female
Key inclusion criteria
Women aged 60-84 years with symptomatic and radiographically confirmed medial knee osteoarthritis.
Able to ambulate independently with or without assistive devices.
No intra-articular knee injection within the previous month.
Written informed consent obtained.
Participants who provided written informed consent.
Key exclusion criteria
Kellgren-Lawrence grade <2.
Contraindications to NMES.
History of spinal or lower-extremity surgery.
History of diabetes mellitus, neurological disease, or rheumatoid arthritis.
Osteoarthritis affecting lower-extremity joints other than the knee.
Regular physiotherapy or resistance training within the previous 3 months.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Ikeda |
Organization
The Open University of Japan
Division name
Graduate School of Cultural Sciences, Doctoral Program in Cultural Sciences, Human Life and Health Sciences Program
Zip code
261-8586
Address
2-11 Wakaba, Mihama-ku, Chiba, Japan
TEL
043-276-5111
judo5411@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Ikeda |
Organization
The Open University of Japan
Division name
Graduate School of Cultural Sciences, Doctoral Program in Cultural Sciences, Human Life and Health S
Zip code
261-8586
Address
Wakaba, Mihama-ku, Chiba, Japan
TEL
043-276-5111
Homepage URL
judo5411@yahoo.co.jp
Sponsor or person
Institute
The Open University of Japan
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Open University of Japan Research Ethics Committee
Address
Wakaba, Mihama-ku, Chiba, Japan
Tel
043-276-5111
rinrishinsa@ouj.ac.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
けやき通り整形外科クリニック（岡山県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | 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
| 2026 | Year | 06 | Month | 30 | Day |
Last modified on
| 2026 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071055
