Tokyo, July 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062100) titled 'Effects of Electrical Stimulation of the Vastus Medialis in Patients with Knee Osteoarthritis' on July 10.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - The Open University of Japan
Condition:
Condition - Knee Osteoarthritis
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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).
Eligibility:
Age-lower limit - 60
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 Size - 40
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071055
Disclaimer: Curated by HT Syndication.