Tokyo, Dec. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060088) titled 'Effect of focused extracorporeal shock waves on walking-induced hypoxia in knee osteoarthritis with bone marrow lesions' on Dec. 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Morinomiya University of Medical Sciences
Condition:
Condition - Knee osteoarthritis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To determine whether focused extracorporeal shock waves improve walking-induced hypoxia in patients with knee osteoarthritis and bone marrow lesions
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - foucusd extracorporeal shock wave therapy: 0.27 mJ/mm2, 2000 shots, 4 Hz, administered once weekly for 3 weeks to the site with bone marrow lesions. Physical therapy: Once weekly.
Interventions/Control_2 - Physical therapy: Once weekly.
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients diagnosed with osteoarthritis of the knee, with a Visual Analogue Scale evaluation of 30 mm or more at the medial knee joint and bone marrow lesions at the medial tibiofemoral joint on MRI.
Key exclusion criteria - Grade IV in the Kellgren-Lawrence classification, history of knee trauma or neurological disease, bilateral symptomatic knee osteoarthritis, bone marrow lesions with osteonecrosis on MRI findings, systemic diseases such as rheumatoid arthritis, autoimmune diseases, tumors, and contraindications to ESWT systemic diseases such as rheumatoid arthritis, autoimmune diseases, and tumors, as well as those with contraindications to extracorporeal shock wave therapy.
Target Size - 32
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 15 Day
Anticipated trial start date - 2025 Year 12 Month 15 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068723
Disclaimer: Curated by HT Syndication.