Tokyo, Sept. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059062) titled 'Sustained Effects of High-Voltage Treatment on the Psoas Muscle in Patients with Acute Low Back Pain' on Sept. 15.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Waseda University
Condition:
Condition - Acute low back pain
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study investigates the sustained efficacy of high-voltage pulsed current therapy applied to the iliopsoas muscle in improving low back pain among patients with acute low back pain.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - While lying on your back, apply high-voltage treatment to left and right psoas muscles for 5minutes (130Hz x 3minutes, 5Hz x 2minutes) per session.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Severe low back pain during activities of daily living
Acute low back pain lasting less than 4 weeks
Aged 18 to 80 years
Moderate pain rated 4 or higher on the Numerical Rating Scale (NRS)
Key exclusion criteria - Waseda University undergraduate and graduate students
Patients with conditions presumed to be specific low back pain
Patients with clearly identifiable traumatic causes of injury
Patients with dementia
Patients with specific implanted electronic devices such as pacemakers
Patients with acute (painful) conditions of unknown cause
Patients with cardiac impairment
Patients with high bleeding risk
Patients with malignant tumors
Patients with febrile illnesses
Patients with infectious diseases
Pregnant women or women who have recently given birth
Patients at risk of vascular disorders such as thrombosis, venous thrombosis, or varicose veins
Other patients deemed unsuitable by the physician
Ischemic tissue
Areas with moderate or severe edema
Areas with sensory impairment
Skin damage or inflamed areas
Skin surfaces with venous distension (where veins are prominent)
Areas with implanted metal or plastic objects (e.g., artificial joints, buried pins)
Above the carotid sinus
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 01 Day
Anticipated trial start date - 2025 Year 09 Month 16 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067560
Disclaimer: Curated by HT Syndication.
