Tokyo, Sept. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063064) titled 'Efficacy of Neuromuscular Electrical Stimulation on Paraspinal Muscle Myosteatosis in Patients with Vertebral Fractures' on Sept. 26.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - Department of Physical Therapy Science, Nagasaki University Graduate School of Biomedical Sciences

Condition: Condition - patients with vertebral fracture Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the efficacy of neuromuscular electrical stimulation (NMES) combined with standard rehabilitation on preventing the progression of paraspinal muscle myosteatosis and improving functional outcomes in patients with fresh osteoporotic vertebral fractures (OVF) through a randomized controlled trial. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - In addition to conventional rehabilitation (including early mobilization, locomotion training, core exercises, and ADL training), participants receive neuromuscular electrical stimulation (NMES) using a portable electrical stimulator (ESPURGE). Electrodes are placed on the paraspinal muscles from L1 to L5. The stimulation parameters are set at a frequency of 50 Hz, pulse width of 250 usec, on-time of 8 seconds, and off-time of 10 seconds, with the intensity adjusted to the maximum tolerable level for each participant. The intervention is administered for 15 minutes per session, twice a day, 5 days a week, for 6 weeks. Interventions/Control_2 - Alongside conventional rehabilitation (including early mobilization, locomotion training, core exercises, and ADL training), participants receive transcutaneous electrical nerve stimulation (TENS) that does not induce muscle contraction. Using the same portable device (ESPURGE), electrodes are placed on the paraspinal muscles from L1 to L5. The parameters are set at a frequency of 1-200 Hz and a pulse width of 200 usec, with the stimulation intensity kept at the sensory threshold level without inducing visible muscle contraction. The application schedule is identical to the intervention group: 15 minutes per session, twice a day, 5 days a week, for 6 weeks.

Eligibility: Age-lower limit - 50 years-old

Gender - Male and Female Key inclusion criteria - 1) Diagnosed with a fresh vertebral fracture via magnetic resonance imaging (MRI). 2) Pre-injury ambulation ability is at an independent level. 3) Mini-Mental State Examination (MMSE) score of 24 or higher. 4) Provided informed consent to participate in this study. Key exclusion criteria - 1)Contraindicated for MRI scans due to active implanted electronic devices, indwelling metals, or other restrictions. 2)Severe comobidity that make exercise difficult. 3)Paraspinal muscle myosteatosis between the fourth and fifth lumbar vertebrae (L4-L5) is 50% or higher. Target Size - 44

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 06 Month 11 Day Date of IRB - 2026 Year 03 Month 18 Day Anticipated trial start date - 2026 Year 06 Month 11 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=R000070571

Disclaimer: Curated by HT Syndication.