Effect of Extracorporeal Shock Wave Therapy on Motor and Sensory Function After Acute Traumatic Spinal Cord Injury Within Six Months

What this Trial Is About

Researchers are investigating the effects of extracorporeal shock wave therapy ESWT on patients with acute traumatic spinal cord injury SCI. SCI causes primary mechanical damage to the spinal cord followed by secondary injury processes that worsen neurological function. The study aims to intervene early, within 48 hours of injury, to reduce neuronal damage by targeting the secondary injury phase. Previous animal studies have shown that ESWT may improve nerve regeneration and motor function after SCI. The trial compares two groups one receiving ESWT applied once at the spinal cord lesion and surrounding segments, plus the soles of both feet, and a control group receiving a sham procedure without shock waves. The treatment is given as soon as possible within 48 hours post-injury. The device used is the Orthogold 100 shockwave generator. The study is randomized, double-blind, and placebo-controlled to assess ESWTs impact. Participants will be evaluated over six months, with measurements including changes in motor scores, sensory function, spasticity, walking ability, urological function, hand grip tests, and independence in daily life. Safety is monitored through adverse event reporting during the first 21 days. The study tracks neurological function changes from baseline to six months to understand ESWTs potential to improve recovery after acute SCI.

NEUROwave - Extracorporeal Shock Wave Therapy (ESWT) in Acute Traumatic Complete (AIS A) and Incomplete (AIS B-D) Cross-sectional Lesions on Motor and Sensory Function Within Six Months After Injury