The effect of extracorporeal shock wave therapy in acute traumatic spinal cord injury on motor and sensory function within 6 months post-injury: a study protocol for a two-arm three-stage adaptive, prospective, multi-center, randomized, blinded, placebo-controlled clinical trial

This study investigates whether extracorporeal shock wave therapy (ESWT) can improve motor and sensory function in patients with acute traumatic spinal cord injury (SCI). ESWT involves applying short-term acoustic pressure pulses to the injured area. The researchers aim to determine if ESWT can help reduce neuronal loss by intervening in the secondary injury phase that follows the initial mechanical damage of SCI. The trial is designed as a two-arm, three-stage adaptive study, involving multiple centers, randomization, blinding, and a placebo control to ensure rigorous and reliable results.

• 1
  ESWT has shown promise in preclinical studies for nerve regeneration, reducing neuronal degeneration, and improving motor function after spinal cord ischemia.
• 2
  The study hypothesizes that ESWT modulates the inflammatory response in tissues when applied during the acute injury phase, potentially promoting healing and recovery.
• 3
  Prior studies indicate that ESWT application, within the planned energy flux density and pulse range, does not cause tissue damage in neural or muscle/tendon tissues.