The efficacy of Intrathecal Methyl-Prednisolone for acute Spinal cord injury: a prospective double-blinded randomized clinical trial

Abstract Study design: randomized clinical trialObjectives: evaluate the safety and effectiveness of intrathecal Methyl-Prednisolone compared to intravenous Methyl-Prednisolone in acute spinal cord injuriesSetting: Imam Reza Hospital, Tabriz University of Medical SciencesMethods: patients meeting our inclusion and exclusion criteria were enrolled in the study and divided randomly into two treatment arms: intrathecal and intravenous. Standard spinal cord injury care (including surgery) was given to each patient based on our institutional policy. Patients were then assessed for neurological status (based on ASIA scores, Frankel scores) and complications for six months and compared to baseline status after injury. To better understand the biological bases of methylprednisolone on SCI, we measured two biomarkers for oxidative stress (serum malondialdehyde and total antioxidant capacity) in these patients at arrival and day three after injury.Results: The present study showed no significant difference between the treatment arms in neurological status (sensory scores or motor scores) or complications. However, the within-group analysis showed improvement in neurological status in each treatment arm within six months. Serum malondialdehyde and total antioxidant capacity were analyzed, and no significant difference between the groups was seen.Conclusion: This is the first known clinical trial investigating the effect of Methyl-Prednisolone in acute SCI patients. We have shown that there might be a role in using MP in young patients with acute SCI. Further studies should be conducted to define the positive and negative effects of this somehow novel technique in different populations as well.