The efficacy of intrathecal methyl-prednisolone for acute spinal cord injury: A pilot study

STUDY DESIGN: Randomized clinical trial. OBJECTIVES: To evaluate the safety and effectiveness of intrathecal methyl-prednisolone compared to intravenous methyl-prednisolone in acute spinal cord injuries. SETTING: Imam Reza Hospital, Tabriz University of Medical Sciences. METHODS: 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 methyl-prednisolone on spinal cord injuries, 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 intrathecal MP in acute SCI patients. Our finding did not show any significant differences in complication rates and neurological outcomes between the two study arms. Further studies should be conducted to define the positive and negative effects of this somehow novel technique in different populations as well.