Evaluation the comparative effect of Riluzole and Methylprednisolone combined treatment and Methylprednisolone in function of acute spinal cord injury (a clinical trial)

Determining the comparative effect of combined treatment of methylprednisolone with Riluzole and Methylprednisolone alone in improving the performance of acute spinal cord injury at thoracolumbar junction.

Clinical trial with controlled group, with parallel group, double-blind, randomized, phase 3 on 94 patients, random block allocation method using randomization.

The number of 94 patients with spinal cord injury in thoracolumbar junction and functional disorder, who meet the entry criteria, who refer to the emergency room of Madani (Karaj) & Sina hospital (Tehran) and need surgery based on the TLICS table, will be included. Riluzole & placebo in the first 12 houts of SCI and Methylprednisolone started in the first 8 hours after the trauma. All patients within 24 hours will undergo surgery. Patients are evaluated in 24 hours and next 6 weeks and 3 months by other neurosurgeon. The information is available to the project manager.

Inclusion criteria: patients with T10-L2 fractures along with spinal cord injuries with TLICS >4 Frankle A to C acute spinal cord injuries Age 18-60 years old Having informed consent to start treatment Exclusion criteria: Liver failure Renal failure Uncontrollable diabetes

The intervention group: patients aged 18 to 60 with T10-L2 fractures along with spinal cord injuries Frankle A to C with TLICS >4 and having informed consent to start treatment with methylprednisolone and riluzole The control group: patients aged 18 to 60 with T10-L2 fractures along with spinal cord injuries Frankle A to C with TLICS >4 and having informed consent to start treatment with methylprednisolone and placebo

Age, gender, treatment start time, functional recovery, Frankle scale, ASIA grade, sensory, movement, sphincter, autonomic disorder, TLICS, AST, ALT

According to the formula of the sample size and after applying the entry and exit criteria, 94 people will enter the study in two groups and will be divided by random block allocation method using randomization software. They will be selected using quadruple blocks, Code A is intervention group ( Riluzole and Methylprednisolone ) and code B is comparison group ( Methylprednisolone and placebo ). We will 6 combinations (AB,BA), (BB,AA), (BA,AB), (BA,BA), (AB,AB), (AA,BB). Randomly one of these blocks is selected and based on the sequence of letters A and B in the selected block, The individuals of the condition unit will be assigned on the treatment or comparison groups. This random process of selecting blocks and assigning people to the intervention and comparison groups will reach the sample size of the case.

Patient with thoracolumbar fractures & neurologic defect and visited by another neurosurgeon and are divided into 2 groups A and B if they meet the entry criteria. Patients and researcher do not know how to allocate Riluzole and Placebo. Placebo and Riluzole are similar of shape and size. Both groups receive Methylprednisolone and undergo surgery.

Information on variables and main outcome

After the publication of results

Researchers & academic institutions

Use of statistical data and treatment effect

Email:bozorgmehrkamal@gmail.com

The desired questions should be sent in PDF format to the relevant email, and the answer will Sent within a week