Spinal injury. Injury of nerves and lumbar spinal cord at abdomen, lower back and pelvis level
Conditions
Interventions
Intervention 1: Rilozul therapy will be performed in group A and after 6 months, sensory, motor and pain examinations will be done in all of patients. Rilozul will be administrated 50mg PO (by mouth)
Treatment - Drugs
Placebo
Rilozul therapy will be performed in group A and after 6 months, sensory, motor and pain examinations will be done in all of patients. Rilozul will be administrated 50mg PO (by mouth) every 12 hours c
Placebo will be administrated to control group and after 6 months, sensory and motor examinations will be done.
Sponsors
Vice Chancellor for research of Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. acute spinal cord injury with Frankel Impairment Scale level A to C; 2. 18 to 70 years old; 3. Informed consent; 4. C4 to L2 vertebral fractures Exclusion criteria: 1. Hepatic or renal disorders; 2. Penetrating brain trauma; 3. Traumatic brain injury; 4. Pregnancy or Breastfeeding; 5. Recent alcohol consumption; 6. Neurological or psychiatric disorders; 7. Life threatening injuries; 8. Unable to receive riluzole orally
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensory injury. Timepoint: Primary, 6 weeks and 6 months following end of treatment. Method of measurement: Frankel classification.;Motor injury. Timepoint: Primary, 6 weeks and 6 months following end of treatment. Method of measurement: Frankel classification.;Pain. Timepoint: Primary, 6 weeks and 6 months following end of treatment. Method of measurement: Visual Analog Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects. Timepoint: Primary, 6 weeks and 6 months following end of treatment. Method of measurement: Physical examination. | — |
Countries
Iran (Islamic Republic of)
Outcome results
None listed