The Role of Riluzole in Acute Traumatic Cervical Spinal Cord Injury with Incomplete Neurological Deficit: A Prospective, Randomised Controlled Study.

Abstract

Riluzole, a benzothiazole sodium channel blocker is acknowledged as a neuroprotective agent in spinal cord injury (SCI). Most of this evidence is based on pre-clinical studies and its effectiveness in clinical setting is undetermined, heretofore. A prospective, randomised-controlled study was conducted between April 2019 and March 2020 at a tertiary-level centre. Patients aged 18-65 years with sub-axial cervical spine injury, who presented within 72 h of injury with incomplete neuro-deficit, were included. They were randomised into groups A (riluzole was administered) and B (no adjuvants). All patients were followed up at 6 weeks/3/6/12 months, and clinical [ASIA motor/sensory scores/grade, SCIM3, and NRS (neuropathic pain)] and radiological evaluation was performed. Twenty-three and 20 patients were included in groups A and B. Two in group A were females, while others were males (<i>p</i> = 0.49). Mean age in groups A and B was 47.7 ± 14.8 and 51.2 ± 14.1 years (<i>p</i> = 0.44). Five patients died prior to 6th-week follow-up. Among the others, there was significant improvement in all neurological parameters in both groups (post-injury vs 1-year; motor score: <i>p</i> < 0.001, sensory score: <i>p</i> < 0.001, SCIM3: <i>p</i> < 0.001, NRS: <i>p</i> < 0.001). In both groups, initial significant improvement was noticed even at the 6th-week follow-up, which further continued until the end of 1 year. There was no statistically significant difference between groups A and B with respect to these neurological parameters (motor: <i>p</i> = 0.15, sensory: <i>p</i> = 0.39, SCIM3: <i>p</i> = 0.68, NRS: <i>p</i> = 0.06). Administration of riluzole did not significantly improve neurological outcome/neuropathic pain in our cohort. Nevertheless, both our groups demonstrated an overall improvement in neurological outcome at 1 year, as compared with immediate post-injury status.