PI: Benjamin Friedman, MD - Montefiore Medical Center

Status: Pending submission

Lumbosacral radiculopathy due to a herniated intervertebral disc affects 1.6% of the population. While many patients recover over the weeks and months after an acute episode, 1/4 - 1/3 of patients develop chronic back pain and functional disability. Lumbosacral radiculopathy is a leading cause of work absenteeism and medical disability in an otherwise young and healthy population, and drives healthcare cost through surgery, rehabilitation, medications, and visits to medical and para-medical professionals. Despite the burden of this illness, there is a paucity of high-grade clinical evidence regarding its initial management. For example, it is often not clear if and when spinal surgery should be performed. Lumbosacral radiculopathy has long been believed to be due to mechanical impingement of a spinal nerve root by components of the intervertebral disc. More recently, compelling evidence has emerged that an inflammatory process triggered by a herniated nucleus pulposus is central to disease pathophysiology. Thus, it is a sensitized, inflamed nerve root that causes radicular pain and functional disability when subjected to normally non-noxious stimuli. In a recently completed randomized trial of 82 subjects, the principal investigator gathered evidence suggesting that early intervention with parenteral corticosteroids improved pain and functional disability outcomes one month after presentation to an Emergency Department for treatment of low back radiculopathy. Because both clinical research and a current understanding of the disease pathophysiology suggest that a safe and easily administered medical intervention may have a substantial impact on this important public health problem, we propose this large-scale randomized controlled trial to determine if a long-acting corticosteroid, methylprednisolone aceate, can improve the pain and functional outcome of patients who present to the emergency department with acute lumbosacral radiculopathy.