Back Pain
Millions of back pain patients receive 10-12 million epidural steroid injections (ESIs) every year for back pain. [2,3]
A herniated disc is the most common cause of this type of back pain.
The injection is usually performed in a fluoroscopy suite to verify placement of the needle in the epidural tissue just outside the spinal cord. A significant portion of ESIs are repeat injections (a 2nd, 3rd, or 4th injection) over the first few months of treatment. Elimination of these repeat ESIs would drastically reduce the number of injection procedures that are performed, reduce procedure related infections and complications, and aid in the management of overall treatment costs. There is a documented risk of paralysis with transforaminal epidural injections of water insoluble generic steroids, which has been communicated by the FDA in 2014. [4]
There is no FDA approved steroid for epidural injection to treat back pain. All ESI's are performed 'off-label'.
(1) Dieleman, J. L. et al. US Health Care Spending by Payer and Health Condition, 1996-2016. JAMA 323, 863–884 (2020). (2) Manchikanti, Laxmaiah, Mark V. Boswell, Sukdeb Datta, Bert Fellows, Salahadin Abdi, Vijay Singh, Ramsin M. Benyamin, et al. 2009. “Comprehensive Review of Therapeutic Interventions in Managing Chronic Spinal Pain.” Pain Physician 12 (4): E123-198. (3) Abbott, Zach I., Kavita V. Nair, Richard R. Allen, and Venu R. Akuthota. 2012. “Utilization Characteristics of Spinal Interventions.” The Spine Journal: Official Journal of the North American Spine Society 12 (1): 35–43. (4) Racoosin, Judith A., Sally M. Seymour, Laurelle Cascio, and Rajdeep Gill. 2015. “Serious Neurologic Events after Epidural Glucocorticoid Injection — The FDA’s Risk Assessment.” New England Journal of Medicine
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