Study protocol for an inception cohort investigating possible predictors of systemic steroids effectiveness in treatment of acute sciatic pain

Abstract

ABSTRACTIntroductionSciatic pain secondary to nerve root compression occurs in approximately 1% of the general population in the United States, which represents enormous costs related to the treatment and loss of function of symptomatic individuals.Acute radicular pain is predominantly caused by herniation of the intervertebral disc but can also be caused by degenerative changes. Compressive and inflammatory mechanical factors are interrelated in the pathophysiology of symptoms.Although radiculopathy is self-limited in most cases, in its acute stage it is associated with painful symptoms and loss of essential function. The first-line treatment usually employed is a conservative approach, including a short rest period and use of common analgesics and nonsteroidal anti-inflammatory drugs.As an alternative to the conservative approach, the systemic administration of oral corticosteroids, such as prednisone, are widely used. However, the current literature shows contradictory results for this treatment in terms of improvement of pain and function.The present study hypothesizes that treatment with prednisone is effective in the treatment of acute sciatic pain in patients with social, clinical, and demographic characteristics favorable to this treatment.Objectivesthe main objective of the present study is to identify predictors, both clinical and imaging, of a positive response, in terms of both function and pain intensity, to prednisone treatment in patients with acute sciatic pain.Methods and analysisthe present study will include a cohort of patients, with a diagnosis of acute sciatica, who will receive treatment with oral prednisone. The pain and functional scores before and after treatment will be compared. Thereafter, the social, clinical, and radiographic characteristics of responsive patients will be compared to those of patients who did not respond well to the treatment.Ethics and disseminationthe study received the approval of Federal University of São Paulo Research Committee (4.232.193) and Research Ethics National Committee (CONEP).ARTICLE SUMMARYStrengths and limitations of this studyThe study is based on samples from a large population recruited from a reference facility for the treatment of acute sciatic pain.There is potential for optimization of treatment response with oral corticosteroids.The study will be conducted with a population with defined clinical characteristics.Due to the relatively short follow-up period, the project will not evaluate alternative treatments, such as surgery.