Gad Shaked1, Daniela Shaked2, Gilbert Sebbag3, David Czeiger3. 1. Department of General Surgery and Trauma Unit, Soroka University Medical Center and Ben-Gurion University, Wingate St. 64, 84101, Beer Sheva, Israel. shakedg@bgu.ac.il. 2. Physical Therapy Department, Recanati School for Community Health Professions, Faculty of Health Sciences, Ben-Gurion University, Beer Sheva, Israel. 3. Department of General Surgery and Trauma Unit, Soroka University Medical Center and Ben-Gurion University, Wingate St. 64, 84101, Beer Sheva, Israel.
Abstract
PURPOSE: There is significant evidence in the literature that low or relatively low cortisol concentrations near the time of an accident are associated with more severe forms of whiplash-associated disorders. We hypothesized that treating patients that were involved in a motor vehicle accident with hydrocortisone would alleviate the incidence and severity of these disabling disorders. METHODS: A prospective, randomized, double-blind, placebo-controlled clinical trial. Blunt trauma patients that underwent a motor vehicle crash were allocated into a study group that received a single bolus of hydrocortisone and a control group that received saline. The patients were followed for 1 month. The incidence and severity of whiplash associated disorder, functional disturbances, and post-traumatic stress disorder were compared between the two groups. The analyses were repeated for sub-divisions into groups of high and low admission cortisol. RESULTS: The more severe forms of whiplash-associated disorders on the day of accident were associated with low cortisol levels; mean cortisol concentration of the lower grade of whiplash patients (13.09 ± 7.35 µg%) was higher than that of whiplash syndrome of the severe forms (8.33 ± 3.45 µg), p = 0.001. There were no differences between study and control groups regarding whiplash-associated disorders, functional tests, and severity of stress disorder 1 month after the accident. Significant differences were evident between high and low cortisol sub-groups. Those who had low cortisol level on admission and received hydrocortisone had worse outcomes. CONCLUSION:Steroid treatment of patients with whiplash might be harmful to those who present with low cortisol concentrations (< 9.5 μg/dL). TRIAL REGISTRATION: Clinical Trials: Association between low cortisol levels and whiplash syndrome. Date of registration: March 18, 2014. Date the first participant was enrolled: May 10, 2014. TRIAL REGISTRATION NUMBER: NCT02090309. URL: https://clinicaltrials.gov/ct2/show/NCT02090309 .
RCT Entities:
PURPOSE: There is significant evidence in the literature that low or relatively low cortisol concentrations near the time of an accident are associated with more severe forms of whiplash-associated disorders. We hypothesized that treating patients that were involved in a motor vehicle accident with hydrocortisone would alleviate the incidence and severity of these disabling disorders. METHODS: A prospective, randomized, double-blind, placebo-controlled clinical trial. Blunt traumapatients that underwent a motor vehicle crash were allocated into a study group that received a single bolus of hydrocortisone and a control group that received saline. The patients were followed for 1 month. The incidence and severity of whiplash associated disorder, functional disturbances, and post-traumatic stress disorder were compared between the two groups. The analyses were repeated for sub-divisions into groups of high and low admission cortisol. RESULTS: The more severe forms of whiplash-associated disorders on the day of accident were associated with low cortisol levels; mean cortisol concentration of the lower grade of whiplash patients (13.09 ± 7.35 µg%) was higher than that of whiplash syndrome of the severe forms (8.33 ± 3.45 µg), p = 0.001. There were no differences between study and control groups regarding whiplash-associated disorders, functional tests, and severity of stress disorder 1 month after the accident. Significant differences were evident between high and low cortisol sub-groups. Those who had low cortisol level on admission and received hydrocortisone had worse outcomes. CONCLUSION:Steroid treatment of patients with whiplash might be harmful to those who present with low cortisol concentrations (< 9.5 μg/dL). TRIAL REGISTRATION: Clinical Trials: Association between low cortisol levels and whiplash syndrome. Date of registration: March 18, 2014. Date the first participant was enrolled: May 10, 2014. TRIAL REGISTRATION NUMBER: NCT02090309. URL: https://clinicaltrials.gov/ct2/show/NCT02090309 .