The noninferiority of the nonparticulate steroid dexamethasone vs the particulate steroids betamethasone and triamcinolone in lumbar transforaminal epidural steroid injections.

OBJECTIVE To assess whether a nonparticulate steroid (dexamethasone, 10 mg) is less clinically effective than the particulate steroids (triamcinolone, 80 mg; betamethasone, 12 mg) in lumbar transforaminal epidural steroid injections (TFESIs) in subjects with radicular pain with or without radiculopathy. DESIGN Retrospective observational study with noninferiority analysis of dexamethasone relative to particulate steroids. SETTING Single academic radiology pain management practice. SUBJECTS Three thousand six hundred forty-five lumbar TFESIs at the L4-5, L5-S1, or S1 neural foramina, performed on 2,634 subjects. METHODS/OUTCOME MEASURES Subjects were assessed with a pain numerical rating scale (NRS, 0-10) and Roland-Morris disability questionnaire (R-M) prior to TFESI, and at 2 weeks and 2 months follow-up. For categorical outcomes, successful pain relief was defined as either ≥50% reduction in NRS or pain 0/10; functional success was defined as ≥40% reduction in R-M score. Noninferiority analysis was performed with δ = -10% as the limit of noninferiority. Continuous outcomes (mean NRS, R-M scores) were analyzed for noninferiority with difference bounds of 0.3 for NRS scores and 1.0 for R-M scores. RESULTS With categorical outcomes, dexamethasone was demonstrated to be noninferior to the particulate steroids in pain relief and functional improvement at 2 months. Using continuous outcomes, dexamethasone was demonstrated to be superior to the particulate steroids in both pain relief and functional improvement at 2 months. CONCLUSION This retrospective observational study reveals no evidence that dexamethasone is less effective than particulate steroids in lumbar TFESIs performed for radicular pain with or without radiculopathy.