A randomized trial of epidural glucocorticoid injections for spinal stenosis.

BACKGROUND: Epidural glucocorticoid injections are widely used to treat symptoms of lumbar spinal stenosis, a common cause of pain and disability in older adults. However, rigorous data are lacking regarding the effectiveness and safety of these injections. METHODS: In a double-blind, multisite trial, we randomly assigned 400 patients who had lumbar central spinal stenosis and moderate-to-severe leg pain and disability to receive epidural injections of glucocorticoids plus lidocaine or lidocaine alone. The patients received one or two injections before the primary outcome evaluation, performed 6 weeks after randomization and the first injection. The primary outcomes were the score on the Roland-Morris Disability Questionnaire (RMDQ, in which scores range from 0 to 24, with higher scores indicating greater physical disability) and the rating of the intensity of leg pain (on a scale from 0 to 10, with 0 indicating no pain and 10 indicating "pain as bad as you can imagine"). RESULTS: At 6 weeks, there were no significant between-group differences in the RMDQ score (adjusted difference in the average treatment effect between the glucocorticoid-lidocaine group and the lidocaine-alone group, -1.0 points; 95% confidence interval [CI], -2.1 to 0.1; P=0.07) or the intensity of leg pain (adjusted difference in the average treatment effect, -0.2 points; 95% CI, -0.8 to 0.4; P=0.48). A prespecified secondary subgroup analysis with stratification according to type of injection (interlaminar vs. transforaminal) likewise showed no significant differences at 6 weeks. CONCLUSIONS: In the treatment of lumbar spinal stenosis, epidural injection of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injection of lidocaine alone. (Funded by the Agency for Healthcare Research and Quality; ClinicalTrials.gov number, NCT01238536.).

A retrospective analysis of vertebral body fractures following epidural steroid injections.

BACKGROUND: Lumbar epidural steroid injections (LESIs) are frequently prescribed for the treatment of radiculopathy or neurogenic claudication arising from compression of spinal nerves. However, there is evidence suggesting that corticosteroids adversely affect bone strength by diminishing new bone formation and increasing bone resorption. Our study sought to assess whether LESIs increase the risk of subsequent vertebral body fracture. METHODS: A retrospective cohort study was conducted to compare patients receiving LESIs with a control group. A total of 50,345 patients with ICD-9 (International Classification of Diseases, Ninth Revision) diagnosis codes involving the spine were identified by searching a corporate database, and 3415 of these were found to have received at least one LESI. We randomly selected a study population of 3000 patients from the injected population, and we selected a matched cohort of 3000 patients from the non-injected group with use of propensity matching. The incidence of vertebral body fractures in each group was assessed with use of survival analysis. RESULTS: There was no significant difference between the injected and non-injected groups with respect to age, predicted propensity score, sex, race, hyperthyroidism, or steroid use. In the survival analysis, an increasing number of injections was associated with an increasing likelihood of fractures. Each successive injection increased the risk of fracture by a factor of 1.21 (95% confidence interval, 1.08 to 1.30) after adjustment for covariates (p = 0.003). CONCLUSIONS: The findings suggest that LESIs, like other forms of exogenous steroid administration, may lead to increased bone fragility. The added exposure to glucocorticoids resulting from LESI use may carry a greater risk than previously thought, suggesting that use of LESIs should be approached cautiously in patients at risk for osteoporotic fractures. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Effect of epidural steroid injection on bone mineral density and markers of bone turnover in postmenopausal women.

STUDY DESIGN: A prospective, observational study. OBJECTIVE: To evaluate the effect of epidural steroid injection (ESI) on bone mineral density (BMD) in postmenopausal women. SUMMARY OF BACKGROUND DATA: ESIs are used to treat the pain associated with radiculopathy. Although it is known that exogenous steroid use can disrupt skeletal architecture, it is less clear whether ESIs result in a decrease of BMD. METHODS: Twenty-eight postmenopausal women experiencing radiculopathy elected L4-L5 ESI treatment. We had a 50% dropout rate due to noncompliance with study requirements. BMD of the hip, femoral neck, and spine along with markers of bone turnover, bone specific-alkaline phosphatase and serum C-telopeptide of collagen I (CTX), was evaluated at baseline preinjection and 3 and 6 months postinjection. RESULTS: There was a significant decline in the hip BMD of 0.018 g/cm (0.028 ± 0.007, P = 0.002) at 6 months compared with baseline. We compared this decline with an age-matched control population that exhibited a decline of 0.003 g/cm(2), significantly less than our study population (P = 0.007). Bone-specific alkaline phosphatase increased significantly by 2.33 U/L from 3 to 6 months (P = 0.012), but the rise of CTX was not significant. CONCLUSION: A single ESI in postmenopausal women adversely affects BMD of the hip. This is in conjunction with a rise in bone remodeling activity, as evidenced by an increase in bone-specific alkaline phosphatase and CTX. In addition, when compared with an age-matched control population, our study population exhibited a greater decline in BMD. Our findings show that epidural administration of corticosteroids has a deleterious effect on bone, which should be considered when contemplating treatment options for radiculopathy. The resulting decrease in BMD, while slight, suggests that ESIs should be used with caution in those at a risk for fracture.