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A Randomized Trial of Epidural Glucocorticoid Injections for Spinal Stenosis
A Randomized Trial of Epidural Glucocorticoid Injections for Spinal Stenosis NEW ENGLAND JOURNAL OF MEDICINE Friedly, J. L., Comstock, B. A., Turner, J. A., Heagerty, P. J., Deyo, R. A., Sullivan, S. D., Bauer, Z., Bresnahan, B. W., Avins, A. L., Nedeljkovic, S. S., Nerenz, D. R., Standaert, C., Kessler, L., Akuthota, V., Annaswamy, T., Chen, A., Diehn, F., Firtch, W., Gerges, F. J., Gilligan, C., Goldberg, H., Kennedy, D. J., Mandel, S., Tyburski, M., Sanders, W., Sibell, D., Smuck, M., Wasan, A., Won, L., Jarvik, J. G. 2014; 371 (1): 11-21Abstract
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.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").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.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.).
View details for DOI 10.1056/NEJMoa1313265
View details for Web of Science ID 000338265700005