COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

A randomized trial of epidural glucocorticoid injections for spinal stenosis

Janna L Friedly, Bryan A Comstock, Judith A Turner, Patrick J Heagerty, Richard A Deyo, Sean D Sullivan, Zoya Bauer, Brian W Bresnahan, Andrew L Avins, Srdjan S Nedeljkovic, David R Nerenz, Christopher Standaert, Larry Kessler, Venu Akuthota, Thiru Annaswamy, Allen Chen, Felix Diehn, William Firtch, Frederic J Gerges, Christopher Gilligan, Harley Goldberg, David J Kennedy, Shlomo Mandel, Mark Tyburski, William Sanders, David Sibell, Matthew Smuck, Ajay Wasan, Lawrence Won, Jeffrey G Jarvik
New England Journal of Medicine 2014 July 3, 371 (1): 11-21
24988555

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.).

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