To determine the overall long-term effectiveness of treatment with epidural corticosteroid injections for lumbar central spinal stenosis and the effect of repeat injections, including crossover injections, on outcomes through 12 months.
Multicenter, double-blind, randomized controlled trial comparing epidural injections of corticosteroid plus lidocaine versus lidocaine alone.
Sixteen clinical sites.
Participants with imaging-confirmed lumbar central spinal stenosis (N=400).
Participants were randomized to receive either epidural injections with corticosteroid plus lidocaine or lidocaine alone with the option of blinded crossover after 6 weeks to receive the alternate treatment. Participants could receive 1 to 2 injections from 0 to 6 weeks and up to 2 injections from 6 to 12 weeks. After 12 weeks, participants received usual care.
Main Outcome Measures
Primary outcomes were the Roland-Morris Disability Questionnaire (RDQ) (range, 0–24, where higher scores indicate greater disability) and leg pain intensity (range, 0 [no pain] to 10 [pain as bad as you can imagine]). Secondary outcomes included opioid use, spine surgery, and crossover rates.
At 12 months, both treatment groups maintained initial observed improvements, with no significant differences between groups on the RDQ (adjusted mean difference, −0.4; 95% confidence interval [CI], −1.6 to 0.9; P=.55), leg pain (adjusted mean difference, 0.1; 95% CI, −0.5 to 0.7; P=.75), opioid use (corticosteroid plus lidocaine: 41.4% vs lidocaine alone: 36.3%; P=.41), or spine surgery (corticosteroid plus lidocaine: 16.8% vs lidocaine alone: 11.8%; P=.22). Fewer participants randomized to corticosteroid plus lidocaine (30%, n=60) versus lidocaine alone (45%, n=90) crossed over after 6 weeks (P=.003). Among participants who crossed over at 6 weeks, the 6- to 12-week RDQ change did not differ between the 2 randomized treatment groups (adjusted mean difference, −1.0; 95% CI, −2.6 to 0.7; P=.24). In both groups, participants crossing over at 6 weeks had worse 12-month trajectories compared with participants who did not choose to crossover.
For lumbar spinal stenosis symptoms, epidural injections of corticosteroid plus lidocaine offered no benefits from 6 weeks to 12 months beyond that of injections of lidocaine alone in terms of self-reported pain and function or reduction in use of opioids and spine surgery. In patients with improved pain and function 6 weeks after initial injection, these outcomes were maintained at 12 months. However, the trajectories of pain and function outcomes after 3 weeks did not differ by injectate type. Repeated injections of either type offered no additional long-term benefit if injections in the first 6 weeks did not improve pain.
List of abbreviations:CI (confidence interval), EMR (electronic medical record), ITT (intention-to-treat), LESS (Lumbar Epidural steroid injections for Spinal Stenosis), RDQ (Roland-Morris Disability Questionnaire)
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Published online: April 07, 2017
Supported by the Agency for Healthcare Research and Quality (award nos. 1R01HS019222-01 and 1R01HS022972-01) and the Patient-Centered Outcomes Research Institute (contract no. CE- 12-11- 4469).
Clinical Trial Registration No.: NCT01238536.
© 2016 by the American Congress of Rehabilitation Medicine