Abstract
Objective
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.
Design
Multicenter, double-blind, randomized controlled trial comparing epidural injections
of corticosteroid plus lidocaine versus lidocaine alone.
Setting
Sixteen clinical sites.
Participants
Participants with imaging-confirmed lumbar central spinal stenosis (N=400).
Interventions
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.
Results
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.
Conclusions
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.
Keywords
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)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: April 07, 2017
Footnotes
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.
Disclosures: none.
Identification
Copyright
© 2016 by the American Congress of Rehabilitation Medicine
