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Long-Term Effects of Repeated Injections of Local Anesthetic With or Without Corticosteroid for Lumbar Spinal Stenosis

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.
CI - Copyright (c) 2016 American Congress of Rehabilitation Medicine. Published by
Elsevier Inc. All rights reserved.

Langue : ANGLAIS

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