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

A Randomized Trial

Janna L. Friedly, Bryan A. Comstock, Judith A. Turner, Patrick J. Heagerty, Richard A. Deyo, Zoya Bauer, Andrew L. Avins, Srdjan S. Nedeljkovic, David R. Nerenz, Xu Shi, Thiru Annaswamy, Christopher J. Standaert, Matthew Smuck, David J. Kennedy, Venu Akuthota, David Sibell, Ajay D. Wasan, Felix Diehn, Pradeep Suri, Sean D. Rundell & 3 others Larry Kessler, Allen S. Chen, Jeffrey G. Jarvik

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish (US)
JournalArchives of Physical Medicine and Rehabilitation
DOIs
StateAccepted/In press - 2016

Fingerprint

Spinal Stenosis
Lidocaine
Local Anesthetics
Adrenal Cortex Hormones
Injections
Epidural Injections
Pain
Opioid Analgesics
Spine
Confidence Intervals
Leg
Therapeutics
Randomized Controlled Trials

Keywords

  • Back pain
  • Injections, epidural
  • Rehabilitation
  • Spinal stenosis

ASJC Scopus subject areas

  • Physical Therapy, Sports Therapy and Rehabilitation
  • Rehabilitation

Cite this

Long-Term Effects of Repeated Injections of Local Anesthetic With or Without Corticosteroid for Lumbar Spinal Stenosis : A Randomized Trial. / Friedly, Janna L.; Comstock, Bryan A.; Turner, Judith A.; Heagerty, Patrick J.; Deyo, Richard A.; Bauer, Zoya; Avins, Andrew L.; Nedeljkovic, Srdjan S.; Nerenz, David R.; Shi, Xu; Annaswamy, Thiru; Standaert, Christopher J.; Smuck, Matthew; Kennedy, David J.; Akuthota, Venu; Sibell, David; Wasan, Ajay D.; Diehn, Felix; Suri, Pradeep; Rundell, Sean D.; Kessler, Larry; Chen, Allen S.; Jarvik, Jeffrey G.

In: Archives of Physical Medicine and Rehabilitation, 2016.

Research output: Contribution to journalArticle

Friedly, JL, Comstock, BA, Turner, JA, Heagerty, PJ, Deyo, RA, Bauer, Z, Avins, AL, Nedeljkovic, SS, Nerenz, DR, Shi, X, Annaswamy, T, Standaert, CJ, Smuck, M, Kennedy, DJ, Akuthota, V, Sibell, D, Wasan, AD, Diehn, F, Suri, P, Rundell, SD, Kessler, L, Chen, AS & Jarvik, JG 2016, 'Long-Term Effects of Repeated Injections of Local Anesthetic With or Without Corticosteroid for Lumbar Spinal Stenosis: A Randomized Trial', Archives of Physical Medicine and Rehabilitation. https://doi.org/10.1016/j.apmr.2017.02.029
Friedly, Janna L. ; Comstock, Bryan A. ; Turner, Judith A. ; Heagerty, Patrick J. ; Deyo, Richard A. ; Bauer, Zoya ; Avins, Andrew L. ; Nedeljkovic, Srdjan S. ; Nerenz, David R. ; Shi, Xu ; Annaswamy, Thiru ; Standaert, Christopher J. ; Smuck, Matthew ; Kennedy, David J. ; Akuthota, Venu ; Sibell, David ; Wasan, Ajay D. ; Diehn, Felix ; Suri, Pradeep ; Rundell, Sean D. ; Kessler, Larry ; Chen, Allen S. ; Jarvik, Jeffrey G. / Long-Term Effects of Repeated Injections of Local Anesthetic With or Without Corticosteroid for Lumbar Spinal Stenosis : A Randomized Trial. In: Archives of Physical Medicine and Rehabilitation. 2016.
@article{6ec12c86be874d9a84c156365d47b707,
title = "Long-Term Effects of Repeated Injections of Local Anesthetic With or Without Corticosteroid for Lumbar Spinal Stenosis: A Randomized Trial",
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 = "Back pain, Injections, epidural, Rehabilitation, Spinal stenosis",
author = "Friedly, {Janna L.} and Comstock, {Bryan A.} and Turner, {Judith A.} and Heagerty, {Patrick J.} and Deyo, {Richard A.} and Zoya Bauer and Avins, {Andrew L.} and Nedeljkovic, {Srdjan S.} and Nerenz, {David R.} and Xu Shi and Thiru Annaswamy and Standaert, {Christopher J.} and Matthew Smuck and Kennedy, {David J.} and Venu Akuthota and David Sibell and Wasan, {Ajay D.} and Felix Diehn and Pradeep Suri and Rundell, {Sean D.} and Larry Kessler and Chen, {Allen S.} and Jarvik, {Jeffrey G.}",
year = "2016",
doi = "10.1016/j.apmr.2017.02.029",
language = "English (US)",
journal = "Archives of Physical Medicine and Rehabilitation",
issn = "0003-9993",
publisher = "W.B. Saunders Ltd",

}

TY - JOUR

T1 - Long-Term Effects of Repeated Injections of Local Anesthetic With or Without Corticosteroid for Lumbar Spinal Stenosis

T2 - A Randomized Trial

AU - Friedly, Janna L.

AU - Comstock, Bryan A.

AU - Turner, Judith A.

AU - Heagerty, Patrick J.

AU - Deyo, Richard A.

AU - Bauer, Zoya

AU - Avins, Andrew L.

AU - Nedeljkovic, Srdjan S.

AU - Nerenz, David R.

AU - Shi, Xu

AU - Annaswamy, Thiru

AU - Standaert, Christopher J.

AU - Smuck, Matthew

AU - Kennedy, David J.

AU - Akuthota, Venu

AU - Sibell, David

AU - Wasan, Ajay D.

AU - Diehn, Felix

AU - Suri, Pradeep

AU - Rundell, Sean D.

AU - Kessler, Larry

AU - Chen, Allen S.

AU - Jarvik, Jeffrey G.

PY - 2016

Y1 - 2016

N2 - 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.

AB - 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.

KW - Back pain

KW - Injections, epidural

KW - Rehabilitation

KW - Spinal stenosis

UR - http://www.scopus.com/inward/record.url?scp=85019622745&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85019622745&partnerID=8YFLogxK

U2 - 10.1016/j.apmr.2017.02.029

DO - 10.1016/j.apmr.2017.02.029

M3 - Article

JO - Archives of Physical Medicine and Rehabilitation

JF - Archives of Physical Medicine and Rehabilitation

SN - 0003-9993

ER -