Epidural steroid injections compared with gabapentin for lumbosacral radicular pain: Multicenter randomized double blind comparative efficacy study

Steven P. Cohen, Steven Hanling, Mark C. Bicket, Ronald L. White, Elias Veizi, Connie Kurihara, Zirong Zhao, Salim Hayek, Kevin B. Guthmiller, Scott R. Griffith, Vitaly Gordin, Mirinda Anderson White, Yakov Vorobeychik, Paul F. Pasquina

Research output: Contribution to journalArticle

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Abstract

OBJECTIVE: To evaluate whether an epidural steroid injection or gabapentin is a better treatment for lumbosacral radiculopathy. DESIGN: A multicenter randomized study conducted between 2011 and 2014. Computer generated randomization was stratified by site. Patients and evaluating physicians were blinded to treatment outcomes. SETTINGS: Eight military, Veterans Administration, and civilian hospitals. PARTICIPANTS: 145 people with lumbosacral radicular pain secondary to herniated disc or spinal stenosis for less than four years in duration and in whom leg pain is as severe or more severe than back pain. INTERVENTIONS: Participants received either epidural steroid injection plus placebo pills or sham injection plus gabapentin. MAIN OUTCOME MEASURES: Average leg pain one and three months after the injection on a 0-10 numerical rating scale. A positive outcome was defined as a ≥2 point decrease in leg pain coupled with a positive global perceived effect. All patients had one month follow-up visits; patients whose condition improved remained blinded for their three month visit. RESULTS: There were no significant diferences for the primary outcome measure at one month (mean pain score 3.3 (SD 2.6) and mean change from baseline -2.2 (SD 2.4) in epidural steroid injection group versus 3.7 (SD 2.6) and -1.7 (SD 2.6) in gabapentin group; adjusted diference 0.4, 95% confidence interval -0.3 to 1.2; P=0.25) and three months (mean pain score 3.4 (SD 2.7) and mean change from baseline -2.0 (SD 2.6) versus 3.7 (SD 2.8) and -1.6 (SD 2.7), respectively; adjusted difference 0.3, -0.5 to 1.2; P=0.43). Among secondary outcomes, one month after treatment those who received epidural steroid injection had greater reductions in worst leg pain (-3.0, SD 2.8) than those treated with gabapentin (-2.0, SD 2.9; P=0.04) and were more likely to experience a positive successful outcome (66% v 46%; number needed to treat=5.0, 95% confidence interval 2.8 to 27.0; P=0.02). At three months, there were no significant differences between treatments. CONCLUSIONS: Although epidural steroid injection might provide greater benefit than gabapentin for some outcome measures, the differences are modest and are transient for most people. TRIAL REGISTRATION: ClinicalTrials.gov Identifer: NCT01495923.

Original languageEnglish (US)
Article numberh1748
JournalBMJ (Online)
Volume350
DOIs
StatePublished - Apr 16 2015
Externally publishedYes

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Epidural Injections
Steroids
Pain
Leg
Outcome Assessment (Health Care)
Confidence Intervals
Spinal Stenosis
Numbers Needed To Treat
Intervertebral Disc Displacement
United States Department of Veterans Affairs
Injections
Radiculopathy
Back Pain
Random Allocation
gabapentin
Multicenter Studies
Therapeutics
Placebos
Physicians

ASJC Scopus subject areas

  • Medicine(all)

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Epidural steroid injections compared with gabapentin for lumbosacral radicular pain : Multicenter randomized double blind comparative efficacy study. / Cohen, Steven P.; Hanling, Steven; Bicket, Mark C.; White, Ronald L.; Veizi, Elias; Kurihara, Connie; Zhao, Zirong; Hayek, Salim; Guthmiller, Kevin B.; Griffith, Scott R.; Gordin, Vitaly; White, Mirinda Anderson; Vorobeychik, Yakov; Pasquina, Paul F.

In: BMJ (Online), Vol. 350, h1748, 16.04.2015.

Research output: Contribution to journalArticle

Cohen, SP, Hanling, S, Bicket, MC, White, RL, Veizi, E, Kurihara, C, Zhao, Z, Hayek, S, Guthmiller, KB, Griffith, SR, Gordin, V, White, MA, Vorobeychik, Y & Pasquina, PF 2015, 'Epidural steroid injections compared with gabapentin for lumbosacral radicular pain: Multicenter randomized double blind comparative efficacy study', BMJ (Online), vol. 350, h1748. https://doi.org/10.1136/bmj.h1748
Cohen, Steven P. ; Hanling, Steven ; Bicket, Mark C. ; White, Ronald L. ; Veizi, Elias ; Kurihara, Connie ; Zhao, Zirong ; Hayek, Salim ; Guthmiller, Kevin B. ; Griffith, Scott R. ; Gordin, Vitaly ; White, Mirinda Anderson ; Vorobeychik, Yakov ; Pasquina, Paul F. / Epidural steroid injections compared with gabapentin for lumbosacral radicular pain : Multicenter randomized double blind comparative efficacy study. In: BMJ (Online). 2015 ; Vol. 350.
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title = "Epidural steroid injections compared with gabapentin for lumbosacral radicular pain: Multicenter randomized double blind comparative efficacy study",
abstract = "OBJECTIVE: To evaluate whether an epidural steroid injection or gabapentin is a better treatment for lumbosacral radiculopathy. DESIGN: A multicenter randomized study conducted between 2011 and 2014. Computer generated randomization was stratified by site. Patients and evaluating physicians were blinded to treatment outcomes. SETTINGS: Eight military, Veterans Administration, and civilian hospitals. PARTICIPANTS: 145 people with lumbosacral radicular pain secondary to herniated disc or spinal stenosis for less than four years in duration and in whom leg pain is as severe or more severe than back pain. INTERVENTIONS: Participants received either epidural steroid injection plus placebo pills or sham injection plus gabapentin. MAIN OUTCOME MEASURES: Average leg pain one and three months after the injection on a 0-10 numerical rating scale. A positive outcome was defined as a ≥2 point decrease in leg pain coupled with a positive global perceived effect. All patients had one month follow-up visits; patients whose condition improved remained blinded for their three month visit. RESULTS: There were no significant diferences for the primary outcome measure at one month (mean pain score 3.3 (SD 2.6) and mean change from baseline -2.2 (SD 2.4) in epidural steroid injection group versus 3.7 (SD 2.6) and -1.7 (SD 2.6) in gabapentin group; adjusted diference 0.4, 95{\%} confidence interval -0.3 to 1.2; P=0.25) and three months (mean pain score 3.4 (SD 2.7) and mean change from baseline -2.0 (SD 2.6) versus 3.7 (SD 2.8) and -1.6 (SD 2.7), respectively; adjusted difference 0.3, -0.5 to 1.2; P=0.43). Among secondary outcomes, one month after treatment those who received epidural steroid injection had greater reductions in worst leg pain (-3.0, SD 2.8) than those treated with gabapentin (-2.0, SD 2.9; P=0.04) and were more likely to experience a positive successful outcome (66{\%} v 46{\%}; number needed to treat=5.0, 95{\%} confidence interval 2.8 to 27.0; P=0.02). At three months, there were no significant differences between treatments. CONCLUSIONS: Although epidural steroid injection might provide greater benefit than gabapentin for some outcome measures, the differences are modest and are transient for most people. TRIAL REGISTRATION: ClinicalTrials.gov Identifer: NCT01495923.",
author = "Cohen, {Steven P.} and Steven Hanling and Bicket, {Mark C.} and White, {Ronald L.} and Elias Veizi and Connie Kurihara and Zirong Zhao and Salim Hayek and Guthmiller, {Kevin B.} and Griffith, {Scott R.} and Vitaly Gordin and White, {Mirinda Anderson} and Yakov Vorobeychik and Pasquina, {Paul F.}",
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T1 - Epidural steroid injections compared with gabapentin for lumbosacral radicular pain

T2 - Multicenter randomized double blind comparative efficacy study

AU - Cohen, Steven P.

AU - Hanling, Steven

AU - Bicket, Mark C.

AU - White, Ronald L.

AU - Veizi, Elias

AU - Kurihara, Connie

AU - Zhao, Zirong

AU - Hayek, Salim

AU - Guthmiller, Kevin B.

AU - Griffith, Scott R.

AU - Gordin, Vitaly

AU - White, Mirinda Anderson

AU - Vorobeychik, Yakov

AU - Pasquina, Paul F.

PY - 2015/4/16

Y1 - 2015/4/16

N2 - OBJECTIVE: To evaluate whether an epidural steroid injection or gabapentin is a better treatment for lumbosacral radiculopathy. DESIGN: A multicenter randomized study conducted between 2011 and 2014. Computer generated randomization was stratified by site. Patients and evaluating physicians were blinded to treatment outcomes. SETTINGS: Eight military, Veterans Administration, and civilian hospitals. PARTICIPANTS: 145 people with lumbosacral radicular pain secondary to herniated disc or spinal stenosis for less than four years in duration and in whom leg pain is as severe or more severe than back pain. INTERVENTIONS: Participants received either epidural steroid injection plus placebo pills or sham injection plus gabapentin. MAIN OUTCOME MEASURES: Average leg pain one and three months after the injection on a 0-10 numerical rating scale. A positive outcome was defined as a ≥2 point decrease in leg pain coupled with a positive global perceived effect. All patients had one month follow-up visits; patients whose condition improved remained blinded for their three month visit. RESULTS: There were no significant diferences for the primary outcome measure at one month (mean pain score 3.3 (SD 2.6) and mean change from baseline -2.2 (SD 2.4) in epidural steroid injection group versus 3.7 (SD 2.6) and -1.7 (SD 2.6) in gabapentin group; adjusted diference 0.4, 95% confidence interval -0.3 to 1.2; P=0.25) and three months (mean pain score 3.4 (SD 2.7) and mean change from baseline -2.0 (SD 2.6) versus 3.7 (SD 2.8) and -1.6 (SD 2.7), respectively; adjusted difference 0.3, -0.5 to 1.2; P=0.43). Among secondary outcomes, one month after treatment those who received epidural steroid injection had greater reductions in worst leg pain (-3.0, SD 2.8) than those treated with gabapentin (-2.0, SD 2.9; P=0.04) and were more likely to experience a positive successful outcome (66% v 46%; number needed to treat=5.0, 95% confidence interval 2.8 to 27.0; P=0.02). At three months, there were no significant differences between treatments. CONCLUSIONS: Although epidural steroid injection might provide greater benefit than gabapentin for some outcome measures, the differences are modest and are transient for most people. TRIAL REGISTRATION: ClinicalTrials.gov Identifer: NCT01495923.

AB - OBJECTIVE: To evaluate whether an epidural steroid injection or gabapentin is a better treatment for lumbosacral radiculopathy. DESIGN: A multicenter randomized study conducted between 2011 and 2014. Computer generated randomization was stratified by site. Patients and evaluating physicians were blinded to treatment outcomes. SETTINGS: Eight military, Veterans Administration, and civilian hospitals. PARTICIPANTS: 145 people with lumbosacral radicular pain secondary to herniated disc or spinal stenosis for less than four years in duration and in whom leg pain is as severe or more severe than back pain. INTERVENTIONS: Participants received either epidural steroid injection plus placebo pills or sham injection plus gabapentin. MAIN OUTCOME MEASURES: Average leg pain one and three months after the injection on a 0-10 numerical rating scale. A positive outcome was defined as a ≥2 point decrease in leg pain coupled with a positive global perceived effect. All patients had one month follow-up visits; patients whose condition improved remained blinded for their three month visit. RESULTS: There were no significant diferences for the primary outcome measure at one month (mean pain score 3.3 (SD 2.6) and mean change from baseline -2.2 (SD 2.4) in epidural steroid injection group versus 3.7 (SD 2.6) and -1.7 (SD 2.6) in gabapentin group; adjusted diference 0.4, 95% confidence interval -0.3 to 1.2; P=0.25) and three months (mean pain score 3.4 (SD 2.7) and mean change from baseline -2.0 (SD 2.6) versus 3.7 (SD 2.8) and -1.6 (SD 2.7), respectively; adjusted difference 0.3, -0.5 to 1.2; P=0.43). Among secondary outcomes, one month after treatment those who received epidural steroid injection had greater reductions in worst leg pain (-3.0, SD 2.8) than those treated with gabapentin (-2.0, SD 2.9; P=0.04) and were more likely to experience a positive successful outcome (66% v 46%; number needed to treat=5.0, 95% confidence interval 2.8 to 27.0; P=0.02). At three months, there were no significant differences between treatments. CONCLUSIONS: Although epidural steroid injection might provide greater benefit than gabapentin for some outcome measures, the differences are modest and are transient for most people. TRIAL REGISTRATION: ClinicalTrials.gov Identifer: NCT01495923.

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