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

doi:10.1136/bmj.h1748

Randomized Controlled Trial

. 2015 Apr 16:350:h1748.

doi: 10.1136/bmj.h1748.

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

Affiliations

¹ Blaustein Pain Treatment Center, Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, USA Walter Reed National Military Medical Center, Bethesda, MD, USA Blaustein Pain Treatment Center, Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, USA scohen40@jhmi.edu.
² Pain Medicine Division, Department of Anesthesiology, Naval Medical Center-San Diego, USA.
³ Department of Anesthesiology, Massachusetts General Hospital, Boston, MA, USA.
⁴ Interdisciplinary Pain Medicine, Department of Surgery, Landstuhl, Regional Medical Center, Landstuhl, Germany.
⁵ Pain Medicine Service Department of Anesthesiology, Louis Stokes Cleveland VA Medical Center, Case Western University, Cleveland, OH, USA.
⁶ Anesthesia Service, Department of Surgery, Walter Reed National Military Medical Center, Bethesda, MD, USA.
⁷ Department of Neurology, District of Columbia VA Hospital, Washington DC, MD, USA Department of Medicine, George Washington University, Washington DC, MD, USA.
⁸ Pain Medicine Division, Department of Anesthesiology, Case Western Reserve School of Medicine, Cleveland, OH, USA.
⁹ Interdisciplinary Pain Management Clinic, Department of Anesthesiology, San Antonio Military Medical Center, San Antonio, TX, USA Pain Medicine Fellowship Program, Department of Anesthesiology, San Antonio Military Medical Center, San Antonio, TX, USA.
¹⁰ Walter Reed National Military Medical Center, Bethesda, MD, USA.
¹¹ Pain Medicine Division, Department of Anesthesiology, Penn State Hershey Medical Center, Hershey, PA, USA.
¹² Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
¹³ Departments of Anesthesiology and Neurology, Penn State Hershey Medical Center, Hershey, PA, USA.
¹⁴ Department of Physical Medicine and Rehabilitation, Walter Reed National Military Medical Center and Uniformed Services University of the Health Sciences, Bethesda, MD, USA.

PMID: 25883095
PMCID: PMC4410617
DOI: 10.1136/bmj.h1748

Randomized Controlled Trial

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

Steven P Cohen et al. BMJ. 2015.

. 2015 Apr 16:350:h1748.

doi: 10.1136/bmj.h1748.

Authors

Affiliations

¹ Blaustein Pain Treatment Center, Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, USA Walter Reed National Military Medical Center, Bethesda, MD, USA Blaustein Pain Treatment Center, Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, USA scohen40@jhmi.edu.
² Pain Medicine Division, Department of Anesthesiology, Naval Medical Center-San Diego, USA.
³ Department of Anesthesiology, Massachusetts General Hospital, Boston, MA, USA.
⁴ Interdisciplinary Pain Medicine, Department of Surgery, Landstuhl, Regional Medical Center, Landstuhl, Germany.
⁵ Pain Medicine Service Department of Anesthesiology, Louis Stokes Cleveland VA Medical Center, Case Western University, Cleveland, OH, USA.
⁶ Anesthesia Service, Department of Surgery, Walter Reed National Military Medical Center, Bethesda, MD, USA.
⁷ Department of Neurology, District of Columbia VA Hospital, Washington DC, MD, USA Department of Medicine, George Washington University, Washington DC, MD, USA.
⁸ Pain Medicine Division, Department of Anesthesiology, Case Western Reserve School of Medicine, Cleveland, OH, USA.
⁹ Interdisciplinary Pain Management Clinic, Department of Anesthesiology, San Antonio Military Medical Center, San Antonio, TX, USA Pain Medicine Fellowship Program, Department of Anesthesiology, San Antonio Military Medical Center, San Antonio, TX, USA.
¹⁰ Walter Reed National Military Medical Center, Bethesda, MD, USA.
¹¹ Pain Medicine Division, Department of Anesthesiology, Penn State Hershey Medical Center, Hershey, PA, USA.
¹² Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
¹³ Departments of Anesthesiology and Neurology, Penn State Hershey Medical Center, Hershey, PA, USA.
¹⁴ Department of Physical Medicine and Rehabilitation, Walter Reed National Military Medical Center and Uniformed Services University of the Health Sciences, Bethesda, MD, USA.

PMID: 25883095
PMCID: PMC4410617
DOI: 10.1136/bmj.h1748

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 differences 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 difference 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 Identifier: NCT01495923.

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Conflict of interest statement

Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: SPC serves as a consultant for Semnur Pharmaceuticals; no other relationships or activities that could appear to have influenced the submitted work.

Figures

None — Flow of progress of participants through clinical trial of epidural steroid injections and gabapentin in people with lumbosacral radicular pain

See this image and copyright information in PMC

Comment in

Authors' reply to Lin and colleagues.
Cohen SP, Vorobeychik Y. Cohen SP, et al. BMJ. 2015 Jun 24;350:h3299. doi: 10.1136/bmj.h3299. BMJ. 2015. PMID: 26108609 No abstract available.
Comparative efficacy trials with no placebo group cannot determine efficacy.
Lin CW, Day RO, Harris I, Maher CG, McLachlan A. Lin CW, et al. BMJ. 2015 Jun 24;350:h3292. doi: 10.1136/bmj.h3292. BMJ. 2015. PMID: 26108670 No abstract available.
[Epidural steroids for lumbosacral radicular pain treatment is no better than an oral gabapentin].
Steurer J. Steurer J. Praxis (Bern 1994). 2015 Aug 19;104(17):926-7. doi: 10.1024/1661-8157/a002107. Praxis (Bern 1994). 2015. PMID: 26286497 German. No abstract available.

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References

1. US Burden of Disease Collaborators. The state of US health, 1990-2010: burden of diseases, injuries, and risk factors. JAMA 2013;310:591-608. - PMC - PubMed
1. Hoy D, Bain C, Williams G, et al. A systematic review of the global prevalence of low back pain. Arthritis Rheum 2012;64:2028-37. - PubMed
1. Juniper M, Le T, Mladsi D. The epidemiology, economic burden, and pharmacological treatment of chronic low back pain in France, Germany, Italy, Spain and the UK: a literature-based review. Expert Opin Pharmacother 2009;10:2581-92. - PubMed
1. Crow W, Willis D. Estimating cost of care for patients with acute low back pain: a retrospective review of patient records. J Am Osteopath Assoc 2009;109:229-33. - PubMed
1. Cohen SP, Mao J. Mechanisms of neuropathic pain and their clinical implications. BMJ 2014;348:f7656. - PubMed

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[1] US Burden of Disease Collaborators. The state of US health, 1990-2010: burden of diseases, injuries, and risk factors. JAMA 2013;310:591-608. - PMC - PubMed

[2] US Burden of Disease Collaborators. The state of US health, 1990-2010: burden of diseases, injuries, and risk factors. JAMA 2013;310:591-608. - PMC - PubMed

[3] Hoy D, Bain C, Williams G, et al. A systematic review of the global prevalence of low back pain. Arthritis Rheum 2012;64:2028-37. - PubMed

[4] Hoy D, Bain C, Williams G, et al. A systematic review of the global prevalence of low back pain. Arthritis Rheum 2012;64:2028-37. - PubMed

[5] Juniper M, Le T, Mladsi D. The epidemiology, economic burden, and pharmacological treatment of chronic low back pain in France, Germany, Italy, Spain and the UK: a literature-based review. Expert Opin Pharmacother 2009;10:2581-92. - PubMed

[6] Juniper M, Le T, Mladsi D. The epidemiology, economic burden, and pharmacological treatment of chronic low back pain in France, Germany, Italy, Spain and the UK: a literature-based review. Expert Opin Pharmacother 2009;10:2581-92. - PubMed

[7] Crow W, Willis D. Estimating cost of care for patients with acute low back pain: a retrospective review of patient records. J Am Osteopath Assoc 2009;109:229-33. - PubMed

[8] Crow W, Willis D. Estimating cost of care for patients with acute low back pain: a retrospective review of patient records. J Am Osteopath Assoc 2009;109:229-33. - PubMed

[9] Cohen SP, Mao J. Mechanisms of neuropathic pain and their clinical implications. BMJ 2014;348:f7656. - PubMed

[10] Cohen SP, Mao J. Mechanisms of neuropathic pain and their clinical implications. BMJ 2014;348:f7656. - PubMed

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

Affiliations

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

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