Epidural steroid injections compared with gabapentin for lumbosacral radicular pain: multicenter randomized double blind comparative efficacy studyBMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h1748 (Published 16 April 2015) Cite this as: BMJ 2015;350:h1748
- Steven P Cohen, director1, director of pain research21,
- Steven Hanling, US Navy pain medicine specialty leader and chief3,
- Mark C Bicket, fellow in pain medicine4,
- Ronald L White, chief5,
- Elias Veizi, staff physician6,
- Connie Kurihara, research nurse7,
- Zirong Zhao, chief of interventional pain management8, staff physician9,
- Salim Hayek, division chief10,
- Kevin B Guthmiller, deputy chief11, associate director12,
- Scott R Griffith, US army pain medicine consultant and pain medicine program director13,
- Vitaly Gordin, chief14,
- Mirinda Anderson White, research nurse15,
- Yakov Vorobeychik, director of interventional pain medicine16,
- Paul F Pasquina, chair17
- 1Blaustein Pain Treatment Center, Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, USA
- 2Walter Reed National Military Medical Center, Bethesda, MD, USA
- 3Pain Medicine Division, Department of Anesthesiology, Naval Medical Center-San Diego, USA
- 4Department of Anesthesiology, Massachusetts General Hospital, Boston, MA, USA
- 5Interdisciplinary Pain Medicine, Department of Surgery, Landstuhl, Regional Medical Center, Landstuhl, Germany
- 6Pain Medicine Service Department of Anesthesiology, Louis Stokes Cleveland VA Medical Center, Case Western University, Cleveland, OH, USA
- 7Anesthesia Service, Department of Surgery, Walter Reed National Military Medical Center, Bethesda, MD, USA
- 8Department of Neurology, District of Columbia VA Hospital, Washington DC, MD, USA
- 9Department of Medicine, George Washington University, Washington DC, MD, USA
- 10Pain Medicine Division, Department of Anesthesiology, Case Western Reserve School of Medicine, Cleveland, OH, USA
- 11Interdisciplinary Pain Management Clinic, Department of Anesthesiology, San Antonio Military Medical Center, San Antonio, TX, USA
- 12Pain Medicine Fellowship Program, Department of Anesthesiology, San Antonio Military Medical Center, San Antonio, TX, USA
- 13Walter Reed National Military Medical Center, Bethesda, MD, USA
- 14Pain Medicine Division, Department of Anesthesiology, Penn State Hershey Medical Center, Hershey, PA, USA
- 15Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, USA
- 16Departments of Anesthesiology and Neurology, Penn State Hershey Medical Center, Hershey, PA, USA
- 17Department of Physical Medicine and Rehabilitation, Walter Reed National Military Medical Center and Uniformed Services University of the Health Sciences, Bethesda, MD, USA
- Correspondence to: S P Cohen, 550 North Broadway, Suite 301, Baltimore, MD 21029, USA
- Accepted 3 March 2015
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.
We thank all patients for their participation in this study, and the project manager (Brad Isaacson), overall pharmacy coordinator (Manisha Hong), Benny Morlando (nurse at Walter Reed), and the pharmacist at Walter Reed National Military Medical Center (Parvaneh Moussavian-Yousefi) for their assistance.
The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of the Army or the Department of Defense.
Contributors: SPC designed the study, wrote protocol, served as overall principal investigator, performed treatments, and wrote and reviewed the manuscript. SH, YV, RLW, KBG, and ZZ (site principal investigators) performed treatments and reviewed the manuscript. SRG, VG, and EV assisted with protocol adaptation for individual sites, performed treatments, and reviewed the manuscript. MAW and CK, research nurses (CK was chief research nurse), collected data and assisted with protocol adaptations and submissions. MCB helped to write the manuscript and carried out statistical analyses. PFP helped with design study, funding source, and critical review of manuscript. SPC and PFP are guarantors.
Funding: This study was funded by a congressional grant from the Center for Rehabilitation Sciences Research, Bethesda, MD. The funders paid for personnel, medications, and procedures.
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.
Ethical approval: This study was approved by the internal review boards at all eight participating institutions, and informed consent was given by all participants.
Data sharing statement: Statistical code, and limited anonymized dataset will be available pending permission from the US Army by contacting the corresponding author.
Transparency: SPC affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies are disclosed.
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