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

doi:10.1136/bmj.h1748

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

BMJ. 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.

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.

Publication types

Comparative Study
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Amines / therapeutic use*
Analgesics / therapeutic use*
Analysis of Variance
Anti-Inflammatory Agents / administration & dosage*
Cyclohexanecarboxylic Acids / therapeutic use*
Double-Blind Method
Female
Gabapentin
Humans
Injections, Epidural
Low Back Pain / drug therapy*
Male
Methylprednisolone / administration & dosage*
Middle Aged
Pain Measurement
Radiculopathy / drug therapy*
gamma-Aminobutyric Acid / therapeutic use*

Substances

Amines
Analgesics
Anti-Inflammatory Agents
Cyclohexanecarboxylic Acids
gamma-Aminobutyric Acid
Gabapentin
Methylprednisolone

Associated data

ClinicalTrials.gov/NCT01495923