Abstract | OBJECTIVE: 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: 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.
|
Authors | 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 |
Journal | BMJ (Clinical research ed.)
(BMJ)
Vol. 350
Pg. h1748
(Apr 16 2015)
ISSN: 1756-1833 [Electronic] England |
PMID | 25883095
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Copyright | © Cohen et al 2015. |
Chemical References |
- Amines
- Analgesics
- Anti-Inflammatory Agents
- Cyclohexanecarboxylic Acids
- gamma-Aminobutyric Acid
- Gabapentin
- Methylprednisolone
|
Topics |
- 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)
|