title: Epidural steroids, etanercept, or saline in subacute sciatica: a multicenter, randomized trial.
abstract: BACKGROUND
  Perineural inhibitors of tumor necrosis factor have recently generated intense interest as an alternative to epidural steroid injections for lumbosacral radiculopathy.
  
  
  OBJECTIVE
  To evaluate whether epidural steroids, etanercept, or saline better improves pain and function in adults with lumbosacral radiculopathy.
  
  
  METHODS
  A multicenter, 3-group, randomized, placebo-controlled trial conducted from 2008 to 2011. Randomization was computer-generated and stratified by site. Pharmacists prepared the syringes. Patients, treating physicians, and nurses assessing outcomes were blinded to treatment assignment. (ClinicalTrials.gov registration number: NCT00733096)
  
  
  METHODS
  Military and civilian treatment centers.
  
  
  METHODS
  84 adults with lumbosacral radiculopathy of less than 6 months' duration.
  
  
  METHODS
  2 epidural injections of steroids, etanercept, or saline, mixed with bupivacaine and separated by 2 weeks.
  
  
  METHODS
  The primary outcome measure was leg pain 1 month after the second injection. All patients had 1-month follow-up visits; patients whose condition improved remained blinded for the 6-month study period.
  
  
  RESULTS
  The group that received epidural steroids had greater reductions in the primary outcome measure than those who received saline (mean difference, -1.26 [95% CI, -2.79 to 0.27]; P = 0.11) or etanercept (mean difference, -1.01 [CI, -2.60 to 0.58]; P = 0.21). For back pain, smaller differences favoring steroids compared with saline (mean difference, -0.52 [CI, -1.85 to 0.81]; P = 0.44) and etanercept (mean difference, -0.92 [CI,-2.28 to 0.44]; P = 0.18) were observed. The largest differences were noted for functional capacity, in which etanercept fared worse than the other treatments: steroids vs. etanercept (mean difference, -16.16 [CI, -26.05 to -6.27]; P = 0.002), steroids vs. saline (mean difference, -5.87 [CI, -15.59 to 3.85]; P = 0.23), and etanercept vs. saline (mean difference, 10.29 [CI, 0.55 to 20.04]; P = 0.04). More patients treated with epidural steroids (75%) reported 50% or greater leg pain relief and a positive global perceived effect at 1 month than those who received saline (50%) or etanercept (42%) (P = 0.09).
  
  
  CONCLUSIONS
  Short-term follow-up, small sample size, and a possibly subtherapeutic dose of etanercept.
  
  
  CONCLUSIONS
  Epidural steroid injections may provide modest short-term pain relief for some adults with lumbosacral radiculopathy, but larger studies with longer follow-up are needed to confirm their benefits.
  
  
  BACKGROUND
  The John P. Murtha Neuroscience and Pain Institute, International Spinal Intervention Society, and Center for Rehabilitation Sciences Research.
authors.affiliation: Johns Hopkins School of Medicine, Baltimore, Maryland, USA. scohen40@jhmi.edu
authors.forename: Steven P
authors.initials: SP
authors.lastname: Cohen
authors.forename: Ronald L
authors.initials: RL
authors.lastname: White
authors.forename: Connie
authors.initials: C
authors.lastname: Kurihara
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Larkin
authors.forename: Audrey
authors.initials: A
authors.lastname: Chang
authors.forename: Scott R
authors.initials: SR
authors.lastname: Griffith
authors.forename: Christopher
authors.initials: C
authors.lastname: Gilligan
authors.forename: Ralph
authors.initials: R
authors.lastname: Larkin
authors.forename: Benny
authors.initials: B
authors.lastname: Morlando
authors.forename: Paul F
authors.initials: PF
authors.lastname: Pasquina
authors.forename: Tony L
authors.initials: TL
authors.lastname: Yaksh
authors.forename: Conner
authors.initials: C
authors.lastname: Nguyen
mesh_terms: D000328:Adult; D000779:Anesthetics, Local / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use; D002045:Bupivacaine / Q000627:therapeutic use; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects / Q000627:therapeutic use*; D007268:Injections, Epidural; D008297:Male; D008775:Methylprednisolone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077555:Methylprednisolone Acetate; D008875:Middle Aged; D018124:Receptors, Tumor Necrosis Factor / Q000037:antagonists & inhibitors* / Q000627:therapeutic use; D012585:Sciatica / Q000188:drug therapy*; D012965:Sodium Chloride / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000779:Anesthetics, Local; D000893:Anti-Inflammatory Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000077555:Methylprednisolone Acetate; D012965:Sodium Chloride; D000068800:Etanercept; D008775:Methylprednisolone; D002045:Bupivacaine