Epidural steroids, etanercept, or saline in subacute sciatica: a multicenter, randomized trial.

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. DESIGN: 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) SETTING: Military and civilian treatment centers. PATIENTS: 84 adults with lumbosacral radiculopathy of less than 6 months' duration. INTERVENTION: 2 epidural injections of steroids, etanercept, or saline, mixed with bupivacaine and separated by 2 weeks. MEASUREMENTS: 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). LIMITATION: Short-term follow-up, small sample size, and a possibly subtherapeutic dose of etanercept. CONCLUSION: 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. PRIMARY FUNDING SOURCE: The John P. Murtha Neuroscience and Pain Institute, International Spinal Intervention Society, and Center for Rehabilitation Sciences Research.

Presentation, diagnoses, mechanisms of injury, and treatment of soldiers injured in Operation Iraqi Freedom: an epidemiological study conducted at two military pain management centers.

UNLABELLED: In recent military conflicts the major source of soldier attrition has not been battle injuries but more mundane causes similar to those encountered in civilian life. In an effort to determine the pain conditions affecting soldiers during wartime, we conducted an observational study among 162 soldiers medically evacuated from Operation Iraqi Freedom who were referred to 2 large pain treatment centers located outside the theaters of combat. Fifty-three percent of soldiers presented with either radicular (n = 49) or axial (n = 37) low back pain, with lumbar herniated disk being the most frequently diagnosed condition (24%). The two most implicated etiologies were exacerbation of a previous pain condition treated with surgery (15%) and motor vehicle accidents(12%). Only 17% of patients were injured during battle. Seventy-two percent of soldiers received at least one nerve block/injection, the most common of which was lumbar epidural steroid administration (22%). Nonsteroidal antiinflammatory drugs were prescribed to 56% of patients, opioids to 49%, and some form of alternative therapy to 17%. Among the 49 patients in whom data were available, only 2% returned to combat duty in Iraq. With the exception of battle-related injuries, the pain conditions suffered during modern warfare seem to be similar to those encountered in civilian pain clinics. To improve the return-to-duty rate, better preventive measures and more aggressive treatment conducted in forward-deployed medical units are recommended. IMPLICATIONS: We conducted an observational study at two large military pain treatment centers among soldiers injured in Operation Iraqi Freedom. Fifty-three percent of soldiers presented with low back pain, with lumbar herniated disk being the most common diagnosis. Only 2% of patients returned to combat duty in Iraq. To improve the return-to-duty rate, better preventive measures and more aggressive treatment in forward-deployed medical units are recommended.