TY - JOUR
T1 - Epidural steroids, etanercept, or saline in subacute sciatica a multicenter, randomized trial
AU - Cohen, Steven P.
AU - White, Ronald L.
AU - Kurihara, Connie
AU - Larkin, Thomas M.
AU - Chang, Audrey
AU - Griffith, Scott R.
AU - Gilligan, Christopher
AU - Larkin, Ralph
AU - Morlando, Benny
AU - Pasquina, Paul F.
AU - Yaksh, Tony L.
AU - Nguyen, Conner
PY - 2012
Y1 - 2012
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84859768287&partnerID=8YFLogxK
U2 - 10.7326/0003-4819-156-8-201204170-00397
DO - 10.7326/0003-4819-156-8-201204170-00397
M3 - Article
AN - SCOPUS:84859768287
SN - 0003-4819
VL - 156
SP - 551
EP - 559
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
IS - 8
ER -