Steven P. Cohen, MD; Ronald L. White, MD; Connie Kurihara, RN; Thomas M. Larkin, MD; Audrey Chang, PhD; Scott R. Griffith, MD; Christopher Gilligan, MD; Ralph Larkin, PhD; Benny Morlando, RN; Paul F. Pasquina, MD; Tony L. Yaksh, PhD; Conner Nguyen, MD
Disclaimer: The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of the Army or the Department of Defense.
Acknowledgment: The authors thank Drs. Robin Howard, Hui Zheng, Shruti Kapoor for their statistical assistance and Ms. Shari Brownlee for constructing the figure.
Grant Support: Funded in part by a Congressional Grant from the John P. Murtha Neuroscience and Pain Institute, the International Spinal Intervention Society, and the Center for Rehabilitation Sciences Research.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-1654.
Reproducible Research Statement:Study protocol: Available from Dr. Cohen (e-mail, mailto:email@example.com). Statistical code: Available from Dr. Chang (e-mail, mailto:firstname.lastname@example.org). Data set: Available from Dr. Cohen (e-mail, mailto:email@example.com) per approval from the U.S. Army and Walter Reed National Military Medical Center.
Requests for Single Reprints: Steven P. Cohen, MD, 550 North Broadway, Suite 301, Baltimore, MD 21029; e-mail, mailto:firstname.lastname@example.org.
Current Author Addresses: Dr. Cohen: 550 North Broadway, Suite 301, Baltimore, MD 21029.
Dr. White: Landstuhl Regional Medical Center, CMR 401, Box 1251, APO AE 09180.
Ms. Kurihara, Dr. Griffith, and Mr. Morlando: Walter Reed National Military Medical Center, Pain Treatment Center, 8901 Wisconsin Avenue, Bethesda, MD 20889.
Dr. T.M. Larkin: Parkway Neuroscience and Spine Institute, 17 Western Maryland Parkway, Hagerstown, MD 21740.
Dr. Chang: Walter Reed National Military Medical Center, Department of Clinical Investigation, Building 17, Bethesda, MD 20889.
Dr. Gilligan: Massachusetts General Hospital, Massachusetts General Hospital Pain Center, Wang Room 330, 15 Parkman Street, Boston, MA 02114.
Dr. R. Larkin: 400 2nd Avenue, 12-D, New York, NY 10010.
Dr. Pasquina: 4325 Rosedale Avenue, Bethesda, MD 20814.
Dr. Yaksh: Department of Anesthesiology, University of California, San Diego, Anesthesia Research Laboratory 0818, 9500 Gilman Drive (CTF-C 312), La Jolla, CA 92093.
Dr. Nguyen: Landstuhl Regional Medical Center, CMR 402, APO AE 09180.
Author Contributions: Conception and design: S.P. Cohen.
Analysis and interpretation of the data: S.P. Cohen, A. Chang, R. Larkin.
Drafting of the article: S.P. Cohen, A. Chang.
Critical revision of the article for important intellectual content: R.L. White, T.M. Larkin, C. Gilligan, T.L. Yaksh.
Final approval of the article: S.P. Cohen, R.L. White, C. Kurihara, T.M. Larkin, A. Chang, S.R. Griffith, C. Gilligan, R. Larkin, B. Morlando, P.F. Pasquina, T.L. Yaksh, C. Nguyen.
Provision of study materials or patients: S.P. Cohen, R.L. White, C. Kurihara, T.M. Larkin, S.R. Griffith, C. Nguyen.
Statistical expertise: A. Chang, R. Larkin.
Obtaining of funding: P.F. Pasquina, T.L. Yaksh.
Administrative, technical, or logistic support: C. Kurihara, T.M. Larkin, C. Gilligan, B. Morlando, C. Nguyen.
Collection and assembly of data: S.P. Cohen, R.L. White, C. Kurihara.
Perineural inhibitors of tumor necrosis factor have recently generated intense interest as an alternative to epidural steroid injections for lumbosacral radiculopathy.
To evaluate whether epidural steroids, etanercept, or saline better improves pain and function in adults with lumbosacral radiculopathy.
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)
Military and civilian treatment centers.
84 adults with lumbosacral radiculopathy of less than 6 months' duration.
2 epidural injections of steroids, etanercept, or saline, mixed with bupivacaine and separated by 2 weeks.
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.
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).
Short-term follow-up, small sample size, and a possibly subtherapeutic dose of etanercept.
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.
The John P. Murtha Neuroscience and Pain Institute, International Spinal Intervention Society, and Center for Rehabilitation Sciences Research.
Cohen SP, White RL, Kurihara C, Larkin TM, Chang A, Griffith SR, et al. Epidural Steroids, Etanercept, or Saline in Subacute Sciatica: A Multicenter, Randomized Trial. Ann Intern Med. ;156:551–559. doi: 10.7326/0003-4819-156-8-201204170-00397
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Published: Ann Intern Med. 2012;156(8):551-559.
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