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CME Information
CME Released: 04/24/2012; Valid for credit through 04/24/2013

Target Audience
This article is intended for primary care clinicians, orthopaedists, pain management specialists, neurosurgeons, radiologists, and other specialists who care for patients with sciatica.

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The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.

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Upon completion of this activity, participants will be able to: 1. Evaluate results of a previous trial of epidural steroid injections vs saline injections among patients with sciatica. 2. Describe outcomes of the current trial of epidural steroids, saline, or etanercept for subacute sciatica.

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Author(s)
Megan Brooks Megan Brooks is a freelance writer for Medscape. Disclosure: Megan Brooks has disclosed no relevant financial relationships.

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Brande Nicole Martin, MA CME Clinical Editor, Medscape, LLC Disclosure: Brande Nicole Martin, MA, has disclosed no relevant financial relationships.

CME Author(s)

Charles P. Vega, MD

Health Sciences Clinical Professor; Residency Director, Department of Family Medicine, University of California, Irvine Disclosure: Charles P. Vega, MD, has disclosed no relevant financial relationships.

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Sarah Fleischman CME Program Manager, Medscape, LLC Disclosure: Sarah Fleischman has disclosed no relevant financial relationships.

Epidural Steroid Injections Provide Modest Relief for Sciatica CME

News Author: Megan Brooks CME Author: Charles P. Vega, MD CME Released: 04/24/2012; Valid for credit through 04/24/2013 Sciatica can be a severe diagnosis associated with high degrees of pain and dysfunction. Epidural injections with corticosteroids are routinely prescribed to patients with sciatica, although a study by Valat and colleagues, which was published in the July 2003 issue of the Annals of the Rheumatic Diseases, calls this practice into question. Researchers in this randomized trial compared epidural injections with corticosteroids vs saline among 85 patients. Treatment success at day 20 after the injection was achieved in only 51% of patients receiving corticosteroids vs 36% of patients receiving saline. This difference was nonsignificant. The proportions of patients eventually requiring surgery or other treatments were similar in the 2 groups, and it appeared that symptoms resolved with time in both groups. There is excitement regarding the possibility of etanercept, an inhibitor of tumor necrosis factor-alpha, as a potential local agent for sciatica. The current study by Cohen and colleagues compares epidural injections with etanercept, steroids, and saline in a randomized trial.

Epidural injections of steroids or the cytokine inhibitor etanercept were not much better than epidural saline injections in relieving leg and back pain in a new multicenter, randomized, controlled study of adults with subacute sciatica. Epidural steroid injections are commonly used for lumbosacral radiculopathy, "yet, studies are decidedly mixed regarding their effectiveness," study investigator Steven P. Cohen, MD, from Johns Hopkins School of Medicine, Baltimore, Maryland, told Medscape Medical News. On the basis of the new study, 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 study team concludes. Their report was published April 17 in Annals of Internal Medicine. Etanercept Findings 'Disappointing' Dr. Cohen said the results with etanercept were "somewhat surprising and disappointing. Unlike steroids, etanercept addresses the underlying cause of many cases of sciatica from a herniated disc by directly blocking the inflammatory molecules responsible for the pain. In animal studies, cytokine inhibitors have been shown to prevent nerve injury from a herniated disc, and a small pilot study in humans yielded very auspicious results," he explained. The current study enrolled 84 adults (mean age, 42 years) with lumbosacral radiculopathy lasting more than 4 weeks but 6 months or less and leg pain that was more than or as severe as back pain. Conservative therapy had failed in all patients, and they all had imaging evidence of a pathologic disc condition correlating with symptoms (eg, herniated disc or annular tear). They were randomly allocated in a 1:1:1 ratio to 2 epidural steroid injections of methylprednisolone acetate, 60 mg, plus 0.5 mL of saline (for a total volume of 2 mL); 2 epidural etanercept injections (4 mg reconstituted in 2 mL of sterile water); or 2 mL normal saline. All injections were mixed with 0.5% bupivacaine and separated by 2 weeks. The segmental level at which the patient was injected was chosen according to symptoms and radiologic findings. Pharmacists prepared the syringes, and patients and physicians were blinded to treatment assignment. The primary outcome measure was a numeric rating scale score of 0 to 10 for leg pain 1 month after the second injection. Mean baseline scores for leg pain were similar in the 3 groups: 5.71, 6.62, and 6.31 in the steroid, etanercept, and saline groups, respectively. The investigators say leg and back pain improved in all groups. The largest reductions in leg pain occurred in the steroid group. The reductions in scores for back pain were "less profound" than those for leg pain. Table 1. Within-Group Mean Change From Baseline at 1 Month for Leg and Back Pain

Change from Baseline in Leg Pain (95% Confidence Interval) Steroids -3.57 (-4.43 to -2.71) Etanercept-2.98 (-4.41 to -1.55) Saline -2.48 (-3.59 to -1.37) Group

Change from Baseline in Back Pain (95% Confidence Interval) -2.14 (-3.23 to -1.06) -1.56 (-2.83 to -0.28) -1.07 (-1.96 to -0.17)

Between-group differences in the primary outcome measure of leg pain at 1 month also favored epidural steroids over etanercept and saline, but the differences were modest and did not reach statistical significance. Table 2. Between-Group Differences in Leg Pain at 1 Month Comparison Between-Group Differences (95% Confidence Interval) P Value Steroids vs saline -1.26 (-2.79 to 0.27) .11 Etanercept vs saline -0.25 (-1.80 to 1.30) .56 Steroids vs etanercept -1.01 (-2.60 to 0.58) .21 For back pain, smaller between-group differences favoring steroids compared with saline and etanercept were seen. At 1 month, both the steroid and saline groups experienced "sizable improvements" in functional capacity based on the Oswestry Disability Index (ODI), whereas the etanercept group reported little change or worsening; this was largely due to worsening in the sections for sleep and sex life, the investigators say. One patient in the etanercept group experienced a clinically significant deterioration in function manifested by a 30-point increase in the ODI score, they note. Table 3. Mean Change in ODI Score at 1 Month Comparison Mean Change (95% Confidence Interval) Steroids vs saline -5.87 (-15.59 to 3.85) Etanercept vs saline 10.29 (0.55 to 20.04) Steroids vs etanercept -16.16 (-26.05 to -6.27) Placebo Effect? According to the study team, 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 = .09). Patients in the study whose condition improved at 1 month remained blinded and were assessed at 3 and 6 months. "Of interest, slightly more patients in the saline (40%) and etanercept (38%) groups had a positive outcome at 6 months than did those in the steroid group (29%), which resulted from a greater recurrence rate in the steroid group." "The most probable explanation for this finding," the authors write, "is that a higher proportion of successful outcomes in patients who did not receive steroids was due to a placebo effect, which is very powerful for pain-alleviating procedures and can persist for months or even years (that is, longer than the effects of epidural injections)." P Value .23 .04 .002

Summing up the findings, Dr. Cohen told Medscape Medical News there was a "trend for steroids to be better than both (etanercept and saline) in the short term (at 1-month), but not long term (3 and 6 months)." "At the low doses administered (which were found to be effective in the pilot study), epidural etanercept was no better than saline. However, our findings cannot rule out that higher doses might be more effective, or that longer-acting cytokine inhibitors could provide longer relief," he added. A study published last month in the journal Spine showed that a much higher dose of epidural etanercept was better than steroids at 2 weeks, but not at 4 weeks. "The downside of using higher doses is that they might suppress the immune system," Dr. Cohen said. In addition to a "possibly subtherapeutic dose of etanercept," other limitations to the study include short-term follow-up and small sample size. "Another consideration that could enhance outcomes would be to allow for more injections on an as-needed basis, as is frequently done in clinical practice and controlled studies," the researchers say. There is "an urgent need to identify safer and more effective treatments" for sciatica, Dr. Cohen concludes. The study was funded by the John P. Murtha Neuroscience and Pain Institute, the International Spinal Intervention Society, and the Center for Rehabilitation Sciences Research. Disclosures can be viewed on the Annals Web site. Ann Intern Med. Published online April 17, 2012. Abstract

The investigators conducted the study at 6 military medical centers and at 2 civilian hospitals. Study participants were between the ages of 18 and 70 years and had experienced lumbosacral radiculopathy for 4 weeks to 6 months. Other study inclusion criteria included leg pain that was at least as severe as back pain, failure of conservative therapy, and magnetic resonance imaging findings of intervertebral disc impingement consistent with patients' symptoms. Patients with a previous spine surgery or epidural steroid injection were excluded from study participation. All participants received 2-mL epidural injections that were designed to look similar and achieve blinding of the treating clinician. The injections included methylprednisolone acetate 60 mg, etanercept 4 mg, and normal saline. 2 injections of the randomly assigned therapy were performed 2 weeks apart. The primary study outcome was leg pain at 1 month. Researchers also followed back pain, disability, and the use of analgesics. Study follow-up concluded at 6 months after the final injection. 84 adults participated in the trial. The mean age of participants was 42 years, and most participants were men. The mean score for leg pain at baseline was 6.2 on a scale of 0 to 10, in which 10 was the maximal rating for pain. Pain declined with time in all treatment groups, but functional capacity improved with time only in the steroid and saline groups. At 1 month, leg pain scores had decreased to 3.63, 2.14, and 3.83 in the etanercept, steroid, and saline groups, respectively. This result significantly favored steroids vs the other treatments.

Back pain scores did not differ among groups. However, disability scores at 1 month were worse in the etanercept group vs the steroid and saline groups, with no significant difference in disability in comparing steroids and saline. Participants who received steroids reported a nonsignificant decline in the use of analgesics vs participants who received etanercept. Participant perceptions of the efficacy of treatment were similar in comparing the 3 different injections. Outcomes at 3 and 6 months were generally similar in comparing the randomly assigned treatments. There were no major adverse events and only 12 minor adverse events. No adverse event was related to study treatment except for a temporary worsening of pain. A previous trial by Valat and colleagues comparing epidural injections with steroids vs saline among patients with sciatica noted no significant difference between the treatments. The current study by Cohen and colleagues does not support the use of etanercept for epidural injection among patients with sciatica. Epidural steroid injections provided modest improvements in short-term pain relief vs saline and etanercept injections.

To receive AMA PRA Category 1 Credit, you must receive a minimum score of 70% on the post-test. You are seeing a 42-year-old man with a history of sciatica unresponsive to oral medications for 10 weeks. You consider whether to recommend an epidural injection with steroids. What did the study by Valat and colleagues conclude regarding steroid vs saline injections among patients with sciatica? Steroids improved both short- and long-term outcomes vs saline Steroids improved short-term outcomes only vs saline Steroids improved long-term outcomes only vs saline Steroids and saline were associated with similar outcomes What should you consider from the current study by Cohen and colleagues as you refer this patient for epidural injection? Steroids were most effective in relieving leg pain Etanercept was most effective in reducing both pain and disability Etanercept was most effective for pain, but only 3 months after injection There was no difference among study treatments in any outcome This article is a CME certified activity. To earn credit for this activity visit: http://www.medscape.org/viewarticle/762548 Medscape Education 2012 Medscape, LLC Disclaimer The material presented here does not necessarily reflect the views of Medscape, LLC, or companies that support educational programming on www.medscape.org. These materials may discuss therapeutic products that have not been approved by the US Food and Drug Administration and off-label uses of approved products. A qualified healthcare

professional should be consulted before using any therapeutic product discussed. Readers should verify all information and data before treating patients or employing any therapies described in this educational activity. This article is a CME certified activity. To earn credit for this activity visit: http://www.medscape.org/viewarticle/762548