• Spine · Mar 2012

    Randomized Controlled Trial Comparative Study

    Epidural administration of spinal nerves with the tumor necrosis factor-alpha inhibitor, etanercept, compared with dexamethasone for treatment of sciatica in patients with lumbar spinal stenosis: a prospective randomized study.

    • Seiji Ohtori, Masayuki Miyagi, Yawara Eguchi, Gen Inoue, Sumihisa Orita, Nobuyasu Ochiai, Shunji Kishida, Kazuki Kuniyoshi, Junichi Nakamura, Yasuchika Aoki, Tetsuhiro Ishikawa, Gen Arai, Hiroto Kamoda, Miyako Suzuki, Masashi Takaso, Takeo Furuya, Tomoaki Toyone, and Kazuhisa Takahashi.
    • Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan. sohtori@faculty.chiba-u.jp
    • Spine. 2012 Mar 15;37(6):439-44.

    Study DesignProspective randomized trial.ObjectiveTo examine the effect of the tumor necrosis factor alpha (TNF-α) inhibitor, etanercept, on radicular pain by its epidural administration onto spinal nerves in patients with lumbar spinal stenosis.Summary Of Background DataTNF-α is thought to play a crucial role in the radicular pain caused by lumbar disc herniation and spinal stenosis. Intravenous infusion of infliximab for sciatica has been examined in 2 studies; however, the results were equivocal.MethodsEighty patients with low back and radicular leg pain were investigated. We diagnosed the patients by physical examination, and X-ray and magnetic resonance imaging. In 40 patients, we epidurally administered 2.0 mL of lidocaine and 10 mg of etanercept onto the affected spinal nerve, and 2.0 mL of lidocaine and 3.3 mg of dexamethasone was used in 40 patients. Low back pain, leg pain, and leg numbness were evaluated using a visual analogue scale (VAS) and Oswestry Disability Index (ODI) score before and for 1 month after epidural administration.ResultsLow back pain, leg pain, and leg numbness in the 2 groups were not significantly different before epidural administration. Epidural administration of etanercept was more effective than dexamethasone for leg pain (3 days, and 1, 2, and 4 weeks: P < 0.05), low back pain (3 days, and 1 and 2 weeks: P < 0.05), and leg numbness (3 days, and 1 and 2 weeks: P < 0.05). No adverse event was observed in either group.ConclusionOur results indicate that epidural administration of a TNF-α inhibitor onto the spinal nerve produced pain relief, but no adverse event. TNF-α inhibitors may be useful tools for the treatment of radicular pain caused by spinal stenosis.

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