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J Spinal Disord Tech · Feb 2010
Randomized Controlled TrialTumor necrosis alpha-blocking agent (etanercept): a triple blind randomized controlled trial of its use in treatment of sciatica.
- Tosan Okoro, Suhayl I Tafazal, Stephen Longworth, and Philip J Sell.
- Department of Orthopaedics and Trauma, University Hospitals Leicester, Leicester, UK.
- J Spinal Disord Tech. 2010 Feb 1;23(1):74-7.
Study DesignTriple blind randomized controlled study.ObjectiveTo establish the treatment effect of etanercept in acute sciatica secondary to lumbar disc herniation.Summary Of Background DataEtanercept is a selective competitor of tumor necrosis factor-alpha which is a proinflammatory cytokine. It is currently used alone or in combination with other medication for the treatment of chronic inflammatory disease.MethodsInclusion criteria were acute unilateral radicular leg pain secondary to herniated nucleus pulposus confirmed on magnetic resonance imaging scan. Exclusions were previous back surgery, spinal stenosis and any contraindications to the use of etanercept such as immunosuppression. The patient, the injector, and assessor were blinded to the agent being used. Follow-up was at 6 weeks and 3 months posttreatment. Oswestry disability index and visual analog scores were among the assessment criteria.ResultsFifteen patients were recruited in a 4 years period with a 3 months follow-up of 80%. The etanercept group had 8 patients whereas the placebo group had 7. The average Oswestry disability index for the etanercept group preintervention was higher than that in the placebo group (53.6 vs. 50.4) and this remained the same after 6 weeks (46.1 vs. 31.2) and 3 months of follow-up (37 vs. 35). Visual analog score was also higher in the etanercept group versus placebo; preinjection (8.6 vs. 7.4), 6 weeks (5.0 vs. 3.8), and 3 months (4.8 vs. 4.5).ConclusionsSmall numbers of trial participants limited statistical analysis. The trend appears to show no benefit to the use of etanercept over placebo in the pharmacologic treatment of sciatica.
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