Tumor necrosis factor-α blockade in recurrent and disabling chronic sciatica associated with post-operative peridural lumbar fibrosis: results of a double-blind, placebo randomized controlled study

Christelle Nguyen, Clémence Palazzo, Sophie Grabar, Antoine Feydy, Katherine Sanchez, Nathalie Zee, Laurent Quinquis, Myriam Ben Boutieb, Michel Revel, Marie-Martine Lefèvre-Colau, Serge Poiraudeau, François Rannou, Christelle Nguyen, Clémence Palazzo, Sophie Grabar, Antoine Feydy, Katherine Sanchez, Nathalie Zee, Laurent Quinquis, Myriam Ben Boutieb, Michel Revel, Marie-Martine Lefèvre-Colau, Serge Poiraudeau, François Rannou

Abstract

Introduction: The aim of this study was to assess the efficacy and safety of tumor necrosis factor (TNF)-α inhibition with infliximab (IFX) in treating recurrent and disabling chronic sciatica pain associated with post-operative peridural lumbar fibrosis.

Method: A double-blind, placebo-controlled study randomized 35 patients presenting with sciatica pain associated with post-operative peridural lumbar fibrosis to two groups: IFX (n = 18), a single intravenous injection of 3 mg/kg IFX; and placebo (n = 17), a single saline serum injection. The primary outcome was a 50 % reduction in sciatica pain on a visual analog scale (VAS) at day 10. Secondary outcomes were radicular and lumbar VAS pain at day 0 and radicular and lumbar VAS pain, Québec disability score, drug-sparing effect and tolerance at days 10, 30, 90, and 180.

Results: At day 10, the placebo and IFX groups did not differ in the primary outcome (50 % reduction in sciatica pain observed in three (17.6 %) versus five (27.8 %) patients; p = 0.69). The number of patients reaching the patient acceptable symptom state for radicular pain was significantly higher in the placebo than IFX group after injection (12 (70.6 %) versus five (27.8 %) patients; p = 0.01). The two groups were comparable for all other secondary outcomes.

Conclusion: Treatment with a single 3 mg/kg IFX injection for post-operative peridural lumbar fibrosis-associated sciatica pain does not significantly reduce radicular symptoms at day 10 after injection.

Trial registration: ClinicalTrials.gov NCT00385086 ; registered 4 October 2006 (last updated 15 October 2015).

Figures

Fig. 1
Fig. 1
Flow of patients in the trial. IFX Infliximab
Fig. 2
Fig. 2
Changes in a radicular and b lumbar pain scores measured on a visual analog scale over time in patients receiving infliximab and placebo. Box-and-whisker plots represent results expressed in median and interquartile range

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