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

doi:10.1186/s13075-015-0838-4

Christelle Nguyen, Sophie Grabar + Show 10 more

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https://doi.org/10.1186/s13075-015-0838-4

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Abstract

IntroductionThe 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.MethodA 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.ResultsAt 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.ConclusionTreatment 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 registrationClinicalTrials.gov NCT00385086; registered 4 October 2006 (last updated 15 October 2015).

Highlights

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
With extended and adhesive post-operative peridural fibrosis being associated with inflammatory changes at the surgical site, nerve root and dural sac neuromechanics are impaired, which leads to nerve root compression, abnormal dura and nerve root bounding and traction during back and limb movements [1, 8]
Inclusion criteria were age >18 years old, sciatica postdiscectomy, radicular pain measured on a visual analog scale (VAS) >40 mm and inability to perform usual activities, surgical discectomy, pain-free between 1 month and 1 year after the discectomy, magnetic resonance imaging (MRI) with gadolinium injection 6 months after the discectomy, presence of peridural fibrosis on MRI, and failure of peridural injection treatment

Summary

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. Recurrent symptoms in the legs are thought to be related to recurrent disc herniation, persistent herniated fragment, spinal stenosis, or post-operative peridural fibrosis secondary to scar formation [2, 3]. With extended and adhesive post-operative peridural fibrosis being associated with inflammatory changes at the surgical site, nerve root and dural sac neuromechanics are impaired, which leads to nerve root compression, abnormal dura and nerve root bounding and traction during back and limb movements [1, 8]. Patients with post-operative peridural lumbar fibrosis-associated sciatica pain often experience loss of function, disability and impaired quality of life and can require the use of opioid analgesics [10]. Etiologic diagnosis of recurrent or persistent post-operative sciatica is currently based on magnetic resonance imaging (MRI), which helps distinguish central and lateral spinal stenosis from disc herniation, persistent herniated fragment or peridural fibrosis [11]. In the case of peridural fibrosis, MRI demonstrates hyposignals in T1weighted sequences with enhancement after gadolinium injection and hypersignals in T2-weighted sequences of the fibrotic tissue in the peridural space

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