title: 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.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00385086 ; registered 4 October 2006 (last updated 15 October 2015).
authors.affiliation: Univ. Paris Descartes, PRES Sorbonne Paris Cité, Service de Rééducation et Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, Paris, France. christelle.nguyen2@aphp.fr.|Univ. Paris Descartes, PRES Sorbonne Paris, Cité Laboratoire de Pharmacologie, Toxicologie et Signalisation Cellulaire, INSERM UMR-S 1124, UFR Biomédicale des Saints Pères, Paris, France. christelle.nguyen2@aphp.fr.
authors.forename: Christelle
authors.initials: C
authors.lastname: Nguyen
authors.affiliation: Univ. Paris Descartes, PRES Sorbonne Paris Cité, Service de Rééducation et Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, Paris, France. clemence.palazzo@aphp.fr.|Univ. Paris Descartes, PRES Sorbonne Paris, INSERM UMR-S 1153 et Institut Fédératif de Recherche sur le Handicap, Paris, France. clemence.palazzo@aphp.fr.
authors.forename: Clémence
authors.initials: C
authors.lastname: Palazzo
authors.affiliation: Univ. Paris Descartes, PRES Sorbonne Paris, Biostatistics and Epidemiology Unit, Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France. sophie.grabar@aphp.fr.|INSERM UMR-S 1136, Institut Pierre Louis d'Épidémiologie et de Santé Publique, F-75013, Paris, France. sophie.grabar@aphp.fr.
authors.forename: Sophie
authors.initials: S
authors.lastname: Grabar
authors.affiliation: Univ. Paris Descartes, PRES Sorbonne Paris Cité, Service de Radiologie B, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, Paris, France. antoine.feydy@aphp.fr.
authors.forename: Antoine
authors.initials: A
authors.lastname: Feydy
authors.affiliation: Univ. Paris Descartes, PRES Sorbonne Paris Cité, Service de Rééducation et Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, Paris, France. sanchez.katherine@gmail.com.
authors.forename: Katherine
authors.initials: K
authors.lastname: Sanchez
authors.affiliation: Univ. Paris Descartes, PRES Sorbonne Paris Cité, Service de Radiologie B, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, Paris, France. nathalie.zee@aphp.fr.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Zee
authors.affiliation: Univ. Paris Descartes, PRES Sorbonne Paris, Biostatistics and Epidemiology Unit, Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France. laurent.quinquis@aphp.fr.
authors.forename: Laurent
authors.initials: L
authors.lastname: Quinquis
authors.affiliation: Univ. Paris Descartes, PRES Sorbonne Paris, Biostatistics and Epidemiology Unit, Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France. myriam.benboutieb@aphp.fr.
authors.forename: Myriam
authors.initials: M
authors.lastname: Ben Boutieb
authors.affiliation: Univ. Paris Descartes, PRES Sorbonne Paris Cité, Service de Rééducation et Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, Paris, France. michel.revel050@orange.fr.
authors.forename: Michel
authors.initials: M
authors.lastname: Revel
authors.affiliation: Univ. Paris Descartes, PRES Sorbonne Paris Cité, Service de Rééducation et Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, Paris, France. marie-martine.lefevre-colau@aphp.fr.
authors.forename: Marie-Martine
authors.initials: MM
authors.lastname: Lefèvre-Colau
authors.affiliation: Univ. Paris Descartes, PRES Sorbonne Paris Cité, Service de Rééducation et Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, Paris, France. serge.poiraudeau@aphp.fr.|Univ. Paris Descartes, PRES Sorbonne Paris, INSERM UMR-S 1153 et Institut Fédératif de Recherche sur le Handicap, Paris, France. serge.poiraudeau@aphp.fr.
authors.forename: Serge
authors.initials: S
authors.lastname: Poiraudeau
authors.affiliation: Univ. Paris Descartes, PRES Sorbonne Paris Cité, Service de Rééducation et Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, Paris, France. francois.rannou@aphp.fr.|Univ. Paris Descartes, PRES Sorbonne Paris, Cité Laboratoire de Pharmacologie, Toxicologie et Signalisation Cellulaire, INSERM UMR-S 1124, UFR Biomédicale des Saints Pères, Paris, France. francois.rannou@aphp.fr.
authors.forename: François
authors.initials: F
authors.lastname: Rannou
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D002908:Chronic Disease; D002921:Cicatrix / Q000150:complications / Q000209:etiology; D017586:Diskectomy / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D005355:Fibrosis; D006801:Humans; D000069285:Infliximab / Q000627:therapeutic use*; D008159:Lumbar Vertebrae / Q000473:pathology; D008161:Lumbosacral Region; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011183:Postoperative Complications / Q000188:drug therapy*; D012585:Sciatica / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D018501:Antirheumatic Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab