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
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Published in |
Arthritis Research & Therapy, November 2015
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DOI | 10.1186/s13075-015-0838-4 |
Pubmed ID | |
Authors |
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 |
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. 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. 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. 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. ClinicalTrials.gov NCT00385086 ; registered 4 October 2006 (last updated 15 October 2015). |
X Demographics
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Turkey | 1 | 25% |
United Kingdom | 1 | 25% |
Iraq | 1 | 25% |
United States | 1 | 25% |
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Members of the public | 2 | 50% |
Practitioners (doctors, other healthcare professionals) | 2 | 50% |
Mendeley readers
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Unknown | 86 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Researcher | 11 | 13% |
Student > Bachelor | 9 | 10% |
Student > Master | 8 | 9% |
Other | 5 | 6% |
Student > Doctoral Student | 5 | 6% |
Other | 18 | 21% |
Unknown | 30 | 35% |
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Medicine and Dentistry | 29 | 34% |
Nursing and Health Professions | 7 | 8% |
Unspecified | 4 | 5% |
Psychology | 4 | 5% |
Biochemistry, Genetics and Molecular Biology | 2 | 2% |
Other | 5 | 6% |
Unknown | 35 | 41% |