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Randomized Controlled Trial Multicenter Study
Intradiscal Glucocorticoid Injection for Patients With Chronic Low Back Pain Associated With Active Discopathy: A Randomized Trial.
- Christelle Nguyen, Isabelle Boutron, Gabriel Baron, Katherine Sanchez, Clémence Palazzo, Raphaël Benchimol, Guillaume Paris, Étienne James-Belin, Marie-Martine Lefèvre-Colau, Johann Beaudreuil, Jean-Denis Laredo, Anne Béra-Louville, Anne Cotten, Jean-Luc Drapé, Antoine Feydy, Philippe Ravaud, François Rannou, and Serge Poiraudeau.
- From Sorbonne Paris Cité, Université Paris Descartes, Hôpitaux Universitaires Paris Centre, Groupe Hospitalier Cochin, INSERM UMR 1124, UFR Biomédicale des Saints-Pères, Assistance Publique-Hôpitaux de Paris, Hôpital Hôtel-Dieu, INSERM UMR 1153, Université Paris Diderot, Hôpitaux Universitaires Saint-Louis-Lariboisière-Fernand-Widal, Groupe Hospitalier Lariboisière, and Institut Fédératif de Recherche sur le Handicap, Paris, France, and Centre Hospitalier Régional Universitaire de Lille, Hôpital Roger Salengro, Lille, France.
- Ann. Intern. Med. 2017 Apr 18; 166 (8): 547-556.
BackgroundActive discopathy is associated with a specific phenotype of chronic low back pain (LBP). Local inflammation has a role in active discopathy-associated symptoms.ObjectiveTo assess the efficacy of a single glucocorticoid intradiscal injection (GC IDI) in patients with chronic LBP with active discopathy.DesignProspective, parallel-group, double-blind, randomized, controlled study. (ClinicalTrials.gov: NCT00804531).Setting3 tertiary care centers in France.Patients135 patients with chronic LBP with active discopathy on magnetic resonance imaging (MRI).InterventionA single GC IDI (25 mg prednisolone acetate) during discography (n = 67) or discography alone (n = 68).MeasurementsThe primary outcome was the percentage of patients with LBP intensity less than 40 on an 11-point numerical rating scale (0 [no pain] to 100 [maximum pain] in 10-point increments) in the previous 48 hours at 1 month after the intervention. The main secondary outcomes were LBP intensity and persistent active discopathy on MRI at 12 months and spine-specific limitations in activities, health-related quality of life, anxiety and depression, employment status, and use of analgesics and nonsteroidal anti-inflammatory drugs at 1 and 12 months.ResultsAll randomly assigned patients were included in the primary efficacy analysis. At 1 month after the intervention, the percentage of responders (LBP intensity <40) was higher in the GC IDI group (36 of 65 [55.4%]) than the control group (21 of 63 [33.3%]) (absolute risk difference, 22.1 percentage points [95% CI, 5.5 to 38.7 percentage points]; P = 0.009). The groups did not differ in LBP intensity at 12 months and in most secondary outcomes at 1 and 12 months.LimitationTertiary care setting.ConclusionIn chronic LBP associated with active discopathy, a single GC IDI reduces LBP at 1 month but not at 12 months.Primary Funding SourceFrench Ministry of Health.
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