title: Efficacy of Duloxetine in Chronic Low Back Pain with a Neuropathic Component: A Randomized, Double-blind, Placebo-controlled Crossover Trial.
abstract: BACKGROUND
  Among patients with chronic low back pain (CLBP), approximately 37% show signs of a neuropathic pain component (radicular pain). Treatment of this condition remains challenging. Therefore, the current study aimed to investigate the efficacy of duloxetine in the treatment of CLBP patients with neuropathic leg pain.
  
  
  METHODS
  The study was conducted as a prospective, randomized, placebo-controlled, double-blind crossover trial. CLBP with a visual analog scale (VAS) score greater than 5 and a neuropathic component that was assessed clinically and by the painDETECT questionnaire (score > 12) were required for inclusion. Patients were randomly assigned to either duloxetine or placebo for 4 weeks followed by a 2-week washout period before they crossed over to the alternate phase that lasted another 4 weeks. Duloxetine was titrated up to 120 mg/day. The primary outcome parameter was mean VAS score during the last week of treatment in each phase (VAS(week4)).
  
  
  RESULTS
  Of 41 patients, 21 patients completed both treatment phases. In the intention-to-treat analysis (n = 25), VAS(week4) was significantly lower in the duloxetine phase compared with placebo (4.1 ± 2.9 vs. 6.0 ± 2.7; P = 0.001), corresponding to an average pain reduction of 32%. The painDETECT score at the end of each treatment phase was significantly lower in the duloxetine phase compared with placebo (17.7 ± 5.7 vs. 21.3 ± 3.6 points; P = 0.0023). Adverse events were distributed equally between the duloxetine (65%) and placebo phases (62%) (P = 0.5).
  
  
  CONCLUSIONS
  In this crossover study, duloxetine proved to be superior to placebo for the treatment of CLBP with a neuropathic leg pain.
authors.affiliation: From the Department of Special Anesthesia and Pain Therapy, Medical University of Vienna, Vienna, Austria (R.P.S., H.G.K., S.P.); Department of Anesthesia, St. Josefs Krankenhaus Balserische Stiftung, Gießen, Germany (M.J.O.); and Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University Vienna, Vienna, Austria (A.G., G.H.).
authors.forename: Regina P
authors.initials: RP
authors.lastname: Schukro
authors.forename: Matthias J
authors.initials: MJ
authors.lastname: Oehmke
authors.forename: Angelika
authors.initials: A
authors.lastname: Geroldinger
authors.forename: Georg
authors.initials: G
authors.lastname: Heinze
authors.forename: Hans-Georg
authors.initials: HG
authors.lastname: Kress
authors.forename: Sibylle
authors.initials: S
authors.lastname: Pramhas
mesh_terms: D000700:Analgesics / Q000494:pharmacology*; D002908:Chronic Disease; D018592:Cross-Over Studies; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride / Q000494:pharmacology*; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000150:complications* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000150:complications* / Q000188:drug therapy*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D000068736:Duloxetine Hydrochloride