A double-blind, randomized trial of duloxetine versus placebo in the management of chronic low back pain

Eur J Neurol. 2009 Sep;16(9):1041-8. doi: 10.1111/j.1468-1331.2009.02648.x. Epub 2009 May 12.

Abstract

Background: Duloxetine has demonstrated analgesic effect in chronic pain states. This study assesses the efficacy of duloxetine in chronic low back pain (CLBP).

Methods: Adult patients with non-radicular CLBP entered this 13-week, double-blind, randomized study comparing duloxetine 20, 60 or 120 mg once daily with placebo. The primary measure was comparison of duloxetine 60 mg with placebo on weekly mean 24-h average pain. Secondary measures included Roland-Morris Disability Questionnaire (RMDQ-24), Patient's Global Impressions of Improvement (PGI-I), Brief Pain Inventory (BPI), safety and tolerability.

Results: Four hundred four patients were enrolled, 267 completed. No significant differences existed between any dose of duloxetine and placebo on reduction in weekly mean 24-h average pain at end-point. Duloxetine 60 mg was superior to placebo from weeks 3-11 in relieving pain, but not at weeks 12-13. Duloxetine 60 mg demonstrated significant improvement on PGI-I, RMDQ-24, BPI-average pain and BPI-average interference. Significantly more patients taking duloxetine 120 mg (24.1%) discontinued because of adverse events, versus placebo (8.5%).

Conclusions: Duloxetine was superior to placebo on the primary objective from weeks 3-11, but superiority was not maintained at end-point. Duloxetine was superior to placebo on many secondary measures, and was well-tolerated.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Analysis of Variance
  • Chronic Disease
  • Dopamine Uptake Inhibitors / therapeutic use
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Duloxetine Hydrochloride
  • Female
  • Humans
  • Low Back Pain / drug therapy*
  • Male
  • Middle Aged
  • Pain Measurement
  • Patient Selection
  • Quality of Life
  • Selective Serotonin Reuptake Inhibitors / therapeutic use
  • Thiophenes / administration & dosage
  • Thiophenes / therapeutic use*
  • Treatment Outcome

Substances

  • Dopamine Uptake Inhibitors
  • Serotonin Uptake Inhibitors
  • Thiophenes
  • Duloxetine Hydrochloride