The efficacy and safety of pregabalin in the treatment of neuropathic pain associated with chronic lumbosacral radiculopathy

Pain. 2010 Sep;150(3):420-427. doi: 10.1016/j.pain.2010.04.013. Epub 2010 May 20.


We evaluated the efficacy of pregabalin in patients with chronic lumbosacral radiculopathy. This randomized, controlled, withdrawal trial included five phases: screening (4-18 days); run-in (4-10 days) to screen out placebo responders; single-blind (28 days) to identify pregabalin responders; double-blind to randomize responders to pregabalin or placebo (35 days); and final study medication taper (7 days). The primary endpoint was time to loss of response (LOR) during the double-blind phase (1-point increase in pain, discontinuation, or rescue-medication use). In the single-blind phase, 58% of patients had 30% pain reduction. In the double-blind phase, pregabalin (n=110) and placebo (n=107) groups did not differ significantly in time to LOR. Adverse events caused the discontinuation of 9.9% and 5.6% of pregabalin-treated and placebo-treated patients, respectively. Most patients with chronic lumbosacral radiculopathy responded to pregabalin therapy; however, time to LOR did not significantly differ between pregabalin and placebo. Considering the results of all phases of the study, it is difficult to draw definitive conclusions from it, suggesting a need for further work to understand the clinical potential of pregabalin treatment for lumbosacral radiculopathy.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Analgesics / therapeutic use*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Evaluation
  • Female
  • Follow-Up Studies
  • Humans
  • Kaplan-Meier Estimate
  • Lumbosacral Region
  • Male
  • Middle Aged
  • Neuralgia / drug therapy*
  • Neuralgia / pathology
  • Pain Measurement / methods
  • Pregabalin
  • Proportional Hazards Models
  • Single-Blind Method
  • gamma-Aminobutyric Acid / analogs & derivatives*
  • gamma-Aminobutyric Acid / therapeutic use


  • Analgesics
  • Pregabalin
  • gamma-Aminobutyric Acid