Double-blind, randomized, controlled, crossover trial of pregabalin for neurogenic claudication

Neurology. 2015 Jan 20;84(3):265-72. doi: 10.1212/WNL.0000000000001168. Epub 2014 Dec 10.


Objectives: To test the effects of pregabalin on the induction of neurogenic claudication.

Methods: This study was a randomized, double-blind, active placebo-controlled, 2-period, crossover trial. Twenty-nine subjects were randomized to receive pregabalin followed by active placebo (i.e., diphenhydramine) or active placebo followed by pregabalin. Each treatment period lasted 10 days, including a 2-step titration. Periods were separated by a 10-day washout period, including a 3-day taper phase after the first period. The primary outcome variable was the time to first moderate pain symptom (Numeric Rating Scale score ≥4) during a 15-minute treadmill test (Tfirst). Secondary outcome measures included pain intensity at rest, pain intensity at the end of the treadmill test, distance walked, and validated self-report measures of pain and functional limitation including the Roland-Morris Disability Questionnaire, modified Brief Pain Inventory-Short Form, Oswestry Disability Index, and Swiss Spinal Stenosis Questionnaire.

Results: No significant difference was found between pregabalin and active placebo for the time to first moderate pain symptom (difference in median Tfirst = -1.08 [95% confidence interval -2.25 to 0.08], p = 0.61). In addition, none of the secondary outcome measures of pain or functional limitation were significantly improved by pregabalin compared with active placebo.

Conclusions: Pregabalin was not more effective than active placebo in reducing painful symptoms or functional limitations in patients with neurogenic claudication associated with lumbar spinal stenosis.

Classification of evidence: This study provides Class I evidence that for patients with neurogenic claudication, compared with diphenhydramine, pregabalin does not increase the time to moderate pain during a treadmill test.

Publication types

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

MeSH terms

  • Aged
  • Analgesics / therapeutic use*
  • Cross-Over Studies
  • Disability Evaluation
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Exercise Test
  • Female
  • Humans
  • Lumbar Vertebrae
  • Male
  • Middle Aged
  • Outcome Assessment, Health Care
  • Pain / drug therapy*
  • Pain / etiology
  • Pain Measurement
  • Pregabalin
  • Spinal Stenosis / complications
  • Surveys and Questionnaires
  • Time Factors
  • gamma-Aminobutyric Acid / analogs & derivatives*
  • gamma-Aminobutyric Acid / therapeutic use


  • Analgesics
  • Pregabalin
  • gamma-Aminobutyric Acid