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

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

John D Markman  1 , Maria E Frazer  2 , Shirley A Rast  2 , Michael P McDermott  2 , Jennifer S Gewandter  2 , Amit K Chowdhry  2 , Kate Czerniecka  2 , Webster H Pilcher  2 , Lee S Simon  2 , Robert H Dworkin  2
Affiliations
Randomized Controlled Trial

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

John D Markman et al. Neurology. .

Abstract

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.

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Figures

Figure 1
Figure 1. Flow of trial participants
Bid = twice a day; LSS = lumbar spinal stenosis.
Figure 2
Figure 2. Distribution of time to walking-induced moderate pain severity (≥4 on 0–10 NRS) by treatment condition
NRS = Numeric Rating Scale.
See this image and copyright information in PMC

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