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OBJECTIVE	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 .
METHODS	Twenty-nine subjects were randomized to receive pregabalin followed by active placebo ( i.e. , diphenhydramine ) or active placebo followed by pregabalin .
METHODS	Each treatment period lasted 10 days , including a 2-step titration .
METHODS	Periods were separated by a 10-day washout period , including a 3-day taper phase after the first period .
METHODS	The primary outcome variable was the time to first moderate pain symptom ( Numeric Rating Scale score 4 ) during a 15-minute treadmill test ( Tfirst ) .
METHODS	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 ) .
RESULTS	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 .
METHODS	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 .

