title: A Randomized, Double-blind, Placebo-Controlled Crossover Trial of Oxymorphone Hydrochloride and Propoxyphene/Acetaminophen Combination for the Treatment of Neurogenic Claudication Associated With Lumbar Spinal Stenosis.
abstract: METHODS
  Randomized, double-blind, placebo-controlled, single-dose crossover study.
  
  
  OBJECTIVE
  To test the analgesic efficacy of oxymorphone hydrochloride (OH) and propoxyphene/acetaminophen (PA) for patients with neurogenic claudication associated with lumbar spinal stenosis.
  
  
  BACKGROUND
  Although opioids are often prescribed for neurogenic claudication, no randomized controlled studies support their efficacy for this condition. Patients with neurogenic claudication are generally excluded from clinical trials or included with patients who have nonspecific chronic low back pain, yielding a heterogeneous study population with very different pathophysiologies and clinical presentations.
  
  
  METHODS
  Participants received a single dose of each of the 3 treatments in random order. Treatments were separated by at least 3-day washout periods. The primary outcome variable was the time to first treadmill walking-induced moderate pain (≥4 out of 10 on a Numeric Rating Scale) (Tfirst) assessed 90 minutes after treatment administration. Secondary outcome measures included patient global assessment of low back pain, Roland-Morris Disability Questionnaire, Modified Brief Pain Inventory-Short Form, Oswestry Disability Index, and Swiss Spinal Stenosis Questionnaire.
  
  
  RESULTS
  The study was prematurely terminated because of the removal of PA from the US market. Twenty-four patients were randomized; 21 completed all 3 treatment periods. There were no significant differences among the treatment groups with respect to the median Tfirst (OH-placebo: median [98.3% confidence limits]=-0.25 min [-6.54, 5.00]; PA-placebo: 0.02 min [-7.65, 4.90]; OH-PA: -0.27 min [-5.56, 6.66]).
  
  
  CONCLUSIONS
  This trial failed to demonstrate a benefit of OH or PA in patients experiencing neurogenic claudication. Considering the potential negative side effects of chronic opioid use, additional research is necessary to evaluate the efficacy of sustained opioid treatment specifically for neurogenic claudication.
  
  
  METHODS
  2.
authors.affiliation: *Department of Neurosurgery, Translational Pain Research Program, University of Rochester, Rochester, NY †Department of Anesthesiology, University of Rochester School of Medicine & Dentistry, Rochester, NY ‡Surgery-Cancer Control Unit, University of Rochester, Rochester, NY; and Departments of §Biostatistics and Computational Biology and ¶Neurology, University of Rochester School of Medicine & Dentistry, Rochester, NY.
authors.forename: John D
authors.initials: JD
authors.lastname: Markman
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Gewandter
authors.forename: Maria E
authors.initials: ME
authors.lastname: Frazer
authors.forename: Nicole M
authors.initials: NM
authors.lastname: Murray
authors.forename: Shirley A
authors.initials: SA
authors.lastname: Rast
authors.forename: Michael P
authors.initials: MP
authors.lastname: McDermott
authors.forename: Amit K
authors.initials: AK
authors.lastname: Chowdhry
authors.forename: Emilie J
authors.initials: EJ
authors.lastname: Tomkinson
authors.forename: Webster H
authors.initials: WH
authors.lastname: Pilcher
authors.forename: Kevin A
authors.initials: KA
authors.lastname: Walter
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dworkin
mesh_terms: D000082:Acetaminophen / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D018712:Analgesics, Non-Narcotic / Q000009:adverse effects / Q000627:therapeutic use*; D000701:Analgesics, Opioid / Q000009:adverse effects / Q000627:therapeutic use*; D018592:Cross-Over Studies; D011431:Dextropropoxyphene / Q000009:adverse effects / Q000627:therapeutic use*; D004185:Disability Evaluation; D004311:Double-Blind Method; D004338:Drug Combinations; D057239:Early Termination of Clinical Trials; D005260:Female; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D053208:Kaplan-Meier Estimate; D008159:Lumbar Vertebrae / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D008910:Minnesota; D010111:Oxymorphone / Q000009:adverse effects / Q000627:therapeutic use*; D010146:Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D010147:Pain Measurement; D056737:Safety-Based Drug Withdrawals; D013130:Spinal Stenosis / Q000150:complications* / Q000175:diagnosis / Q000503:physiopathology; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018712:Analgesics, Non-Narcotic; D000701:Analgesics, Opioid; D004338:Drug Combinations; D000082:Acetaminophen; D010111:Oxymorphone; D011431:Dextropropoxyphene