title: OnabotulinumtoxinA Improves Pain in Patients With Post-Stroke Spasticity: Findings From a Randomized, Double-Blind, Placebo-Controlled Trial.
abstract: Patients with post-stroke spasticity (PSS) commonly experience pain in affected limbs, which may impact quality of life.
  
  
  
  To assess onabotulinumtoxinA for pain in patients with PSS from the BOTOX(®) Economic Spasticity Trial, a multicenter, randomized, double-blind, placebo-controlled trial.
  
  
  
  Patients with PSS (N = 273) were randomized to 22- to 34-week double-blind treatment with onabotulinumtoxinA + standard care (SC) or placebo injection + SC and were eligible to receive open-label onabotulinumtoxinA up to 52 weeks. Assessments included change from baseline on the 11-point pain numeric rating scale, proportion of patients with baseline pain ≥4 achieving ≥30% and ≥50% improvement in pain, and pain interference with work at Week 12, end of double-blind treatment, and Week 52.
  
  
  
  At baseline, most patients (74.3%) experienced pain and 47.4% had pain ≥4 (pain subgroup). Mean pain reduction from baseline at Week 12 was significantly greater with onabotulinumtoxinA + SC (-0.77, 95% CI -1.14 to -0.40) than placebo + SC (-0.13, 95% CI -0.51 to 0.24; P < 0.05). Higher proportions of patients in the pain subgroup achieved ≥30% and ≥50% reductions in pain at Week 12 with onabotulinumtoxinA + SC (53.7% and 37.0%, respectively) compared with placebo (28.8% and 18.6%, respectively; P < 0.05). Reductions in pain were sustained through Week 52. Compared with placebo + SC, onabotulinumtoxinA consistently reduced pain interference with work.
  
  
  
  This is the first randomized, placebo-controlled trial demonstrating statistically significant and clinically meaningful reductions in pain and pain interference with work with onabotulinumtoxinA in patients with PSS.
authors.affiliation: Neurological Rehabilitation, Department of Neurology, Vivantes Klinikum Spandau, Berlin, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Wissel
authors.affiliation: Health Economics & Outcomes Research, Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA.
authors.forename: Vaidyanathan
authors.initials: V
authors.lastname: Ganapathy
authors.affiliation: North Staffordshire Rehabilitation Centre, Haywood Hospital, Stoke on Trent, United Kingdom.
authors.forename: Anthony B
authors.initials: AB
authors.lastname: Ward
authors.affiliation: Department of Clinical Sciences, Karolinska Institute and Rehabilitation Medicine, Danderyd Hospital, Stockholm, Sweden.
authors.forename: Jörgen
authors.initials: J
authors.lastname: Borg
authors.affiliation: Department of Rehabilitation Medicine and Department of Medicine and Health Sciences, Linköping University, Linköping, Sweden.
authors.forename: Per
authors.initials: P
authors.lastname: Ertzgaard
authors.affiliation: Department of Neurological Rehabilitation and Early Rehabilitation, Asklepios-Kliniken Schildautal, Seesen, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Herrmann
authors.affiliation: Department of Rehabilitation Medicine, Orebro University Hospital, Orebro, Sweden.
authors.forename: Anders
authors.initials: A
authors.lastname: Haggstrom
authors.affiliation: East Kent University Hospital NHS, Canterbury, Kent, United Kingdom.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Sakel
authors.affiliation: Allergan Plc, Irvine, California, USA.
authors.forename: Julia
authors.initials: J
authors.lastname: Ma
authors.affiliation: Allergan Plc, Irvine, California, USA.
authors.forename: Rozalina
authors.initials: R
authors.lastname: Dimitrova
authors.affiliation: Allergan Holdings Ltd., Marlow International, The Parkway, Marlow, Buckinghamshire, United Kingdom.
authors.forename: Antony
authors.initials: A
authors.lastname: Fulford-Smith
authors.affiliation: Allergan Plc, Irvine, California, USA. Electronic address: Gillard_Patrick@allergan.com.
authors.forename: Patrick
authors.initials: P
authors.lastname: Gillard
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000627:therapeutic use*; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy / Q000209:etiology* / Q000503:physiopathology; D009465:Neuromuscular Agents / Q000627:therapeutic use; D010146:Pain / Q000188:drug therapy* / Q000209:etiology* / Q000503:physiopathology; D010147:Pain Measurement; D020521:Stroke / Q000150:complications* / Q000188:drug therapy / Q000503:physiopathology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000700:Analgesics; D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A
keywords: OnabotulinumtoxinA; disability; pain; post-stroke spasticity