title: Botulinum Toxin for the Upper Limb after Stroke (BoTULS) Trial: effect on impairment, activity limitation, and pain.
abstract: OBJECTIVE
  Botulinum toxin is increasingly used to treat upper limb spasticity due to stroke, but its impact on arm function is unclear. We evaluated botulinum toxin for upper limb spasticity and function poststroke.
  
  
  METHODS
  Three hundred thirty-three patients with stroke with upper limb spasticity and reduced arm function participated in a multicenter randomized controlled trial. The intervention group received botulinum toxin type A injection(s) plus a 4-week therapy program. The control group received the therapy program alone. Repeat injection(s) and therapy were available at 3, 6, and 9 months. The primary outcome was upper limb function at 1 month (Action Research Arm Test). Secondary outcomes included measures of impairment, activity limitation, and pain at 1, 3, and 12 months. Outcome assessments were blinded and analysis was by intention to treat.
  
  
  RESULTS
  There was no significant difference in achievement of improved arm function (Action Research Arm Test) at 1 month (intervention group: 42 of 167 [25.1%], control group 30 of 154 [19.5%]; P=0.232). Significant differences in favor of the intervention group were seen in muscle tone at 1 month; upper limb strength at 3 months; basic arm functional tasks (hand hygiene, facilitation of dressing) at 1, 3, and 12 months; and pain at 12 months.
  
  
  CONCLUSIONS
  Botulinum toxin type A is unlikely to be useful for improving active upper limb function (eg, reaching and grasping) in the majority of patients with spasticity after stroke, but it may improve basic upper limb tasks (hand hygiene, facilitation of dressing) and pain.
authors.affiliation: Institute for Ageing and Health, Stroke Research Group, 3-4 Claremont Terrace, Newcastle University, and Nwecastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK, NE2 4AE.
authors.forename: Lisa C
authors.initials: LC
authors.lastname: Shaw
authors.forename: Christopher I M
authors.initials: CI
authors.lastname: Price
authors.forename: Frederike M J
authors.initials: FM
authors.lastname: van Wijck
authors.forename: Phil
authors.initials: P
authors.lastname: Shackley
authors.forename: Nick
authors.initials: N
authors.lastname: Steen
authors.forename: Michael P
authors.initials: MP
authors.lastname: Barnes
authors.forename: Gary A
authors.initials: GA
authors.lastname: Ford
authors.forename: Laura A
authors.initials: LA
authors.lastname: Graham
authors.forename: Helen
authors.initials: H
authors.lastname: Rodgers
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018726:Anti-Dyskinesia Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001132:Arm / Q000503:physiopathology*; D001905:Botulinum Toxins / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009043:Motor Activity / Q000187:drug effects / Q000502:physiology*; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000503:physiopathology; D053580:Muscle Strength / Q000187:drug effects / Q000502:physiology; D009129:Muscle Tonus / Q000187:drug effects / Q000502:physiology; D010146:Pain / Q000188:drug therapy* / Q000503:physiopathology; D020127:Recovery of Function / Q000187:drug effects / Q000502:physiology; D020521:Stroke / Q000503:physiopathology*; D016896:Treatment Outcome
chemical_list: D018726:Anti-Dyskinesia Agents; D001905:Botulinum Toxins