title: Botulinum toxin injection for hypertonicity of the upper extremity within 12 weeks after stroke: a randomized controlled trial.
abstract: BACKGROUND
  Botulinum neurotoxin type A (BoNT-A) reduces upper-extremity poststroke spasticity when given 6 or more months after stroke. Effects on functional use of the arm and hand are less apparent.
  
  
  OBJECTIVE
  To determine the effect and safety of very early use of BoNT-A for patients with upper-limb spasticity.
  
  
  METHODS
  The Asia Botulinum Toxin-A Clinical Trial
  
  
  METHODS
  ed for Early Post-stroke Spasticity (ABCDE-S; NCT00234546) was a multicenter, randomized, placebo-controlled trial conducted in patients recruited within 2 -12 weeks of first-ever stroke. Participants with a Modified Ashworth Scale (MAS) score of 1+ or above received BoNT-A (Dysport) 500 U or placebo to one or more wrist and elbow mover muscles, plus unstructured rehabilitation. The primary outcome was the MAS score in the most affected joint 4 weeks after first injection. Follow-up was 24 weeks.
  
  
  RESULTS
  A total of 163 patients were enrolled and assigned to placebo (n = 83) or BoNT-A (n = 80). Mean time since stroke was about 7 weeks. At 4 weeks postinjection, BoNT-A significantly improved MAS scores. Treatment effect-size estimates increased with higher baseline MAS scores from 0.45 (Q1) to 0.70 (Q3). MAS scores for all secondary end points improved with BoNT-A versus placebo at all time points (P < .0001, all visits). The Functional Motor Assessment Scale did not reveal clinically significant differences. No group differences in adverse events were found. Interpretation. BoNT-A 500 U can provide a sustained reduction in poststroke upper-limb spasticity when combined with rehabilitation in Asian patients who have mild-to-moderate hypertonicity and voluntary movement, within 2 -12 weeks of stroke. Functional use of the arm and hand was not affected.
authors.affiliation: University of Santo Tomas, Manila, Philippines. rlrosales@mnl.ust.edu.ph
authors.forename: Raymond L
authors.initials: RL
authors.lastname: Rosales
authors.forename: Keng He
authors.initials: KH
authors.lastname: Kong
authors.forename: Khean Jin
authors.initials: KJ
authors.lastname: Goh
authors.forename: Witsanu
authors.initials: W
authors.lastname: Kumthornthip
authors.forename: Vincent Chung Tong
authors.initials: VC
authors.lastname: Mok
authors.forename: Mary Mildred
authors.initials: MM
authors.lastname: Delgado-De Los Santos
authors.forename: Karen Sui Geok
authors.initials: KS
authors.lastname: Chua
authors.forename: Saini Jeffery Bin Freddy
authors.initials: SJ
authors.lastname: Abdullah
authors.forename: Benjamin
authors.initials: B
authors.lastname: Zakine
authors.forename: Pascal
authors.initials: P
authors.lastname: Maisonobe
authors.forename: Axel
authors.initials: A
authors.lastname: Magis
authors.forename: K S Lawrence
authors.initials: KS
authors.lastname: Wong
mesh_terms: D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004551:Elbow Joint; D005260:Female; D006801:Humans; D007270:Injections, Intra-Articular; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D009465:Neuromuscular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D010919:Placebos; D012720:Severity of Illness Index; D020521:Stroke / Q000150:complications* / Q000188:drug therapy; D000071939:Stroke Rehabilitation; D013997:Time Factors; D016896:Treatment Outcome; D034941:Upper Extremity / Q000503:physiopathology*; D014955:Wrist Joint
chemical_list: D009465:Neuromuscular Agents; D010919:Placebos; D019274:Botulinum Toxins, Type A