Document Detail

Botulinum Toxin for the Upper Limb after Stroke (BoTULS) Trial: effect on impairment, activity limitation, and pain.
MedLine Citation:
PMID:  21415398     Owner:  NLM     Status:  MEDLINE    
BACKGROUND AND PURPOSE: 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.
Lisa C Shaw; Christopher I M Price; Frederike M J van Wijck; Phil Shackley; Nick Steen; Michael P Barnes; Gary A Ford; Laura A Graham; Helen Rodgers;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2011-03-17
Journal Detail:
Title:  Stroke; a journal of cerebral circulation     Volume:  42     ISSN:  1524-4628     ISO Abbreviation:  Stroke     Publication Date:  2011 May 
Date Detail:
Created Date:  2011-04-26     Completed Date:  2011-06-30     Revised Date:  2011-08-16    
Medline Journal Info:
Nlm Unique ID:  0235266     Medline TA:  Stroke     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1371-9     Citation Subset:  IM    
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.
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MeSH Terms
Activities of Daily Living
Aged, 80 and over
Anti-Dyskinesia Agents / pharmacology,  therapeutic use*
Arm / physiopathology*
Botulinum Toxins / pharmacology,  therapeutic use*
Follow-Up Studies
Middle Aged
Motor Activity / drug effects,  physiology*
Muscle Spasticity / drug therapy*,  physiopathology
Muscle Strength / drug effects,  physiology
Muscle Tonus / drug effects,  physiology
Pain / drug therapy*,  physiopathology
Recovery of Function / drug effects,  physiology
Stroke / physiopathology*
Treatment Outcome
Reg. No./Substance:
0/Anti-Dyskinesia Agents; EC Toxins
David Barer / ; David Bruce / ; Tim Cassidy / ; Paul Davies / ; Philip Earnshaw / ; Akif Gani / ; Chris Gray / ; Ali Mehrzad / ; Jon Scott / ; Lydia Aird / ; Louise Baxter / ; Lianne Brkic / ; Caroline Deacon / ; Hilary Ford / ; Heather Hunter / ; Nina Lishman / ; Paul McNeillie / ; Dadirayi Mhiripiri / ; Janet Nesbitt / ; Frances Sapsford / ; Jessie Cowe / ; Katharine Foster / ; Linda Goulbourne / ; Anne Harrison / ; Joseph Hoben / ; Debbie Jones / ; Ruth Wood / ; Tony Field /
Comment In:
Stroke. 2011 Jul;42(7):e412; author reply e413   [PMID:  21636823 ]

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