Optimal Muscle Selection for OnabotulinumtoxinA Injections in Poststroke Lower-Limb Spasticity: A Randomized Trial.

Authors:
Alberto Esquenazi
Alberto Esquenazi
Moss Rehabilitation Research Institute
United States
Theodore H Wein
Theodore H Wein
St. Mary's Hospital
Canada
Anthony B Ward
Anthony B Ward
University of Warwick
United Kingdom
Chengcheng Liu
Chengcheng Liu
Beijing National Laboratory for Molecular Sciences
China
Rozalina Dimitrova
Rozalina Dimitrova
University of Rochester School of Medicine and Dentistry
United States

Am J Phys Med Rehabil 2019 May;98(5):360-368

From the MossRehab Gait and Motion Analysis Laboratory, Elkins Park, Pennsylvania (AE); McGill University, Division of Neurology, Montreal General Hospital, Montreal, Quebec, Canada (THW); Staffordshire University, Faculty of Health and North Staffordshire Rehabilitation Centre, Haywood Hospital, Stoke-on-Trent, United Kingdom (ABW); Halifax Health, Brooks Rehabilitation, Daytona Beach, Florida (CG); Allergan plc, Bridgewater, New Jersey (CL); and Allergan plc, Irvine, California (RD).

Objective: The aim of the study was to identify optimal muscle selection patterns for onabotulinumtoxinA treatment of poststroke lower-limb spasticity.

Design: Adults with poststroke lower-limb spasticity (ankle Modified Ashworth Scale ≥3) were randomized to onabotulinumtoxinA (300 U, mandatory ankle plantar flexors; ≤100 U, optional lower-limb muscles) or placebo. Post hoc analysis assessed the impact of muscle selection patterns on ankle Modified Ashworth Scale and physician-assessed Clinical Global Impression of Change based on change from baseline to average of weeks 4/6 versus placebo.

Results: Among 468 patients randomized, onabotulinumtoxinA improved ankle Modified Ashworth Scale (-0.81 vs -0.61, P = 0.01) and Clinical Global Impression of Change (0.86 vs 0.65, P = 0.012) versus placebo. Injection of mandatory muscles alone was not sufficient in improving ankle Modified Ashworth Scale (P = 0.255) or Clinical Global Impression of Change (P = 0.576) versus placebo but was adequate 24 mos or less after stroke (Modified Ashworth Scale, -1.13 vs -0.62, P = 0.019; Clinical Global Impression of Change, 1.24 vs 0.68, P = 0.006). Additional injections into toe muscles (flexor digitorum longus, flexor hallucis longus) improved ankle Modified Ashworth Scale (-0.98 vs -0.52, P = 0.002) and Clinical Global Impression of Change (0.80 vs 0.38, P = 0.023) versus placebo regardless of time since stroke. OnabotulinumtoxinA was well tolerated, with no new safety findings.

Conclusions: Post hoc analyses suggested additional injections of onabotulinumtoxinA into toe flexors improved ankle Modified Ashworth Scale and Clinical Global Impression of Change scores versus mandatory muscles alone overall and with treatment initiation more than 24 mos after stroke.

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Source
http://dx.doi.org/10.1097/PHM.0000000000001101DOI Listing
May 2019
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