A randomized controlled trial of botulinum toxin on lower limb spasticity following acute acquired severe brain injury.
OBJECTIVE
To determine whether serial casting combined with botulinum toxin reduces the development of calf contracture after severe head injury.


METHODS
A double-blind placebo-controlled trial of three parallel treatments for lower limb spasticity.


METHODS
Acute general hospital in the UK.


METHODS
Adults aged 17-70 years admitted to hospital following a severe brain


METHODS
Current physical treatment (group I), lower leg casting plus injections with either saline (group II), or with botulinum toxin (group III) into gastrocnemius and soleus muscles.


METHODS
Limit of ankle dorsiflexion at entry and exit after up to 12 weeks, the Glasgow Outcome Scale (GOS) and Modified Ashworth Scale (MAS).


RESULTS
Two hundred and fifty-three patients were screened and 35 were entered into the trial. Three patients died and four failed to complete the trial. Eighty-eight per cent of those entering the randomized part of the study developed spasticity within 14 days of their injury and the mean range of improvement in the angle of passive ankle dorsiflexion was 4.59 degrees in controls, 11.69 degrees in cast and saline and 13.59 degrees in cast and botulinum toxin. There were significant improvements in the MAS scores in actively treated groups, but not in controls. Cast and botulinum toxin patients also demonstrated a significant improvement in the GOS.


CONCLUSIONS
Active intervention with casting prevents talipes equinovarus deformities in patients losing ankle movement following severe brain injury. Casting alone in these patients is sufficient; the role of additional botulinum toxin needs further investigation, but is safe in these patients.
Verplancke
D
D
North Staffordshire Rehabilitation Centre, University Hospital of North Staffordshire NHS Trust, UK.
Snape
S
S
Salisbury
C F
CF
Jones
P W
PW
Ward
A B
AB
D000293:Adolescent; D000328:Adult; D000368:Aged; D018726:Anti-Dyskinesia Agents / Q000627:therapeutic use*; D001905:Botulinum Toxins / Q000627:therapeutic use*; D001930:Brain Injuries / Q000150:complications*; D004311:Double-Blind Method; D005260:Female; D023261:Glasgow Outcome Scale; D006801:Humans; D035002:Lower Extremity; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology; D016059:Range of Motion, Articular / Q000187:drug effects
D018726:Anti-Dyskinesia Agents; D001905:Botulinum Toxins