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.

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

SETTING: Acute general hospital in the UK.

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

INTERVENTIONS: 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.

MEASURES: 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.