Can the early use of botulinum toxin in post stroke spasticity reduce contracture development? A randomised controlled trial

Abstract

Objective: Does early treatment of spasticity with botulinum-toxin (BoNTA), in (hyper)acute stroke patients without arm-function, reduce contractures and improve function. Design: Randomised placebo-controlled-trial Setting: Specialised stroke-unit. Participants & Intervention: Patients with an Action Research Arm Test (ARAT) grasp-score⩽2 who developed spasticity within six-weeks of a first stroke were randomised to receive injections of: 0.9%sodium-chloride solution (placebo) or onabotulinumtoxin-A (treatment). Outcome-Measures: Spasticity, contractures, splint use and arm function (ARAT) were taken at baseline, 12-weeks post-injection and six-months after stroke. Additionally, spasticity and contractures were measured at weeks-two, four and six post-injection. Results: Ninety three patients were randomised. Mean time to intervention was 18-days (standard deviation = 9.3). Spasticity was lower in the treatment group with difference being significant between week-2 to 12 (elbow) and week-2 to 6 (wrist). Mean-difference (MD) varied between –8.5(95% CI –17 to 0) to –9.4(95% CI –14 to –5) µV. Contracture formation was slower in the treatment group. Passive range of motion was higher in the treatment group and was significant at week-12 (elbow MD6.6 (95% CI –0.7 to –12.6)) and week-6 (wrist MD11.8 (95% CI 3.8 to 19.8)). The use of splints was lower in the treatment group odds ratio was 7.2 (95% CI 1.5 to 34.1) and 4.2 (95% CI 1.3 to 14.0) at week-12 and month-6 respectively. Arm-function was not significantly different between the groups MD2.4 (95% CI –5.3 to 10.1) and 2.9 (95% CI –5.8 to 11.6) at week-12 and month-6 respectively. Conclusion: BoNTA reduced spasticity and contractures after stroke and effects lasted for approximately 12-weeks. BoNTA reduced the need for concomitant contracture treatment and did not interfere with recovery of arm function. Trial Registration: EudraCT (2010-021257-39) and ClinicalTrials.gov-Identifier: NCT01882556.