Extracorporeal shock waves versus botulinum toxin type A in the treatment of post-stroke upper limb spasticity – A randomized, non-inferiority trial

Abstract

Botulinum toxin type A (BoNT-A) is the recommended first-line treatment for regional spasticity affecting the upper limb in patients with stroke. Despite optimal treatment, BoNT-A injection might induce muscle weakness and might be associated with high cost and invasiveness. Recent studies have suggested that extracorporeal shock wave therapy (ESWT) is an effect method for the treatment of spasticity in stroke patients. The objective of this study was to investigate whether extracorporeal shock wave therapy is non-inferior to botulinum toxin type A (BoNT-A) for treatment of post-stroke upper limb spasticity. Forty-two patients with chronic stroke (28 men; mean age, 61.0 ± 10.6 years) were randomly assigned to receive either ESWT or BoNT-A. During the study period, all patients continued their regular rehabilitation. Assessments were performed at baseline and at one, four, and eight weeks after the intervention. The outcome was the change from baseline of the Modified Ashworth Scale (MAS) at the wrist flexors at week 4. The outcome in ESWT group (−0.80 ± 0.41) was similar to that in BoNT-A group (−0.90 ± 0.44), with the higher confidence limit (0.33) for the difference between groups within the pre-specified margin of 0.5, indicating non-inferiority of ESWT to BoNT-A. Our results suggest that ESWT is a non-inferior treatment alternative to BoNT-A for post-stroke upper limb spasticity. Our results provide physicians with more options for the treatment of spasticity in patients with stroke.