Extracorporeal Shock Waves Versus Botulinum Toxin Type A in the Treatment of Poststroke Upper Limb Spasticity: A Randomized Noninferiority Trial

Abstract

Objective: To investigate whether extracorporeal shock wave therapy (ESWT) is noninferior to botulinum toxin type A (BoNT-A) for the treatment of poststroke upper limb spasticity.

Design: Randomized noninferiority trial.

Setting: Referral medical center.

Participants: Patients (N=42) with chronic stroke (28 men; mean age, 61.0±10.6y).

Interventions: Patients received either ESWT or BoNT-A. During the study period, all patients continued their regular rehabilitation.

Main outcome measures: Assessments were performed at baseline and at 1, 4, and 8 weeks after the intervention. The primary outcome was the change from baseline of the modified Ashworth scale (MAS) score of the wrist flexors at week 4. Secondary outcomes included the change of the MAS scores, Tardieu angles of the wrist and elbow flexors, wrist and elbow passive range of motion (PROM), and upper extremity Fugl-Meyer Assessment (UE-FMA) score during the study period, as well as the treatment response rate.

Results: The primary outcome result in the ESWT group (-0.80±0.41) was similar to that in the BoNT-A group (-0.90±0.44), with a higher confidence limit (0.4) for the difference between groups within the prespecified margin of 0.5, indicating the noninferiority of ESWT to BoNT-A. The response rate was not significantly different between the 2 groups. Both groups showed significant improvement in secondary outcomes relative to baseline; however, the ESWT group yielded greater improvement in wrist and elbow PROM and UE-FMA score.

Conclusion: Our results suggest that ESWT is a noninferior treatment alternative to BoNT-A for poststroke upper limb spasticity. ESWT and BoNT-A caused similar reduction in spasticity of the wrist and elbow flexors; however, ESWT yielded greater improvement in wrist and elbow PROM and UE-FMA score.

Trial registration: ClinicalTrials.gov NCT03131791.

Keywords: Botulism; High energy shock waves; Muscle spasticity; Rehabilitation; Stroke.