Efficacy of radial extracorporeal shock wave therapy compared to botulinum toxin type a in the treatment of lower extremity spasticity in patients with cerebral palsy

Introduction/Background Radial extracorporeal shock wave therapy (rESWT) and infiltration with botulinum toxin type A (BoNT-A) are established therapies for spasticity in cerebral palsy. Using a randomized, controlled, cross-over clinical trial design (level of evidence, 1) this study tested the null hypothesis that infiltration with BoNT-A is more efficient in reducing plantar flexor muscle spasticity in patients with cerebral palsy than rESWT. Material and method Seventy patients were randomly allocated to rESWT (Group A; n  = 35) (three rESWT sessions; one session per week; 2000 radial extracorporeal shock waves [rESWs] per session; positive energy flux density of the rESWs between 0.10 and 0.12 mJ/mm 2 ) or a single infiltration with BoNT-A (Group B; n  = 35) at time point T0. Six months after T0 (i.e., at time point T1) patients in Group A received a single infiltration with BoNT-A, and patients in Group B three rESWT sessions as described for patients in Group A. Treatment success was evaluated using V1 and V3 of the Tardieu scale at three weeks (W3), two months (M2) and three months (M3) after both T0 and T1. Results In six out of 32 direct comparisons (two muscles [soleus and gastrocnemius], two tests [V1 and V3 of the Tardieu scale], two rounds of treatment [starting at T0 and T1] and four times of evaluation per round of treatment [at T0 and T1 baseline as well as at W3, M2 and M3 after both T0 and T1]) rESWT resulted in statistically significantly better outcome than infiltration with BoNT-A. The null hypothesis was rejected. There were no significant complications. Conclusion This study demonstrates that rESWT may be superior to infiltration with BoNT-A in the treatment of plantar flexor muscle spasticity in patients with cerebral palsy. Further studies need to evaluate long-term effectiveness and safety of rESWT in the treatment of plantar flexor muscle spasticity in patients with cerebral palsy.