Skip to main content
. 2019 Oct 8;2019(10):CD001408. doi: 10.1002/14651858.CD001408.pub2

NCT02400619.

Trial name or title Public title: Shockwaves therapy and botulinum toxin for the treatment of spasticity in patients with CP: a cross‐over RCT
Scientific title: Efficacy of radial extracorporeal shock waves compared to botulinum toxin type A in the treatment of spasticity of the lower extremities in patients with CP: a crossover randomized clinical trial
Methods Cross‐over RCT
Participants Sample: individuals with CP and lower limb spasticity
Target sample size: 70
Inclusion criteria:
  • Either sex

  • Aged 5 to 55 years

  • Any level of GMFCS

  • Patient consents to participate in the study

  • Diagnosis of spastic CP

  • Spasiticity in triceps surae

  • Dynamic foot deformity

  • Extensibility between 0° and 20° in dorsal flexion passive way

  • Not diagnosed with important cutaneous alterations


Exclusion criteria:
  • Associate neuromuscular disease

  • Surgical intervention to augment the balance articulate or reduce (or both) the spasticity in the last 6 months

  • Fixed foot deformity

  • Aetiology of factors: or genetic bone disorders/disturbances soft parts. Position with anomalies or alterations in soft parts or bone alterations (mechanical)

  • Unable to follow the treatment

  • Allergy to BoNT‐A

  • Healthy volunteer

Interventions BoNT‐A injections versus shockwave therapy
Outcomes Muscular elongation of spastic muscle, participant's perceived pain, if type of GMFCS influences either treatment, and participant and family perception and experience
Starting date September 2014
Contact information Xavi Vidal Novellas (email not provided)
Notes Comment:
  1. We will include this study only if data pertaining to children can be extracted separately.


Status: completed (June 2015)
Date completed: December 2016, not published at the time of last electronic search
Last updated: 13 March 2017
Sponsor: Xavi Vidal Novellas (email not provided)