title: Efficacy of two injection-site localisation techniques for botulinum toxin injections: a single-blind, crossover, randomised trial protocol among adults with hemiplegia due to stroke.
abstract: Botulinum toxin injections are an effective treatment for limb spasticity following stroke. Different tracking techniques are used for this purpose: palpation, electrostimulation, electromyography and ultrasound. Yet very few studies have compared these different techniques, and none has successfully proved the superior efficacy of ultrasound-guided injections compared to another tracking method. The primary objective of our study was therefore to compare the efficacy of botulinum toxin injections depending on the tracking technique used: ultrasound versus electrostimulation.
  
  
  
  This is a clinical, single-centre, prospective, interventional, single-blind, crossover, randomised trial. In total, 30 patients aged between 18 and 80 years presenting with triceps surae spasticity (evaluated >1 on the modified Ashworth scale) associated with hemiplegia sequelae due to stroke will be included. The patients will be selected among those who attend for consultation the Physical Medicine and Rehabilitation Department of the Clermont-Ferrand University Hospital. One group will receive the abobotulinumtoxinA (BoNT-A) injection guided by electrostimulation then ultrasound, and the second group's botulinum toxin injections will be guided by ultrasound then electrostimulation. For each patient, the duration of study participation is 5 months. The primary end point is variation in passive ankle dorsiflexion range of motion at slow and high speeds (Tardieu scale) with the knee straight.
  
  
  
  This study received ethics approval form the CPP of Rhônes-Alpes region. Results will be published in a peer-reviewed journal.
  
  
  
  NCT01935544; pre-results.
authors.affiliation: Service de Médecine Physique et de Réadaptation; CHU Clermont-Ferrand, Clermont-Ferrand, France.|Université Clermont Auvergne, Clermont-Ferrand, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Morel
authors.affiliation: Service de Médecine Physique et de Réadaptation; CHU Clermont-Ferrand, Clermont-Ferrand, France.|Centre médical Etienne Clémentel, Enval, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Hauret
authors.affiliation: Biostatistics Unit, Délégation Recherche Clinique & Innovation (DRCI), CHU Clermont-Ferrand, Clermont-Ferrand, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Andant
authors.affiliation: Service de Médecine Physique et de Réadaptation; CHU Clermont-Ferrand, Clermont-Ferrand, France.|Université Clermont Auvergne, Clermont-Ferrand, France.
authors.forename: Armand
authors.initials: A
authors.lastname: Bonnin
authors.affiliation: Biostatistics Unit, Délégation Recherche Clinique & Innovation (DRCI), CHU Clermont-Ferrand, Clermont-Ferrand, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Pereira
authors.affiliation: Service de Médecine Physique et de Réadaptation; CHU Clermont-Ferrand, Clermont-Ferrand, France.|Université Clermont Auvergne, Clermont-Ferrand, France.|INRA, Unité de Nutrition Humaine (UNH, UMR 1019), Clermont-Ferrand, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Coudeyre
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D002985:Clinical Protocols; D018592:Cross-Over Studies; D005260:Female; D005602:France; D006429:Hemiplegia / Q000150:complications*; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy*; D009465:Neuromuscular Agents / Q000008:administration & dosage*; D011446:Prospective Studies; D016059:Range of Motion, Articular; D016037:Single-Blind Method; D020521:Stroke / Q000150:complications*; D016896:Treatment Outcome; D014463:Ultrasonography; D055815:Young Adult
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A
keywords: echography; electrostimulation; gastrocnemius; soleus