Effectiveness of Two Techniques in Injection Site Spotting for Botulinum Toxin Injections: Echography or Electro Stimulation.
Condition: Stroke
MeSH terms: Metrorrhagia
Study type: Interventional

Summary: 
      Botulinum toxin injections are an effective treatment of limb spasticity after stroke.
      Different tracking techniques are used to locate a proper injection spot. Palpatory technique
      is barely effective and induces a high risk of error. Localization by electro stimulation is
      frequently used in adults, but often requires multiple painful repositioning of the needle.
      Ultrasound tracking is sometimes used in children but not much in adults.

      The advantages of ultrasound-guided botulinum toxin injections are a painless localization
      and greater injection accuracy. Safety is therefore enhanced since intravascular injection is
      easily avoided.

      The few existing publications on the subject are essentially case reports. Few studies have
      focused on comparing different injection techniques and so far, no well-conducted study has
      highlighted superior efficiency of ultrasound-guided injections.
    

Detailed description: 
      Objectives:

      The main objective is to compare the efficiency of botulinum toxin injections depending on
      the localization technique: ultrasound vs. electrical stimulation.

      The secondary objective is to demonstrate less painful localization associated to
      ultrasound-guidance.

      Evaluations:

      The primary endpoint is the variation of passive range of motion of ankle dorsiflexion at
      slow speed and high speed ("Tardieu scale") while keeping knee straight.

      The secondary endpoints are:

        -  The other components of the "Tardieu scale": quality of muscle reaction (X) at slow
           speed and fast speed, angle of apparition of the muscle reaction (Y) at slow speed and
           fast speed.

        -  Assessment of spasticity of the triceps surae on the modified Ashworth scale.

        -  The walking speed.

        -  The extent of pain at the injection site by visual analogue scale.

        -  The duration of tracking and injection.

      Methodology:

      This prospective, randomized, single-center, single-blind, cross-over, study will be
      conducted in chronic stroke patients with spasticity of the triceps surae.

      Patients will receive two injections during the protocol, each with a different technique of
      localization. Randomization will determine which technique will be used in the first and the
      second place.

      Patients will be selected from the cohort of patients supported by consultation of Physical
      Medicine and Rehabilitation Department of the University Hospital of Clermont-Ferrand.
      Injections of botulinum toxin and assessments will take place in the same department.

      The study period is five months for each patient. This study does not present a major risk
      for the subjects. The main inconvenience is injection pain or side effects of botulinum toxin
      (increase of motor deficits or dysphagia).
    

Intervention name(s): Botulinum toxin injection
Intervention type(s): Device
Intervention MeSH terms: Botulinum Toxins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Botulinum Toxin; Ultrasound-guidance; Stroke; Spasticity; Ultrasonography; Hemiplegia