Effectiveness of Two Techniques in Injection Site Spotting for Botulinum Toxin Injections: Echography or Electro Stimulation.

Recruiting

Phase N/A Results N/A

Trial Description

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).

Conditions

Interventions

  • Botulinum toxin injection Drug
    ARM 1: Kind: Experimental
    Label: botulinum toxin injections
    Description: The main objective is to compare the efficiency of botulinum toxin injections depending on the localization technique: ultrasound vs. electrical stimulation.
    ARM 2: Kind: Experimental
    Label: ultrasound guidance
    Description: The secondary objective is to demonstrate less painful localization associated to ultrasound-guidance

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Subject)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight at inclusion No
Secondary Tardieu scale: quality of muscle reaction at slow speed and fast speed at Inclusion, D1, D60, D120 and D150 Yes
Secondary Angle of apparition of the muscle reaction at slow speed and fast speed at Inclusion, D1, D60, D120 and D150 Yes
Secondary Spasticity of the triceps surae on the modified Ashworth scale at Inclusion, D1, D60, D120 and D150 Yes
Secondary Walking speed at Inclusion, D1, D60, D120 and D150 Yes
Secondary Extent of pain at the injection site by visual analogue scale at D1, D120 Yes
Secondary Duration of tracking and injection at D1, D120 Yes

Sponsors