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Completed
NCT01935544
Effectiveness of Two Techniques in Injection Site Spotting for Botulinum Toxin Injections: Echography or Electro Stimulation.
Conditions: Stroke
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: University Hospital, Clermont-Ferrand
Location: CHU Clermont-Ferrand Clermont-Ferrand
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.
Eligibility Criteria
Inclusion Criteria:
* Age 18 to 80 years.
* Hemiplegia sequelae of stroke
* Spasticity of the triceps surae listed at least 1 + / 4 on the modified Ashworth scale
* Ability to give written consent
Exclusion Criteria:
* Injection of botulinum toxin older than 3 months
* Patient who has already received ultrasound-guided injection of botulinum toxin
* Indication of botulinum toxin injection in other muscle groups in the lower limb than triceps surae
* Swallowing impairment
* Ongoing AVK anticoagulation treatment with INR greater than 3 during one week before randomization.
* Ongoing treatment by aminoglycosides
* General anesthesia with injection of curare planned during the participation in the protocol
* Wearing a pacemaker
* History of ankle arthrodesis
* Other cons-indication for botulinum toxin injection: myasthenia gravis, pregnancy, lactation.
Source: ClinicalTrials.gov (NCT01935544). StuddyBuddy aggregates publicly available trial information.