Effectiveness of Two Techniques in Injection Site Spotting for Botulinum Toxin Injections: Echography or Electro Stimulation.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
botulinum toxin injections
The main objective is to compare the efficiency of botulinum toxin injections depending on the localization technique: ultrasound vs. electrical stimulation.
Intervention: Botulinum toxin injection (Device)
ultrasound guidance
The secondary objective is to demonstrate less painful localization associated to ultrasound-guidance
Intervention: Botulinum toxin injection (Device)
Outcomes
Primary Outcomes
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Time Frame: at day 150
Secondary Outcomes
- Duration of tracking and injection(at D1, D120)
- Angle of apparition of the muscle reaction at slow speed and fast speed(at Inclusion, D1, D60, D120 and D150)
- Tardieu scale: quality of muscle reaction at slow speed and fast speed(at Inclusion, D1, D60, D120 and D150)
- Walking speed(at Inclusion, D1, D60, D120 and D150)
- Extent of pain at the injection site by visual analogue scale(at D1, D120)
- Spasticity of the triceps surae on the modified Ashworth scale(at Inclusion, D1, D60, D120 and D150)