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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.
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| botulinum toxin injections | Experimental | The main objective is to compare the efficiency of botulinum toxin injections depending on the localization technique: ultrasound vs. electrical stimulation. |
|
| ultrasound guidance | Other | The secondary objective is to demonstrate less painful localization associated to ultrasound-guidance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin injection | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight | at inclusion | |
| Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight | at day 1 (first injection) | |
| Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight | at day 60 | |
| Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight | at day 120 (second injection) | |
| Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight | at day 150 |
| Measure | Description | Time Frame |
|---|---|---|
| Tardieu scale: quality of muscle reaction at slow speed and fast speed | at Inclusion, D1, D60, D120 and D150 | |
| Angle of apparition of the muscle reaction at slow speed and fast speed | at Inclusion, D1, D60, D120 and D150 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle HAURET | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27852706 | Derived | Morel C, Hauret I, Andant N, Bonnin A, Pereira B, Coudeyre E. 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. BMJ Open. 2016 Nov 15;6(11):e011751. doi: 10.1136/bmjopen-2016-011751. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Spasticity of the triceps surae on the modified Ashworth scale | 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 |
| Duration of tracking and injection | at D1, D120 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010243 | Paralysis |