Effectiveness of Two Techniques in Injection Site Spotting for Botulinum Toxin Injections: Echogr… (NCT01935544) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of Two Techniques in Injection Site Spotting for Botulinum Toxin Injections: Echography or Electro Stimulation.
France30 participantsStarted 2013-11-19
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Timeframe: at inclusion
2
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Timeframe: at day 1 (first injection)
3
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Timeframe: at day 60
4
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight
Timeframe: at day 120 (second injection)
5
Passive range of motion of ankle dorsiflexion (Tardieu scale) while keeping knee straight