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Can ultrasound make spasticity injections more precise and less painful?

NCT ID NCT01935544

Disease control Sponsor: University Hospital, Clermont-Ferrand Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial compares two techniques for guiding botulinum toxin injections to treat leg spasticity after a stroke: ultrasound and electrostimulation. The goal is to see which method improves ankle flexibility and reduces pain during the procedure. Adults with stroke-related spasticity in the calf muscles are eligible to participate.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Botulinum toxin injection guided by either ultrasound or electrostimulation
What this could lead to
If ultrasound proves superior, it could become the preferred method for guiding botulinum toxin injections, improving accuracy and reducing pain for stroke survivors with spasticity.
What could go wrong
This is a small, early-stage trial, and the results may not be conclusive. Ultrasound guidance might not show a clear advantage over the existing technique, and individual responses can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Nov 2013

Finished

Feb 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hemiplegia Muscle Spasticity stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stroke

Contacts and locations

Locations

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.