Could freezing nerves beat botox for spastic shoulder pain?
NCT ID NCT06782464
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether freezing specific nerves (cryoneurolysis) can reduce shoulder pain and improve movement in people with spasticity from conditions like stroke or brain injury. Fifty adults will either receive one session of nerve freezing or one session of Botox injections, then follow a 24-week rehab program. The goal is to see if the freezing treatment works as well as Botox and lasts longer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cryoneurolysis (nerve freezing)
- What this could lead to
- If it works, this could offer a longer-lasting alternative to Botox for shoulder pain and stiffness caused by spasticity, reducing the need for repeat injections.
- What could go wrong
- This is a small, early-stage trial with only 50 participants. The procedure is new for this use, and it may not work as well as expected or could have unknown side effects.
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
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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
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Be over 18 years old. * Have a clinically and functionally stable condition. * Present spastic hemiplegia of the upper limb caused by a stroke, traumatic, or hypoxic brain event occurring more than 6 months before the study. * The paretic upper limb must present significant spastic plegia at the shoulder adductors and/or shoulder internal rotators (≥ 1+ on the Modified Ashworth Scale). * Have a Visual Analogue Scale (VAS) pain score \> 40/100 mm. * Have spasticity causing limitations in providing care. * Have the cognitive capacity to make informed decisions. A comprehensive explanation of the study will be provided orally and in writing to participants and a trusted relative of their choosing. * Maintain any medications on a stable schedule. * Accept and have access to an interdisciplinary rehabilitation program and standardized evaluation sessions throughout the study. Exclusion Criteria: * In the investigator's opinion, the subject will be exposed to unacceptable risk by participation. * Previous intervention or condition that altered the target neural anatomy of the upper limb. * Any injection (neurolytic, sclerosing, anesthesia, etc.) to the upper limb within the last 4 months. * Spasticity invasive treatment such as intrathecal baclofen during the trial. * Current enrollment in an investigational drug or device study targeting spasticity management. * Pregnancy or lactation. * Allergy or intolerance to local anesthesia/BoNT-A. * Contraindications to BoNT-A administration, such as: * Myasthenia Gravis * Eaton-Lambert syndrome * Possible drug interactions (e.g., aminoglycosides and BoNT-A) * Any local skin condition at the treatment site that may adversely affect treatment or outcomes. * Chronic medication use (prescription or over-the-counter) that, in the investigator's opinion, would affect study participation or subject safety. * Contraindications to cryoneurolysis, including: * Diagnosis of cryoglobulinemia * Paroxysmal cold hemoglobinuria * Cold urticaria * Raynaud's disease * Any form of peripheral neuropathy * Open and/or infected wounds on the affected limb * Diagnosis of concomitant progressive neurological diseases such as Amyotrophic Lateral Sclerosis. * Any reason, in the investigator's opinion, that the subject may not be suitable for study participation (e.g., history of noncompliance, drug addiction, or any related upper limb injury).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Rehazenter, Centre National de Rééducation fonctionnelle et de Réadaptation
RECRUITINGLuxembourg, 2674, Luxembourg
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