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Could freezing nerves beat botox for spastic shoulder pain?

NCT ID NCT06782464

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

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 years and older

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: * 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Rehazenter, Centre National de Rééducation fonctionnelle et de Réadaptation

    RECRUITING

    Luxembourg, 2674, Luxembourg

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