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Could freezing nerves beat botox for spasticity pain?

NCT ID NCT07303582

Symptom relief Sponsor: Oxford University Hospitals NHS Trust Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study compares a nerve-freezing technique called cryoneurolysis to standard Botox injections for treating pain and stiffness caused by spasticity in people with brain or spinal cord injuries, multiple sclerosis, or stroke. Fifty adults will be randomly assigned to receive either cryoneurolysis or Botox, and researchers will track pain, goal achievement, and side effects over 24 weeks. The goal is to see if cryoneurolysis is a safe and effective option that might require fewer repeat treatments.

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 procedure)
What this could lead to
If it works, this could offer a new, longer-lasting option for managing pain and stiffness from spasticity, reducing the need for frequent repeat treatments.
What could go wrong
This is a small pilot study with only 50 people, so results may not apply to everyone. The freezing procedure may cause temporary numbness or other side effects, and it may not work better than existing treatments.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 50 people

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

Started

Dec 2025

Expected to finish

Nov 2026

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: * Participant is willing and able to give informed consent for participation in the trial OR a positive opinion from a consultee is provided by a family member or carer (relative or friend) willing to provide personal consultee (PC) advice. * Male or Female, aged 18 years or above. * Diagnosed with a central neurological condition, including acquired brain injury (e.g. from ischaemic stroke, trauma, or haemorrhage), multiple sclerosis, and spinal cord injury. * Clinical indication for Botulinum Toxin and Cryoneurolysis treatment, including pain associated with spasticity and with a clinically meaningful response to diagnostic nerve block to specific nerves or nerve branches that can be treated with cryoneurolysis. * At least one rehabilitation goal related to management of pain resulting from spasticity. Exclusion Criteria: * Participant has received Botulinum toxin or cryoneurolysis within the last 90 days. * Raynaud's syndrome. * Cryoglobulinaemia. * Cold urticaria. * Bleeding disorders. * Localised infection at intended treatment site. * Planned oral antispasmodic medication dose changes. * Pregnancy, breastfeeding, or planning pregnancy in the trial period. * Scheduled elective surgery or other procedures requiring general anaesthesia during the trial. * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. * Participants who are currently enrolled in another trial may be excluded if it is deemed (in the investigator's opinion) that participation could influence the results for either study.

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Conditions

The condition(s) this trial relates to.

brain injury central nervous system disorder multiple sclerosis Muscle Spasticity Pain spinal cord injury stroke disorder

As listed by the trial registrant

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

Acquired brain injury including stroke Centreal neurological condition Multiple sclerosis Spinal cord injury

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

  • Oxford Centre for Enablement (OUH NHS-FT)

    RECRUITING

    Oxford, OX3 7HE, United Kingdom

More trials for these conditions

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