RecruitingPhase IVInterventional

Cryoneurolysis to treat pain in the context of spasticity

This study is investigating a new way to treat pain from stiff muscles, known as spasticity, which affects people with brain or spinal cord conditions like stroke, multiple sclerosis, or spinal cord injury. Spasticity can cause pain, stiffness, and make daily activities difficult. The new treatment, called cryoneurolysis, involves freezing nerves that control problematic muscles. This study aims to understand if cryoneurolysis is more effective or safer than the usual treatment, which involves Botox injections. It will compare both treatments to see how they affect pain, daily activities, and any possible side effects, helping us learn more about this promising new option.

At a glance

Status

Recruiting

Phase

Phase IV

Sponsor

Oxford University Hospitals NHS Trust

Enrolment target

Start

01 Jun 2026

Estimated completion

01 Sep 2027

Medical condition: Central neurological condition, including acquired brain injury (e.g. from ischaemic stroke, trauma, or haemorrhage), multiple sclerosis, and spinal cord injury. Medical condition in lay language: Condition affecting the brain or spinal cord Therapeutic areas: Diseases [C] - Nervous System Diseases [C10]

What is this study about?

This study is looking into new ways to help people who experience pain due to stiff muscles, a condition called spasticity. Spasticity often affects individuals who have had a brain injury (like from a stroke or accident), multiple sclerosis, or a spinal cord injury. These stiff muscles can cause a lot of discomfort, limit movement, and make everyday tasks challenging. Current treatments don't always work perfectly, so doctors are always looking for better options.

One promising treatment is called cryoneurolysis. This involves carefully freezing and then thawing specific nerves that are responsible for the stiff and painful muscles. It's already approved in the UK for treating this kind of pain, and some hospitals, including Oxford University Hospitals, have been offering it since January 2024. This study is designed to learn more about how well cryoneurolysis works and what side effects it might have, especially when compared to a more common treatment.

The study will compare cryoneurolysis with another widely used treatment: injections of Botulinum Toxin (often known as Botox). By comparing these two approaches, researchers hope to get a clearer picture of cryoneurolysis's potential benefits and side effects. This will help doctors understand when this treatment might be most helpful for people living with spasticity and its associated pain.

Key takeaways

Researches a new treatment (cryoneurolysis) for pain from stiff muscles (spasticity).
Compares cryoneurolysis with standard Botox injections.
For adults with brain or spinal cord conditions like stroke or MS.
Aims to understand how well it works and any side effects.
Participation involves treatment and follow-up visits over 24 weeks.

Who may be eligible?

To join this study, you need to be an adult aged 18 or over. You should have a condition that affects your brain or spinal cord, such as a brain injury (from a stroke, accident, or bleeding), multiple sclerosis, or a spinal cord injury. A key requirement is that you experience pain from stiff muscles (spasticity) that doctors believe could be eased by both Botox injections and cryoneurolysis. You also need to have shown a good response to an earlier test (a diagnostic nerve block) where a nerve was temporarily numbed, confirming that it's the right nerve to target. Finally, you should have at least one personal goal for your rehabilitation that focuses on reducing this spasticity-related pain.

There are also some reasons why you might not be able to take part. For example, if you've recently had Botox or cryoneurolysis treatment (within the last 90 days), or if you have certain conditions like Raynaud's syndrome, cryoglobulinaemia, or cold urticaria, which react badly to cold. Bleeding disorders, taking certain antibiotics, or having an infection at the treatment site would also prevent you from joining. The study also cannot include pregnant or breastfeeding individuals, or those planning pregnancy during the study period. If you have upcoming major surgery or any other health condition that the doctors think might make the study unsafe for you or affect the results, you might also be excluded.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a condition affecting your brain or spinal cord (e.g., stroke, MS, spinal cord injury)?
Do you have pain from stiff muscles (spasticity) that your doctor thinks could be treated with Botox or cryoneurolysis?
Do you have a goal to reduce pain caused by spasticity?
Have you recently avoided Botox or cryoneurolysis (in the last 3 months)?
Are you not pregnant, breastfeeding, or planning pregnancy during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to one of two groups: either you'll receive the usual care with Botulinum Toxin injections, or you'll receive the innovative cryoneurolysis treatment. Neither you nor the researchers will choose which group you're in, it's like flipping a coin to keep the study fair. You'll have several appointments to check your progress. These will happen at the start, and then at 6, 12, 18, and 24 weeks after your treatment. During these visits, the research team will assess your pain levels, how well you're achieving your personal goals, any side effects you might be having, the stiffness of your muscles, your ability to do daily activities independently, and how well you can move your arms and legs. Importantly, if you're in the group that initially receives Botulinum Toxin, you will have the chance to try the cryoneurolysis treatment after your 12-week assessment.

Potential risks and benefits

This study aims to understand if a newer treatment for spasticity-related pain, cryoneurolysis, is effective and safe compared to standard care. While the specific benefits and risks are not fully detailed yet, potential benefits might include better pain relief or improved daily function. As with any medical procedure, there could be risks such as discomfort, bruising, swelling, or temporary numbness at the treatment site for either treatment. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Nuffield Orthopaedic Centre
Approximate
Oxford, England

Common questions

What is spasticity?

Spasticity is when muscles become unusually stiff, tight, or go into spasms, often due to conditions affecting the brain or spinal cord.

What is cryoneurolysis?

Cryoneurolysis is a medical procedure that involves freezing specific nerves for a short time to help reduce pain or muscle stiffness.

How is cryoneurolysis different from Botox?

Cryoneurolysis uses cold to temporarily block nerve signals, while Botox uses a medication injected into the muscle to relax it.

Will I know which treatment I'm getting?

You will be assigned to a group by chance (like drawing lots) so you might not know which treatment you will receive initially. However, if you receive Botox first, you'll get the chance to try cryoneurolysis later.

Where is the study happening?

The study is being run from Oxford University Hospitals NHS Trust in the UK.

How to find out more

Anton Pick

anton.pick@ouh.nhs.uk +44 (0)1865 737306 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.