RecruitingPHASE4INTERVENTIONAL

Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities

This study is investigating two ways to treat pain caused by spasticity, which is muscle stiffness due to conditions like stroke, multiple sclerosis (MS), or spinal cord injury. One treatment is cryoneurolysis, which involves carefully freezing nerves that control affected muscles. The other is botulinum toxin (Botox) injections, a more common treatment. We want to understand how effective cryoneurolysis is and if it has any side effects, compared to Botox. Participants will be put into two groups: one receiving Botox and the other cryoneurolysis. We will track their pain, daily activities, and how well they can achieve their personal goals over several weeks to see which treatment helps more.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Oxford University Hospitals NHS Trust

Enrolment target

Start

02 Dec 2025

Estimated completion

30 Nov 2026

Centreal Neurological Condition Acquired Brain Injury (Including Stroke)Multiple Sclerosis Spinal Cord Injury

What is this study about?

When someone has damage to their brain or spinal cord, from conditions like a stroke, multiple sclerosis (MS), or a spinal cord injury, they might experience something called spasticity. This is where muscles become stiff, tight, and can cause a lot of pain. It can also make everyday tasks, like personal care or moving around, much harder. While there are treatments available, they don't always fully reduce the spasticity, and some, like Botox injections, need to be repeated quite often.

This study is looking at a new treatment called cryoneurolysis alongside a more established one, botulinum toxin (Botox). Cryoneurolysis works by carefully freezing the nerves that are causing the problematic muscle stiffness and pain. This temporarily stops the nerve from sending signals, which can help relax the muscle. This treatment has been used at Oxford University Hospitals since January 2024 for pain related to spasticity, and we want to learn more about how well it works and if it has any side effects compared to Botox.

By comparing these two treatments, we hope to understand if cryoneurolysis could be a better or longer-lasting option for people living with spasticity. The information gathered from this study will be very important in helping doctors decide the best ways to treat spasticity-related pain in the future.

Key takeaways

This study compares freezing nerves (cryoneurolysis) with Botox for spasticity pain.
It aims to find out if cryoneurolysis is a better treatment option.
Participants will be randomly assigned to one of two treatment groups.
Assessments will track pain, movement, and daily life for 24 weeks.
If in the Botox group, you may try cryoneurolysis after 12 weeks.
Your involvement helps improve future treatments for spasticity pain.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with a condition affecting their brain or spinal cord, such as a stroke, multiple sclerosis, or a spinal cord injury. You might be suitable if your spasticity causes pain and your doctor thinks that either Botox or cryoneurolysis could help you.

Before joining, doctors will need to check if the specific nerves causing your pain can be targeted with cryoneurolysis. Also, you should have at least one personal goal related to managing your spasticity pain that you hope treatment will help you achieve. You should also be able to understand and agree to take part in the study, or have a family member or friend who can help make that decision for you.

You wouldn't be able to join if you've already had Botox or cryoneurolysis in the last 90 days. Certain other health conditions, like Raynaud's syndrome, bleeding problems, or being pregnant or breastfeeding, would also prevent you from taking part. If you have any infections at the injection site or are planning major surgery during the study period, you also wouldn't be eligible. The study team will review your full medical history to ensure it's safe for you to participate.

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 like stroke, MS, or spinal cord injury causing spasticity pain?
Has your doctor suggested either Botox or cryoneurolysis for your pain?
Do you have at least one personal goal for managing your spasticity pain?
Have you avoided Botox or cryoneurolysis in the last 3 months?
Are you NOT pregnant or breastfeeding, or planning to be during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly put into one of two groups, like flipping a coin. One group will receive the standard treatment, which is injections of botulinum toxin (Botox). The other group will receive cryoneurolysis, which involves careful freezing of the nerves.

Before treatment, and then at 6, 12, 18, and 24 weeks afterwards, you'll have appointments for assessments. During these appointments, the study team will check your pain levels, how much you've achieved your personal goals, any side effects you might be having, your spasticity, how much help you need with daily activities, and how well you can move your arm and leg. This helps us see how well each treatment is working. If you're in the Botox group, you'll have the chance to try cryoneurolysis after your 12-week check-up if you wish. The total duration of your active participation in the study, including follow-up, will be about 24 weeks (6 months).

Potential risks and benefits

Taking part in this study may offer benefits, such as receiving a treatment that could reduce your pain and improve your movement and daily activities. You would also be contributing to important research that could help many other people with spasticity in the future. As with all medical treatments, there are potential risks, though these will be carefully explained to you by the study team. Both treatments might cause some temporary discomfort, bruising, or swelling at the treatment site. Cryoneurolysis carries a small risk of temporary numbness or weakness. The study team will monitor you closely for any side effects. Remember, joining this study is completely voluntary, and you have the right to withdraw at any time without explaining why, and this will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Oxford Centre for Enablement (OUH NHS-FT)
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What is spasticity?

Spasticity is muscle stiffness and tightness due to damage in the brain or spinal cord, which can cause pain and make movement difficult.

What is cryoneurolysis?

Cryoneurolysis is a treatment that uses controlled freezing to temporarily stop nerves from sending pain signals to muscles.

Will I definitely get cryoneurolysis if I join?

You will be randomly assigned to either receive cryoneurolysis or botulinum toxin (Botox). If you get Botox first, you might be able to try cryoneurolysis later.

How long will the study last for me?

Your involvement in the study, including all follow-up appointments, will last for about 24 weeks (6 months).

What if I change my mind after joining?

You can leave the study at any time without giving a reason, and it won't affect your future medical care.

How to find out more

Anton Pick, MBChB

anton.pick@ouh.nhs.uk (+44) 01865 737306 Official trial record

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