ICE Trial

Treatment tested

• Onabotulinumtoxina

  Synaptosomal nerve-associated protein 25 (SNAP-25) inhibitor

Other measures (1)

Inclusion: 1. 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. 2. Male or Female, aged 18 years or above. 3. Diagnosed with a central neurological condition, including acquired brain injury (e.g. from ischaemic stroke, trauma, or haemorrhage), multiple sclerosis, and spinal cord injury. 4. 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. 5. At least one rehabilitation goal related to the management of pain resulting from spasticity. Exclusion: 1. Participant has received Botulinum toxin or cryoneurolysis within the last 90 days 2. Raynaud’s syndrome 3. Cryoglobulinaemia 4. Cold urticaria 5. Bleeding disorders 6. Prescribed, or taking antibiotics from the aminoglycoside family 7. Localised infection at the intended treatment site 8. Planned oral antispasmodic medication dose changes 9. Pregnancy, breastfeeding, or planning pregnancy in the trial period 10. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial. 11. 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. 12. 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.

Background and study aims Spasticity is an umbrella term for impairments of muscle activity and control in people with damage to the brain and spinal cord. It is common and results in pain, stiffness, limb deformities, and contributes to difficulties in activities of daily living. Current treatment options, such as stretching, splinting, and Botulinum Toxin injections, are limited, many people experience only partial reduction in spasticity and frequent repeated treatments are needed. Cryoneurolysis is a medical technique which involves the controlled freezing and thawing of nerves. It has been approved in the UK for the treatment of pain in the context of spasticity through the targeting of nerves which control problematic muscles. Oxford University Hospitals NHS Foundation Trust has been offering this treatment routinely since January 2024. This pilot study aims to improve our understanding of the potential effectiveness of this treatment and its potential side effects when compared with a more commonly used treatment (Botulinum Toxin). Who can participate? Adults aged 18 or older who have a central nervous system condition such as brain injury (from stroke, trauma, or bleeding), multiple sclerosis, or spinal cord injury can take part. They need to have spasticity-related pain that is suitable for treatment with Botulinum Toxin and cryoneurolysis, and they should have shown a clear benefit from a diagnostic nerve block. They must have at least one rehabilitation goal focused on reducing pain caused by spasticity. What does the study involve? Participants will be randomly allocated to receive usual care with Botulinum Toxin (control group) or usual care with Cryoneurolysis (intervention group). We will assess pain, goal attainment, side effects, spasticity, disability and independence in daily activities, and movement of the arm and leg. Assessments will be at baseline and then 6-, 12-, 18-, and 24-weeks following treatment. Participants who are randomised to the control group will have the opportunity to receive cryoneurolysis treatment after the 12 week follow up assessment. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? Oxford University Hospitals NHS Trust (UK) When is the study starting and how long is it expected to run for? April 2027 to November 2027 Who is funding the study? Pacira BioSciences (USA) Who is the main contact? Dr Anton Pick, Anton.Pick@ouh.nhs.uk