Individualised cryoneurolysis for pain from spasticity in the arms and legs
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities (ICE): a Pilot Randomised Controlled Trial
This will try freezing specific nerves (cryoneurolysis) or using botulinum toxin to see which reduces pain from spasticity in adults with stroke, spinal cord injury, brain injury, or multiple sclerosis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oxford University Hospitals NHS Trust Academic / other |
| Locations | 1 site (Oxford) |
| Trial ID | NCT07303582 on ClinicalTrials.gov |
What this trial studies
This pilot, randomized comparison at Oxford will allocate eligible adults with central nervous system conditions and pain from spasticity to receive either targeted cryoneurolysis or standard botulinum toxin injections. Cryoneurolysis uses controlled freezing of nerve tissue to temporarily disrupt nerve function and relieve pain, while botulinum toxin reduces muscle overactivity through chemical denervation. Participants must show a meaningful response to a diagnostic nerve block for treatable nerves before enrollment and will be followed for effectiveness and side effects. The goal is to gather preliminary data on pain relief, functional impact, duration of benefit, and adverse events to inform larger trials and clinical use.
Who should consider this trial
Good fit: Adults (18+) with a central neurological condition (acquired brain injury including stroke, multiple sclerosis, or spinal cord injury), pain related to spasticity, a clinical indication for botulinum toxin or cryoneurolysis, and a positive diagnostic nerve block to targetable nerves.
Not a fit: People with recent botulinum toxin or cryoneurolysis within 90 days, or with contraindications such as Raynaud's syndrome, cryoglobulinaemia, or cold urticaria, and those whose spasticity does not respond to diagnostic nerve block are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, cryoneurolysis could provide longer-lasting pain relief from spasticity with fewer repeat treatments and lower overall treatment burden than repeated botulinum toxin injections.
How similar studies have performed: Cryoneurolysis has been approved in the UK for pain in the context of spasticity and is in routine use at Oxford since January 2024, but direct comparative data versus botulinum toxin remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Oxford
- Oxford Centre for Enablement (OUH NHS-FT) — Oxford, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Anton Pick, MBChB
- Email: anton.pick@ouh.nhs.uk
- Phone: (+44) 01865 737306
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.