Individualised cryoneurolysis for pain from spasticity in the arms and legs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.