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Taking people in United KingdomPhase 4

Nerve freezing compared with botulinum toxin for pain from muscle spasticity

Compares nerve freezing with botulinum toxin for spasticity pain after brain or spinal cord damage.

Key facts

Who runs it
Oxford University Hospitals NHS Trust
Where
Oxford, United KingdomSee the site
Trial code
Registry title
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Status
Recruiting
Phase
Phase 4
People taking part
50 people, planned
Started
2 Dec 2025
Expected to end
1 Apr 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Cryoneurolysis
  • Botulinum toxin
Record updated
5 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a central neurological condition (brain injury or stroke, multiple sclerosis, or spinal cord injury) who have pain linked to spasticity.

Age
18 years or older
Sex
Women and men can join.
Disease stage
A central neurological condition: acquired brain injury (for example from stroke, trauma or bleeding), multiple sclerosis, or spinal cord injury. Pain linked to spasticity, with a clinically meaningful response to a diagnostic nerve block of nerves that can be treated with cryoneurolysis.
Earlier treatment
People who had Botulinum toxin or cryoneurolysis within the last 90 days cannot join.

Main reasons for not taking part

  • Botulinum toxin or cryoneurolysis within the last 90 days
  • Raynaud's syndrome, cryoglobulinaemia, cold urticaria or a bleeding disorder
  • Infection at the planned treatment site
  • Pregnancy, breastfeeding, or planning pregnancy during the trial
  • Planned surgery needing general anaesthesia during the trial

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Participant has received Botulinum toxin or cryoneurolysis within the last 90 days
  • Planned oral antispasmodic medication dose changes
  • Scheduled elective surgery or other procedures requiring general anaesthesia during the trial
  • Raynaud's syndrome
  • Bleeding disorders
  • Localised infection at intended treatment site
  • 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
  • Cryoglobulinaemia
  • Cold urticaria
  • Pregnancy, breastfeeding, or planning pregnancy in the trial period
  • 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 in United Kingdom

  • Oxford Centre for Enablement (OUH NHS-FT)Oxford, United KingdomContact: Anton Pick, MBChBTaking people

About the trial

What the trial wants to find out

Spasticity is an umbrella term for impairments of muscle tone and control in people with damage to the brain and spinal cord. It is highly prevalent and results in pain, stiffness, and contribute to difficulties in activities of daily living. Current treatment options are limited, and many people experience only partial reduction in spasticity and frequent repeated treatments are needed.

Read full original descriptionShow less

Cryoneurolysis is a medical technique which involves the controlled freezing of the 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 the understanding of the potential effectiveness of this treatment and its potential side effects when compared with a more commonly used treatment (Botulinum Toxin).

Participants will be randomly allocated to receive usual care with Botulinum Toxin (control group) or usual care with Cryoneurolysis (intervention group). The investigators 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.

The results of this study will help to guide future studies to examine the effectiveness of this treatment.

The 2 groups in the trial

  • Cryoneurolysis (+ usual care)Treatment being tested

    Treatment: Cryoneurolysis

  • Botulinum Toxin (+ usual care)Existing treatment, for comparison

    Treatment: Botulinum toxin

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities (ICE): a Pilot Randomised Controlled Trial
Plain-language title
Nerve freezing compared with botulinum toxin for pain from muscle spasticityGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
5 November 2026