ICE Trial
Research type
Research Study
Full title
Individualised Cryoneurolysis to treat pain in the context of spasticity in the upper and lower Extremities: a pilot randomised controlled trial
IRAS ID
1011743
Contact name
Anton Pick
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN50433077
Research summary
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, and 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).
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.
The results of this study will inform the feasibility and guide future studies to examine the effectiveness of this treatment.REC name
Wales REC 1
REC reference
25/WA/0286
Date of REC Opinion
2 Dec 2025
REC opinion
Further Information Favourable Opinion