Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities

Recruiting now · Phase 4

Conditions studied: Centreal Neurological Condition, Acquired Brain Injury (Including Stroke), Multiple Sclerosis, Spinal Cord Injury

In brief

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. 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.

Key facts

Study ID

NCT07303582

Run by

Oxford University Hospitals NHS Trust

People needed

50

Starts

2025-12-02

Expected to finish

2026-11-30

Last updated by the study team

2025-12-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Oxford Centre for Enablement (OUH NHS-FT) — Oxford, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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