Individualised Cryoneurolysis to treat pain in the context of spasticity in the upper and lower Extremities (ICE): a pilot randomised controlled trial (ICE Trial)

Research summary

Spasticity is an umbrella term for impairments of muscle activity and control in the context of damage or dysfunction in the central nervous system,occurring in up to 87% of spinal cord injury patients (Skoog et al 2020),42% of stroke patients (Wissel et al 2013) and 80% of patients with multiple sclerosis (Rizzo et al 2004). Spasticity results in pain,stiffness,and restrictions to activity including difficulties in personal care and mobility and a significant impact on quality of life (Bihimani et al 2014). Treatments including oral medications,botulinum toxin injections,and physical therapies can provide some degree of relief,but effectiveness varies widely. Many patients experience only partial reduction in spasticity,contributing to ongoing functional limitations. Botulinum toxin injections provide temporary relief necessitating frequent treatments (every 3-4 months). This is burdensome for patients and healthcare providers,with associated time and treatment costs. Pharmacological treatments can lead to systemic side effects including drowsiness,dizziness,and cognitive impairments. Surgical interventions are resource-intensive and require specialized medical facilities. Their associated costs,in terms of financial resources and healthcare infrastructure,significantly limit access. Cryoneurolysis,a novel medical technique,involves the controlled freezing of nerve tissue to temporarily disrupt its function (Biel et al2023). While primarily used for pain,there is a growing interest in its application for managing spasticity (Winson et al 2019) and it is currently approved for the treatment of pain in the context of spasticity at Oxford University Hospitals NHS Trust. Observational studies suggest immediate relaxation of the affected muscles,resulting in improved joint range of motion,enhanced functional mobility,and reduced pain (Kim et al 1998; Winston et al 2019). Our own open-label proof-of-principle clinical data suggest the potential for substantial improvements in the impact of spasticity on quality of life. As spasticity is a complex condition treatment should be directed to achieve passive or active goals,guided by the specific presentation and functional challenges faced by the patient. Passive goals may include reducing pain,improving ease of personal care tasks such as washing and dressing. Active goals may include improving gait,reducing falls,or enhancing upper limb function. This pilot randomised controlled study aims to improve our understanding of the potential clinical effectiveness and side effect profile of cryoneurolysis as a treatment for pain in the context of spasticity in people with a range of neurological conditions (e.g. acquired brain injury (ABI),spinal cord injury,stroke,multiple sclerosis). The comparator is Botulinum toxin (marketing authorisation number: PL 29978/0001),with administration and dosage of treatment provided as per standard clinical care.

Principal Investigator

Dr Anton Pick

Contact us

Email: dendron@ouh.nhs.uk

IRAS number

344063