Medical condition: Central neurological condition, including acquired brain injury (e.g. from ischaemic stroke, trauma, or haemorrhage), multiple sclerosis, and spinal cord injury. Medical condition in lay language: Condition affecting the brain or spinal cord Therapeutic areas: Diseases [C] - Nervous System Diseases [C10] Nervous System Diseases
Conditions
Interventions
Randomisation (to cryoneurolysis or control, in 1:1 ratio) will be undertaken by the trial team (Trial coordinator or CI) following baseline, using freely available online randomisation software (rand
Sponsors
Oxford University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. 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. 2. Male or Female, aged 18 years or above. 3. Diagnosed with a central neurological condition, including acquired brain injury (e.g. from ischaemic stroke, trauma, or haemorrhage), multiple sclerosis, and spinal cord injury. 4. 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. 5. At least one rehabilitation goal related to the management of pain resulting from spasticity.
Exclusion criteria
Exclusion criteria: 1. Participant has received Botulinum toxin or cryoneurolysis within the last 90 days 2. Raynaud’s syndrome 3. Cryoglobulinaemia 4. Cold urticaria 5. Bleeding disorders 6. Prescribed, or taking antibiotics from the aminoglycoside family 7. Localised infection at the intended treatment site 8. Planned oral antispasmodic medication dose changes 9. Pregnancy, breastfeeding, or planning pregnancy in the trial period 10. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial. 11. 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. 12. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variability in goal attainment assessed using the Goal Attainment Scale at 6-weeks post-treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain using a numerical rating scale (1–10), DN4, NPSI, and pressure pain thresholds (PPT) — all standard measures, carried out at 6, 12, 18, and 24 weeks. 2. Self-report side effect questionnaire; free-text answers to questionnaire, taken at 6, 12, 18, and 24 weeks. 3. Goal Attainment Scale, standard rating scale at 12, 18, and 24 weeks. 4. Modified Ashworth Scale, standard clinical scale at 6, 12, 18, and 24 weeks. 5. Modified Tardieu Scale, standard clinical scale at 6, 12, 18, and 24 weeks. 6. Spasticity directly assessed by measuring muscle activity to a passive stretch, clinically at 6, 12, 18, and 24 weeks. 7. Range of Motion, standard testing using a goniometer at 6, 12, 18, and 24 weeks. 8. Patient Reported Impact of Spasticity Measure, standard outcome measure at 6, 12, 18, and 24 weeks. 9. EQ-5D, standard measure at 6, 12, 18, and 24 weeks. 10. Spasticity Related Quality of Life instrument (SQoL-6D), standard measure at 6, 12, 18, and 24 weeks. 11. Barthel Index, standard measure at 6, 12, 18, and 24 weeks. 12. Gait assessment, standard assessment in gait lab at 6 and 12 weeks. 13. Leg Activity Measure (LEG-A), standard measure at 6 and 12 weeks. 14. Shriners Hospital Upper Extremity Evaluation (SHUEE), standard measure at 6 and 12 weeks. 15. Arm Activity Measure (ARM-A), standard measure at 6 and 12 weeks. 16. Functional Assessment Test for Upper Limb (FAST-UL), standard measure at 6 and 12 weeks. 17. Questionnaire/interview (exploring patient satisfaction, experience, barriers, and facilitators) at 24 weeks only. | — |
Countries
United Kingdom
Contacts
Public ContactAnton Pick
Outcome results
None listed