Centreal Neurological ConditionPhase 4ICENCT07303582
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
A Phase 4 study testing Cryoneurolysis and Botulinum toxin in people with Centreal Neurological Condition and Acquired Brain Injury (Including Stroke), run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Centreal Neurological Condition, Acquired Brain Injury (Including Stroke), Multiple Sclerosis
- What is being tested?
- Cryoneurolysis and Botulinum toxin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Dec 2025to 1 Apr 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Barbara Robinson, MSc contact
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford Centre for Enablement (OUH NHS-FT)
Oxford, OX3 7HE
Anton Pick, MBChB, +44 01865 737 306, anton.pick@ouh.nhs.uk
Anton Pick, MBChB
About this study
Official title: Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities (ICE): a Pilot Randomised Controlled Trial
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).
Read more
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.
Read the detailed description
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, 42% of stroke patients, and 80% of patients with multiple sclerosis. Spasticity results in pain, stiffness, and restrictions to activity including difficulties in personal care and mobility and a significant impact on quality of life.
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 specialised medical facilities. Their associated costs, in terms of financial resources and healthcare infrastructure, significantly limit access for certain patients.
Cryoneurolysis, a novel medical technique, involves the controlled freezing of nerve tissue to temporarily disrupt its function. While primarily used for pain, there is a growing interest in its application for managing spasticity 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. The investigators' own open-label proof-of-principle clinical data suggest the potential for substantial improvements in the impact of spasticity on quality of life.
This pilot randomised controlled study aims to improve the 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).
- Conditions
- Centreal Neurological Condition, Acquired Brain Injury (Including Stroke), Multiple Sclerosis, Spinal Cord Injury
- Being tested
- Cryoneurolysis, Botulinum toxin
- Keywords
- Cryoneurolysis, Spasticity, Pain, Acquired Brain Injury, Stroke, Multiple Sclerosis, Spinal Cord Injury, Central Neurological Condition, Botulinum Toxin (botox), Iovera, Chemodenervation, BoNT-A, Cryoneurotomy, Cryoneurectomy, Cryoanalgesia
- Medical subject headings
- Brain Injuries, Multiple Sclerosis, Spinal Cord Injuries, Muscle Spasticity, Pain, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoneurolysisProcedure or surgery
Also called Iovera, Cryoneurotomy, Cryoneurectomy, Cryoanalgesia
Nerves that require treatment, and the number of treatments required for each nerve will be identified by routine clinical judgement. Nerve targets are identified using an ultrasound machine. The handheld Iovera cryoneurolysis device will be used for treatment.
Participants will receive up to 4 treatments of cryoneurolysis for each nerve or nerve branch that requires treatment. It is anticipated that participants will have between 1 and 5 nerves or nerve branches per limb treated. Each Cryoneurolysis treatment takes 110 seconds. Total treatment time will be determined by number of nerves targeted and number of cryoneurolysis treatments per nerve. The shortest duration, with setup, is likely to be 60 minutes and the longest 120 minutes.
Botulinum toxinProcedure or surgery
Also called Botox, Xeomin, Chemodenervation, BoNT-A
Muscles that require treatment with Botulinum Toxin will be identified by routine clinical assessment. Muscle targets will be identified using an ultrasound machine.
It is anticipated that participants will have between 2 and 8 muscles identified for target. The participant will receive up to 200 units of Xeomin (Botulinum Toxin) per muscle that requires treatment. Treatment session of Botulinum Toxin will take 60 to 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Cryoneurolysis (+ usual care) | Experimental | Not described Receives: Procedure: Cryoneurolysis |
| Botulinum Toxin (+ usual care) | Active comparator | Not described Receives: Procedure: Botulinum toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal Attainment Scale
An individualised outcome measure involving goal selection and goal scaling that is standardised in order to calculate the extent to which a patient's goals are met. GAS comprises of goals divided into a 5-point scale of level of expected outcome: from -2 (much less than expected) to +2 (much more than expected).
Measured: 6-weeks post-treatment
Secondary outcomes (20)
Self-reported Pain
Self-report, as measured by a numerical rating scale (range 0 - 10, higher scores indicating higher pain levels).
Measured: 6, 12, 18, and 24 weeks post-treatment
Douleur Neuropathique en 4 (DN4)
Questionnaire used to determine whether pain is neuropathic in origin (range 0 - 10; a score of 4 or more suggests the presence of neuropathic pain).
Measured: 6, 12, 18, and 24 weeks post-treatment
Neuropathic Pain Symptom Inventory (NPSI)
Questionnaire used to quantify neuropathic pain (range 0 - 100, higher scores reflect worse neuropathic pain).
Measured: 6, 12, 18, and 24 weeks post-treatment
Side Effects
As measured by self-report side effects questionnaire
Measured: 6, 12, 18, and 24 weeks post-treatment
Goal Attainment Scale
An individualised outcome measure involving goal selection and goal scaling that is standardised in order to calculate the extent to which a patient's goals are met. GAS comprises of goals divided into a 5-point scale of level of expected outcome: from -2 (much less than expected) to +2 (much more than expected).
Measured: 12-weeks post treatment
Modified Ashworth Scale
Assessment which requires the researcher to passively move the person's affected limb(s) and assess their resistance to movement (score range 0 - 4, higher score indicating increased in tone).
Measured: 6- and 12-weeks post treatment
Modified Tardieu Scale
Assessment which requires the researcher to passively move the person's affected limb(s) and assess their resistance to movement (score range 0 - 4, higher score indicating increased resistance).
Measured: 6- and 12-weeks post treatment
Spasticity
Directly assessed by measuring the muscle activity to a passive stretch
Measured: 6- and 12-weeks post treatment
Range of Motion
Assessed using a goniometer
Measured: 6- and 12-weeks post treatment
Patient Reported Impact of Spasticity Measure (PRISM)
Questionnaire assessing spasticity related quality of life (41 items that describe impacts of spasticity, each of which is rated on a scale of 0-4 from "never true for me" to "very often true for me").
Measured: 6- and 12-weeks post treatment
EQ5D
Questionnaire assessing quality of life across 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels which are scored 1 - 5, with higher scores indicating worse outcome.
Measured: 6- and 12-weeks post treatment
Spasticity Related Quality of Life instrument (SQoL-6D)
Questionnaire assessing spasticity related quality of life (range 0 - 24, higher score indicating worse condition)
Measured: 6- and 12-weeks post treatment
Barthel Index
Scale measuring a person's ability to complete activities of daily living (range 0 - 100, higher scores indicating more independence)
Measured: 6- and 12-weeks post treatment
Gait assessment - Walking Speed
Kinematic assessment of lower extremity function, using EMG and motion capture cameras. Walking speed is measured in meters per second (m/s), with slower speed indicating worse outcome.
Measured: 6- and 12-weeks post treatment
Gait assessment - Gait profile score
Kinematic assessment of lower extremity function using EMG and motion capture cameras. The gait profile score is measured in degrees, with higher scores indicating more abnormality, and no maximum score.
Measured: 6- and 12-weeks post treatment
Leg Activity Measure (LEG-A)
Questionnaire assessing lower extremity function (3 sections: Section A range: 0-36; Section B range 0-60; Section C range 0 - 36. Higher score indicates more difficulty/severity.)
Measured: 6- and 12-weeks post treatment
Shriners Hospital Upper Extremity Evaluation (SHUEE)
Kinematic assessment of upper extremity function using motion capture cameras.
Measured: 6- and 12-weeks post treatment
Arm Activity Measure (ARM-A)
Questionnaire assessing upper extremity function (2 sections: Section A range: 0-32; Section B range 0-52. Higher score indicates more difficulty.)
Measured: 6- and 12-weeks post treatment
Functional Assessment Test for Upper Limb (FAST-UL)
Assessment of upper extremity function (selected movements assessed and scored between 0 - 3, with higher scores indicating ability to complete movement more fully).
Measured: 6- and 12-weeks post treatment
Pressure Pain Thresholds (PPT)
Sensory testing using a manual algometer to assess pain thresholds.
Measured: 6, 12, 18, and 24 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start2 Dec 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Centreal Neurological ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants randomised to control will be given the opportunity (but are not required) to crossover to the intervention arm at 12-weeks post-treatment. The intervention arm will not crossover to control arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, Bournemouth University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303582
- Sponsor's protocol ID
- PID 18403
- Acronym
- ICE
- Status last verified
- Nov 2026
- First submitted
- 10 Sep 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data are available upon reasonable request.
Publications
Wissel J, Manack A, Brainin M. Toward an epidemiology of poststroke spasticity. Neurology. 2013 Jan 15;80(3 Suppl 2):S13-9. doi: 10.1212/WNL.0b013e3182762448.
PubMed 23319481Winston P, Mills PB, Reebye R, Vincent D. Cryoneurotomy as a Percutaneous Mini-invasive Therapy for the Treatment of the Spastic Limb: Case Presentation, Review of the Literature, and Proposed Approach for Use. Arch Rehabil Res Clin Transl. 2019 Oct 17;1(3-4):100030. doi: 10.1016/j.arrct.2019.100030. eCollection 2019 Dec.
PubMed 33543059Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
PubMed 26092476Turner-Stokes L, Jacinto J, Fheodoroff K, Brashear A, Maisonobe P, Lysandropoulos A, Ashford S; Upper Limb International Spasticity (ULIS-III) study group. Longitudinal goal attainment with integrated upper limb spasticity management including repeat injections of botulinum toxin A: Findings from the prospective, observational Upper Limb International Spasticity (ULIS-III) cohort study. J Rehabil Med. 2021 Feb 24;53(2):jrm00157. doi: 10.2340/16501977-2801.
PubMed 33616192Skoog B, Jakobsson KE. Prevalence of Spasticity and Below-Level Neuropathic Pain Related to Spinal Cord Injury Level and Damage to the Lower Spinal Segments. J Rehabil Med Clin Commun. 2020 Mar 8;3:1000039. doi: 10.2340/20030711-1000039. eCollection 2020.
PubMed 33884141Rizzo MA, Hadjimichael OC, Preiningerova J, Vollmer TL. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler. 2004 Oct;10(5):589-95. doi: 10.1191/1352458504ms1085oa.
PubMed 15471378Kim PS, Ferrante FM. Cryoanalgesia: a novel treatment for hip adductor spasticity and obturator neuralgia. Anesthesiology. 1998 Aug;89(2):534-6. doi: 10.1097/00000542-199808000-00036. No abstract available.
PubMed 9710418Biel E, Aroke EN, Maye J, Zhang SJ. The applications of cryoneurolysis for acute and chronic pain management. Pain Pract. 2023 Feb;23(2):204-215. doi: 10.1111/papr.13182. Epub 2022 Dec 4.
PubMed 36370129Bhimani R, Anderson L. Clinical understanding of spasticity: implications for practice. Rehabil Res Pract. 2014;2014:279175. doi: 10.1155/2014/279175. Epub 2014 Sep 4.
PubMed 25276432
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities (ICE): a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07303582
- Acronym / sponsor ID
- ICE / PID 18403
- Conditions
- Centreal Neurological Condition, Acquired Brain Injury (Including Stroke), Multiple Sclerosis, Spinal Cord Injury
- Keywords
- Cryoneurolysis, Spasticity, Pain, Acquired Brain Injury, Stroke, Multiple Sclerosis, Spinal Cord Injury, Central Neurological Condition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Oxford, Bournemouth University
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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, 42% of stroke patients, and 80% of patients with multiple sclerosis. Spasticity results in pain, stiffness, and restrictions to activity including difficulties in personal care and mobility and a significant impact on quality of life.
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 specialised medical facilities. Their associated costs, in terms of financial resources and healthcare infrastructure, significantly limit access for certain patients.
Cryoneurolysis, a novel medical technique, involves the controlled freezing of nerve tissue to temporarily disrupt its function. While primarily used for pain, there is a growing interest in its application for managing spasticity 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. The investigators' own open-label proof-of-principle clinical data suggest the potential for substantial improvements in the impact of spasticity on quality of life.
This pilot randomised controlled study aims to improve the 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants randomised to control will be given the opportunity (but are not required) to crossover to the intervention arm at 12-weeks post-treatment. The intervention arm will not crossover to control arm.
| Arm | Type | Receives |
|---|---|---|
| Cryoneurolysis (+ usual care) | Experimental | Procedure: Cryoneurolysis |
| Botulinum Toxin (+ usual care) | Active comparator | Procedure: Botulinum toxin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- Participant has received Botulinum toxin or cryoneurolysis within the last 90 days.
- Raynaud's syndrome.
- Cryoglobulinaemia.
- Cold urticaria.
- Bleeding disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoneurolysisAlso: Iovera, Cryoneurotomy, Cryoneurectomy, CryoanalgesiaNerves that require treatment, and the number of treatments required for each nerve will be identified by routine clinical judgement. Nerve targets are identified using an ultrasound machine. The handheld Iovera cryoneurolysis device will be used for treatment. Participants will receive up to 4 treatments of cryoneurolysis for each nerve or nerve branch that requires treatment. It is anticipated that participants will have between 1 and 5 nerves or nerve branches per limb treated. Each Cryoneurolysis treatment takes 110 seconds. Total treatment time will be determined by number of nerves targeted and number of cryoneurolysis treatments per nerve. The shortest duration, with setup, is likely to be 60 minutes and the longest 120 minutes. | Procedure or surgery | Cryoneurolysis (+ usual care) |
| Botulinum toxinAlso: Botox, Xeomin, Chemodenervation, BoNT-AMuscles that require treatment with Botulinum Toxin will be identified by routine clinical assessment. Muscle targets will be identified using an ultrasound machine. It is anticipated that participants will have between 2 and 8 muscles identified for target. The participant will receive up to 200 units of Xeomin (Botulinum Toxin) per muscle that requires treatment. Treatment session of Botulinum Toxin will take 60 to 90 minutes. | Procedure or surgery | Botulinum Toxin (+ usual care) |
Primary outcome
Goal Attainment Scale
Time frame: 6-weeks post-treatment
An individualised outcome measure involving goal selection and goal scaling that is standardised in order to calculate the extent to which a patient's goals are met. GAS comprises of goals divided into a 5-point scale of level of expected outcome: from -2 (much less than expected) to +2 (much more than expected).
20 secondary outcomes
Self-reported Pain
Time frame: 6, 12, 18, and 24 weeks post-treatment
Douleur Neuropathique en 4 (DN4)
Time frame: 6, 12, 18, and 24 weeks post-treatment
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: 6, 12, 18, and 24 weeks post-treatment
Side Effects
Time frame: 6, 12, 18, and 24 weeks post-treatment
Goal Attainment Scale
Time frame: 12-weeks post treatment
Modified Ashworth Scale
Time frame: 6- and 12-weeks post treatment
Modified Tardieu Scale
Time frame: 6- and 12-weeks post treatment
Spasticity
Time frame: 6- and 12-weeks post treatment
Range of Motion
Time frame: 6- and 12-weeks post treatment
Patient Reported Impact of Spasticity Measure (PRISM)
Time frame: 6- and 12-weeks post treatment
EQ5D
Time frame: 6- and 12-weeks post treatment
Spasticity Related Quality of Life instrument (SQoL-6D)
Time frame: 6- and 12-weeks post treatment
Barthel Index
Time frame: 6- and 12-weeks post treatment
Gait assessment - Walking Speed
Time frame: 6- and 12-weeks post treatment
Gait assessment - Gait profile score
Time frame: 6- and 12-weeks post treatment
Leg Activity Measure (LEG-A)
Time frame: 6- and 12-weeks post treatment
Shriners Hospital Upper Extremity Evaluation (SHUEE)
Time frame: 6- and 12-weeks post treatment
Arm Activity Measure (ARM-A)
Time frame: 6- and 12-weeks post treatment
Functional Assessment Test for Upper Limb (FAST-UL)
Time frame: 6- and 12-weeks post treatment
Pressure Pain Thresholds (PPT)
Time frame: 6, 12, 18, and 24 weeks post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 23319481Wissel J, Manack A, Brainin M. Toward an epidemiology of poststroke spasticity. Neurology. 2013 Jan 15;80(3 Suppl 2):S13-9. doi: 10.1212/WNL.0b013e3182762448.
- Background: PubMed 33543059Winston P, Mills PB, Reebye R, Vincent D. Cryoneurotomy as a Percutaneous Mini-invasive Therapy for the Treatment of the Spastic Limb: Case Presentation, Review of the Literature, and Proposed Approach for Use. Arch Rehabil Res Clin Transl. 2019 Oct 17;1(3-4):100030. doi: 10.1016/j.arrct.2019.100030. eCollection 2019 Dec.
- Background: PubMed 26092476Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
- Background: PubMed 33616192Turner-Stokes L, Jacinto J, Fheodoroff K, Brashear A, Maisonobe P, Lysandropoulos A, Ashford S; Upper Limb International Spasticity (ULIS-III) study group. Longitudinal goal attainment with integrated upper limb spasticity management including repeat injections of botulinum toxin A: Findings from the prospective, observational Upper Limb International Spasticity (ULIS-III) cohort study. J Rehabil Med. 2021 Feb 24;53(2):jrm00157. doi: 10.2340/16501977-2801.
- Background: PubMed 33884141Skoog B, Jakobsson KE. Prevalence of Spasticity and Below-Level Neuropathic Pain Related to Spinal Cord Injury Level and Damage to the Lower Spinal Segments. J Rehabil Med Clin Commun. 2020 Mar 8;3:1000039. doi: 10.2340/20030711-1000039. eCollection 2020.
- Background: PubMed 15471378Rizzo MA, Hadjimichael OC, Preiningerova J, Vollmer TL. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler. 2004 Oct;10(5):589-95. doi: 10.1191/1352458504ms1085oa.
- Background: PubMed 9710418Kim PS, Ferrante FM. Cryoanalgesia: a novel treatment for hip adductor spasticity and obturator neuralgia. Anesthesiology. 1998 Aug;89(2):534-6. doi: 10.1097/00000542-199808000-00036. No abstract available.
- Background: PubMed 36370129Biel E, Aroke EN, Maye J, Zhang SJ. The applications of cryoneurolysis for acute and chronic pain management. Pain Pract. 2023 Feb;23(2):204-215. doi: 10.1111/papr.13182. Epub 2022 Dec 4.
- Background: PubMed 25276432Bhimani R, Anderson L. Clinical understanding of spasticity: implications for practice. Rehabil Res Pract. 2014;2014:279175. doi: 10.1155/2014/279175. Epub 2014 Sep 4.
- Individual participant dataSharing planned: Yes. De-identified data are available upon reasonable request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barbara Robinson, MSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cryoneurolysis and Botulinum toxin in people with Centreal Neurological Condition and Acquired Brain Injury (Including Stroke), run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anton Pick, MBChB ((+44) 01865 737306, anton.pick@ouh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Attainment Scale (time frame: 6-weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07303582, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.