Toward an epidemiology of poststroke spasticity.
Jörg Wissel, Aubrey Manack, Michael Brainin
https://pubmed.ncbi.nlm.nih.gov/23319481Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID07303582
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities (ICE): a Pilot Randomised Controlled Trial
Led by Oxford University Hospitals NHS Trust · Updated on 2025-12-26
50
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
O
Oxford University Hospitals NHS Trust
Lead Sponsor
U
University of Oxford
Collaborating Sponsor
AI-Summary
What this Trial Is About
Spasticity refers to problems with muscle tone and control caused by damage to the brain or spinal cord. It is common in conditions like acquired brain injury, stroke, multiple sclerosis, and spinal cord injury, causing pain, stiffness, and difficulty with daily activities. Current treatments often provide only partial relief and need frequent repetition, so this study aims to compare a new treatment called cryoneurolysis with the more common botulinum toxin therapy to see how well it works and what side effects it may cause. Participants will be randomly assigned to receive either cryoneurolysis plus usual care or botulinum toxin plus usual care. Cryoneurolysis uses a device to freeze specific nerves identified by ultrasound to reduce muscle spasticity. Each participant may have between 1 and 5 nerves treated, with up to 4 freezes per nerve, and treatment sessions lasting 60 to 120 minutes. Botulinum toxin treatment targets 2 to 8 muscles per session, with up to 200 units per muscle, and sessions lasting 60 to 90 minutes. After 12 weeks, those initially receiving botulinum toxin can opt to have cryoneurolysis. Participants will undergo assessments before treatment and at 6, 12, 18, and 24 weeks afterward. Researchers will measure pain levels, how well patients meet their personal goals, side effects, spasticity severity, disability, independence in daily activities, and arm and leg movement. The main outcome is goal achievement at 6 weeks. This pilot study will provide important information to guide future research on the effectiveness and safety of cryoneurolysis for spasticity-related pain.
CONDITIONS
Brief Title
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Participant is willing and able to give informed consent or has a positive opinion from a personal consultee.
- Male or female aged 18 years or older.
- Diagnosed with a central neurological condition such as acquired brain injury, multiple sclerosis, or spinal cord injury.
- Clinical indication for Botulinum Toxin and Cryoneurolysis treatment, including pain associated with spasticity and positive response to diagnostic nerve block.
- Has at least one rehabilitation goal related to managing pain from spasticity.
You will not qualify if you...
- Received Botulinum toxin or cryoneurolysis within the last 90 days.
- Has Raynaud's syndrome.
- Has cryoglobulinaemia.
- Has cold urticaria.
- Has bleeding disorders.
- Has localized infection at intended treatment site.
- Planned changes to oral antispasmodic medication dosage.
- Is pregnant, breastfeeding, or planning pregnancy during the trial.
- Scheduled for elective surgery or procedures requiring general anesthesia during the trial.
- Has any significant disease or disorder that may risk participant safety or affect trial results.
- Currently enrolled in another trial that could influence results or participation ability.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single treatment session per intervention
Participants receive up to 4 treatments of cryoneurolysis targeting affected nerves or Botulinum toxin injections targeting muscles to manage pain associated with spasticity. Treatment duration varies depending on number of nerves or muscles treated.
1 treatment visit lasting 60 to 120 minutes for Cryoneurolysis or 60 to 90 minutes for Botulinum toxin
Follow-up
Duration - Up to 24 weeks post-treatment
Participants are monitored for treatment effects and side effects, including assessments of pain, spasticity, function, and quality of life.
Multiple visits at 6, 12, 18, and 24 weeks post-treatment
Trial Site Locations
Total: 1 location
1
Oxford Centre for Enablement (OUH NHS-FT)
Oxford, United Kingdom, OX3 7HE
Actively Recruiting
Loading map...
Research Team
A
Anton Pick, MBChB
B
Barbara Robinson, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
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.
Paul Winston, Patricia Branco Mills, Rajiv Reebye...
https://pubmed.ncbi.nlm.nih.gov/33543059Estimating 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.
Amy L Whitehead, Steven A Julious, Cindy L Cooper...
https://pubmed.ncbi.nlm.nih.gov/26092476Longitudinal 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.
Lynne Turner-Stokes, Jorge Jacinto, Klemens Fheodoroff...
https://pubmed.ncbi.nlm.nih.gov/33616192Prevalence of Spasticity and Below-Level Neuropathic Pain Related to Spinal Cord Injury Level and Damage to the Lower Spinal Segments.
Bengt Skoog, Karl-Erik Jakobsson
https://pubmed.ncbi.nlm.nih.gov/33884141Prevalence and treatment of spasticity reported by multiple sclerosis patients.
M A Rizzo, O C Hadjimichael, J Preiningerova...
https://pubmed.ncbi.nlm.nih.gov/15471378Cryoanalgesia: a novel treatment for hip adductor spasticity and obturator neuralgia.
P S Kim, F M Ferrante
https://pubmed.ncbi.nlm.nih.gov/9710418The applications of cryoneurolysis for acute and chronic pain management.
Emily Biel, Edwin N Aroke, John Maye...
https://pubmed.ncbi.nlm.nih.gov/36370129Clinical understanding of spasticity: implications for practice.
Rozina Bhimani, Lisa Anderson
https://pubmed.ncbi.nlm.nih.gov/25276432