What is cryoneurolysis studying for spasticity-related pain?

Cryoneurolysis is being studied as a treatment for pain linked to muscle spasticity caused by central neurological conditions like stroke and multiple sclerosis. Researchers are comparing it to botulinum toxin to understand its potential benefits and side effects. This study is sponsored by Oxford University Hospitals NHS Trust to explore new ways to improve symptoms and quality of life.

Who may be eligible for this spasticity clinical trial?

Adults aged 18 or older with a central neurological condition such as acquired brain injury, multiple sclerosis, or spinal cord injury may be eligible. Participants must have pain linked to spasticity and a positive response to nerve block testing. Both males and females can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this spasticity clinical trial?

Study-related care, including the study treatment and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 4

Age: 18Years +

All Genders

ID07303582

Pilot Study Comparing Cryoneurolysis and Botulinum Toxin for Treating Pain from Spasticity in Adults with Neurological Conditions

Led by Oxford University Hospitals NHS Trust · Updated on 2025-12-26

Participants Needed

Research Sites

26 weeks

Total Duration

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.

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