RecruitingPhase 4MS (type not specified)NCT07303582

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Cryoneurolysis
  • Botulinum toxin

What it measured

Main measures

  • Goal Attainment Scale

    6-weeks post-treatment

Other measures (20)

  • Self-reported Pain

    6, 12, 18, and 24 weeks post-treatment

    Pain
  • Douleur Neuropathique en 4 (DN4)

    6, 12, 18, and 24 weeks post-treatment

    Pain
  • Neuropathic Pain Symptom Inventory (NPSI)

    6, 12, 18, and 24 weeks post-treatment

    Pain
  • Side Effects

    6, 12, 18, and 24 weeks post-treatment

    Safety
  • Goal Attainment Scale

    12-weeks post treatment

  • Modified Ashworth Scale

    6- and 12-weeks post treatment

    Spasticity
  • Modified Tardieu Scale

    6- and 12-weeks post treatment

  • Spasticity

    6- and 12-weeks post treatment

    Spasticity
  • Range of Motion

    6- and 12-weeks post treatment

  • Patient Reported Impact of Spasticity Measure (PRISM)

    6- and 12-weeks post treatment

    SpasticityQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Dec 2025

    2. Main results due

      May 2026

    3. Finished

      Nov 2026

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