Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities (ICE): a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Goal Attainment Scale
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Goal Attainment Scale
时间窗: 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).
次要结局
- Self-reported Pain(6, 12, 18, and 24 weeks post-treatment)
- Douleur Neuropathique en 4 (DN4)(6, 12, 18, and 24 weeks post-treatment)
- Neuropathic Pain Symptom Inventory (NPSI)(6, 12, 18, and 24 weeks post-treatment)
- Side Effects(6, 12, 18, and 24 weeks post-treatment)
- Goal Attainment Scale(12-weeks post treatment)
- Modified Ashworth Scale(6- and 12-weeks post treatment)
- Modified Tardieu Scale(6- and 12-weeks post treatment)
- Spasticity(6- and 12-weeks post treatment)
- Range of Motion(6- and 12-weeks post treatment)
- Patient Reported Impact of Spasticity Measure (PRISM)(6- and 12-weeks post treatment)
- EQ5D(6- and 12-weeks post treatment)
- Spasticity Related Quality of Life instrument (SQoL-6D)(6- and 12-weeks post treatment)
- Barthel Index(6- and 12-weeks post treatment)
- Gait assessment - Walking Speed(6- and 12-weeks post treatment)
- Gait assessment - Gait profile score(6- and 12-weeks post treatment)
- Leg Activity Measure (LEG-A)(6- and 12-weeks post treatment)
- Shriners Hospital Upper Extremity Evaluation (SHUEE)(6- and 12-weeks post treatment)
- Arm Activity Measure (ARM-A)(6- and 12-weeks post treatment)
- Functional Assessment Test for Upper Limb (FAST-UL)(6- and 12-weeks post treatment)
- Pressure Pain Thresholds (PPT)(6, 12, 18, and 24 weeks post-treatment)
研究者
Anton Pick
Primary Investigator
Oxford University Hospitals NHS Trust