Exoskeleton Training for Spinal Cord Injury Neuropathic Pain (ExSCIP): Protocol for a Phase 2 Feasibility Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- International Spinal Cord Injury Pain Basic Data Set Version 3.0 (ISCIPBDS 3.0) (Pain intensity)
研究概览
简要总结
The goal of this feasibility trial is to learn if exoskeleton or robotic walking works to reduce nerve (neuropathic) pain after spinal cord injury.
This study asks is:
- Providing walking practice through use of a robotic device (exoskeleton) three times per week for twelve weeks possible to deliver?
- Would people sign up and stick to the programme?
- And will it help to reduce neuropathic pain levels after spinal injury?
Researchers will compare robotic walking and a relaxation program to see if robotic walking works to reduce neuropathic pain levels after spinal injury.
Participants will:
- Complete a number of questionnaires and tests related to their pain before the trial.
- Complete robotic walking or a relaxation program three times per week for twelve weeks.
- Complete the same questionnaires and tests after the trial finishes and 6 months after.
- Complete an interview telling researchers about their experiences of the trial.
详细描述
Background and Rationale:
Following SCI, approximately 53% of people develop neuropathic pain (NP). Irish SCI data identifies high pain intensity and pain interference levels with NP and significantly poorer quality of life (QoL) than other pain phenotypes. Individuals can describe NP as more debilitating than the other consequences of SCI, as their most persistent health issue and adequate pain relief as an unmet need.
International data identify the proportional burden of NP following SCI as significant. Ninety-four percent of individuals are prescribed >1 medication, the mean number of physician office visits in a 6-month period due to SCI NP is reported as 2 and the total annualised cost of NP per subject in the United States (US) is reported as $26,270 (direct $8,636, indirect $17,634).
The presence of pain is further associated with lower return to work rates following injury, and more than a third of individuals with SCI in employment report frequent pain interference with their work . Pain interference with function, health status and work are noted to be significantly worse in individuals with more severe NP, where overall work impairment is reported at 38%.
NP after SCI is multi-faceted and heterogenous, making isolation of specific mechanisms more challenging. Mechanisms hypothesised for NP after SCI include neuronal hyperexcitability (central and peripheral sensitisation) and corticothalamic maladaptive neuroplasticity. Additionally, NP symptom severity post SCI has been reported to be associated with a combination of residual spinothalamic tract (STT) function below the level of injury and with catastrophising pain coping mechanisms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who are 18 years and over.
- •Confirmed traumatic SCI (injury resulted from an external physical impact and not an acute or chronic disease process) of >6 months duration with complete or incomplete paraplegia or tetraplegia.
- •Individuals with above confirmed traumatic SCI who have below-level NP (≥ 3 levels below neurological level and/or extending to at-level region) starting after the SCI and persisting for > 3 continuous months, despite pharmacotherapy.
- •NP will be confirmed based on a neurological examination, a score of ≥4 on the Douleur Neuropathique 4 (DN4) (48) and a comprehensive pain history supported by the use of the ISCIP Pain Classification. They endorse one or more of the following pain descriptors to assist in confirmation of below level NP "'hot-burning', 'tingling', 'pricking', 'pins and needles', 'sharp', 'shooting', 'squeezing', 'painful cold' and 'electric shock-like'" (45).
- •Moderate and severe NP as confirmed above will be described as pain ≥ 3 and ≥ 6 on the 0-10 Numerical Rating Scale (NRS) for NP (averaged over a week).
- •Exoskeleton naive
- •Stable medication regimen
- •Have the capacity to provide informed consent.
排除标准
- •Non-traumatic SCI, cauda equina lesions or Guillain Barré diagnoses
- •NP intensities of <3 (NRS) or nociceptive pain profiles only based on the ISCIP pain classification convention.
- •Recent lower limb fracture
- •Inadequate bone density (z score < -2)
- •Anthropometric measurements incompatible with the exoskeleton device (i.e. height >1.9m, weight >100kgs, significant lower limb spasticity)
- •Unstable comorbid medical condition/psychiatric condition/medication regimen
- •Planned surgery coinciding with intervention
- •Pregnancy
- •Drug and alcohol abuse
研究组 & 干预措施
Relaxation (Comparator)
An equally dosed blended relaxation program delivered online for two sessions per week and in-person one session per week.
干预措施: Relaxation (Comparator) (Other)
Exoskeleton (Intervention)
Exoskeleton walking delivered three times per week for twelve weeks. Each session will be one hour duration.
干预措施: Ekoskeleton (Intervention) (Device)
结局指标
主要结局
International Spinal Cord Injury Pain Basic Data Set Version 3.0 (ISCIPBDS 3.0) (Pain intensity)
时间窗: This will be measured at baseline, week 13 and at 6-month follow-up.
This outcome measure will be used to capture average neuropathic pain intensity in participants
International Spinal Cord Injury Pain Basic Data Set Version 3.0 (ISCIPBDS 3.0) (Pain interference)
时间窗: This will be measured at baseline, week 13 and at 6-month follow-up.
This outcome measure will be used to capture average neuropathic pain interference in participants. Pain interference entails interference with sleep, daily activities and overall mood.
次要结局
- Electroencephelography (EEG)(This will be measured at baseline, week 13 and at 6-month follow-up.)
- Neuropathic Pain Symptom Inventory (NPSI)(This will be measured at baseline, week 13 and at 6-month follow-up.)
研究者
Olive Lennon
Associate Professor
University College Dublin