Pain Phenotyping in Patients With Neuropathic Pain After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity
研究概览
简要总结
The development of neuropathic pain is one of the most debilitating sequels after a spinal cord injury (SCI). The overall aim of this study is to investigate potential underlying pathophysiological mechanisms of neuropathic pain after SCI. The functionality of the nociceptive pathway in humans as well as its plastic changes following SCI will be inferred with sophisticated sensory and pain phenotyping using quantitative sensory testing (i.e., psychophysical measures), objective neurophysiological measures of pain processing and the recording of pain-related autonomic responses (i.e., galvanic skin response, cardiovascular measures and pupil dilation). In addition, the interplay between the somatosensory and autonomic nervous system and its association with the development and maintenance of neuropathic pain after SCI will be investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Spinal injury cohort - general inclusion criteria:
- •Aged between 18-80 years
- •Traumatic and non-traumatic etiology
- •Para- and tetraplegic SCI
- •Complete and incomplete SCI
- •SCI with and without neuropathic pain
- •Additional inclusion criteria for longitudinal study:
- •SCI since less than one month
- •Additional inclusion criteria for cross-sectional study:
- •SCI since more than one year
- •Control cohorts with peripheral neuropathy:
- •General inclusion criteria:
- •Aged between 18-80 years
- •Neurological disorder affecting the peripheral nervous system (i.e., peripheral neuropathy)
- •Peripheral neuropathy with or without neuropathic pain
- •Additional inclusion criteria for longitudinal study:
- •Peripheral neuropathy since less than one month
- •Additional inclusion criteria for cross-sectional study:
- •Peripheral neuropathy since more than one year
- •Control cohorts without neuropathy / healthy volunteers
- •General inclusion criteria:
- •Aged between 18-80 years
- •No medical condition affecting the peripheral and/or central nervous system (e.g., pain, systemic disease, psychological disorder)
排除标准
- •Inability to follow study instructions
- •Pregnancy
- •Medically manifested psychological disorder
- •Medical condition affecting the peripheral and/or central nervous system other than the desired experimental condition (e.g., additional peripheral neuropathy in the SCI cohort)
研究组 & 干预措施
Patients with peripheral neuropathy
干预措施: Clinical pain phenotype (Diagnostic Test)
Patients with peripheral neuropathy
干预措施: Pupillometry (Diagnostic Test)
Patients with spinal cord injury with neuropathic pain
干预措施: Neurophysiology (Diagnostic Test)
Patients with spinal cord injury with neuropathic pain
干预措施: Cardiovascular test (Diagnostic Test)
Patients with spinal cord injury with neuropathic pain
干预措施: Experimental pain paradigms (Diagnostic Test)
Healthy subjects
干预措施: Neurophysiology (Diagnostic Test)
Patients with peripheral neuropathy
干预措施: Cardiovascular test (Diagnostic Test)
Patients with peripheral neuropathy
干预措施: Experimental pain paradigms (Diagnostic Test)
Patients with peripheral neuropathy
干预措施: Quantitative sensory testing (Diagnostic Test)
Patients with spinal cord injury with neuropathic pain
干预措施: Quantitative sensory testing (Diagnostic Test)
Patients with spinal cord injury with neuropathic pain
干预措施: Clinical pain phenotype (Diagnostic Test)
Patients with spinal cord injury with neuropathic pain
干预措施: Pupillometry (Diagnostic Test)
Patients with spinal cord injury but without neuropathic pain
干预措施: Neurophysiology (Diagnostic Test)
Patients with spinal cord injury but without neuropathic pain
干预措施: Cardiovascular test (Diagnostic Test)
Patients with spinal cord injury but without neuropathic pain
干预措施: Experimental pain paradigms (Diagnostic Test)
Patients with spinal cord injury but without neuropathic pain
干预措施: Quantitative sensory testing (Diagnostic Test)
Patients with spinal cord injury but without neuropathic pain
干预措施: Pupillometry (Diagnostic Test)
Patients with peripheral neuropathy
干预措施: Neurophysiology (Diagnostic Test)
Healthy subjects
干预措施: Cardiovascular test (Diagnostic Test)
Healthy subjects
干预措施: Experimental pain paradigms (Diagnostic Test)
Healthy subjects
干预措施: Quantitative sensory testing (Diagnostic Test)
Healthy subjects
干预措施: Pupillometry (Diagnostic Test)
结局指标
主要结局
Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity
时间窗: Cross-sectional: once in a chronic stage (1 year post-injury)
Pain drawings, plus and minus signs of pain
Patients with peripheral neuropathy: clinical pain phenotype including the spatial pain extent and pain intensity
时间窗: Cross-sectional: once in a chronic stage (1 year post-injury)
Pain drawings, plus and minus signs of pain
Spinal cord injury patients: clinical pain phenotype including the spatial pain extent and pain intensity
时间窗: Longitudinal: change from 1 month up to 12 months
Pain drawings, plus and minus signs of pain
次要结局
- Spinal cord injury patients / healthy controls: resting blood pressure(Cross-sectional: once in a chronic stage (1 year post-injury))
- Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a Valsalva maneuvre(Cross-sectional: once in a chronic stage (1 year post-injury))
- Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a sit-up test(Cross-sectional: once in a chronic stage (1 year post-injury))
- Spinal cord injury patients / healthy controls: conditioned pain modulation(Longitudinal: change from 1 month up to 12 months)
- Patients with peripheral neuropathy / healthy controls: thermal sensory testing tested with a thermode(Longitudinal: change from 1 month up to 12 months)
- Spinal cord injury patients / healthy controls: somato-sensory evoked potentials(Longitudinal: change from 1 month up to 12 months)
- Patients with peripheral neuropathy / healthy controls: baro-reflex sensitivity(Cross-sectional: once in a chronic stage (1 year post-injury))
- Patients with peripheral neuropathy / healthy controls: changes in blood pressure after a cold pressure test(Cross-sectional: once in a chronic stage (1 year post-injury))
- Spinal cord injury patients / healthy controls: temporal summation of pain after repetitive application of 12 pinprick stimuli(Longitudinal: change from 1 month up to 12 months)
- Spinal cord injury patients / healthy controls: thermal sensory testing tested with a thermode(Longitudinal: change from 1 month up to 12 months)
- Patients with peripheral neuropathy / healthy controls: temporal summation of pain after repetitive application of 12 pinprick stimuli(Longitudinal: change from 1 month up to 12 months)
- Spinal cord injury patients / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks(Longitudinal: change from 1 month up to 12 months)
- Patients with peripheral neuropathy / healthy controls: heart rate variability(Cross-sectional: once in a chronic stage (1 year post-injury))
- Patients with peripheral neuropathy / healthy controls: conditioned pain modulation(Longitudinal: change from 1 month up to 12 months)
- Spinal cord injury patients / healthy controls: contact-heat evoked potentials(Longitudinal: change from 1 month up to 12 months)
- Spinal cord injury patients / healthy controls: N13 spinal potential(Longitudinal: change from 1 month up to 12 months)
- Spinal cord injury patients / healthy controls: motor neurographies(Longitudinal: change from 1 month up to 12 months)
- Spinal cord injury patients / healthy controls: sensory neurography(Longitudinal: change from 1 month up to 12 months)
- Patients with peripheral neuropathy / healthy controls: mechanical sensory testing tested with von Frey monofilaments/pinpricks(Longitudinal: change from 1 month up to 12 months)
- Spinal cord injury patients / patients with peripheral neuropathy / healthy controls: pupillometry(Cross-sectional: once in a chronic stage (1 year post-injury))
- Spinal cord injury patients / patients with peripheral neuropathy / healthy controls: offset analgesia (psychophysical)(Cross-sectional: once in a chronic stage (1 year post-injury))
- Spinal cord injury patients / patients with peripheral neuropathy / healthy controls: offset analgesia (pupillometry)(Cross-sectional, once in a chronic stage (1 year post-injury))