europhysiological assessment of residual thermonociceptive sensation following spinal cord injury - a pilot study

Associate Professor Paul Wrigley0 个研究点目标入组 41 人开始时间: 2022年3月9日最近更新: 2022年3月14日

试验速览

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•1. people with complete spinal cord injury (SCI) without neuropathic pain
•2. people with complete SCI and neuropathic pain below the level of their injury and
•3. age and gender matched control subjects without SCI or pain
•All subjects are older than 18 years.
•Subjects with SCI have complete thoracic spinal cord injuries (The American Spinal Injury Association (ASIA) impairment scale - Grade A: AIS A). The zone of partial preservation (ZPP) below the level of injury must be above the testing area.
•SCI subjects must be greater than or equal to 3 months following injury and be medically stable. In those subjects with neuropathic pain this must have been present for longer than 3 months and be moderate to severe in intensity (greater than or equal to 4/10).
•SCI subjects in the no neuropathic pain group have not had pain below their injury level since the time of injury.
•Able bodied subjects are to be free of chronic or acute pain, medication and neurological disorder. They are age and sex matched.
•As far as possible, SCI subjects are matched for level and duration of injury.
•Below level neuropathic pain is defined as persistent pain in an area of sensory abnormality occurring at least three dermatomes below the neurological level of injury.

•Subjects with a mental health condition that may interfere with their ability to be tested psychophysically.
•Subject with intellectual or mental impairment: Participants need to understand the risks and benefits of participating in the study and be able to complete study questionnaires. Altered brain function and alteration of central nervous system function may also impact upon the cortical potentials obtained during the project.
•Subjects with a history of severe dysreflexia are excluded due to the theoretical risk of triggering during stimulation.
•Primary language is other than English: Two elements of the study require the use of standardised instructions the patients are required to understand and follow. The instructions are all in English. Failure to understand the instructions would impact upon the results obtained and affect the quality of the data collected. In addition, participants need to understand the risks and benefits of participating in the study and be able to complete study questionnaires.
•<18 years: Participants need to be of a legal age to consent to take part in the study.

发起方

Associate Professor Paul Wrigley