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临床试验/NCT03312881
NCT03312881已完成不适用

Characterisation of Neuropathic Pain in Children: Multimodal Assessment and Diagnosis

Institute of Child Health1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
Self-Report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaire

研究概览

简要总结

Some children experience chronic pain that is related to damage or diseases that affect the nerves that send pain signals. This is known as neuropathic pain. This is not well understood and can be difficult to diagnose. It can often produce unusual feelings such as sensitivity of the skin to light touch. Neuropathic pain is often severe and difficult to treat, and can affect quality of life for the child and family. This study aims to better characterise the symptoms and signs, and impact of neuropathic pain in children.

详细描述

The Investigators will determine whether a questionnaire to identify neuropathic pain in adults is also useful in children. This will help paediatricians and other doctors to recognise neuropathic pain and start appropriate treatment or know when to refer children to a chronic pain clinic.The Investigators will also measure the effects of neuropathic pain on mood, sleep, and quality of life (using questionnaires); identify changes in the sensitivity of the skin to touch and other sensations (using specialised sensory tests); and determine the feasibility of brain imaging for assessing changes in the brain (using magnetic resonance imaging or MRI), in children with neuropathic pain. This information will allow the investigators to measure how effective different types of treatment are, and help ensure children get the most appropriate treatment or interventions to reduce pain and effects on quality of life.

This pilot study of 10-18 year olds diagnosed with neuropathic pain will involve completion of questionnaires by the child and parent, and sensory testing in the child, after their clinic appointment. For some families, there will be an additional visit for MRI. Children will be recruited from the Chronic Pain Outpatients service at Great Ormond Street Hospital NHS Trust. This research is funded by Great Ormond Street Hospital Children's Charity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • children with a clinical diagnosis of chronic neuropathic pain for the full protocol
  • children with a clinical diagnosis of non-neuropathic origin for S-LANSS validation and questionnaires
  • children aged 10-18 years

排除标准

  • significant impairment of comprehension (less than school level for 10 year old) that will limit understanding of sensory testing instructions
  • inadequate english language skills as questionnaires are validated in English and sensory testing instructions can only be delivered by the Investigators in English For brain imaging, patients will be excluded if they have
  • significant medical illness or other (non-neuropathic) neurological disease
  • pregnancy
  • magnetic implants of any type.

结局指标

主要结局

Self-Report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaire

时间窗: 3 years

Sensitivity and specificity of a neuropathic screening tool in children; includes 5 questions related to symptoms and pain descriptors and 2 related to examination

次要结局

  • Quantitative Sensory Testing(3 years)
  • Paediatric Index of Emotional Distress(3 years)
  • Paediatric Quality of Life Inventory (Child and Parent report)(3 years)
  • Pain Catastrophizing Scale (Child and Parent versions)(3 years)
  • Pain Coping Questionnaire(3 years)
  • Adolescent Sleep-Wake Scale-Revised(3 years)
  • Hospital Anxiety and Depression Scale(3 years)
  • Magnetic Resonance Imaging(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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