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Completed

NCT Number: NCT03312881

Neuropathic Pain in Children: Multimodal Assessment and Diagnosis

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.

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Key information

Conditions

Neuropathic Pain Child, Only Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IChildHealth

London, WC1N 1EH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

quantitative sensory testing

Diagnostic Test

multiple modality testing of generalized and localized changes in somatosensory perception

neuroimaging

Diagnostic Test

magnetic resonance imaging (MRI)

Patient Reported Outcome Measures

Other

neuropathic pain screening tool; validated questionnaires

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. Paediatric Quality of Life Inventory (Child and Parent report)

    Time frame: 3 years

    evaluates 23 items relating to the child's functioning in four dimensions: physical; emotional; social; and school.

  2. Pain Catastrophizing Scale (Child and Parent versions)

    Time frame: 3 years

    13 items assessing 3 aspects of pain experience: the tendency to magnify the threat value of pain (magnification), to feel helpless in the context of pain (helplessness), and to worry about it more (rumination)

  3. Pain Coping Questionnaire

    Time frame: 3 years

    comprises 39 items relating to information seeking; problem solving; seeking social support; positive self-statements; behavioural distraction; cognitive distraction; externalising; and internalising/catastrophizing

  4. Adolescent Sleep-Wake Scale-Revised

    Time frame: 3 years

    evaluates 10 items relating to: falling asleep and reinitiating sleep; returning to wakefulness; and going to bed

  5. Paediatric Index of Emotional Distress

    Time frame: 3 years

    comprises 14 items related to symptoms of anxiety and depression, with a maximum score of 42

  6. Hospital Anxiety and Depression Scale

    Time frame: 3 years

    measures anxiety and depression in adults (parents) and comprises 14 items

  7. Quantitative Sensory Testing

    Time frame: 3 years

    Sensory profile in terms of gain or loss of sensitivity

  8. Magnetic Resonance Imaging

    Time frame: 3 years

    pilot study to assess feasibility and acceptability of MRI in this patient group

Sponsors and collaborators

Lead sponsor

Institute of Child Health

Other

Registry information

Official study title

Characterisation of Neuropathic Pain in Children: Multimodal Assessment and Diagnosis

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Oct 18, 2017
Registry last updated
Feb 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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