Neuropathic Pain in Children: Multimodal Assessment and Diagnosis

Neuropathic Pain Clinical Trial

Official title:

Characterisation of Neuropathic Pain in Children: Multimodal Assessment and Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03312881
• Other study ID #: 17NC03
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Institute of Child Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child, Only
• Neuralgia
• Neuropathic Pain

Intervention

Diagnostic Test:
• quantitative sensory testing
multiple modality testing of generalized and localized changes in somatosensory perception
• neuroimaging
magnetic resonance imaging (MRI)

Other:
• Patient Reported Outcome Measures
neuropathic pain screening tool; validated questionnaires

Locations

Country	Name	City	State
United Kingdom	IChildHealth	London

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Child Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaire	Sensitivity and specificity of a neuropathic screening tool in children; includes 5 questions related to symptoms and pain descriptors and 2 related to examination	3 years
Secondary	Paediatric Quality of Life Inventory (Child and Parent report)	evaluates 23 items relating to the child's functioning in four dimensions: physical; emotional; social; and school.	3 years
Secondary	Pain Catastrophizing Scale (Child and Parent versions)	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 years
Secondary	Pain Coping Questionnaire	comprises 39 items relating to information seeking; problem solving; seeking social support; positive self-statements; behavioural distraction; cognitive distraction; externalising; and internalising/catastrophizing	3 years
Secondary	Adolescent Sleep-Wake Scale-Revised	evaluates 10 items relating to: falling asleep and reinitiating sleep; returning to wakefulness; and going to bed	3 years
Secondary	Paediatric Index of Emotional Distress	comprises 14 items related to symptoms of anxiety and depression, with a maximum score of 42	3 years
Secondary	Hospital Anxiety and Depression Scale	measures anxiety and depression in adults (parents) and comprises 14 items	3 years
Secondary	Quantitative Sensory Testing	Sensory profile in terms of gain or loss of sensitivity	3 years
Secondary	Magnetic Resonance Imaging	pilot study to assess feasibility and acceptability of MRI in this patient group	3 years