Neuropathic Pain in Children: Multimodal Assessment and Diagnosis

January 18, 2022 updated by: Institute of Child Health

Characterisation of 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.

Study Overview

Detailed 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.

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study will recruit children and adolescents aged 10-18 years referred to the Great Ormond Street Hospital Pain Service who are clinically diagnosed as having neuropathic pain.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
neuropathic pain
Children with clinical diagnosis of neuropathic pain. Interventions: patient reported outcome measures, quantitative sensory testing, neuroimaging
multiple modality testing of generalized and localized changes in somatosensory perception
magnetic resonance imaging (MRI)
neuropathic pain screening tool; validated questionnaires
non-neuropathic pain
Children with clinical diagnosis of non-neuropathic pain. Interventions: patient reported outcome measures
neuropathic pain screening tool; validated questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years
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 years
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
3 years
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
3 years
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
3 years
Hospital Anxiety and Depression Scale
Time Frame: 3 years
measures anxiety and depression in adults (parents) and comprises 14 items
3 years
Quantitative Sensory Testing
Time Frame: 3 years
Sensory profile in terms of gain or loss of sensitivity
3 years
Magnetic Resonance Imaging
Time Frame: 3 years
pilot study to assess feasibility and acceptability of MRI in this patient group
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Suellen M Wallker, MBBS PhD, UCL GOS Institute of Child Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

September 27, 2017

First Submitted That Met QC Criteria

October 17, 2017

First Posted (Actual)

October 18, 2017

Study Record Updates

Last Update Posted (Actual)

February 2, 2022

Last Update Submitted That Met QC Criteria

January 18, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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