Neuropathic Pain in Children: Multimodal Assessment and Diagnosis

NCT ID: NCT03312881

Last Updated: 2022-02-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2021-12-31

Brief 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.

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.

Conditions

Neuropathic Pain; Child, Only

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

neuropathic pain

Children with clinical diagnosis of neuropathic pain. Interventions: patient reported outcome measures, quantitative sensory testing, neuroimaging

quantitative sensory testing

Intervention Type: DIAGNOSTIC_TEST

multiple modality testing of generalized and localized changes in somatosensory perception

neuroimaging

Intervention Type: DIAGNOSTIC_TEST

magnetic resonance imaging (MRI)

Patient Reported Outcome Measures

Intervention Type: OTHER

neuropathic pain screening tool; validated questionnaires

non-neuropathic pain

Children with clinical diagnosis of non-neuropathic pain. Interventions: patient reported outcome measures

Patient Reported Outcome Measures

Intervention Type: OTHER

neuropathic pain screening tool; validated questionnaires

Interventions

quantitative sensory testing

multiple modality testing of generalized and localized changes in somatosensory perception

Intervention Type: DIAGNOSTIC_TEST

neuroimaging

magnetic resonance imaging (MRI)

Intervention Type: DIAGNOSTIC_TEST

Patient Reported Outcome Measures

neuropathic pain screening tool; validated questionnaires

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Child Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suellen M Wallker, MBBS PhD

Role: PRINCIPAL_INVESTIGATOR

UCL GOS Institute of Child Health

Locations

IChildHealth

London, , United Kingdom

Countries

United Kingdom

References

Walker SM, Peters J, Verriotis M, Farag F, Jay MA, Howard RF. Sensitivity and Specificity of a Neuropathic Screening Tool (Self-Report Leeds Assessment of Neuropathic Symptoms and Signs, S-LANSS) in Adolescents With Moderate-Severe Chronic Pain. J Pain. 2024 Feb;25(2):451-465. doi: 10.1016/j.jpain.2023.09.006. Epub 2023 Sep 21.

Reference Type: DERIVED

PMID: 37741521 (View on PubMed)

Verriotis M, Peters J, Sorger C, Walker SM. Phenotyping peripheral neuropathic pain in male and female adolescents: pain descriptors, somatosensory profiles, conditioned pain modulation, and child-parent reported disability. Pain. 2021 Jun 1;162(6):1732-1748. doi: 10.1097/j.pain.0000000000002172.

Reference Type: DERIVED

PMID: 33394878 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17NC03

Identifier Type: -

Identifier Source: org_study_id