NCT03312881

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 18, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

3.9 years

First QC Date

September 27, 2017

Last Update Submit

January 18, 2022

Conditions

Keywords

painneuropathicchildrenQST

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

  • Paediatric Index of Emotional Distress

    3 years

  • +3 more secondary outcomes

Study Arms (2)

neuropathic pain

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

Diagnostic Test: quantitative sensory testingDiagnostic Test: neuroimagingOther: Patient Reported Outcome Measures

non-neuropathic pain

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

Other: Patient Reported Outcome Measures

Interventions

multiple modality testing of generalized and localized changes in somatosensory perception

neuropathic pain
neuroimagingDIAGNOSTIC_TEST

magnetic resonance imaging (MRI)

neuropathic pain

neuropathic pain screening tool; validated questionnaires

neuropathic painnon-neuropathic pain

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IChildHealth

London, WC1N 1EH, United Kingdom

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

NeuralgiaPain

Interventions

NeuroimagingPatient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalInvestigative TechniquesHealth Care SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsHealth Services ResearchHealth PlanningHealth Care Economics and OrganizationsPatient Outcome AssessmentOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Officials

  • Suellen M Wallker, MBBS PhD

    UCL GOS Institute of Child Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 18, 2017

Study Start

September 1, 2017

Primary Completion

July 31, 2021

Study Completion

December 31, 2021

Last Updated

February 2, 2022

Record last verified: 2022-01

Locations