- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03312881
Neuropathic Pain in Children: Multimodal Assessment and Diagnosis
Characterisation of Neuropathic Pain in Children: Multimodal Assessment and Diagnosis
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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London, United Kingdom, WC1N 1EH
- IChildHealth
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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multiple modality testing of generalized and localized changes in somatosensory perception
magnetic resonance imaging (MRI)
neuropathic pain screening tool; validated questionnaires
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non-neuropathic pain
Children with clinical diagnosis of non-neuropathic pain.
Interventions: patient reported outcome measures
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neuropathic pain screening tool; validated questionnaires
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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
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Sensitivity and specificity of a neuropathic screening tool in children; includes 5 questions related to symptoms and pain descriptors and 2 related to examination
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Paediatric Quality of Life Inventory (Child and Parent report)
Time Frame: 3 years
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evaluates 23 items relating to the child's functioning in four dimensions: physical; emotional; social; and school.
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3 years
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Pain Catastrophizing Scale (Child and Parent versions)
Time Frame: 3 years
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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)
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3 years
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Pain Coping Questionnaire
Time Frame: 3 years
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comprises 39 items relating to information seeking; problem solving; seeking social support; positive self-statements; behavioural distraction; cognitive distraction; externalising; and internalising/catastrophizing
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3 years
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Adolescent Sleep-Wake Scale-Revised
Time Frame: 3 years
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evaluates 10 items relating to: falling asleep and reinitiating sleep; returning to wakefulness; and going to bed
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3 years
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Paediatric Index of Emotional Distress
Time Frame: 3 years
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comprises 14 items related to symptoms of anxiety and depression, with a maximum score of 42
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3 years
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Hospital Anxiety and Depression Scale
Time Frame: 3 years
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measures anxiety and depression in adults (parents) and comprises 14 items
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3 years
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Quantitative Sensory Testing
Time Frame: 3 years
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Sensory profile in terms of gain or loss of sensitivity
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3 years
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Magnetic Resonance Imaging
Time Frame: 3 years
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pilot study to assess feasibility and acceptability of MRI in this patient group
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3 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Suellen M Wallker, MBBS PhD, UCL GOS Institute of Child Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17NC03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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