Clinical trial NCT03312881: Neuropathic Pain in Children: Multimodal Assessment and Diagnosis
Official title: Characterisation of Neuropathic Pain in Children: Multimodal Assessment and Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathic Pain
Child, Only
Keywords: pain
neuropathic
children
QST
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 160
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Self-Report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaire
timeFrame: 3 years
Secondary outcomes:
measure: Paediatric Quality of Life Inventory (Child and Parent report)
timeFrame: 3 years
measure: Pain Catastrophizing Scale (Child and Parent versions)
timeFrame: 3 years
measure: Pain Coping Questionnaire
timeFrame: 3 years
measure: Adolescent Sleep-Wake Scale-Revised
timeFrame: 3 years
measure: Paediatric Index of Emotional Distress
timeFrame: 3 years
measure: Hospital Anxiety and Depression Scale
timeFrame: 3 years
measure: Quantitative Sensory Testing
timeFrame: 3 years
measure: Magnetic Resonance Imaging
timeFrame: 3 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: IChildHealth
Study officials:
affiliation: UCL GOS Institute of Child Health
name: Suellen M Wallker, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.