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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neuropathic pain | Children with clinical diagnosis of neuropathic pain. Interventions: patient reported outcome measures, quantitative sensory testing, neuroimaging |
| |
| non-neuropathic pain | Children with clinical diagnosis of non-neuropathic pain. Interventions: patient reported outcome measures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quantitative sensory testing | Diagnostic Test | multiple modality testing of generalized and localized changes in somatosensory perception |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Paediatric Quality of Life Inventory (Child and Parent report) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Suellen M Wallker, MBBS PhD | UCL GOS Institute of Child Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IChildHealth | London | WC1N 1EH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37741521 | Derived | 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. | |
| 33394878 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 3, 2024 | |
| Reset | Nov 22, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2017 | Sep 26, 2017 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 3, 2024 | Nov 22, 2024 |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D059906 | Neuroimaging |
| D000071066 | Patient Reported Outcome Measures |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
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| neuroimaging | Diagnostic Test | magnetic resonance imaging (MRI) |
|
| Patient Reported Outcome Measures | Other | neuropathic pain screening tool; validated questionnaires |
|
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 | 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 | evaluates 10 items relating to: falling asleep and reinitiating sleep; returning to wakefulness; and going to bed | 3 years |
| Paediatric Index of Emotional Distress | comprises 14 items related to symptoms of anxiety and depression, with a maximum score of 42 | 3 years |
| Hospital Anxiety and Depression Scale | measures anxiety and depression in adults (parents) and comprises 14 items | 3 years |
| Quantitative Sensory Testing | Sensory profile in terms of gain or loss of sensitivity | 3 years |
| Magnetic Resonance Imaging | pilot study to assess feasibility and acceptability of MRI in this patient group | 3 years |
| 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008919 | Investigative Techniques |
| D019538 | Health Care Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D063868 | Patient Outcome Assessment |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |