Neuropathic PainNCT03312881
Neuropathic Pain in Children: Multimodal Assessment and Diagnosis
An observational study of Neuropathic Pain and Child, Only, run by Institute of Child Health at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Neuropathic Pain, Child, Only
- What is being tested?
- quantitative sensory testing, neuroimaging and Patient Reported Outcome Measures
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2017to 31 Dec 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterisation of Neuropathic Pain in Children: Multimodal Assessment and Diagnosis
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.
Read the 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
- Being tested
- quantitative sensory testing, neuroimaging, Patient Reported Outcome Measures
- Keywords
- pain, neuropathic, children, QST
- Medical subject headings
- Neuralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quantitative sensory testingDiagnostic test
multiple modality testing of generalized and localized changes in somatosensory perception
neuroimagingDiagnostic test
magnetic resonance imaging (MRI)
Patient Reported Outcome MeasuresOther
neuropathic pain screening tool; validated questionnaires
| Study group | Role | What they receive |
|---|---|---|
| neuropathic pain | Children with clinical diagnosis of neuropathic pain. Interventions: patient reported outcome measures, quantitative sensory testing, neuroimaging Receives: Diagnostic Test: quantitative sensory testing; Diagnostic Test: neuroimaging; Other: Patient Reported Outcome Measures | |
| non-neuropathic pain | Children with clinical diagnosis of non-neuropathic pain. Interventions: patient reported outcome measures Receives: Other: Patient Reported Outcome Measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (8)
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.
Measured: 3 years
Pain Catastrophizing Scale (Child and Parent versions)
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)
Measured: 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
Measured: 3 years
Adolescent Sleep-Wake Scale-Revised
evaluates 10 items relating to: falling asleep and reinitiating sleep; returning to wakefulness; and going to bed
Measured: 3 years
Paediatric Index of Emotional Distress
comprises 14 items related to symptoms of anxiety and depression, with a maximum score of 42
Measured: 3 years
Hospital Anxiety and Depression Scale
measures anxiety and depression in adults (parents) and comprises 14 items
Measured: 3 years
Quantitative Sensory Testing
Sensory profile in terms of gain or loss of sensitivity
Measured: 3 years
Magnetic Resonance Imaging
pilot study to assess feasibility and acceptability of MRI in this patient group
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start1 Sep 2017
- Primary completion31 Jul 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suellen M Wallker, MBBS PhD, Principal investigator, UCL GOS Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312881
- Sponsor's protocol ID
- 17NC03
- Status last verified
- Jan 2022
- First submitted
- 27 Sep 2017
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37741521Verriotis 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.
PubMed 33394878
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Neuropathic Pain in Children: Multimodal Assessment and Diagnosis
- ClinicalTrials.gov ID
- NCT03312881
- Acronym / sponsor ID
- 17NC03
- Conditions
- Neuropathic Pain, Child, Only
- Keywords
- pain, neuropathic, children, QST
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neuropathic pain | – | Diagnostic Test: quantitative sensory testing, Diagnostic Test: neuroimaging, Other: Patient Reported Outcome MeasuresChildren with clinical diagnosis of neuropathic pain. Interventions: patient reported outcome measures, quantitative sensory testing, neuroimaging |
| non-neuropathic pain | – | Other: Patient Reported Outcome MeasuresChildren with clinical diagnosis of non-neuropathic pain. Interventions: patient reported outcome measures |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quantitative sensory testingmultiple modality testing of generalized and localized changes in somatosensory perception | Diagnostic test | neuropathic pain |
| neuroimagingmagnetic resonance imaging (MRI) | Diagnostic test | neuropathic pain |
| Patient Reported Outcome Measuresneuropathic pain screening tool; validated questionnaires | Other | neuropathic pain, non-neuropathic pain |
Primary outcome
Self-Report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaire
Time frame: 3 years
Sensitivity and specificity of a neuropathic screening tool in children; includes 5 questions related to symptoms and pain descriptors and 2 related to examination
8 secondary outcomes
Paediatric Quality of Life Inventory (Child and Parent report)
Time frame: 3 years
Pain Catastrophizing Scale (Child and Parent versions)
Time frame: 3 years
Pain Coping Questionnaire
Time frame: 3 years
Adolescent Sleep-Wake Scale-Revised
Time frame: 3 years
Paediatric Index of Emotional Distress
Time frame: 3 years
Hospital Anxiety and Depression Scale
Time frame: 3 years
Quantitative Sensory Testing
Time frame: 3 years
Magnetic Resonance Imaging
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Derived from this study: PubMed 37741521Walker 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.
- Derived from this study: PubMed 33394878Verriotis 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suellen M Wallker, MBBS PhD principal investigator
UCL GOS Institute of Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain and Child, Only, run by Institute of Child Health at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaire (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03312881, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.