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Exploring the Genetics of Neuropathic Pain

Exploring the Genetics of Neuropathic Pain

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03862365
Acronym
GeNeup
Enrollment
5000
Registered
2019-03-05
Start date
2018-08-01
Completion date
2027-12-31
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic Pain, Genetic Predisposition, Polyneuropathies

Keywords

reliability, validity

Brief summary

In the present study the investigators will search for new genetic variants relevant for the development of neuropathic pain.

Detailed description

Neuropathic pain is defined as pain caused by a lesion or disease of the somatosensory nervous system. Neuropathic pain is a huge health problem worldwide, with an estimated prevalence of 7-8 % in the general population. In the present study the investigators will search for new genetic variants relevant for the development of this type of pain. Peripheral nerve lesions only progress to neuropathic pain in some patients, yet is not completely understood why or how. Genetic studies of patients with rare neuropathic disorders have been important for elucidating novel molecular mechanisms of neuropathic pain, and new drugs for neuropathic pain are now being developed based on these findings. By using genetic association studies, one may identify new genetic variants which may help to identify key molecular mechanisms for a larger group of patients with neuropathic pain. This project will use existing population-based cohorts, as well as establish a specific registry and biobank for patients with neuropathy in order to address these specific needs. This will allow the investigators to identify a large number of individuals with probable neuropathic pain and individuals with pain-free peripheral neuropathy (disease controls). International collaboration will contribute to study a large group of patients, which will be important in order to reach the project's goals. The results from the project are expected to increase current knowledge on the mechanisms of neuropathic pain, opening up new opportunities for innovative and improved treatments. Dissemination of results will be organized in close collaboration with patient representatives, and will be done regularly throughout the course of the project. The will focus both on internal dissemination to the participating hospitals, and external dissemination through participation in conferences, submissions to scientific journals and by publishing patient-friendly information booklets and proactively informing media outlets and patient organizations.

Interventions

Patients will be genotyped for comparison of patients With and without pain, With different clinical subgroups as mentioned.

Sponsors

Haukeland University Hospital
CollaboratorOTHER
Helse Stavanger HF
CollaboratorOTHER_GOV
St. Olavs Hospital
CollaboratorOTHER
University Hospital of North Norway
CollaboratorOTHER
University of Oxford
CollaboratorOTHER
Danish Pain Research Center
CollaboratorOTHER
Oslo Metropolitan University
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. The patient is between 18 and 70 years old. 2. The patient has consented. 3. The patient is referred for evaluation of possible distal symmetric polyneuropathy (DSPN). 4. The patient has filled out the questionnaires.

Exclusion criteria

1. The patient is too sick to participate (eg. bedridden, fever). 2. The patient is unable to consent (eg. dementia, speech problems, psychiatric disorder). 3. Inflammatory acute polyneuropathy.

Design outcomes

Primary

MeasureTime frameDescription
Genetic variants associated with neuropathic pain.BaselineRelevant genotypes will be found using genome-wide association study (GWAS) methodology, ie. with no assumptions regarding which genetic variants that may be relevant (no hypotheses regarding specific variants). This is going to be conducted by using array genotyping (SNPs) in order to identify genetic variants that might be associated with neuropathic pain. Genetic variants will be defined and named according to standard practice, without any room for local or study specific adaptations.
Phenotype; neuropathic pain yes/noBaselinePatients will be divided in two groups; neuropathy With pain (= neuropathic pain) and neuropathy without pain. For definition of neuropathic pain, the Neupsig guidelines (Finnerup et al, Pain 2016) will be used.It is estimated that about 600 patients will be included yearly for this purpose
Phenotype; subgroup analysis of patients with neuropathic pain based on grading of painBaselinePatients with neuropathic pain will be further subdivided in groups based on pain reports. Pain will be graded using validated questionnaires. The Brief Pain Inventory-BPI (Cleeland et al, 1994) questionnaire will be used as primary resource for pain grading, on a scale from 0 to 10 (0: no pain, 1-3: mild pain, 4-10: strong pain).

Countries

Norway

Contacts

Primary ContactKristian B. Nilsen, M.D
uxnikq@ous-hf.no+4791372241

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026