An observational study in Neuropathic Pain, Genetic Predisposition and Polyneuropathies, sponsored by Oslo University Hospital. Recruiting at 5 sites in Norway. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Oslo University Hospital · Observational
In the present study the investigators will search for new genetic variants relevant for the development of neuropathic pain.
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.
1,100 studies on the registry are indexed under Neuralgia; 241 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 102 across 231 observational studies indexed under Neuralgia.
Browse Neuralgia studies →Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
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All patients that are referred for suspected distal symmetric polyneuropathy and meet the inclusion criteria, will be included in the project. Furthermore, there will be collected blood tests from patients with definite and probable polyneuropathy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Clinical and diagnostic test evaluation for the establishment of polyneuropathy with pain.
Genetic: Nerve conduction Studies
Clinical and diagnostic test evaluation for the establishment of polyneuropathy without pain.
Genetic: Nerve conduction Studies
Clinical and diagnostic test evaluation for the establishment of diabetic polyneuropathy with pain.
Genetic: Nerve conduction Studies
Clinical and diagnostic test evaluation for the establishment of diabetic polyneuropathy without pain.
Genetic: Nerve conduction Studies
Clinical and diagnostic test evaluation for the establishment of carpal tunnel syndrome with pain.
Genetic: Nerve conduction Studies
Clinical and diagnostic test evaluation for the establishment of carpal tunnel syndrome without pain.
Genetic: Nerve conduction Studies
Patients will be genotyped for comparison of patients With and without pain, With different clinical subgroups as mentioned.
Also known as: Genetical analysis
Genetic variants associated with neuropathic pain.
Relevant 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.
Time frame: Baseline
Phenotype; neuropathic pain yes/no
Patients 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
Time frame: Baseline
Phenotype; subgroup analysis of patients with neuropathic pain based on grading of pain
Patients 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).
Time frame: Baseline
Plan to share: Undecided
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