Exploring the Genetics of Neuropathic Pain

NCT ID: NCT03862365

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2027-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Neuropathic Pain Genetic Predisposition Polyneuropathies

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Polyneuropathy with pain

Clinical and diagnostic test evaluation for the establishment of polyneuropathy with pain.

Nerve conduction Studies

Intervention Type GENETIC

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

Polyneuropathy without pain

Clinical and diagnostic test evaluation for the establishment of polyneuropathy without pain.

Nerve conduction Studies

Intervention Type GENETIC

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

Diabetic polyneuropathy with pain

Clinical and diagnostic test evaluation for the establishment of diabetic polyneuropathy with pain.

Nerve conduction Studies

Intervention Type GENETIC

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

Diabetic polyneuropathy without pain

Clinical and diagnostic test evaluation for the establishment of diabetic polyneuropathy without pain.

Nerve conduction Studies

Intervention Type GENETIC

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

Carpal tunnel syndrome with pain

Clinical and diagnostic test evaluation for the establishment of carpal tunnel syndrome with pain.

Nerve conduction Studies

Intervention Type GENETIC

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

Carpal tunnel syndrome without pain

Clinical and diagnostic test evaluation for the establishment of carpal tunnel syndrome without pain.

Nerve conduction Studies

Intervention Type GENETIC

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

Interventions

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Nerve conduction Studies

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

Intervention Type GENETIC

Other Intervention Names

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Genetical analysis

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

Danish Pain Research Center

OTHER

Sponsor Role collaborator

Oslo Metropolitan University

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kristian Bernhard Nilsen

Senior Consultant, phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Anker Zwart, M.D.

Role: STUDY_CHAIR

Oslo University Hospital

David Benett, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Ina Hjelland, M.D.

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Margreth Grotle, Pr.

Role: PRINCIPAL_INVESTIGATOR

Oslo Metropolitan University

Marie Bu Kvaløy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Helse Stavanger HF

Trond Sand, M.D.

Role: PRINCIPAL_INVESTIGATOR

St. Olavs Hospital

Sissel Løseth, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of North Norway

Troels Jensen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Danish pain research senter

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status RECRUITING

Oslo University Hospital

Oslo, , Norway

Site Status RECRUITING

Helse Stavanger HF

Stavanger, , Norway

Site Status RECRUITING

University Hospital of North Norway

Tromsø, , Norway

Site Status RECRUITING

St. Olavs Hospital

Trondheim, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Kristian B. Nilsen, M.D

Role: CONTACT

+4791372241

Facility Contacts

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Ina Hjelland, M.D.

Role: primary

+4755975000

Kristian B. Nilsen, M.D.

Role: primary

+4791372241

Øystein Dunker, M.D.

Role: backup

+4793293484

Marie Bu Kvaløy, M.D.

Role: primary

+4751518430

Sissel Løseth, M.D.

Role: primary

+4777627102

Trond Sand, M.D.

Role: primary

+4772576006

Other Identifiers

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2017/1593

Identifier Type: -

Identifier Source: org_study_id

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