Exploring the Genetics of Neuropathic Pain

Neuropathic Pain Clinical Trial

— GeNeup  

Official title:

Exploring the Genetics of Neuropathic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03862365
• Other study ID #: 2017/1593
• Status: Recruiting
• Start date: August 1, 2018
• Est. completion date: December 31, 2027

Study information

• Verified date: November 2023
• Source: Oslo University Hospital
• Contact: Kristian B. Nilsen, M.D
• Phone: +4791372241
• Email: uxnikq[@]ous-hf.no
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Genetic Predisposition
• Genetic Predisposition to Disease
• Neuralgia
• Neuropathic Pain
• Polyneuropathies

Intervention

Genetic:
• Nerve conduction Studies
Patients will be genotyped for comparison of patients With and without pain, With different clinical subgroups as mentioned.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Oslo University Hospital	Oslo
Norway	Helse Stavanger HF	Stavanger
Norway	University Hospital of North Norway	Tromsø
Norway	St. Olavs Hospital	Trondheim

Sponsors (8)

Lead Sponsor	Collaborator
Oslo University Hospital	Danish Pain Research Center, Haukeland University Hospital, Helse Stavanger HF, Oslo Metropolitan University, St. Olavs Hospital, University Hospital of North Norway, University of Oxford

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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	Baseline
Primary	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).	Baseline