Exploring the Genetics of Neuropathic Pain

NCT03862365 | Recruiting

• 1 other identifier: 2017/1593
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Neuropathic Pain; Genetic Predisposition; Polyneuropathies

Keywords

reliability; validity

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (6)

Polyneuropathy with pain

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

Genetic: Nerve conduction Studies

Polyneuropathy without pain

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

Genetic: Nerve conduction Studies

Diabetic polyneuropathy with pain

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

Genetic: Nerve conduction Studies

Diabetic polyneuropathy without pain

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

Genetic: Nerve conduction Studies

Carpal tunnel syndrome with pain

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

Genetic: Nerve conduction Studies

Carpal tunnel syndrome without pain

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

Genetic: Nerve conduction Studies

Interventions

Nerve conduction Studies GENETIC

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

Also known as: Genetical analysis

Carpal tunnel syndrome with pain; Carpal tunnel syndrome without pain; Diabetic polyneuropathy with pain; Diabetic polyneuropathy without pain; Polyneuropathy with pain; Polyneuropathy without pain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Haukeland University Hospital: collaborator
• Helse Stavanger HF: collaborator
• St. Olavs Hospital: collaborator
• University Hospital of North Norway: collaborator
• University of Oxford: collaborator
• Danish Pain Research Center: collaborator
• Oslo Metropolitan University: collaborator

Study Sites (5)

Haukeland University Hospital

Bergen, 5021, Norway

RECRUITING

Oslo University Hospital

Oslo, 0450, Norway

RECRUITING

Helse Stavanger HF

Stavanger, 4011, Norway

RECRUITING

University Hospital of North Norway

Tromsø, 9019, Norway

RECRUITING

St. Olavs Hospital

Trondheim, 7030, Norway

RECRUITING

Related Publications (1)

• Spildrejorde M, Dunker O, Allen SM, Kvaloy MB, Uglem M, Hjelland I, Loseth S, Bennett DL, Zwart JA, Winsvold BS, Gervin K, Selmer KK, Nilsen KB. Genome-wide association study of neuropathic pain. Pain. 2025 Nov 21. doi: 10.1097/j.pain.0000000000003848. Online ahead of print.

  PMID: 41359007 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood + blood for Expression analysis

MeSH Terms

Conditions

Neuralgia; Genetic Predisposition to Disease; Polyneuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Susceptibility; Disease Attributes; Pathologic Processes

Study Officials

• John Anker Zwart, M.D.

  Oslo University Hospital

  STUDY CHAIR

• David Benett, M.D.

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Ina Hjelland, M.D.

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

• Margreth Grotle, Pr.

  Oslo Metropolitan University

  PRINCIPAL INVESTIGATOR

• Marie Bu Kvaløy, M.D.

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

• Trond Sand, M.D.

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

• Sissel Løseth, M.D.

  University of North Norway

  PRINCIPAL INVESTIGATOR

• Troels Jensen, M.D.

  Danish pain research senter

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristian B. Nilsen, M.D

CONTACT

+4791372241; uxnikq@ous-hf.no

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, phd

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: March 5, 2019
• Study Start: August 1, 2018
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

NO (5)