Exploring the Genetics of Neuropathic Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorOslo University Hospital
About this trial
In the present study the investigators will search for new genetic variants relevant for the development of neuropathic pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Nerve conduction Studies
GeneticPatients will be genotyped for comparison of patients With and without pain, With different clinical subgroups as mentioned.
Treatment groups
5,000 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Polyneuropathy with pain1 intervention
Group B: Polyneuropathy without pain1 intervention
Group C: Diabetic polyneuropathy with pain1 intervention
Group D: Diabetic polyneuropathy without pain1 intervention
Group E: Carpal tunnel syndrome with pain1 intervention
Group F: Carpal tunnel syndrome without pain1 intervention
Trial outcomes
Primary outcomes
1
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
Baseline2
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
Baseline3
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
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oslo University Hospital
Lead sponsor
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
Source ClinicalTrials.gov