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临床试验/NCT03862365
NCT03862365招募中不适用

Exploring the Genetics of Neuropathic Pain

Oslo University Hospital5 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
5,000
试验地点
5
主要终点
Phenotype; subgroup analysis of patients with neuropathic pain based on grading of pain

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Phenotype; subgroup analysis of patients with neuropathic pain based on grading of pain

时间窗: Baseline

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).

Genetic variants associated with neuropathic pain.

时间窗: Baseline

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.

Phenotype; neuropathic pain yes/no

时间窗: Baseline

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

次要结局

未报告次要终点

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristian Bernhard Nilsen

Senior Consultant, phd

Oslo University Hospital

研究点 (5)

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