Official Title
Neuropathic Pain: Association Between Phenotype and Biomarkers
Brief Title
Analysis of Markers in the Blood Correlated With Neuropathic Pain
Protocol ID
NCT02208206
Lead Sponsor
Christoph Stein, MD
Brief Summary
The purpose of this study is to analyze associations between symptoms and specific
markers in the blood in patients suffering from neuropathic pain linked to diseases of
different origin. Such markers could be utilized in the future for precise diagnosis of
neuropathic pain and might lead to targeted pain treatment.
Detailed Description
On average, 3-8% of the German population suffers from neuropathic pain, which can occur
after damage of somatosensory nerves in the peripheral or central nervous system. In
terms of a "personalized" medicine, only a strict separation of neuropathic and chronic
pain allows an individualized therapy to reduce pain severity and to enhance patients'
quality of life.
Currently, the diagnosis of neuropathic pain is based on the medical history, the
subjective description of somatosensory symptoms and the application of (non-genetic)
diagnostic tests. To improve diagnosis and therapy of complex disorders for individual
patients, novel methods are introduced based on flow cytometric (FACS) analysis of human
immune cells or analysis of the human genome (genomics). Those techniques can support the
identification of characteristic features indicating ongoing individual pathophysiologic
processes in the body (biomarkers).
Often diseases are based on a complex relationship between genetics, environmental
factors and the manifestation of the disease. To capture this complexity via genomics,
phenotypical and genotypical data of high quality and detailed information about the
study population are required.
This observational study includes patients suffering from painful and non-painful
neuropathies associated with HIV-infection, diabetes mellitus and breast cancer. With the
targeted application of validated questionnaires (such as the Brief Pain Inventory, Pain
Catastrophizing Scale, Hospital Anxiety and Depression Scale, Ten-Item Personality
Inventory, 36-Item Short Form Health Survey, and the Insomnia Severity Index) and
parallel usage of genomics or FACS analysis of selected biomarkers in the blood, this
study will provide information about the manifestation of certain genes or immune markers
which are directly correlated to the symptoms of the disease. Additional performance of
neuropsychological/cognitive tests and quantitative sensory testing (QST) will enhance
the phenotypic profile. Identification of potential indicators could be utilized
prospectively to precisely diagnose and effectively treat neuropathic pain.
Enrollment Count
50 participants
Eligibility Criteria
Inclusion Criteria:
- HIV-associated neuropathy
- Sufficient knowledge of the German language
Exclusion Criteria:
- Co-incident severe central nervous system diseases
- Major psychiatric conditions
- Dementia
- Limited mental capacity or limited German language skills
- Intoxication with alcohol or recreational drugs within the last 48 hours of the
study
Filters
Neuropathy
COMPLETED
ADULT
OLDER_ADULT