A Retrospective Study to Identify New "Omics" Biomarkers of Chronic/Persistent Low Back Pain
| Status: | Recruiting |
|---|---|
| Conditions: | Back Pain, Back Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | March 2014 |
| End Date: | August 2018 |
| Contact: | MASSIMO ALLEGRI, MD |
| Email: | m.allegri@smatteo.pv.it |
Low back pain (LBP) is one of the most common medical problems encountered in daily life; it
is related to disability and work absence and accounts for high economical costs in Western
societies.
Low-back pain is a diverse group of mixed pain syndromes (neuropathic and nociceptive) with
different molecular pathologies at different structural levels displaying similar clinical
manifestations. Currently, there are limited biomarkers (mostly imaging) or clinical
findings that can be used objectively to help the physician in precise anatomic diagnosis
leading to the safest and most cost-effective treatment for the patient (reduction of direct
and indirect costs and improvement of treatment efficacy).
The main aim of this trial is to identify all "omics biomarkers" associated with
susceptibility to chronic/persistent LBP and its different pathophysiology.
is related to disability and work absence and accounts for high economical costs in Western
societies.
Low-back pain is a diverse group of mixed pain syndromes (neuropathic and nociceptive) with
different molecular pathologies at different structural levels displaying similar clinical
manifestations. Currently, there are limited biomarkers (mostly imaging) or clinical
findings that can be used objectively to help the physician in precise anatomic diagnosis
leading to the safest and most cost-effective treatment for the patient (reduction of direct
and indirect costs and improvement of treatment efficacy).
The main aim of this trial is to identify all "omics biomarkers" associated with
susceptibility to chronic/persistent LBP and its different pathophysiology.
Retrospective observational multinational clinical study, with a case control design.
Investigators will compare "omic biomarkers" between patients with and without persistent
chronic low back pain (CLBP).
"OMIC" biomarkers investigated will be genetics, glycomics and activomic. Genetics through
GWA studies has already obtained important results in pain research; however concerning low
back pain, there is not yet suitable genotype-phenotype correlations helpful to stratify
patients.
Glycomics is an emerging field that has recently been identified as a priority for the next
decade by the US National Academies of Science. Many common complex diseases will be
associated with specific changes in glycan structures. In addition, common genetic
polymorphisms influencing glycosylation and consequent differences in glycome composition
could be important diagnostic and prognostic markers. The first studies reporting protein
glycosylation in large human population samples have been recently published by partners in
the consortium. Reliable identification of valid associations between specific
glyco-phenotypes and predisposition for the development or progression of a specific disease
requires analysis of thousands of patients.
Activomics: combines data about enzymatic activity of numerous numerous post-translational
modification proteins in an integrated model which provides dynamic characterization of the
current state of an organism. In this project information about numerous proteases, kinases,
phosphatases and glycosidases will be collected and used to complement the existing
phenotype information.
Investigators will compare "omic biomarkers" between patients with and without persistent
chronic low back pain (CLBP).
"OMIC" biomarkers investigated will be genetics, glycomics and activomic. Genetics through
GWA studies has already obtained important results in pain research; however concerning low
back pain, there is not yet suitable genotype-phenotype correlations helpful to stratify
patients.
Glycomics is an emerging field that has recently been identified as a priority for the next
decade by the US National Academies of Science. Many common complex diseases will be
associated with specific changes in glycan structures. In addition, common genetic
polymorphisms influencing glycosylation and consequent differences in glycome composition
could be important diagnostic and prognostic markers. The first studies reporting protein
glycosylation in large human population samples have been recently published by partners in
the consortium. Reliable identification of valid associations between specific
glyco-phenotypes and predisposition for the development or progression of a specific disease
requires analysis of thousands of patients.
Activomics: combines data about enzymatic activity of numerous numerous post-translational
modification proteins in an integrated model which provides dynamic characterization of the
current state of an organism. In this project information about numerous proteases, kinases,
phosphatases and glycosidases will be collected and used to complement the existing
phenotype information.
Inclusion Criteria of patients with persistent CLBP:
- age: older than 18;
- chronic/persistent pain (pain lasting longer than 12 weeks) between the costal
margins and gluteal fold, with or without symptoms into one or both legs
- written informed consent signed;
- Caucasian ancestry
Inclusion Criteria of healthy volunteers:
- age: older than 18;
- without any chronic/persistent pain (pain lasting longer than 12 weeks) in the last
one year;
- written informed consent signed;
- Caucasian ancestry
Exclusion Criteria:
- evidence of clinically unstable disease;
- severe psychiatric disorder (excluding mild depression) or mental impairment;
- recent history ( < 1 year) of spinal fracture;
- pain in the back due to spinal tumor or infection;
- pregnancy
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