A Retrospective Study to Identify New "Omics" Biomarkers of Chronic/Persistent Low Back Pain
Condition: Persistent/Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Cases will be collected at each participating centre. Every effort will be made to
        accumulate a well phenotyped cohort of patients with persistent CLBP, sub-grouped into 6
        categories: discogenic pain, spinal stenosis (congenital or acquired), facet joint pain,
        sacroiliac joint pain, low back pain with radicular pain (not predominant radicular pain)
        and widespread low back pain.

        Controls (patients without chronic/persistent pain as defined above) will be retrieved from
        2 different sources:

        Existing biobanks of healthy subjects which have collected information about
        chronic/persistent back pain.

        Subjects from the companion prospective study on acute LBP who will not have developed
        CLBP.

        Age (decades) and gender distribution of controls will be similar to cases.
      
Biospecimen description: 
      Whole blood samples will be collected from cases (patients already diagnosed with
      persistent/chronic low back pain) and from controls (healthy subjects).
    
Keywords: pain; low back pain; GWAS; glycomics; activomics