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Completed

NCT Number: NCT02037789

A Retrospective Study to Identify New "Omics" Biomarkers of Chronic/Persistent Low Back Pain

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Edith Cowan University (ECU), Perth, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. GENETIC OUTCOME

    Time frame: 30 months

    The primary objective is to recognize genetic variants associated with persistent CLBP patients compared to patients without chronic/persistent pain. Through a Genetic Wide Association Study (GWAS) investigators will correlate genetic variants associated with persistent CLBP in a wide, international population of European ancestry.

Secondary outcomes

  1. GLYCOMIC AND ACTIVOMIC OUTCOME

    Time frame: 30 months

    Recognize Glycomic and Activomic data associated with persistent CLBP patients compared to patients without chronic/persistent pain. The sample size will better defined after the first interim analysis of first 400 patients.

  2. STRATIFICATION OF OUR POPULATION

    Time frame: 30 months

    All "omic" data will be compared stratifying our population according to:

    • Pathophysiology: discogenic pain, spinal stenosis, facet joint pain, sacroiliac joint pain, low back pain with radicular pain (not predominant radicular pain) and widespread pain.
    • pain intensity
    • response to treatment
    • duration of pain

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Collaborators

  • GENOS
  • Helmholtz Zentrum München
  • Ip Research Consulting Sasu
  • King's College London
  • YURII AULCHENKO

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 16, 2014
Registry last updated
Sep 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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