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A Prospective Trial to Identify Biomarkers Involved in the Transition From Acute to Persistent Chronic Low Back Pain

NCT02037763 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2016-09-26

No results posted yet for this study

Summary

This is a prospective observational cohort multinational clinical study. There are no biomarkers to help predict in which patients acute low back pain (LBP) will transform into chronic low back pain (CLBP). Human variability and different common comorbidities complicate the picture and make stratification of patients into correct subgroups difficult. However, drugs act by targeting specific molecular pathways and are therefore efficient only in a subgroup of patients sharing common molecular pathology and common genetics. Both CLBP and disc degeneration are known to be heritable. Little investigation has taken place for genetic variants in CLBP. The main aim of this trial is to identify "omics biomarkers" associated with the transition from acute (single episode of low back pain) to persistent/chronic LBP (pain lasting more than 12 weeks).

Conditions

  • Acute Low Back Pain
  • Chronic Low Back Pain

Sponsors & Collaborators

  • GENOS

    collaborator OTHER

  • Ip Research Consulting Sasu

    collaborator INDUSTRY

  • Helmholtz Zentrum München

    collaborator INDUSTRY

  • YURII AULCHENKO

    collaborator UNKNOWN

  • King's College London

    collaborator OTHER

  • University of Parma

    lead OTHER

Principal Investigators

  • MASSIMO ALLEGRI, MD · Pain Therapy Service Azienda Ospedaliera Universitaria Parma Italy

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United States
  • Australia
  • Belgium
  • Croatia
  • Italy
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02037763 on ClinicalTrials.gov