Recruiting

Biomarkers

Sponsor:

University of Parma

Code:

NCT02037763

Conditions

Acute Low Back Pain

Chronic Low Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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

Study ID

NCT02037763

Start date

Dec, 2014

Status verified date

Sep, 2016

Completion date

Aug, 2018

Anticipated

Primary completion date

Aug, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • age: older than 18;
  • acute episode of pain between the costal margins and gluteal fold, with or without symptoms into one or both legs lasting less than 6 weeks;
  • written informed consent signed;
  • Caucasian ancestry

Exclusion Criteria:

  • evidence of clinically unstable disease;
  • severe psychiatric disorder (excluding mild depression) or mental impairment;
  • history (in the last 6 months) of persistent chronic low back pain or acute LBP episodes
  • recent history (< 1 year) of spinal fracture;
  • pain in the back due to spinal tumor or infection;
  • pregnancy;

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Genetic outcome [ Time Frame: 54 months ]

Central Contacts and Locations

Central contacts

MASSIMO ALLEGRI, MD

mallegri@parmanesthesia.com

Locations

The Center for Clinical Research (CPI)

Recruiting

Winston-Salem, North Carolina, United States

Principal Investigator:

LEONARDO KAPURAL, MD

More Information

Sponsor

University of Parma

Last update posted

Sep 26, 2016

Last verified

Sep, 2016

Keywords

  • Low back pain
  • GWAS
  • Glycomics
  • Activomics
  • Epigenetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Parma on 2016-09-26.