A Prospective Trial to Identify Biomarkers Involved in the Transition From Acute to Persistent Chronic Low Back Pain
Unknown statusNCT02037763
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- A Prospective Controlled Trial to Identify Biomarkers Involved in the Transition From Acute to Persistent Chronic Low Back Pain
- Conditions
- Acute Low Back Pain
- Chronic Low Back Pain
- Sponsor
- University of Parma
- Collaborators
- GENOS; Ip Research Consulting Sasu; Helmholtz Zentrum München; YURII AULCHENKO; King's College London
- Start date
- 2014-12
- Primary completion
- 2018-08
- Sex
- All
- Age range
- from 18 Years to 99 Years
- Results posted
- No results posted in this snapshot
- Countries
- Australia, Belgium, Croatia, Italy, United Kingdom, United States
- Total sites listed
- 7
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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;
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02037763