A Prospective Trial to Identify Biomarkers Involved in the Transition From Acute to Persistent Chronic Low Back Pain
Status unconfirmed
Conditions studied: Acute Low Back Pain, Chronic Low Back Pain
In brief
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).
Key facts
- Study ID
- NCT02037763
- Run by
- University of Parma
- People needed
- 5000
- Starts
- 2014-12-01
- Expected to finish
- 2018-08-01
- Last updated by the study team
- 2016-09-26
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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;
Where it is running
- The Center for Clinical Research (CPI) — Winston-Salem, North Carolina, United States (enrolling)
- Edith Cowan University (ECU) — Perth, Australia (enrolling)
- Multidisciplinary Pain Centre, Hospital Oost-Limburg (ZOL) — Genk, Belgium (enrolling)
- "St.Catharine" Orthopedics, Surgery, Neurology and Physical Medicine and Rehabilitation Specialty Hospital (St-Cat) — Zabok, Croatia (enrolling)
- Anesthesia and Pain Therapy Department, Università degli Studi di Parma (UNIPR) — Parma, Italy (enrolling)
- Fondazione IRCCS Policlinico San Matteo (OSM) — Pavia, Italy (enrolling)
- King's College London (KCL) — London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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