A Retrospective Study to Identify New "Omics" Biomarkers of Chronic/Persistent Low Back Pain
- Conditions
- Persistent/Chronic Low Back Pain
- Registration Number
- NCT02037789
- Lead Sponsor
- University of Parma
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method GENETIC OUTCOME 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 Outcome Measures
Name Time Method STRATIFICATION OF OUR POPULATION 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 painGLYCOMIC AND ACTIVOMIC OUTCOME 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.
Trial Locations
- Locations (6)
The Center for Clinical Research (CPI)
🇺🇸Winston-salem, North Carolina, United States
Edith Cowan University (ECU)
🇦🇺Perth, Australia
Fondazione IRCCS Policlinico San Matteo (OSM)
🇮🇹Pavia, Italy
Anesthesia and Pain Therapy Department, Università degli Studi di Parma (UNIPR)
🇮🇹Parma, Italy
"St.Catharine" Orthopedics, Surgery, Neurology and Physical Medicine and Rehabilitation Specialty Hospital (St-Cat)
🇭🇷Zabok, Croatia
Multidisciplinary Pain Centre, Hospital Oost-Limburg (ZOL)
🇧🇪Genk, Belgium