Persistent/Chronic Low Back Pain Clinical Trial
Official title:
A Retrospective Study to Identify New "Omics" Biomarkers of Chronic/Persistent Low Back Pain
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | February 2016 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 99 Years |
| Eligibility |
Inclusion Criteria of patients with persistent CLBP: - age: older than 18; - chronic/persistent pain (pain lasting longer than 12 weeks) between the costal margins and gluteal fold, with or without symptoms into one or both legs - written informed consent signed; - Caucasian ancestry Inclusion Criteria of healthy volunteers: - age: older than 18; - without any chronic/persistent pain (pain lasting longer than 12 weeks) in the last one year; - written informed consent signed; - Caucasian ancestry Exclusion Criteria: - 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 |
Observational Model: Case Control, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Australia | Edith Cowan University (ECU) | Perth | |
| Belgium | Multidisciplinary Pain Centre, Hospital Oost-Limburg (ZOL) | Genk | |
| Croatia | "St.Catharine" Orthopedics, Surgery, Neurology and Physical Medicine and Rehabilitation Specialty Hospital (St-Cat) | Zabok | |
| Italy | Anesthesia and Pain Therapy Department, Università degli Studi di Parma (UNIPR) | Parma | |
| Italy | Fondazione IRCCS Policlinico San Matteo (OSM) | Pavia | |
| United States | The Center for Clinical Research (CPI) | Winston-salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| University of Parma | GENOS DOO, Helmholtz Zentrum München, Ip Research Consulting Sasu, King's College London, YURII AULCHENKO |
United States, Australia, Belgium, Croatia, Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | GENETIC OUTCOME | 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. | 30 months | No |
| Secondary | GLYCOMIC AND ACTIVOMIC OUTCOME | 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. | 30 months | No |
| Secondary | STRATIFICATION OF OUR POPULATION | 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 pain |
30 months | No |