A Retrospective Study to Identify New "Omics" Biomarkers of Chronic/Persistent Low Back Pain

NCT02037789 | Completed DMC

• 1 other identifier: Pain-OMICS RT
• Study Type: observational
• Target: N/A
• Locations: 5 countries
• Sites: 6

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.

Conditions

Persistent/Chronic Low Back Pain

Keywords

pain; low back pain; GWAS; glycomics; activomics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• GLYCOMIC AND ACTIVOMIC OUTCOME

  30 months

• STRATIFICATION OF OUR POPULATION

  30 months

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cases will be collected at each participating centre. Every effort will be made to accumulate a well phenotyped cohort of patients with persistent CLBP, sub-grouped into 6 categories: discogenic pain, spinal stenosis (congenital or acquired), facet joint pain, sacroiliac joint pain, low back pain with radicular pain (not predominant radicular pain) and widespread low back pain. Controls (patients without chronic/persistent pain as defined above) will be retrieved from 2 different sources: Existing biobanks of healthy subjects which have collected information about chronic/persistent back pain. Subjects from the companion prospective study on acute LBP who will not have developed CLBP. Age (decades) and gender distribution of controls will be similar to cases.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Parma: lead
• GENOS: collaborator
• Ip Research Consulting Sasu: collaborator
• Helmholtz Zentrum München: collaborator
• YURII AULCHENKO: collaborator
• King's College London: collaborator

Study Sites (6)

The Center for Clinical Research (CPI)

Winston-Salem, North Carolina, United States

Location

Edith Cowan University (ECU)

Perth, Australia

Location

Multidisciplinary Pain Centre, Hospital Oost-Limburg (ZOL)

Genk, Belgium

Location

"St.Catharine" Orthopedics, Surgery, Neurology and Physical Medicine and Rehabilitation Specialty Hospital (St-Cat)

Zabok, Croatia

Location

Anesthesia and Pain Therapy Department, Università degli Studi di Parma (UNIPR)

Parma, Italy

Location

Fondazione IRCCS Policlinico San Matteo (OSM)

Pavia, Italy

Location

Related Publications (1)

• Allegri M, De Gregori M, Minella CE, Klersy C, Wang W, Sim M, Gieger C, Manz J, Pemberton IK, MacDougall J, Williams FM, Van Zundert J, Buyse K, Lauc G, Gudelj I, Primorac D, Skelin A, Aulchenko YS, Karssen LC, Kapural L, Rauck R, Fanelli G; PainOMICS Group. 'Omics' biomarkers associated with chronic low back pain: protocol of a retrospective longitudinal study. BMJ Open. 2016 Oct 19;6(10):e012070. doi: 10.1136/bmjopen-2016-012070.

  PMID: 27798002 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples will be collected from cases (patients already diagnosed with persistent/chronic low back pain) and from controls (healthy subjects).

MeSH Terms

Conditions

Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Study Officials

• MASSIMO ALLEGRI, MD

  Fondazione IRCCS Policlinico San Matteo di Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 16, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: September 26, 2016

Record last verified: 2016-09

Locations

CR (1); AU (1); BE (1); US (1); IT (2)