‘Omics’ biomarkers associated with chronic low back pain: protocol of a retrospective longitudinal study

Abstract

IntroductionChronic low back pain (CLBP) produces considerable direct costs as well as indirect burdens for society, industry and health systems. CLBP is characterised by heterogeneity, inclusion of several pain syndromes, different underlying molecular pathologies and interaction with psychosocial factors that leads to a range of clinical manifestations. There is still much to understand in the underlying pathological processes and the non-psychosocial factors which account for differences in outcomes. Biomarkers that may be objectively used for diagnosis and personalised, targeted and cost-effective treatment are still lacking. Therefore, any data that may be obtained at the ‘-omics’ level (glycomics, Activomics and genome-wide association studies—GWAS) may be helpful to use as dynamic biomarkers for elucidating CLBP pathogenesis and may ultimately provide prognostic information too. By means of a retrospective, observational, case-cohort, multicentre study, we aim to investigate new promising biomarkers potentially able to solve some of the issues related to CLBP.Methods and analysisThe study follows a two-phase, 1:2 case–control model. A total of 12 000 individuals (4000 cases and 8000 controls) will be enrolled; clinical data will be registered, with particular attention to pain characteristics and outcomes of pain treatments. Blood samples will be collected to perform -omics studies. The primary objective is to recognise genetic variants associated with CLBP; secondary objectives are to study glycomics and Activomics profiles associated with CLBP.Ethics and disseminationThe study is part of the PainOMICS project funded by European Community in the Seventh Framework Programme. The study has been approved from competent ethical bodies and copies of approvals were provided to the European Commission before starting the study. Results of the study will be reviewed by the Scientific Board and Ethical Committee of the PainOMICS Consortium. The scientific results will be disseminated through peer-reviewed journals.Trial registration numberNCT02037789; Pre-results.

Validation of standard operating procedures in a multicenter retrospective study to identify -omics biomarkers for chronic low back pain

“…Indeedthe study details were already published in our first manuscript[12] underling how it was important to adopt the technically sound and standardized procedures (an harmonisation of the procedures from collecting, handling, shipping to, finally, analysing of each samples)to get the best result in a large number of the patient’ samples managed in all the Centres participating in this study.…”

Defining the genetic control of human blood plasma N-glycome using genome-wide association study

“…The PainOR [61] is the University of Parma cohort of patients of a retrospective multicenter study (ClinicalTrials.gov Identifier NCT02037789) part of the PainOMICS project funded by European Community in the Seventh Framework Programme (Project ID: 602736). The primary objective is to recognize genetic variants associated with chronic low back pain (CLBP); secondary objectives are to study glycomics and activomics profiles associated with CLBP.…”

Plasma N-glycome composition associates with chronic low back pain

“…Retrospective plasma samples of CLBP patients and healthy controls (people without acute or CLBP) were collected in several clinical centers in Italy, Belgium and Croatia that are involved in PainOmics project, following previously established and validated protocol for blood sample collection, storage and shipping [30,31] (Table 1). In short, blood for glycomics analysis has been collected into EDTA containing vacutainer tube and mixed well for balanced clotting.…”

“…Volume of 1 mL of plasma after second centrifugation step has been transferred to a clean tube and stored at -80 ˚C or -20 ˚C before further processing. CLBP patients were defined according to previously published criteria [31]: all Caucasian adult patients, referred to participant pain clinics, with pain localized to the column between the costal margins and gluteal fold, with or without symptoms into one or both legs, that was lasting more than 12 weeks. We excluded all patients with an acute episode of LBP, any history of spine tumor or infection or recent (less than 12 months) vertebral fractures, or psychiatric disorders.…”