title: 'Omics' biomarkers associated with chronic low back pain: protocol of a retrospective longitudinal study.
abstract: Chronic 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.
  
  
  
  The 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.
  
  
  
  The 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.
  
  
  
  NCT02037789; Pre-results.
authors: Department of surgical science, University of Parma, Parma, Italy.|Anesthesia Intensive Care and Pain Therapy service, Azienda Ospedaliera Universitaria Parma, Parma, Italy.
authors: Massimo
authors: M
authors: Allegri
authors: Anesthesia, Intensive Care and Pain Therapy, Emergency Department, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
authors: Manuela
authors: 0000-0002-3507-497X
authors: M
authors: De Gregori
authors: Anesthesia, Intensive Care and Pain Therapy, Emergency Department, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
authors: Cristina E
authors: 0000-0001-8642-7168
authors: CE
authors: Minella
authors: Research Department, Service of Biometry & Statistics, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
authors: Catherine
authors: C
authors: Klersy
authors: School of Medical and Health Sciences, Edith Cowan University, Perth, Western Australia, Australia.
authors: Wei
authors: W
authors: Wang
authors: School of Medical and Health Sciences, Edith Cowan University, Perth, Western Australia, Australia.
authors: Moira
authors: M
authors: Sim
authors: Research Unit of Molecular Epidemiology, Helmholtz Zentrum Muenchen, German Research Center for Environmental Health, Neuherberg, Germany.|Institute of Epidemiology II, Helmholtz Zentrum Muenchen, German Research Center for Environmental Health, Neuherberg, Germany.
authors: Christian
authors: C
authors: Gieger
authors: Research Unit of Molecular Epidemiology, Helmholtz Zentrum Muenchen, German Research Center for Environmental Health, Neuherberg, Germany.|Institute of Epidemiology II, Helmholtz Zentrum Muenchen, German Research Center for Environmental Health, Neuherberg, Germany.
authors: Judith
authors: J
authors: Manz
authors: Photeomix, IP Research Consulting SAS, Noisy le Grand, France.
authors: Iain K
authors: IK
authors: Pemberton
authors: Photeomix, IP Research Consulting SAS, Noisy le Grand, France.
authors: Jane
authors: J
authors: MacDougall
authors: Department of Twin Research and Genetic Epidemiology, King's College London, London, UK.
authors: Frances Mk
authors: FM
authors: Williams
authors: Department of Anesthesiology, Critical Care and Multidisciplinary Pain Center, Ziekenhuis Oost-Limburg, Genk, Belgium.
authors: Jan
authors: J
authors: Van Zundert
authors: Department of Anesthesiology, Critical Care and Multidisciplinary Pain Center, Ziekenhuis Oost-Limburg, Genk, Belgium.
authors: Klaas
authors: K
authors: Buyse
authors: Genos Glycoscience Research Laboratory, Zagreb, Croatia.
authors: Gordan
authors: G
authors: Lauc
authors: Genos Glycoscience Research Laboratory, Zagreb, Croatia.
authors: Ivan
authors: I
authors: Gudelj
authors: St. Catherine Specialty Hospital, Zabok, Croatia.|Eberly College of Science, State College, Penn State University, Pennsylvania, USA.|Faculty of Medicine, University of Osijek, Osijek, Croatia.|University of Split School of Medicine, Split, Croatia.|Children's Hospital Srebrnjak, Zagreb, Croatia.
authors: Dragan
authors: D
authors: Primorac
authors: Genos Glycoscience Research Laboratory, Zagreb, Croatia.|St. Catherine Specialty Hospital, Zabok, Croatia.
authors: Andrea
authors: A
authors: Skelin
authors: PolyOmica, Groningen, The Netherlands.
authors: Yurii S
authors: YS
authors: Aulchenko
authors: PolyOmica, Groningen, The Netherlands.
authors: Lennart C
authors: LC
authors: Karssen
authors: Carolinas Pain Institute, Winston-Salem, North Carolina, USA.
authors: Leonardo
authors: L
authors: Kapural
authors: Carolinas Pain Institute, Winston-Salem, North Carolina, USA.
authors: Richard
authors: R
authors: Rauck
authors: Department of surgical science, University of Parma, Parma, Italy.|Anesthesia Intensive Care and Pain Therapy service, Azienda Ospedaliera Universitaria Parma, Parma, Italy.
authors: Guido
authors: G
authors: Fanelli
mesh_terms: D015415:Biomarkers / Q000378:metabolism*; D016022:Case-Control Studies; D059350:Chronic Pain / Q000097:blood / Q000453:epidemiology / Q000235:genetics* / Q000503:physiopathology; D005260:Female; D055106:Genome-Wide Association Study; D054794:Glycomics; D006801:Humans; D008137:Longitudinal Studies; D017116:Low Back Pain / Q000097:blood / Q000453:epidemiology / Q000235:genetics* / Q000503:physiopathology; D008297:Male; D010147:Pain Measurement; D015203:Reproducibility of Results; D012189:Retrospective Studies
chemical_list: D015415:Biomarkers
keywords: ACTIVOMICS; CHRONIC LOW BACK PAIN; GENOME-WIDE ASSOCIATION STUDY; GLYCOMICS