M. Allegri, Universita degli Studi di Parma, Parma, Italy
Manuela De Gregori, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
Cristina E. Minella, Fondazione IRCCS Policlinico San Matteo
Catherine Klersy, Fondazione IRCCS Policlinico San Matteo
Wei Wang, Edith Cowan UniversityFollow
Moira G. Sim, Edith Cowan UniversityFollow
Christian Gieger, Helmholtz Center Munich German Research Center for Environmental Health
Judith Manz, Helmholtz Center Munich German Research Center for Environmental Health
Iain K. Pemberton, IP Research Consulting SAS, Noisy-le-Grand, France
Jane MacDougall, IP Research Consulting SAS, Noisy-le-Grand, France
Frances M. Williams, Guy's and St Thomas' NHS Foundation Trust, Twin Research and Genetic Epidemiology Unit, London
Jan Van Zundert, Maastricht University
Klaas Buyse, Ziekenhuis Oost-Limburg, Department of Anesthesiology, Genk, Belgium
Gordan Lauc, Genos Glycoscience Research Laboratory, Zagreb, Croatia
Ivan Gudelj, Genos Glycoscience Research Laboratory, Zagreb, Croatia
Dragan Primorac, Pennsylvania State University
Andrea Skelin, St. Catherine Specialty Hospital, , Croatia
Yurii S. Aulchenko, Institute of Cytology and Genetics, Siberian Branch, Russian Academy of Sciences
Lennart C. Karssen, PolyOmica, Groningen, Netherlands
Leonardo Kapural, Carolinas Pain Institute and Center for Clinical Research, Winston Salem, United States
Richard L. Rauck, Carolinas Pain Institute, Winston Salem, United States
Guido Fanelli, Azienda Ospedaliero - Universitaria di Parma, 2nd Department of Anesthesia, Parma, Italy

Document Type

Journal Article


BMJ Publishing Group

Place of Publication

United Kingdom


School of Medical and Health Sciences




European Commission - Seventh Framework Programme of the European Community for Research, Technological Development and Demonstration Activities—(FP7)—THEME (HEALTH.2013.2.2.1-5—Understanding and controlling pain)


Allegri, M., De Gregori, M., Minella, C. E., Klersy, C., Wang, W., Sim, M., ... & Fanelli, G. (2016). ‘Omics’ biomarkers associated with chronic low back pain: protocol of a retrospective longitudinal study. BMJ open, 6(10), e012070.



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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

NCT02037789; Pre-results.



Creative Commons License

Creative Commons Attribution-Noncommercial 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License