Allegri Massimo, De Gregori Manuela, Minella Cristina E, Klersy Catherine, Wang Wei, Sim Moira, Gieger Christian, Manz Judith, Pemberton Iain K, MacDougall Jane, Williams Frances Mk, Van Zundert Jan, Buyse Klaas, Lauc Gordan, Gudelj Ivan, Primorac Dragan, Skelin Andrea, Aulchenko Yurii S, Karssen Lennart C, Kapural Leonardo, Rauck Richard, Fanelli Guido
Department of surgical science, University of Parma, Parma, Italy.
Anesthesia Intensive Care and Pain Therapy service, Azienda Ospedaliera Universitaria Parma, Parma, Italy.
BMJ Open. 2016 Oct 19;6(10):e012070. doi: 10.1136/bmjopen-2016-012070.
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.
慢性下腰痛（CLBP）给社会、行业和卫生系统带来了可观的直接成本以及间接负担。CLBP具有异质性，包含多种疼痛综合征、不同的潜在分子病理学以及与心理社会因素的相互作用，导致了一系列临床表现。在潜在病理过程以及导致结果差异的非心理社会因素方面，仍有许多需要了解的地方。目前仍缺乏可客观用于诊断以及个性化、靶向性和具有成本效益治疗的生物标志物。因此，在“组学”水平（糖组学、活性组学和全基因组关联研究-GWAS）获得的任何数据，可能有助于用作动态生物标志物来阐明CLBP的发病机制，最终也可能提供预后信息。通过一项回顾性、观察性、病例队列、多中心研究，我们旨在研究可能有助于解决一些与CLBP相关问题的新的有前景的生物标志物。
本研究采用两阶段1:2病例对照模型。总共将招募12000名个体（4000例病例和8000名对照）；将记录临床数据，特别关注疼痛特征和疼痛治疗结果。将采集血样进行组学研究。主要目标是识别与CLBP相关的基因变异；次要目标是研究与CLBP相关的糖组学和活性组学特征。
本研究是由欧洲共同体在第七框架计划资助的PainOMICS项目的一部分。该研究已获得主管伦理机构的批准，并在研究开始前向欧盟委员会提供了批准文件副本。研究结果将由PainOMICS联盟的科学委员会和伦理委员会进行审查。科学结果将通过同行评审期刊进行传播。
NCT02037789；预结果。
