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'Omics' biomarkers associated with chronic low back pain: protocol of a retrospective longitudinal study.

ABSTRACT: INTRODUCTION: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.

SUBMITTER: Allegri M

PROVIDER: S-EPMC5073566 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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'Omics' biomarkers associated with chronic low back pain: protocol of a retrospective longitudinal study.

Allegri Massimo M De Gregori Manuela M Minella Cristina E CE Klersy Catherine C Wang Wei W Sim Moira M Gieger Christian C Manz Judith J Pemberton Iain K IK MacDougall Jane J Williams Frances Mk FM Van Zundert Jan J Buyse Klaas K Lauc Gordan G Gudelj Ivan I Primorac Dragan D Skelin Andrea A Aulchenko Yurii S YS Karssen Lennart C LC Kapural Leonardo L Rauck Richard R Fanelli Guido G

BMJ open 20161019 10

<h4>Introduction</h4>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 differe ...[more]

PMID: 27798002

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Project description:BackgroundSelf-management (SM) is a key recommended strategy for managing chronic low back pain (CLBP). However, SM programmes generate small to moderate benefits for reducing pain and disability in patients with CLBP. The benefits of the SM programme can potentially be optimised by identifying specific subgroups of patients who are the best responders. To date, no longitudinal study has examined the predictive relationships between SM and biopsychosocial factors in patients with CLBP. The aim was to determine whether biopsychosocial factors predict SM and its change over time in patients with CLBP.MethodsIn this multi-centre longitudinal cohort study, we recruited 270 working-age patients with CLBP (mean age 43.74, 61% female) who consulted outpatient physiotherapy for their CLBP. Participants completed self-reported validated measures of pain intensity, disability, physical activity, kinesiophobia, catastrophising, depression and SM at baseline and six months. SM constructs were measured using eight subscales of the Health Education Impact Questionnaire (heiQ), including Health Directed Activity (HDA), Positive and Active Engagement in Life (PAEL), Emotional Distress (ED), Self-Monitoring and Insight (SMI), Constructive Attitudes and Approaches (CAA), Skill and Technique Acquisition (STA), Social Integration and Support (SIS) and Health Service Navigation (HSN). Data were analysed using General Linear Model (GLM) regression.ResultsPhysical activity and healthcare use (positively) and disability, depression, kinesiophobia, catastrophising (negatively) predicted (p < 0.05, R2 0.07-0.55) SM constructs at baseline in patients with CLBP. Baseline depression (constructs: PAEL, ED, SMI, CAA and STA), kinesiophobia (constructs: CAA and HSN), catastrophising (construct: ED), and physical disability (constructs: PAEL, CAA and SIS) negatively predicted a range of SM constructs. Changes over six months in SM constructs were predicted by changes in depression, kinesiophobia, catastrophising, and physical activity (p < 0.05, R2 0.13-0.32).ConclusionsSelf-reported disability, physical activity, depression, catastrophising and kinesiophobia predicted multiple constructs of SM measured using the heiQ subscales in working-age patients with CLBP. Knowledge of biopsychosocial predictors of SM may help triage patients with CLBP into targeted pain management programmes.Trial registrationThe study protocol was registered at ClinicalTrials.gov on 22 December 2015 (ID: NCT02636777).

Project description:Chronic back pain is a major public health problem and the primary reason patients seek acupuncture treatment. Therefore, an objective assessment of acupuncture efficacy is critical for making informed decisions about its appropriate role for patients with this common condition. This study addresses methodological shortcomings that have plagued previous studies evaluating acupuncture for chronic low back pain.A total of 640 participants (160 in each of four arms) between the ages of 18 and 70 years of age who have low back pain lasting at least 3 months will be recruited from integrated health care delivery systems in Seattle and Oakland. They will be randomized to one of two forms of Traditional Chinese Medical (TCM) acupuncture needling (individualized or standardized), a "control" group (simulated acupuncture), or to continued usual medical care. Ten treatments will be provided over 7 weeks. Study participants and the "Diagnostician" acupuncturists who evaluate participants and propose individualized treatments will be masked to the acupuncture treatment actually assigned each participant. The "Therapist" acupuncturists providing the treatments will not be masked but will have limited verbal interaction with participants. The primary outcomes, standard measures of dysfunction and bothersomeness of low back pain, will be assessed at baseline, and after 8, 26, and 52 weeks by telephone interviewers masked to treatment assignment. General health status, satisfaction with back care, days of back-related disability, and use and costs of healthcare services for back pain will also be measured. The primary analysis comparing outcomes by randomized treatment assignment will be analysis of covariance adjusted for baseline value. For both primary outcome measures, this trial will have 99% power to detect the presence of a minimal clinically significant difference among all four treatment groups and over 80% power for most pairwise comparisons. Secondary analyses will compare the proportions of participants in each group that improve by a clinically meaningful amount.Results of this trial will help clarify the value of acupuncture needling as a treatment for chronic low back pain.Clinical Trials.gov NCT00065585.

Project description:BackgroundThere are few longitudinal cohort studies examining associations between incident MRI findings and incident spine-related symptom outcomes. Prior studies do not discriminate between the two distinct outcomes of low back pain (LBP) and radicular symptoms. To address this gap in the literature, we conducted a secondary analysis of existing data from the Longitudinal Assessment of Imaging and Disability of the Back (LAIDBACK). The purpose of this study was to examine the association of incident lumbar MRI findings with two specific spine-related symptom outcomes: 1) incident chronic bothersome LBP, and 2) incident radicular symptoms such as pain, weakness, or sensation alterations in the lower extremity.MethodsThe original LAIDBACK study followed 123 participants without current LBP or sciatica, administering standardized MRI assessments of the lumbar spine at baseline and at 3-year follow-up, and collecting information on participant-reported spine-related symptoms and signs every 4 months for 3 years. These analyses examined bivariable and multivariable associations between incident MRI findings and symptom outcomes (LBP and radicular symptoms) using logistic regression.ResultsThree-year cumulative incidence of new MRI findings ranged between 2 and 8%, depending on the finding. Incident annular fissures were associated with incident chronic LBP, after adjustment for prior back pain and depression (adjusted odds ratio [OR] 6.6; 95% confidence interval [CI] 1.2-36.9). All participants with incident disc extrusions (OR 5.4) and nerve root impingement (OR 4.1) reported incident radicular symptoms, although associations were not statistically significant. No other incident MRI findings showed large magnitude associations with symptoms.ConclusionsEven when applying more specific definitions for spine-related symptom outcomes, few MRI findings showed large magnitude associations with symptom outcomes. Although incident annular fissures, disc extrusions, and nerve root impingement were associated with incident symptom outcomes, the 3-year incidence of these MRI findings was extremely low, and did not explain the vast majority of incident symptom cases.

Project description:BackgroundChronic low back pain (cLBP) is a complex with a heterogenous clinical presentation. A better understanding of the factors that contribute to cLBP is needed for accurate diagnosis, optimal treatment, and identification of mechanistic targets for new therapies. The Back Pain Consortium (BACPAC) Research Program provides a unique opportunity in this regard, as it will generate large clinical datasets, including a diverse set of harmonized measurements. The Theoretical Model Working Group was established to guide BACPAC research and to organize new knowledge within a mechanistic framework. This article summarizes the initial work of the Theoretical Model Working Group. It includes a three-stage integration of expert opinion and an umbrella literature review of factors that affect cLBP severity and chronicity.MethodsDuring Stage 1, experts from across BACPAC established a taxonomy for risk and prognostic factors (RPFs) and preliminary graphical depictions. During Stage 2, a separate team conducted a literature review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to establish working definitions, associated data elements, and overall strength of evidence for identified RPFs. These were subsequently integrated with expert opinion during Stage 3.ResultsThe majority (∼80%) of RPFs had little strength-of-evidence confidence, whereas seven factors had substantial confidence for either a positive association with cLBP (pain-related anxiety, serum C-reactive protein, diabetes, and anticipatory/compensatory postural adjustments) or no association with cLBP (serum interleukin 1-beta / interleukin 6, transversus muscle morphology/activity, and quantitative sensory testing).ConclusionThis theoretical perspective will evolve over time as BACPAC investigators link empirical results to theory, challenge current ideas of the biopsychosocial model, and use a systems approach to develop tools and algorithms that disentangle the dynamic interactions among cLBP factors.

Dataset Information

'Omics' biomarkers associated with chronic low back pain: protocol of a retrospective longitudinal study.

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'Omics' biomarkers associated with chronic low back pain: protocol of a retrospective longitudinal study.

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