Evidence-Based Management for Low Back Pain : Quality, Mechanisms and Reporting

Use of the best available evidence is fundamental to provide high-value care for people with low back pain. However, the global burden of low back pain continues to rise, partly attributable to low-value and mismanaged healthcare. The findings from this thesis have provided new data on the quality, mechanisms and reporting of research evidence that informs the care provided to people with low back pain. Chapter Two provided evidence that muscle relaxant medicines, considered first-line pharmacological care by the American College of Physicians guideline, do not provide clinically important improvements in pain and function and are associated with increased risk of experiencing an adverse event in adults with low back pain. Chapter Three and Four highlighted the need and provided recommendations for improved methodological quality and reporting of randomised controlled trials investigating physiotherapy treatments in low back pain. Chapter Five showed that the policies of 10 leading pain journals do not support transparent and open communication of pain research. These findings led to an update in the policies of a leading pain journal. Chapter Six identified how patient education, recommended first-line non-pharmacological care for low back pain, can be adapted to produce clinically important improvements in function. Chapter Seven found suboptimal reporting and methodological limitations in studies conducting mediation analysis in health research. This finding provided evidence for the need to develop a specific reporting guideline for studies conducting mediation analyses. Chapters Eight and Nine describe the development of a guideline for reporting mediation analyses, including a checklist of reporting items derived from an international Delphi exercise. This program of work provides new evidence to improve the evidence-based management of low back pain relating to quality, mechanisms and reporting. The implications for future research and clinical practice are discussed. Through the conscious and judicious use of the best available evidence, we can improve the care, and ultimately the lives of people with low back pain

Consumer understanding of terms used in imaging reports requested for low back pain: a cross-sectional survey

OBJECTIVES: To investigate (1) self-reported societal comprehension of common and usually non-serious terms found in lumbar spine imaging reports and (2) its relationship to perceived seriousness, likely persistence of low back pain (LBP), fear of movement, back beliefs and history and intensity of LBP. DESIGN: Cross-sectional online survey of the general public. SETTING: Five English-speaking countries: UK, USA, Canada, New Zealand and Australia. PARTICIPANTS: Adults (age >18 years) with or without a history of LBP recruited in April 2019 with quotas for country, age and gender. PRIMARY AND SECONDARY OUTCOME MEASURES: Self-reported understanding of 14 terms (annular fissure, disc bulge, disc degeneration, disc extrusion, disc height loss, disc protrusion, disc signal loss, facet joint degeneration, high intensity zone, mild canal stenosis, Modic changes, nerve root contact, spondylolisthesis and spondylosis) commonly found in lumbar spine imaging reports. For each term, we also elicited worry about its seriousness, and whether its presence would indicate pain persistence and prompt fear of movement. RESULTS: From 774 responses, we included 677 (87.5%) with complete and valid responses. 577 (85%) participants had a current or past history of LBP of whom 251 (44%) had received lumbar spine imaging. Self-reported understanding of all terms was poor. At best, 235 (35%) reported understanding the term ‘disc degeneration’, while only 71 (10.5%) reported understanding the term ‘Modic changes’. For all terms, a moderate to large proportion of participants (range 59%–71%), considered they indicated a serious back problem, that pain might persist (range 52%–71%) and they would be fearful of movement (range 42%–57%). CONCLUSION: Common and usually non-serious terms in lumbar spine imaging reports are poorly understood by the general population and may contribute to the burden of LBP. TRIAL REGISTRATION NUMBER: ACTRN12619000545167

Is there a causal relationship between acute stage sensorimotor cortex activity and the development of chronic low back pain? : a protocol and statistical analysis plan

Introduction: Why some people develop chronic pain following an acute episode of low back pain is unknown. Recent cross-sectional studies have suggested a relationship between aberrant sensorimotor cortex activity and pain persistence. The UPWaRD (Understanding persistent Pain Where it ResiDes) cohort study is the first prospective, longitudinal investigation of sensorimotor cortex activity in low back pain. This paper describes the development of a causal model and statistical analysis plan for investigating the causal effect of sensorimotor cortex activity on the development of chronic low back pain. Methods and analysis: Sensorimotor cortex activity was assessed within 6 weeks of low back pain onset using somatosensory evoked potentials and transcranial magnetic stimulation mapping techniques. Chronic low back pain is defined as ongoing pain (Numerical Rating score ≥1) or disability (Roland Morris Disability Questionnaire score ≥3) at 6 months follow-up. Variables that could confound the relationship between sensorimotor cortex activity and chronic low back pain were identified using a directed acyclic graph and content expertise was used to specify known causal paths. The statistical model was developed ‘a priori’ to control for confounding variables identified in the directed acyclic graph, allowing an unbiased estimate of the causal effect of sensorimotor activity in acute low back pain on the development of chronic pain. The statistical analysis plan was finalised prior to follow-up of all participants and initiation of analysis. Ethics and dissemination: Ethical approval has been obtained from Western Sydney University Human Research Ethics Committee (H10465) and from Neuroscience Research Australia (SSA: 16/002). Dissemination will occur through presentations at national and international conferences and publications in international peer-reviewed journals. Trial registration number: ACTRN12619000002189 (retrospectively registered)

Development of recommendations for a minimum dataset for Identifying Social factors that Stratify Health Opportunities and Outcomes (ISSHOOs) in pain research

There is increasing recognition of the need for researchers to collect and report data that can illuminate health inequities. In pain research, routinely collecting equity-relevant data has the potential to inform about the generalisability of findings; whether the intervention has differential effects across strata of society; or it could be used to guide population targeting for clinical studies. Developing clarity and consensus on what data should be collected and how to collect it is required to prompt researchers to further consider equity issues in the planning, conduct, interpretation, and reporting of research. The overarching aim of the 'Identifying Social Factors that Stratify Health Opportunities and Outcomes' (ISSHOOs) in pain research project is to provide researchers in the pain field with recommendations to guide the routine collection of equity-relevant data. The design of this project is consistent with the methods outlined in the 'Guidance for Developers of Health Research Reporting Guidelines' and involves 4 stages: (i) Scoping review; (ii) Delphi Study; (iii) Consensus Meeting; and (iv) Focus Groups. This stakeholder-engaged project will produce a minimum dataset that has global, expert consensus. Results will be disseminated along with explanation and elaboration as a crucial step towards facilitating future action to address avoidable disparities in pain outcomes. </p

Development of recommendations for a minimum dataset for Identifying Social factors that Stratify Health Opportunities and Outcomes (ISSHOOs) in pain research

There is increasing recognition of the need for researchers to collect and report data that can illuminate health inequities. In pain research, routinely collecting equity-relevant data has the potential to inform about the generalisability of findings; whether the intervention has differential effects across strata of society; or it could be used to guide population targeting for clinical studies. Developing clarity and consensus on what data should be collected and how to collect it is required to prompt researchers to further consider equity issues in the planning, conduct, interpretation, and reporting of research. The overarching aim of the 'Identifying Social Factors that Stratify Health Opportunities and Outcomes' (ISSHOOs) in pain research project is to provide researchers in the pain field with recommendations to guide the routine collection of equity-relevant data. The design of this project is consistent with the methods outlined in the 'Guidance for Developers of Health Research Reporting Guidelines' and involves 4 stages: (i) Scoping review; (ii) Delphi Study; (iii) Consensus Meeting; and (iv) Focus Groups. This stakeholder-engaged project will produce a minimum dataset that has global, expert consensus. Results will be disseminated along with explanation and elaboration as a crucial step towards facilitating future action to address avoidable disparities in pain outcomes. </p

It\u27s safe to move! A protocol for a randomised controlled trial investigating the effect of a video designed to increase people\u27s confidence becoming more active despite back pain

Introduction Social media provide promising contemporary platforms for sharing public health information with a broad audience. Before implementation, testing social media campaigns that are intended to engage audiences and initiate behaviour change is necessary. This trial aims to investigate the effectiveness of a public health campaign to increase people\u27s confidence in becoming more active despite low back pain in comparison with no intervention. Methods and analysis This is an online randomised controlled trial with two intervention groups and one control group in a 1:1:1 allocation. People over 18 years of age and fluent in English will be recruited via social media advertising. We developed a social media-based public health campaign to support recommendations for managing low back pain. The interventions are two videos. Participants in the control group will be asked questions about low back pain but will not view either video intervention. The primary outcome will be item 10 of the Pain Self-Efficacy Questionnaire, which asks participants to rate how confident they would feel to gradually become more active despite pain ranging from 0 (not at all confident) to 6 (completely confident). This outcome will be measured immediately in all participant groups. We will compare group mean of the three arms of the trial using univariate analyses of variance. Ethics and dissemination This trial has been prospectively registered with the Australian New Zealand Clinical Trials Registry. We obtained ethical approval from our institutions Human Research Ethics Committee before data collection. We will publish the results in a peer-reviewed medical journal and on institution websites

Pain catastrophising and kinesiophobia mediate pain and physical function improvements with Pilates exercise in chronic low back pain::a mediation analysis of a randomised controlled trial

How much are the reductions in pain intensity and improvements in physical function from Pilates exercise mediated by changes in pain catastrophising and kinesiophobia? This was a secondary causal mediation analysis of a four-arm randomised controlled trial testing Pilates exercise dosage (once, twice or thrice per week) against a booklet control. Two hundred and fifty-five people with chronic low back pain. All analyses were conducted in R software (version 4.1.2) following a preregistered analysis plan. A directed acyclic graph was constructed to identify potential pre-treatment mediator-outcome confounders. For each mediator model, we estimated the intervention-mediator effect, the mediator-outcome effect, the total natural indirect effect (TNIE), the pure natural direct effect (PNDE), and the total effect (TE). Pain catastrophising mediated the effect of Pilates exercise compared with control on the outcomes pain intensity (TNIE MD -0.21, 95% CI -0.47 to -0.03) and physical function (TNIE MD -0.64, 95% CI -1.20 to -0.18). Kinesiophobia mediated the effect of Pilates exercise compared with control on the outcomes pain intensity (TNIE MD -0.31, 95% CI -0.68 to -0.02) and physical function (TNIE MD -1.06, 95% CI -1.70 to -0.49). The proportion mediated by each mediator was moderate (21 to 55%). Reductions in pain catastrophising and kinesiophobia partially mediated the pathway to improved pain intensity and physical function when using Pilates exercise for chronic low back pain. These psychological components may be important treatment targets for clinicians and researchers to consider when prescribing exercise for chronic low back pain. [Abstract copyright: Copyright © 2023 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

Development and measurement properties of the AxEL (attitude toward education and advice for low-back-pain) questionnaire

Introduction: Clinician time and resources may be underutilised if the treatment they offer does not match patient expectations and attitudes. We developed a questionnaire (AxEL-Q) to guide clinicians toward elements of first-line care that are pertinent to their patients with low back pain. Methods: We used guidance from the COSMIN consortium to develop the questionnaire and evaluated it in a sample of people with low back pain of any duration. Participants were recruited from the community, were over 18 years and fluent in English. Statements that represented first-line care were identified. Semantic scales were used to measure attitude towards these statements. These items were combined to develop the questionnaire draft. Construct validity was evaluated with exploratory factor analysis and hypotheses testing, comparing to the Back Beliefs Questionnaire and modified Pain Self-Efficacy Questionnaire. Reliability was evaluated and floor and ceiling effects calculated. Results: We recruited 345 participants, and had complete data for analysis for 313 participants. The questionnaire draft was reduced to a 3-Factor questionnaire through exploratory factor analysis. Factor 1 comprised 9 items and evaluated Attitude toward staying active, Factor 2 comprised 4 items and evaluated Attitude toward low back pain being rarely caused by a serious health problem, Factor 3 comprised 4 items and evaluated Attitude toward not needing to know the cause of back pain to manage it effectively. There was a strong inverse association between each factor and the Back Beliefs Questionnaire and a moderate positive association with the modified Pain Self-Efficacy Questionnaire. Each independent factor demonstrated acceptable internal consistency; Cronbach α Factor 1 = 0.92, Factor 2 = 0.91, Factor 3 = 0.90 and adequate interclass correlation coefficients; Factor 1 = 0.71, Factor 2 = 0.73, Factor 3 = 0.79. Conclusion: This study demonstrates acceptable construct validity and reliability of the AxEL-Q, providing clinicians with an insight into the likelihood of patients following first-line care at the outset

Complex regional pain syndrome: advances in epidemiology, pathophysiology, diagnosis, and treatment.

Complex regional pain syndrome (CRPS) is a rare pain disorder that usually occurs in a limb after trauma. The features of this disorder include severe pain and sensory, autonomic, motor, and trophic abnormalities. Research from the past decade has offered new insights into CRPS epidemiology, pathophysiology, diagnosis, and treatment. Early identification of individuals at high risk of CRPS is improving, with several risk factors established and some others identified in prospective studies during the past 5 years. Better understanding of the pathophysiological mechanisms of CRPS has led to its classification as a chronic primary pain disorder, and subtypes of CRPS have been updated. Procedures for diagnosis have also been clarified. Although effective treatment of CRPS remains a challenge, evidence-based integrated management approaches provide new opportunities to improve patient care. Further advances in diagnosis and treatment of CRPS will require coordinated, international multicentre initiatives

Efficacy, acceptability, and safety of muscle relaxants for adults with non-specific low back pain : systematic review and meta-analysis

Abstract: Objective To investigate the efficacy, acceptability, and safety of muscle relaxants for low back pain. Design: Systematic review and meta-analysis of randomised controlled trials. Data sources: Medline, Embase, CINAHL, CENTRAL, ClinicalTrials.gov, clinicialtrialsregister.eu, and WHO ICTRP from inception to 23 February 2021. Eligibility criteria for study selection: Randomised controlled trials of muscle relaxants compared with placebo, usual care, waiting list, or no treatment in adults (≥18 years) reporting non-specific low back pain. Data extraction and synthesis: Two reviewers independently identified studies, extracted data, and assessed the risk of bias and certainty of the evidence using the Cochrane risk-of-bias tool and Grading of Recommendations, Assessment, Development and Evaluations, respectively. Random effects meta-analytical models through restricted maximum likelihood estimation were used to estimate pooled effects and corresponding 95% confidence intervals. Outcomes included pain intensity (measured on a 0-100 point scale), disability (0-100 point scale), acceptability (discontinuation of the drug for any reason during treatment), and safety (adverse events, serious adverse events, and number of participants who withdrew from the trial because of an adverse event). Results: 49 trials were included in the review, of which 31, sampling 6505 participants, were quantitatively analysed. For acute low back pain, very low certainty evidence showed that at two weeks or less non-benzodiazepine antispasmodics were associated with a reduction in pain intensity compared with control (mean difference -7.7, 95% confidence interval-12.1 to-3.3) but not a reduction in disability (-3.3, -7.3 to 0.7). Low and very low certainty evidence showed that non-benzodiazepine antispasmodics might increase the risk of an adverse event (relative risk 1.6, 1.2 to 2.0) and might have little to no effect on acceptability (0.8, 0.6 to 1.1) compared with control for acute low back pain, respectively. The number of trials investigating other muscle relaxants and different durations of low back pain were small and the certainty of evidence was reduced because most trials were at high risk of bias. Conclusions: Considerable uncertainty exists about the clinical efficacy and safety of muscle relaxants. Very low and low certainty evidence shows that non-benzodiazepine antispasmodics might provide small but not clinically important reductions in pain intensity at or before two weeks and might increase the risk of an adverse event in acute low back pain, respectively. Large, high quality, placebo controlled trials are urgently needed to resolve uncertainty. Systematic review registration PROSPERO CRD42019126820 and Open Science Framework https://osf.io/mu2f5/