Behavioural 'nudging' interventions to reduce low-value care for low back pain in the emergency department (NUDG-ED): protocol for a 2×2 factorial, before-after, cluster randomised trial.

INTRODUCTION: Opioids and imaging are considered low-value care for most people with low back pain. Yet around one in three people presenting to the emergency department (ED) will receive imaging, and two in three will receive an opioid. NUDG-ED aims to determine the effectiveness of two different behavioural 'nudge' interventions on low-value care for ED patients with low back pain. METHODS AND ANALYSIS: NUDG-ED is a 2×2 factorial, open-label, before-after, cluster randomised controlled trial. The trial includes 8 ED sites in Sydney, Australia. Participants will be ED clinicians who manage back pain, and patients who are 18 years or over presenting to ED with musculoskeletal back pain. EDs will be randomly assigned to receive (i) patient nudges, (ii) clinician nudges, (iii) both interventions or (iv) no nudge control. The primary outcome will be the proportion of encounters in ED for musculoskeletal back pain where a person received a non-indicated lumbar imaging test, an opioid at discharge or both. We will require 2416 encounters over a 9-month study period (3-month before period and 6-month after period) to detect an absolute difference of 10% in use of low-value care due to either nudge, with 80% power, alpha set at 0.05 and assuming an intra-class correlation coefficient of 0.10, and an intraperiod correlation of 0.09. Patient-reported outcome measures will be collected in a subsample of patients (n≥456) 1 week after their initial ED visit. To estimate effects, we will use a multilevel regression model, with a random effect for cluster and patient, a fixed effect indicating the group assignment of each cluster and a fixed effect of time. ETHICS AND DISSEMINATION: This study has ethical approval from Southwestern Sydney Local Health District Human Research Ethics Committee (2023/ETH00472). We will disseminate the results of this trial via media, presenting at conferences and scientific publications. TRIAL REGISTRATION NUMBER: ACTRN12623001000695.

Which clinical research questions are the most important? Development and preliminary validation of the Australia & New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network Research Question Importance Tool (ANZMUSC-RQIT).

BACKGROUND AND AIMS: High quality clinical research that addresses important questions requires significant resources. In resource-constrained environments, projects will therefore need to be prioritized. The Australia and New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network aimed to develop a stakeholder-based, transparent, easily implementable tool that provides a score for the 'importance' of a research question which could be used to rank research projects in order of importance. METHODS: Using a mixed-methods, multi-stage approach that included a Delphi survey, consensus workshop, inter-rater reliability testing, validity testing and calibration using a discrete-choice methodology, the Research Question Importance Tool (ANZMUSC-RQIT) was developed. The tool incorporated broad stakeholder opinion, including consumers, at each stage and is designed for scoring by committee consensus. RESULTS: The ANZMUSC-RQIT tool consists of 5 dimensions (compared to 6 dimensions for an earlier version of RQIT): (1) extent of stakeholder consensus, (2) social burden of health condition, (3) patient burden of health condition, (4) anticipated effectiveness of proposed intervention, and (5) extent to which health equity is addressed by the research. Each dimension is assessed by defining ordered levels of a relevant attribute and by assigning a score to each level. The scores for the dimensions are then summed to obtain an overall ANZMUSC-RQIT score, which represents the importance of the research question. The result is a score on an interval scale with an arbitrary unit, ranging from 0 (minimal importance) to 1000. The ANZMUSC-RQIT dimensions can be reliably ordered by committee consensus (ICC 0.73-0.93) and the overall score is positively associated with citation count (standardised regression coefficient 0.33, p<0.001) and journal impact factor group (OR 6.78, 95% CI 3.17 to 14.50 for 3rd tertile compared to 1st tertile of ANZMUSC-RQIT scores) for 200 published musculoskeletal clinical trials. CONCLUSION: We propose that the ANZMUSC-RQIT is a useful tool for prioritising the importance of a research question.

Management of patients with low back pain admitted to hospital: An observational study of usual care.

BACKGROUND: Knowledge gaps exist around diagnostic and treatment approaches for patients admitted to hospital with low back pain. METHODS: Medical record review of patients admitted to three Sydney teaching hospitals with a provisional emergency department diagnosis of non-serious low back pain, from 2016 to 2020. Data on demographic variables, hospital costs, length of stay (LOS), diagnostic imaging and analgesic administration were extracted. Logistic regression was used to identify predictors of longer hospital stay, advanced imaging, and concomitant use of sedating medicines. RESULTS: Median inpatient LOS for non-specific low back pain was 4 days (interquartile range [IQR] 2-7), and for radicular low back pain was 4 days (IQR 3-10). Older patients with non-serious low back pain were more likely to stay longer, as were arrivals by ambulance. Plain lumbar radiography was used in 8.3% of admissions, whereas 37.6% of patients received advanced lumbar imaging (computed tomography or magnetic resonance imaging). Opioids were administered in ~80% of admissions; 49% of patients with radicular low back pain were given an antiepileptic in addition to an opioid. In all, 18.4% of admissions resulted in at least one hospital-acquired complication, such as an accidental fall (3.1%) or a medication-related adverse effect (13.3%). Physiotherapists saw 82.6% of low back pain admissions. Costs of inpatient care were estimated at a mean of AU$ 14 000 per admission. CONCLUSIONS: We noted relatively high rates of concomitant use of sedating pain medicines and referrals for advanced lumbar imaging and laboratory tests. Strategies to address these issues in inpatient care of low back pain are needed.

Healthcare costs due to low back pain in the emergency department and inpatient setting in Sydney, Australia.

BACKGROUND: Low back pain is the leading cause of disability worldwide and a common presentation to emergency departments, often resulting in subsequent admissions to hospital. There have been several studies investigating the cost of low back pain to society, but few specific to the emergency department and inpatient setting, especially in Australia. The aim was to describe the cost of low back pain in Australian public hospital emergency departments, and inpatient settings, and explore healthcare costs associated with different care pathways. METHODS: In this retrospective observational study, we explored the costs associated with an episode of care for low back pain in adults that attended three emergency departments in Sydney between 1 July 2014 and 30 June 2019. Systematised Nomenclature of Medicine-Clinical Terms (SNOMED) diagnosis codes were used to identify episodes of care where the patients had been diagnosed with non-specific low back pain or lumbosacral radicular syndromes. Serious spinal pathologies were excluded. We determined the costs for different treatment pathways involving the ambulance service, emergency department and inpatient ward care. Hospital costs were adjusted for inflation to 2019 Australian dollars (AUD). FINDINGS: There were 12,399 non-serious low back pain episodes of care during the study period. 4006 (32%) arrived by ambulance and 2067 (17%) were admitted for inpatient care. The total costs of inpatient and emergency department care across the 5-year period were AUD$36.7 million, with a mean of AUD$2959 per episode of care. The mean cost for a patient who had a non-ambulance presentation to the emergency department and was discharged was AUD$584. Patients presenting to the emergency department via ambulance and were discharged had a mean cost of AUD$1022. Patients who presented without the need of an ambulance and were admitted had a mean cost of $13,137. The most expensive care pathway was for patients arriving by ambulance with subsequent admission, with a mean cost of AUD$14,949. INTERPRETATION: The common practice of admitting patients with non-serious low back pain for inpatient care comes at great cost to the healthcare system. In a resource constrained environment, our data highlights the economic need to implement innovative, evidence-based strategies to reduce the inpatient management of these patients. FUNDING: Nil.

Completeness and quality of low back pain prevalence data in the Global Burden of Disease Study 2017.

INTRODUCTION: Completeness of Global Burden of Disease (GBD) Study data is acknowledged as a limitation. To date, no study has evaluated this issue for low back pain, a leading contributor to disease burden globally. METHODS: We retrieved reports, in any language, based on citation details from the GBD 2017 study website. Pairs of raters independently extracted the following data: number of prevalence reports tallied across countries, age groups, gender and years from 1987 to 2017. We also considered if studies enrolled a representative sample and/or used an acceptable measure of low back pain. RESULTS: We retrieved 488 country-level reports that provide prevalence data for 103 of 204 countries (50.5%), with most prevalence reports (61%) being for high-income countries. Only 16 countries (7.8%) have prevalence reports for each of the three decades of the GBD. Most of the reports (79%) did not use an acceptable measure of low back pain when estimating prevalence. CONCLUSION: We found incomplete coverage across countries and time, and limitations in the primary prevalence studies included in the GBD 2017 study. This means there is considerable uncertainty about GBD estimates of low back pain prevalence and the disease burden metrics derived from prevalence.

Evaluation of the efficacy of an internet-based pain education and exercise program for chronic musculoskeletal pain in comparison with online self-management booklet: a protocol of a randomised controlled trial with assessor-blinded, 12-month follow-up, and economic evaluation.

BACKGROUND: Chronic musculoskeletal pain is one of the main causes of years lived with disability and generates the highest cost of health care among chronic pain conditions. Internet-based treatments have been shown to be an alternative for the treatment of musculoskeletal conditions, in addition to reducing barriers such as travel, high demands on the public health system, lack of time, lack of insurance coverage for private care, and high costs for long-term treatment. The aim of this clinical trial is to develop and test the effectiveness and cost-effectiveness of, an internet-based self-management program based on pain education and exercise for people with chronic musculoskeletal pain. METHODS: This is a prospectively registered, assessor-blinded, two-arm randomised controlled trial with economic evaluation comparing the Internet-based pain education and exercise intervention with a control group that will receive an online booklet. One hundred and sixty patients will be recruited from Sao Paulo, Brazil. Follow-ups will be conducted in post-treatment, 6 and 12 months after randomisation. The conduct of the study, as well as the evaluations and follow-ups will be carried out entirely remotely, through online platforms and telephone calls. The primary outcome will be pain intensity at post-treatment (8 weeks) measured using the 11-item Pain Numerical Rating Scale. Secondary outcomes will be biopsychosocial factors presents in the chronic musculoskeletal pain condition. Costs due to chronic musculoskeletal pain will be also measured, and cost-effectiveness analysis from a societal perspective will performed. DISCUSSION: Our hypothesis is that internet-based pain education and exercise will be better than an online booklet in reducing pain and improving biopsychosocial outcomes in patients with chronic musculoskeletal pain. In addition, we believe that there will be good acceptance of patients for the internet-based intervention and that internet-based intervention will be more cost effective than the online booklet. TRIAL REGISTRATION: The study was prospectively registered at ClinicalTrials.gov ( NCT04274439 , registered 18 February 2020).

TOPS - a randomized controlled trial of exercise and education to prevent recurrence of low back pain: statistical analysis plan.

BACKGROUND: This a priori statistical analysis plan describes the methods of analysis for the Trial Of Prevention Strategies for low back pain (TOPS). OBJECTIVES: TOPS aimed to investigate the effectiveness and cost-effectiveness of exercise and education classes compared with a minimal intervention control in preventing recurrence of low back pain (LBP) in people who have recently recovered from an episode of LBP. METHODS: TOPS is a superiority, pragmatic, parallel-group randomized controlled trial with allocation concealment, blinded outcome assessors, and intention-to-treat analysis. Participants were randomized to a physical therapist-led exercise and education program for 12 weeks or minimal intervention. The primary outcome was days to recurrence of an episode of LBP. The three key secondary outcomes were days to recurrence of an episode of LBP resulting in (1) activity limitation, (2) care seeking for LBP; and (3) work absence of at least 1 day. Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression. Hazard ratios (HRs) and median survival times with 95% confidence intervals (CI) will be calculated. The number of adverse events, including serious adverse events will be reported and the proportion of adverse events between groups will be compared using a Chi-squared test. DISCUSSION: This paper will provide a detailed description of the planned analyses for the TOPS trial. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12615000939594).

Defining and measuring imaging appropriateness in low back pain studies: a scoping review.

PURPOSE: Patients with low back pain (LBP) rarely have serious underlying pathology but frequently undergo inappropriate imaging. A range of guidelines and red flag features are utilised to characterise appropriate imaging. This scoping review explores how LBP imaging appropriateness is determined and calculated in studies of primary care practice. METHODS: This scoping review builds upon a previous meta-analysis, incorporating articles identified that were published since 2014, with an updated search to capture articles published since the original search. Electronic databases were searched, and citation lists of included papers were reviewed. Inclusion criteria were studies assessing adult LBP imaging appropriateness in a primary care setting. Twenty-three eligible studies were identified. RESULTS: A range of red flag features were utilised to determine imaging appropriateness. Most studies considered appropriateness in a binary manner, by the presence of any red flag feature. Ten guidelines were referenced, with 7/23 (30%) included studies amending or not referencing any guideline. The method for calculating the proportion of inappropriate imaging varied. Ten per cent of the studies used the total number of patients presenting with LBP as the denominator, suggesting most studies overestimated the rate of inappropriate imaging, and did not capture where imaging is not performed for clinically suspicious LBP. CONCLUSION: Greater clarity is needed on how we define and measure imaging appropriateness for LBP, which also accounts for the problem of failing to image when indicated. An internationally agreed methodology for imaging appropriateness studies would ultimately lead to an improvement in the care delivered to patients. These slides can be retrieved under Electronic Supplementary Material.

Care for low back pain: can health systems deliver?

Low back pain is the leading cause of years lived with disability globally. In 2018, an international working group called on the World Health Organization to increase attention on the burden of low back pain and the need to avoid excessively medical solutions. Indeed, major international clinical guidelines now recognize that many people with low back pain require little or no formal treatment. Where treatment is required the recommended approach is to discourage use of pain medication, steroid injections and spinal surgery, and instead promote physical and psychological therapies. Many health systems are not designed to support this approach. In this paper we discuss why care for low back pain that is concordant with guidelines requires system-wide changes. We detail the key challenges of low back pain care within health systems. These include the financial interests of pharmaceutical and other companies; outdated payment systems that favour medical care over patients' self-management; and deep-rooted medical traditions and beliefs about care for back pain among physicians and the public. We give international examples of promising solutions and policies and practices for health systems facing an increasing burden of ineffective care for low back pain. We suggest policies that, by shifting resources from unnecessary care to guideline-concordant care for low back pain, could be cost-neutral and have widespread impact. Small adjustments to health policy will not work in isolation, however. Workplace systems, legal frameworks, personal beliefs, politics and the overall societal context in which we experience health, will also need to change.

Les lombalgies sont la principale cause d'années de vie vécues avec une incapacité dans le monde. En 2018, un groupe de travail international a invité l'Organisation mondiale de la Santé à attirer l'attention sur la charge que représentent les lombalgies et sur la nécessité d'éviter le recours excessif aux solutions médicales. En effet, selon les dernières recommandations cliniques internationales, de nombreux cas de lombalgie ne nécessitent pas ou peu de traitement formel. Lorsqu'un traitement est requis, il est recommandé de limiter la prise d'analgésiques, les injections de stéroïdes et la chirurgie rachidienne, et d'encourager plutôt les thérapeutiques physiques et psychologiques. Très souvent, les systèmes de santé ne sont pas conçus pour appliquer cette approche. Dans cet article, nous abordons les raisons pour lesquelles un changement des systèmes s'impose si l'on veut prendre en charge les lombalgies suivant les recommandations. Nous détaillons les principales difficultés de la prise en charge des lombalgies dans le cadre des systèmes de santé. Il s'agit notamment des intérêts financiers des laboratoires pharmaceutiques, entre autres; des systèmes de paiement obsolètes qui privilégient la prise en charge médicale à l'autogestion par les patients; et de croyances et traditions médicales profondément ancrées parmi les médecins et la population. Nous donnons des exemples internationaux de solutions, de politiques et de pratiques prometteuses pour les systèmes de santé confrontés de plus en plus souvent à une prise en charge inefficace des lombalgies. Nous suggérons des politiques qui, sans incidence sur les coûts, en transférant les ressources allouées aux soins inutiles vers des soins conformes aux recommandations, pourraient avoir un impact considérable. De petits ajustements des politiques de santé ne suffiront cependant pas. Les systèmes des milieux professionnels, les cadres juridiques, les croyances personnelles, les politiques et le contexte sociétal global dans lequel s'inscrit la santé devront également changer.

El dolor lumbar es la causa principal de vivir con discapacidad durante años en todo el mundo. En 2018, un grupo de trabajo internacional pidió a la Organización Mundial de la Salud que prestara más atención a la carga del dolor lumbar y a la necesidad de evitar soluciones excesivamente médicas. De hecho, las principales directrices clínicas internacionales reconocen ahora que muchas personas con dolor lumbar requieren poco o ningún tratamiento formal. Cuando se requiere tratamiento, el enfoque recomendado es desalentar el uso de analgésicos, inyecciones de esteroides y cirugía de la columna vertebral y, en su lugar, promover las terapias físicas y psicológicas. Muchos sistemas de salud no están diseñados para apoyar este enfoque. En este documento, se expone por qué el cuidado del dolor lumbar de acuerdo con las directrices requiere cambios en todo el sistema. Se detallan los retos clave de la atención del dolor lumbar en los sistemas de salud. Estos incluyen los intereses financieros de las compañías farmacéuticas y de otro tipo, los sistemas de pago obsoletos que favorecen la atención médica por encima del autocuidado de los pacientes, así como las tradiciones y las creencias médicas profundamente arraigadas sobre la atención del dolor de espalda entre los médicos y el público general. Se presentan ejemplos internacionales de soluciones prometedoras y de políticas y prácticas para los sistemas de salud que se enfrentan a una carga cada vez mayor de la atención ineficaz para el dolor lumbar. Se sugieren políticas que, al desplazar los recursos de la atención innecesaria a la atención acorde con las directrices para el dolor lumbar, podrían ser neutras en cuanto a costes y tener un impacto generalizado. Sin embargo, los pequeños ajustes en la política sanitaria no funcionarán de forma aislada. Los sistemas del lugar de trabajo, los marcos jurídicos, las creencias personales, la política y el contexto social general en el que vivimos la salud también tendrán que cambiar.

Review article: A scoping review of physiotherapists in the adult emergency department.

To provide an overview of the literature that considers physiotherapists working in the ED in relation to their roles, training levels, patient profile, safety, effectiveness, efficiency, cost-effectiveness and the provision of low-value care. We performed a scoping review of the literature. Four databases (PubMed, EMBASE, CINAHL and Cochrane CENTRAL) were searched from their inception to December 2016 and we updated searches on PubMed in September 2017. Two reviewers independently screened studies for eligibility. We performed a narrative synthesis of quantitative data. We included 27 studies: five randomised controlled trials (n = 1434), 12 prospective observational studies (n = 153 767), six retrospective studies (n = 9968), two survey studies (n = 61), one case report (n = 3) and one qualitative study (n = 11). Physiotherapists primarily managed patients with low urgency musculoskeletal conditions. Physiotherapists appeared to have similar clinical effectiveness and costs compared to other health providers (four randomised controlled trials). Physiotherapists were associated with increased efficiency (eight observational studies) and reduced low-value care (one observational study). Three observational studies reported very low adverse event rates. However, none of the studies followed participants to measure adverse events that became apparent after the ED visit, nor did they consider unsafe discharge decisions or suboptimal follow-up care. The available evidence suggests that physiotherapists may be as effective as other health providers in managing low urgency musculoskeletal conditions in the ED. There is uncertainty about appropriate training and a lack of robust studies investigating the efficiency, safety and cost-effectiveness of this model of care.

Prevention and treatment of low back pain: evidence, challenges, and promising directions.

Many clinical practice guidelines recommend similar approaches for the assessment and management of low back pain. Recommendations include use of a biopsychosocial framework to guide management with initial non-pharmacological treatment, including education that supports self-management and resumption of normal activities and exercise, and psychological programmes for those with persistent symptoms. Guidelines recommend prudent use of medication, imaging, and surgery. The recommendations are based on trials almost exclusively from high-income countries, focused mainly on treatments rather than on prevention, with limited data for cost-effectiveness. However, globally, gaps between evidence and practice exist, with limited use of recommended first-line treatments and inappropriately high use of imaging, rest, opioids, spinal injections, and surgery. Doing more of the same will not reduce back-related disability or its long-term consequences. The advances with the greatest potential are arguably those that align practice with the evidence, reduce the focus on spinal abnormalities, and ensure promotion of activity and function, including work participation. We have identified effective, promising, or emerging solutions that could offer new directions, but that need greater attention and further research to determine if they are appropriate for large-scale implementation. These potential solutions include focused strategies to implement best practice, the redesign of clinical pathways, integrated health and occupational interventions to reduce work disability, changes in compensation and disability claims policies, and public health and prevention strategies.

A physiotherapist-led exercise and education program for preventing recurrence of low back pain: a randomised controlled pilot trial.

BACKGROUND: Before beginning a large and complex trial it is considered good practice to run a pilot study to assess the feasibility and acceptability so that quality is maintained and resources are not wasted. OBJECTIVE: To assesses the feasibility and acceptability of procedures for TOPS: Trial Of Prevention Strategies for low back pain. DESIGN: Randomised controlled pilot trial. METHODS: This is a trial of an 8 week, physiotherapist-led group exercise and education program for preventing recurrence of low back pain (LBP) in those recently recovered from LBP. We assessed the feasibility of recruitment and data-collection procedures, acceptability of the trial interventions and loss-to-follow up. RESULTS: The feasibility of recruitment, acceptability of the intervention and feasibility of physical activity data-collection procedures were all below anticipated levels. We enrolled 12 participants over 44 weeks, the adherence rate for the intervention group was 63% and valid physical activity data were obtained for 67% of the measurements. Follow-up methods for collection of LBP recurrence were successful with this information able to be collected for 100% of participants. CONCLUSION: In response to the pilot, modifications were made to the main trial protocol. We will increase recruitment by relaxing inclusion criteria and expanding recruitment sites to include workplaces, community centres and via social media. We will facilitate compliance by expanding treatment sites to provide more options for participants to access the program and we will limit missing data by checking the validity of baseline physical activity measures prior to enrolment. TRIAL REGISTRATION: The study was prospectively registered with the Australian and New Zealand Clinical Trials Registry (ref: ACTRN12614000706673).

Managing non-serious low back pain in the emergency department: Time for a change?

Low back pain is a common condition seen in the ED. However, its management in this setting has received relatively little attention and there have been few efforts to develop strategies to improve emergency care of low back pain. In order to ensure that care is appropriately delivered for low back pain patients in the ED, emergency physicians must understand issues of providing low-value care and consider potential solutions to the problem. In this paper, we describe the usual emergency care provided for non-serious low back pain and present possible strategies for restructuring ED practice and approaches for changing physician and patient behaviour. A better understanding of how non-serious low back pain is currently being managed and discussion on how to provide evidence-based care according to current guideline recommendations will help emergency physicians improve the value of care for these patients.

Trends, Complications, and Costs for Hospital Admission and Surgery for Lumbar Spinal Stenosis.

MINI: Trends in lumbar spinal stenosis surgery are largely unknown outside of the United States. This population-based health record linkage study revealed that complex fusion surgery had a four-fold increase from 2003-2013 in Australia. This surgical procedure increased the risk of complications and resource use compared with decompression surgery alone. STUDY DESIGN: Population-based health record linkage study. OBJECTIVE: The aim of this study was to determine trends in hospital admissions and surgery for lumbar spinal stenosis, as well as complications and resource use in Australia. SUMMARY OF BACKGROUND DATA: In the United States, rates of decompression surgery have declined, whereas those of fusion have increased. It is unclear whether this trend is also happening elsewhere. METHODS: We included patients 18 years and older admitted to a hospital in New South Wales between 2003 and 2013 who were diagnosed with lumbar spinal stenosis. We investigated the rates of hospital admission and surgical procedures, as well as hospital costs, length of hospital stay, and complications. Surgical procedures were: decompression alone, simple fusion (one to two disc levels, single approach), and complex fusion (three or more disc levels or a combined posterior and anterior approach). RESULTS: The rates of decompression alone increased from 19.0 to 22.1 per 100,000 people. Simple fusion rates increased from 1.3 to 2.8 per 100,000 people, whereas complex fusion increased from 0.6 to 2.4 per 100,000 people. The odds of major complications for complex fusion compared with decompression alone was 4.1 (95% confidence interval [CI]: 1.7-10.1), although no significant difference was found for simple fusion (odds ratio 2.0, 95% CI: 0.7-6.1). Mean hospital costs with decompression surgery were AU $12,168, whereas simple and complex fusion cost AU $30,811 and AU $32,350, respectively. CONCLUSION: In Australia, decompression rates for lumbar spinal stenosis increased from 2003 to 2013. The fastest increasing surgical procedure was complex fusion. This procedure increased the risk of major complications and resource, although recent evidence suggest fusion provides no additional benefits to the traditional decompression surgery. LEVEL OF EVIDENCE: 3.

Non-specific low back pain.

Non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide. Management guidelines endorse triage to identify the rare cases of low back pain that are caused by medically serious pathology, and so require diagnostic work-up or specialist referral, or both. Because non-specific low back pain does not have a known pathoanatomical cause, treatment focuses on reducing pain and its consequences. Management consists of education and reassurance, analgesic medicines, non-pharmacological therapies, and timely review. The clinical course of low back pain is often favourable, thus many patients require little if any formal medical care. Two treatment strategies are currently used, a stepped approach beginning with more simple care that is progressed if the patient does not respond, and the use of simple risk prediction methods to individualise the amount and type of care provided. The overuse of imaging, opioids, and surgery remains a widespread problem.

OPAL: a randomised, placebo-controlled trial of opioid analgesia for the reduction of pain severity in people with acute spinal pain. Trial protocol.

INTRODUCTION: Low back pain and neck pain are extremely prevalent and are responsible for an enormous burden of disease globally. Strong analgesics, such as opioid analgesics, are recommended by clinical guidelines for people with acute low back pain or neck pain who are slow to recover and require more pain relief. Opioid analgesics are widely and increasingly used, but there are no strong efficacy data supporting the use of opioid analgesics for acute low back pain or neck pain. Concerns regarding opioid use are further heightened by the risks of adverse events, some of which can be serious (eg, dependency, misuse and overdose). METHODS AND ANALYSIS: OPAL is a randomised, placebo-controlled, triple-blinded trial that will investigate the judicious use of an opioid analgesic in 346 participants with acute low back pain and/or neck pain who are slow to recover. Participants will be recruited from general practice and randomised to receive the opioid analgesic (controlled release oxycodone plus naloxone up to 20 mg per day) or placebo in addition to guideline-based care (eg, reassurance and advice of staying active) for up to 6 weeks. Participants will be followed-up for 3 months for effectiveness outcomes. The primary outcome will be pain severity. Secondary outcomes will include physical functioning and time to recovery. Medication-related adverse events will be assessed and a cost-effectiveness analysis will be conducted. We will additionally assess long-term use and risk of misuse of opioid analgesics for up to 12 months. ETHICS AND DISSEMINATION: Ethical approval has been obtained. Trial results will be disseminated by publications and conference presentations, and via the media. TRIAL REGISTRATION NUMBER: ACTRN12615000775516: Pre-results.