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Refereed/Peer-reviewed A new wave of treatments has emerged to target nervous system alterations and mal-adaptive conceptualizations about pain for chronic low back pain. The acceptability of these treatments is still uncertain. We conducted a qualitative study alongside a randomized controlled trial to identify perceptions of facilitators or barriers to participation in a non-pharmacological intervention that resulted in clinically meaningful reductions across 12 months for disability compared to a sham intervention. We conducted semi-structured interviews with participants from the trial’s active arm after they completed the 12-week program. We included a purposeful sample (baseline and clinical characteristics) (n = 20). We used reflexive thematic analysis informed by the Theoretical Framework of Acceptability for health care interventions. We identified positive and negative emotional/cognitive responses associated with treatment acceptability and potential efficacy, including emotional support, cognitive empowerment, readiness for self-management, and acceptance of face-to-face and online components designed to target the brain. These findings suggest the importance of psychoeducation and behavior change techniques to create a positive attitude towards movement and increase the perception of pain control; systematic approaches to monitor and target misconceptions about the interventions during treatment; and psychoeducation and behavior change techniques to maintain the improvements after the cessation of formal care. Perspective: This article presents the experiences of people with chronic low back pain participating in a new non-pharmacological brain-targeted treatment that includes face-to-face and self-directed approaches. The facilitators and barriers of the interventions could potentially inform adaptations and optimization of treatments designed to target the brain to treat chronic low back pain.

Refereed/Peer-reviewed Introduction: Chronic low back pain (CLBP) is pain that has persisted for greater than three months. It is common and burdensome and represents a significant proportion of primary health presentations. For the majority of people with CLBP, a specific nociceptive contributor cannot be reliably identified, and the pain is categorised as 'non-specific'. Exercise therapy is recommended by international clinical guidelines as a first-line treatment for non-specific CLBP. Aim: This comprehensive review aims to synthesise and appraise the current research to provide practical, evidence-based guidance concerning exercise prescription for non-specific CLBP. We discuss detailed initial assessment and being informed by patient preferences, values, expectations, competencies and goals. Methods: We searched the Cochrane Database of Systematic Reviews, PubMed and the Physiotherapy Evidence Database (PEDro) using broad search terms from January 2000 to March 2021, to identify the most recent clinical practice guidelines, systematic reviews and randomised controlled trials on exercise for CLBP. Results/Discussion: Systematic reviews show exercise is effective for small, short-term reductions in pain and disability, when compared with placebo, usual care, or waiting list control, and serious adverse events are rare. A range of individualised or group-based exercise modalities have been demonstrated as effective in reducing pain and disability. Despite this consensus, controversies and significant challenges remain. Conclusion: To promote recovery, sustainable outcomes and self-management, exercise can be coupled with education strategies, as well as interventions that enhance adherence, motivation and patient self-efficacy. Clinicians might benefit from intentionally considering their own knowledge and competencies, potential harms of exercise and costs to the patient. This comprehensive review provides evidence-based practical guidance to health professionals who prescribe exercise for people with non-specific CLBP.

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.

Patient education is recommended as first-line care for low back pain (LBP), although its efficacy for providing clinically meaningful reductions in disability has been questioned. One way to improve treatment effects is to identify and improve targeting of treatment mechanisms. We conducted a pre-planned causal mediation analysis of a randomized, placebo-controlled trial investigating the effectiveness of patient education for patients with acute LBP. 202 patients who had fewer than six-weeks’ duration of LBP and were at high-risk of developing chronic LBP completed two, one-hour treatment sessions of either intensive patient education, or placebo patient education. 189 participants provided data for the outcome self-reported disability at three-months and the mediators, pain self-efficacy, pain catastrophizing, and back beliefs at one-week post treatment. This causal mediation analysis found that pain catastrophizing (mediated effect, -0.64; 95% Confidence Interval [CI], -1.31 to -0.15) and back beliefs (mediated effect, -0.51; 95% CI, -1.15 to -0.02) partly explained the effect of patient education on disability but pain self-efficacy did not (mediated effect, -0.40; 95% CI -1.13 to 0.28). Considering the mediator-outcome relationship, patient education would need to induce an 8 point difference on the pain self-efficacy questionnaire (0-60); an 11 point difference on the back beliefs questionnaire (9-45); and a 21 point difference on the pain catastrophizing scale (0-52) to achieve a minimally clinically important difference of 2 points on the Roland Morris Disability Questionnaire (0-24). PERSPECTIVE Understanding the mechanisms of patient education can inform how this treatment can be adapted to provide clinically meaningful reductions in disability. Our findings suggest that adapting patient education to better target back beliefs and pain self-efficacy could result in clinically meaningful reductions in disability whereas the role of pain catastrophizing in acute LBP is less clear.

Objective Low back pain is the leading contributor to the global disability burden. The Global Spine Care Initiative (GSCI) recommend patient-centred care to stem the cost of low back pain. One way to enhance patient-centred care is by better understanding what is relevant for people with low back pain. Exploring social media posts about low back pain could offer this insight and provide valuable information for health care professionals to facilitate active participation in patient-centred care. Methods We used an inductive content analysis method. In the form of social media posts, data on Twitter and Instagram were collected from June to August 2018. The posts were geo-targeted to Australia. We recorded the number of status broadcasts that contained a low back pain keyword and responses. We developed a codebook to describe the data and applied it to identify low back pain themes. Results We analysed 768 posts containing 457 status broadcasts and 311 responses. Almost half (49%) of status broadcasts about low back pain seemed to seek validation. Expressing sympathy (31%) was the most common response to a status broadcast about low back pain. There were no public responses to 76% of status broadcasts about low back pain. Our analysis yielded two core themes, “hear my pain” and “I feel for you". Conclusions Posts about low back pain on social media often seem to suggest that the person posting is seeking validation. Responses typically express sympathy or a shared experience; yet, there is no response to most social media posts about low back pain.

© 2017, Psychonomic Society, Inc. Eyetracking is commonly used to investigate attentional bias. Although some studies have investigated the internal consistency of eyetracking, data are scarce on the test–retest reliability and agreement of eyetracking to investigate attentional bias. This study reports the test–retest reliability, measurement error, and internal consistency of 12 commonly used outcome measures thought to reflect the different components of attentional bias: overall attention, early attention, and late attention. Healthy participants completed a preferential-looking eyetracking task that involved the presentation of threatening (sensory words, general threat words, and affective words) and nonthreatening words. We used intraclass correlation coefficients (ICCs) to measure test–retest reliability (ICC >.70 indicates adequate reliability). The ICCs(2, 1) ranged from –.31 to.71. Reliability varied according to the outcome measure and threat word category. Sensory words had a lower mean ICC (.08) than either affective words (.32) or general threat words (.29). A longer exposure time was associated with higher test–retest reliability. All of the outcome measures, except second-run dwell time, demonstrated low measurement error (.93). Recommendations are discussed for improving the reliability of eyetracking tasks in future research.

Objectives It has been hypothesised that attentional bias to environmental threats can contribute to persistent pain. It is unclear whether people with acute low back pain (LBP) have an attentional bias to environmental threats. We investigated if attentional bias of threat related words is different in people with acute LBP and pain-free controls. Methods People with acute LBP and pain-free people completed a free viewing eye tracking task. Participants were simultaneously presented with two words, a threat related word and a neutral control word. Threat related words were general threat, affective pain and sensory pain. We conducted linear mixed models to detect differences between acute LBP and pain-free participants on five eye tracking outcome measures (dwell time, first fixation, latency to first fixation, first run dwell time and number of fixations). We calculated absolute reliability, (standard error of measure), and relative reliability (intraclass correlation coefficients [ICC 2,1]) for each eye tracking outcome measures. Results We recruited 65 people with acute LBP and 65 pain-free controls. Participants with acute LBP had a higher proportion of fixations towards the affective pain words (M=0.5009, 95% CI=0.4941, 0.5076) than the pain-free controls had (M=0.4908, 95% CI=0.4836, 0.4979), mean between group difference = −0.0101, 95% CI [−0.0198, −0.0004], p=0.0422. There was no difference between acute LBP and pain-free controls for the remaining eye tracking outcome measures (all p>0.05). The only outcome measure that had an ICC of more than 0.7 was the latency to first fixation (affective pain words ICC=0.73, general threat words ICC=0.72). Conclusions When compared with pain-free controls, people with acute LBP looked more often at affective pain words relative to neutral control words. This may indicate a form of engagement bias for people with acute LBP. Attentional bias was not consistent across outcome measures or word groups. Further research is needed to investigate the potential role of attentional bias in the development of persistent pain.

© 2018 2018 American Medical Association. All rights reserved. Importance: Many patients with acute low back pain do not recover with basic first-line care (advice, reassurance, and simple analgesia, if necessary). It is unclear whether intensive patient education improves clinical outcomes for those patients already receiving first-line care. Objective: To determine the effectiveness of intensive patient education for patients with acute low back pain. Design, Setting, and Participants: This randomized, placebo-controlled clinical trial recruited patients from general practices, physiotherapy clinics, and a research center in Sydney, Australia, between September 10, 2013, and December 2, 2015. Trial follow-up was completed in December 17, 2016. Primary care practitioners invited 618 patients presenting with acute low back pain to participate. Researchers excluded 416 potential participants. All of the 202 eligible participants had low back pain of fewer than 6 weeks' duration and a high risk of developing chronic low back pain according to Predicting the Inception of Chronic Pain (PICKUP) Tool, a validated prognostic model. Participants were randomized in a 1:1 ratio to either patient education or placebo patient education. Interventions: All participants received recommended first-line care for acute low back pain from their usual practitioner. Participants received additional 2 × 1-hour sessions of patient education (information on pain and biopsychosocial contributors plus self-management techniques, such as remaining active and pacing) or placebo patient education (active listening, without information or advice). Main Outcomes and Measures: The primary outcome was pain intensity (11-point numeric rating scale) at 3 months. Secondary outcomes included disability (24-point Roland Morris Disability Questionnaire) at 1 week, and at 3, 6, and 12 months. Results: Of 202 participants randomized for the trial, the mean (SD) age of participants was 45 (14.5) years and 103 (51.0%) were female. Retention rates were greater than 90% at all time points. Intensive patient education was not more effective than placebo patient education at reducing pain intensity (3-month mean [SD] pain intensity: 2.1 [2.4] vs 2.4 [2.2]; mean difference at 3 months, -0.3 [95% CI, -1.0 to 0.3]). There was a small effect of intensive patient education on the secondary outcome of disability at 1 week (mean difference, -1.6 points on a 24-point scale [95% CI, -3.1 to -0.1]) and 3 months (mean difference, -1.7 points, [95% CI, -3.2 to -0.2]) but not at 6 or 12 months. Conclusions and Relevance: Adding 2 hours of patient education to recommended first-line care for patients with acute low back pain did not improve pain outcomes. Clinical guideline recommendations to provide complex and intensive support to high-risk patients with acute low back pain may have been premature. Trial Registration: Australian Clinical Trial Registration Number: 12612001180808.

Background: Marketing communication and brand identity is a fundamental principle of advertising and end-user engagement. Health researchers have begun to apply this principle to trial recruitment in primary care. The aim of this study was to evaluate whether a Teaser Campaign using a series of postcards in advance of a conventional mail-out increases the number of primary care clinics that engage with a clinical trial. Methods: Embedded randomised recruitment trial across primary care clinics (general practitioners and physiotherapists) in the Sydney metropolitan area. Clinics in the Teaser Campaign group received a series of branded promotional postcards in advance of a standard letter inviting them to participate in a clinical trial. Clinics in the Standard Mail group did not receive the postcards. Results: From a total of 744 clinics that were sent an invitation letter, 46 clinics in the Teaser Campaign group and 40 clinics in the Standard Mail group responded (11.6% total response rate). There was no between-group difference in the odds of responding to the invitation letter (odds ratio = 1.18, 95% confidence interval = 0.75–1.85, p = 0.49). For physiotherapy clinics and general practice clinics, the odds ratios were 1.43 (confidence interval = 0.82–2.48, p = 0.21) and 0.77 (confidence interval = 0.34–1.75, p = 0.54), respectively. Conclusion: A Teaser Campaign using a series of branded promotional postcards did not improve clinic engagement for a randomised controlled trial in primary care.

© 2016 Elsevier Ireland Ltd Objective Professional appearance is easily modifiable, and might alter the effects of a clinical encounter. We aimed to determine whether professional attire influences a patient's perception of treatment credibility. Methods We performed a single-blind randomized controlled study on 128 patients with acute non-specific low back pain who were about to receive treatment in primary care. The treating clinician was randomly allocated to wear formal attire (experimental condition) or casual attire (control condition) to the consultation. Clinicians provided a standardized briefing on the rationale behind the patient's forthcoming treatment. Treatment credibility (Credibility and Expectancy Questionnaire) was assessed immediately after this briefing. Results All patients received the experimental or control condition as allocated and provided complete primary outcome data. Formal attire had no effect on perceived treatment credibility (Mean difference between groups 1.2 [95%CI-1.1 to 3.5]). Age was the only significant predictor of treatment credibility; older patients rated treatment credibility higher (Beta = 0.16 [95%CI 0.08 to 0.24]). Conclusion In a trial setting, whether or not a clinician is formally dressed has no effect on perceptions of treatment credibility in patients with acute low back pain. Practice implication Clinicians should dress comfortably without fear of losing credibility.

Evidence from randomized controlled studies shows that reconceptualizing pain improves patients' knowledge of pain biology, reduces catastrophizing thoughts, and improves pain and function. However, causal relationships between these variables remain untested. It is hypothesized that reductions in catastrophizing could mediate the relationship between improvements in pain knowledge and improvements in pain and function. To test this causal mechanism, we conducted longitudinal mediation analyses on a cohort of 799 patients who were exposed to a pain education intervention. Patients provided responses to the neurophysiology of pain questionnaire, catastrophic thoughts about pain scale, visual analogue pain scale, and the patient specific functional scale, at baseline, 1-month, 6-month, and 12-month follow-up. With adjustment for potential confounding variables, an improvement in pain biology knowledge was significantly associated with a reduction in pain intensity (total effect =-2.20, 95% confidence interval [CI] =-2.96 to-1.44). However, this effect was not mediated by a reduction in catastrophizing (indirect effect =-0.16, 95% CI =-0.36 to 0.02). This might be due to a weak, nonsignificant relationship between changes in catastrophizing and pain intensity (path b = 0.19, 95% CI =-0.03 to 0.41). Similar trends were found in models with function as the outcome. Our findings indicate that change in catastrophizing did not mediate the effect of pain knowledge acquisition on change in pain or function. The strength of this conclusion is moderated, however, if patient-clinician relational factors are conceptualized as a consequence of catastrophizing, rather than a cause. Refereed/Peer-reviewed

Worldwide, the incidence of wrist fracture is increasing. There are currently no externally validated prognostic models to inform early decision making for these patients.To develop and validate a prognostic model from a comprehensive range of candidate prognostic factors that can identify patients who are at risk of developing persistent pain following wrist or hand fracture.We developed and validated a prognostic model using secondary data derived from a prospective cohort study (n = 715), with recruitment sites in 3 metropolitan hospitals in Sydney, Australia. The primary outcome was persistent pain 4 months following the injury. The current study used a backward stepwise regression analysis to develop the model in 2 hospitals (n = 408) and externally validate it in a third hospital (n = 307). To determine the accuracy of the model, we assessed calibration and discrimination in accordance with the PROGnosis RESearch Strategy framework.Complete data were available for 95% of the cohort. Of 14 candidate variables, the final model contained 2 prognostic factors: patient age and pain intensity reported at initial presentation. The area under the receiver operating characteristic curve was 0.63 (95% confidence interval: 0.56, 0.69) in the development sample and 0.61 (95% confidence interval: 0.51, 0.70) in the validation sample. The model systematically overestimated risk (intercept, -1.13; slope, 0.73).We developed and externally validated a prognostic model to predict persistent pain 4 months after a wrist or hand fracture. Future studies are needed to assess whether the accuracy of this model can be improved by updating and validating it in local settings.Prognosis, level 1b. J Orthop Sports Phys Ther 2019;49(1):28-35. Epub 12 Sep 2018. doi:10.2519/jospt.2019.8342.

Background Delivering efficient and effective healthcare is crucial for a condition as burdensome as low back pain (LBP). Stratified care strategies may be worthwhile, but rely on early and accurate patient screening using a valid and reliable instrument. The purpose of this study was to evaluate the performance of LBP screening instruments for determining risk of poor outcome in adults with LBP of less than 3 months duration. Methods Medline, Embase, CINAHL, PsycINFO, PEDro, Web of Science, SciVerse SCOPUS, and Cochrane Central Register of Controlled Trials were searched from June 2014 to March 2016. Prospective cohort studies involving patients with acute and subacute LBP were included. Studies administered a prognostic screening instrument at inception and reported outcomes at least 12 weeks after screening. Two independent reviewers extracted relevant data using a standardised spreadsheet. We defined poor outcome for pain to be ≥ 3 on an 11-point numeric rating scale and poor outcome for disability to be scores of ≥ 30% disabled (on the study authors' chosen disability outcome measure). Results We identified 18 eligible studies investigating seven instruments. Five studies investigated the STarT Back Tool: performance for discriminating pain outcomes at follow-up was ‘non-informative’ (pooled AUC = 0.59 (0.55–0.63), n = 1153) and ‘acceptable’ for discriminating disability outcomes (pooled AUC = 0.74 (0.66–0.82), n = 821). Seven studies investigated the Orebro Musculoskeletal Pain Screening Questionnaire: performance was ‘poor’ for discriminating pain outcomes (pooled AUC = 0.69 (0.62–0.76), n = 360), ‘acceptable’ for disability outcomes (pooled AUC = 0.75 (0.69–0.82), n = 512), and ‘excellent’ for absenteeism outcomes (pooled AUC = 0.83 (0.75–0.90), n = 243). Two studies investigated the Vermont Disability Prediction Questionnaire and four further instruments were investigated in single studies only. Conclusions LBP screening instruments administered in primary care perform poorly at assigning higher risk scores to individuals who develop chronic pain than to those who do not. Risks of a poor disability outcome and prolonged absenteeism are likely to be estimated with greater accuracy. It is important that clinicians who use screening tools to obtain prognostic information consider the potential for misclassification of patient risk and its consequences for care decisions based on screening. However, it needs to be acknowledged that the outcomes on which we evaluated these screening instruments in some cases had a different threshold, outcome, and time period than those they were designed to predict. Systematic review registration PROSPERO international prospective register of systematic reviews registration number CRD42015015778. Electronic supplementary material The online version of this article (doi:10.1186/s12916-016-0774-4) contains supplementary material, which is available to authorized users.

Highlights • Patient education is recommended in the primary care management of acute low back pain. • The PREVENT Trial is the first placebo-controlled randomized trial to evaluate the efficacy of patient education. • Statistical analysis plans increase the transparency around how researchers plan to estimate and interpret treatment effects from randomized trials. • This protocol describes the pre-specified principles, methods, and procedures to be adhered to in the statistical analysis of the PREVENT trial data., Background Statistical analysis plans increase the transparency of decisions made in the analysis of clinical trial results. The purpose of this paper is to detail the planned analyses for the PREVENT trial, a randomized, placebo-controlled trial of patient education for acute low back pain. Results We report the pre-specified principles, methods, and procedures to be adhered to in the main analysis of the PREVENT trial data. The primary outcome analysis will be based on Mixed Models for Repeated Measures (MMRM), which can test treatment effects at specific time points, and the assumptions of this analysis are outlined. We also outline the treatment of secondary outcomes and planned sensitivity analyses. We provide decisions regarding the treatment of missing data, handling of descriptive and process measure data, and blinded review procedures. Conclusions Making public the pre-specified statistical analysis plan for the PREVENT trial minimizes the potential for bias in the analysis of trial data, and in the interpretation and reporting of trial results. Trial registration ACTRN12612001180808 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001180808)

Prognostic screening in patients with low back pain (LBP) offers a practical approach to guiding clinical decisions. Whether screening is helpful in secondary care is unclear. This prospective cohort study in adults with LBP placed on outpatient clinic waiting lists, compared the performance of the short-form Orebro Musculoskeletal Pain Screening Questionnaire, the Predicting the Inception of Chronic Pain Tool, and the STarT Back Tool. We assessed predictive validity for outcome at 4-month follow-up, by calculating estimates of discrimination, calibration, and overall performance. We applied a decision curve analysis approach to describe the clinical value of screening in this setting via comparison with a 'treat-all' strategy. Complete data were available for 89% of enrolled participants (n = 195). Eighty-four percent reported 'poor outcome' at follow-up. The area under the receiver operating characteristic curve (95% confidence interval) was .66 (.54-.78) for the Orebro Musculoskeletal Pain Screening Questionnaire, .61 (.49-.73) for the Predicting the Inception of Chronic Pain Tool, and .69 (.51-.80) for the STarT Back Tool. All instruments were miscalibrated and underestimated risk. The decision curve analysis indicated that, in this setting, prognostic screening does not add value over and above a treat-all approach. The potential for LBP patients to be misclassified using screening and the high incidence of nonrecovery indicate that care decisions should be made with the assumption that all patients are 'at risk.'. Perspective: This article presents a head-to-head comparison of 3 LBP screening instruments in a secondary care setting. Early patient screening is likely to hold little clinical value in this setting and care pathways that consider all patients at risk of a poor outcome are suggested to be most appropriate. Refereed/Peer-reviewed

Refereed/Peer-reviewed

Purpose: To determine whether emotional distress reported at the initial consultation affects subsequent healthcare use either directly or indirectly via moderating the influence of symptoms. Methods: Longitudinal observational study of 2891 participants consulting primary care for low back pain. Negative binomial regression models were constructed to estimate independent effects of emotional distress on healthcare use. Potential confounders were identified using directed acyclic graphs. Results: After the initial consultation, participants had a mean (SD) of one (1.2) visit for back pain over 3 months, and nine (14) visits for back pain over 12 months. Higher reports of anxiety during the initial consultation led to increased short-term healthcare use (IRR 1.06, 95 % CI 1.01–1.11) and higher reports of depression led to increased long-term healthcare use (IRR 1.04, 95 % CI 1.02–1.07). The effect sizes suggest that a patient with a high anxiety score (8/10) would consult 50 % more frequently over 3 months, and a person with a high depression score (8/10) would consult 30 % more frequently over 12 months, compared to a patient with equivalent pain and disability and no reported anxiety or depression. Conclusions: Emotional distress in the acute stage of low back pain increased subsequent consultation rates. Interventions that target emotional distress during the initial consultation are likely to reduce costly and potentially inappropriate future healthcare use for patients with non-specific low back pain. Refereed/Peer-reviewed

Introduction Around 40% of people presenting to primary care with an episode of acute low back pain develop chronic low back pain. In order to reduce the risk of developing chronic low back pain, effective secondary prevention strategies are needed. Early identification of at-risk patients allows clinicians to make informed decisions based on prognostic profile, and researchers to select appropriate participants for secondary prevention trials. The aim of this study is to develop and validate a prognostic screening tool that identifies patients with acute low back pain in primary care who are at risk of developing chronic low back pain. This paper describes the methods and analysis plan for the development and validation of the tool. Methods/analysis The prognostic screening tool will be developed using methods recommended by the Prognosis Research Strategy (PROGRESS) Group and reported using the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) statement. In the development stage, we will use data from 1248 patients recruited for a prospective cohort study of acute low back pain in primary care. We will construct 3 logistic regression models to predict chronic low back pain according to 3 definitions: any pain, high pain and disability at 3 months. In the validation stage, we will use data from a separate sample of 1643 patients with acute low back pain to assess the performance of each prognostic model. We will produce validation plots showing Nagelkerke R2 and Brier score (overall performance), area under the curve statistic (discrimination) and the calibration slope and intercept (calibration). Ethics and dissemination Ethical approval from the University of Sydney Ethics Committee was obtained for both of the original studies that we plan to analyse using the methods outlined in this protocol (Henschke et al, ref 11-2002/3/3144; Williams et al, ref 11638).

Disability is an important outcome from a clinical and public health perspective. However, it is unclear how disability develops in people with low back pain or neck pain. More specifically, the mechanisms by which pain leads to disability are not well understood. Mediation analysis is a way of investigating these mechanisms by examining the extent to which an intermediate variable explains the effect of an exposure on an outcome. This systematic review and meta-analysis aimed to identify and examine the extent to which putative mediators explain the effect of pain on disability in people with low back pain or neck pain. Five electronic databases were searched. We found 12 studies (N = 2961) that examined how pain leads to disability with mediation analysis. Standardized regression coefficients (β) of the indirect and total paths were pooled. We found evidence to show that self-efficacy (β = 0.23, 95% confidence interval [CI] = 0.10 to 0.34), psychological distress (β = 0.10, 95% CI = 0.01 to 0.18), and fear (β = 0.08, 95% CI = 0.01 to 0.14) mediated the relationship between pain and disability, but catastrophizing did not (β = 0.07, 95% CI = -0.06 to 0.19). The methodological quality of these studies was low, and we highlight potential areas for development. Nonetheless, the results suggest that there are significant mediating effects of self-efficacy, psychological distress, and fear, which underpins the direct targeting of these constructs in treatment.

Background Low back pain (LBP) is a major health problem. Globally it is responsible for the most years lived with disability. The most problematic type of LBP is chronic LBP (pain lasting longer than 3 mo); it has a poor prognosis and is costly, and interventions are only moderately effective. Targeting interventions according to risk profile is a promising approach to prevent the onset of chronic LBP. Developing accurate prognostic models is the first step. No validated prognostic models are available to accurately predict the onset of chronic LBP. The primary aim of this study was to develop and validate a prognostic model to estimate the risk of chronic LBP. Methods and Findings We used the PROGRESS framework to specify a priori methods, which we published in a study protocol. Data from 2,758 patients with acute LBP attending primary care in Australia between 5 November 2003 and 15 July 2005 (development sample, n = 1,230) and between 10 November 2009 and 5 February 2013 (external validation sample, n = 1,528) were used to develop and externally validate the model. The primary outcome was chronic LBP (ongoing pain at 3 mo). In all, 30% of the development sample and 19% of the external validation sample developed chronic LBP. In the external validation sample, the primary model (PICKUP) discriminated between those who did and did not develop chronic LBP with acceptable performance (area under the receiver operating characteristic curve 0.66 [95% CI 0.63 to 0.69]). Although model calibration was also acceptable in the external validation sample (intercept = −0.55, slope = 0.89), some miscalibration was observed for high-risk groups. The decision curve analysis estimated that, if decisions to recommend further intervention were based on risk scores, screening could lead to a net reduction of 40 unnecessary interventions for every 100 patients presenting to primary care compared to a “treat all” approach. Limitations of the method include the model being restricted to using prognostic factors measured in existing studies and using stepwise methods to specify the model. Limitations of the model include modest discrimination performance. The model also requires recalibration for local settings. Conclusions Based on its performance in these cohorts, this five-item prognostic model for patients with acute LBP may be a useful tool for estimating risk of chronic LBP. Further validation is required to determine whether screening with this model leads to a net reduction in unnecessary interventions provided to low-risk patients., Adrian Traeger and colleagues report the development and validation of a prognostiv model (PICKUP) for estimating risk of developing chronic low back pain., Author Summary Why Was This Study Done? A minority of patients who experience an episode of low back pain develop persistent (chronic) pain. Offering tests and treatments to all these patients exposes high numbers of low-risk patients to unnecessary intervention, which is very costly and potentially harmful. A tool to help healthcare practitioners accurately predict whether a patient with a recent episode of low back pain will develop persistent pain stands to greatly reduce the burden of low back pain on the health system and on patients. What Did the Researchers Do and Find? We developed a five-item screening questionnaire using study data from 1,230 patients with a recent episode of low back pain. We tested how well this screening questionnaire could predict the onset of persistent pain in a separate sample of 1,528 patients. We found that the screening questionnaire could predict the onset of persistent pain with acceptable levels accuracy (area under the receiver operating characteristic curve = 0.66 [95% CI 0.63 to 0.69]; intercept = 0.55, slope = 0.89). What Do These Findings Mean? This brief, easy-to-use screening questionnaire could help healthcare practitioners and researchers make an early estimate of a patient’s risk of persistent low back pain. The screening questionnaire predicted outcome more accurately in patients with low risk scores than in those with high risk scores. Screening patients with a recent episode of low back pain could reduce the number of unnecessary interventions provided to low-risk patients.