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Objectives: This study explored the relationship between sleep quality and next-day pain intensity for people with low back pain and investigated whether there was any evidence that this relationship was causal., Methods: We conducted a secondary analysis of an observational study that investigated sleep quality in people with low back pain. People with low back pain were recruited from primary care and the community. Sleep quality was measured with subjective (self-report) and objective (polysomnography (PSG)) measures. PSG analysis classifies sleep into stages, of which slow-wave sleep (SWS) is thought to have a key role in maintaining or increasing pain intensity. We drew directed acyclic graphs to identify possible confounders of the relationship between both measures of sleep quality, and pain intensity. We constructed two linear regression models to explore the effect of subjective and objective sleep quality on next-day pain intensity before and after confounder adjustment., Results: Thirty-nine participants were included in the study. For participants with low back pain, self-reported better quality sleep β=-0.38 (95% CI -0.63 to -0.13), or spending a greater proportion of time in SWS β=-0.12 (95% CI -0.22 to -0.02) was associated with lower next day pain intensity. After confounder adjustment, the effect reduced and was no longer significant for either self-reported β=-0.18 (95% CI -0.46 to 0.10), or SWS β=-0.08 (95% CI -0.18 to 0.03)., Conclusions: Sleep quality, whether measured by self-report or proportion of time in SWS, was associated with next day pain intensity for people with low back pain. However, this relationship is likely to be confounded and therefore not likely to be causal., (© 2023 Walter de Gruyter GmbH, Berlin/Boston.)

Importance: The effects of altered neural processing, defined as altering neural networks responsible for perceptions of pain and function, on chronic pain remains unclear., Objective: To estimate the effect of a graded sensorimotor retraining intervention (RESOLVE) on pain intensity in people with chronic low back pain., Design, Setting, and Participants: This parallel, 2-group, randomized clinical trial recruited participants with chronic (>3 months) nonspecific low back pain from primary care and community settings. A total of 276 adults were randomized (in a 1:1 ratio) to the intervention or sham procedure and attention control groups delivered by clinicians at a medical research institute in Sydney, Australia. The first participant was randomized on December 10, 2015, and the last was randomized on July 25, 2019. Follow-up was completed on February 3, 2020., Interventions: Participants randomized to the intervention group (n = 138) were asked to participate in 12 weekly clinical sessions and home training designed to educate them about and assist them with movement and physical activity while experiencing lower back pain. Participants randomized to the control group (n = 138) were asked to participate in 12 weekly clinical sessions and home training that required similar time as the intervention but did not focus on education, movement, and physical activity. The control group included sham laser and shortwave diathermy applied to the back and sham noninvasive brain stimulation., Main Outcomes and Measures: The primary outcome was pain intensity at 18 weeks, measured on an 11-point numerical rating scale (range, 0 [no pain] to 10 [worst pain imaginable]) for which the between-group minimum clinically important difference is 1.0 point., Results: Among 276 randomized patients (mean [SD] age, 46 [14.3] years; 138 [50%] women), 261 (95%) completed follow-up at 18 weeks. The mean pain intensity was 5.6 at baseline and 3.1 at 18 weeks in the intervention group and 5.8 at baseline and 4.0 at 18 weeks in the control group, with an estimated between-group mean difference at 18 weeks of -1.0 point ([95% CI, -1.5 to -0.4]; P = .001), favoring the intervention group., Conclusions and Relevance: In this randomized clinical trial conducted at a single center among patients with chronic low back pain, graded sensorimotor retraining, compared with a sham procedure and attention control, significantly improved pain intensity at 18 weeks. The improvements in pain intensity were small, and further research is needed to understand the generalizability of the findings., Trial Registration: ANZCTR Identifier: ACTRN12615000610538.

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., (© 2021 John Wiley & Sons Ltd.)

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., (Copyright © 2021 United States Association for the Study of Pain, Inc. Published by Elsevier Inc. All rights reserved.)

Question: Does feeling reassured after a consultation reduce future disability or healthcare use in people with acute low back pain (LBP)?, Design: Mediation analysis of a randomised, sham-controlled trial., Participants: Two hundred and two people with acute LBP at above average risk (high risk) of developing chronic LBP., Intervention: All participants received guideline-based care from their usual clinician. Participants received two additional 1-hour sessions of patient education focused on emphasising the benign nature of LBP or sham patient education that included active listening only., Outcome Measures: The two primary outcomes for this study were self-reported disability and healthcare use. The mediator was feeling reassured that LBP was not caused by serious illness., Results: Data from 194 (96%) participants and 178 (88%) participants were included in the analysis for disability and healthcare use outcome models, respectively. Feeling reassured did not mediate the effect of the intervention on disability (indirect effect -0.23, 95% CI -0.71 to 0.18) or healthcare use (indirect effect 0.00, 95% CI -0.04 to 0.04). Patient education intervention increased feeling reassured (1.14 points, 95% CI 0.43 to 1.85) compared with sham patient education. However, the mediator (ie, feeling reassured) did not reduce disability (-0.20 points, 95% CI -0.58 to 0.19) or healthcare use (OR 1.09, 95% CI 0.98 to 1.21)., Conclusion: Feeling reassured after a consultation did not lead to improvements in disability and healthcare use for people with acute LBP. Clinicians should reflect on the time that they allocate to reassuring their patients and consider reallocating time to other aspects of the consultation that could reduce disability and future healthcare use., Trial Registration: ACTRN12612001180808, study protocol https://osf.io/4tfaz/., (Copyright © 2021 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.)

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., (© 2021 Walter de Gruyter GmbH, Berlin/Boston.)

Background: Statistical analysis plans describe the planned data management and analysis for clinical trials. This supports transparent reporting and interpretation of clinical trial results. This paper reports the statistical analysis plan for the RESOLVE clinical trial. The RESOLVE trial assigned participants with chronic low back pain to graded sensory-motor precision training or sham-control., Results: We report the planned data management and analysis for the primary and secondary outcomes. The primary outcome is pain intensity at 18-weeks post randomization. We will use mixed-effects models to analyze the primary and secondary outcomes by intention-to-treat. We will report adverse effects in full. We also describe analyses if there is non-adherence to the interventions, data management procedures, and our planned reporting of results., Conclusion: This statistical analysis plan will minimize the potential for bias in the analysis and reporting of results from the RESOLVE trial., Trial Registration: ACTRN12615000610538 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368619)., (Copyright © 2020 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier España, S.L.U. All rights reserved.)

Objective: Systematic reviews of analgesics for low back pain generally include published data only. Obtaining data from unpublished trials is potentially important because they may impact effect sizes in meta-analyses. We determined whether including unpublished data from trial registries changes the effect sizes in meta-analyses of analgesics for low back pain., Study Design and Setting: Trial registries were searched for unpublished data that conformed to the inclusion criteria of n = 5 individual source systematic reviews. We reproduced the meta-analyses using data available from the original reviews and then reran the same analyses with the addition of new unpublished data., Results: Sixteen completed, unpublished, trials were eligible for inclusion in four of the source reviews. Data were available for five trials. We updated the analyses for two of the source reviews. The addition of data from two trials reduced the effect size of muscle relaxants, compared with sham, for recent-onset low back pain from -21.71 (95% CI: -28.23 to -15.19) to -2.34 (95% CI: -3.34 to -1.34) on a 0-100 scale for pain intensity. The addition of data from three trials (one enriched design) reduced the effect size of opioid analgesics, compared with sham, for chronic low back pain from -10.10 (95% CI: -12.81 to -7.39) to -9.31 (95% CI: -11.51 to -7.11). The effect reduced in the subgroup of enriched design studies, from -12.40 (95% CI: -16.90 to -7.91) to -11.34 (95% CI: -15.36 to -7.32), and in the subgroup of nonenriched design studies, from -7.27 (95% CI: -9.97 to -4.57) to -7.19 (95% CI: -9.24 to -5.14)., Conclusion: Systematic reviews should include reports of unpublished trials. The result for muscle relaxants conflicts with the conclusion of the published review and recent international guidelines. Adding unpublished data strengthens the evidence that opioid analgesics have small effects on persistent low back pain and more clearly suggests these effects may not be clinically meaningful., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Purpose: Despite the growing evidence that physical activity and familial factors play a role in low back pain (LBP), there is a lack of robust longitudinal studies that (1) investigate the types and dosages of physical activity that are protective or harmful for LBP, (2) employ objective measures of physical activity and (3) conduct appropriate adjustment for confounders. The AUstralian Twin BACK (AUTBACK) study was established to elucidate the longitudinal LBP-physical activity relationship with the benefits of controlling for familial (both genetic/nongenetic) factors that may influence physical activity engagement and LBP., Participants: Participants are twins registered at Twins Research Australia (TRA), older than 18 years, with access to internet. We collected data on LBP status (weekly) and physical activity levels (monthly) for 12 months as well as a wide range of health, lifestyle and physical activity (objective, self-reported, including different types and dosages) data., Findings to Date: We included 401 twins, 157 being complete twin pairs (n=314). Lifetime prevalence of LBP was 85%. Participants spent 61% of their week in sedentary time and only 4% in moderate/vigorous intensity physical activity (accelerometer). So far, 168 participants (40% of the sample) have completed the 12-month follow-up. A total of 7150 weekly (LBP status) and 1763 monthly questionnaires (physical activity status) have been answered (92% response rate)., Future Plans: The 12-month follow-up will be completed by June 2020. This cohort represents a novel and comprehensive resource for researchers in the field, and includes high-quality, and frequent data on LBP and physical activity. It allows the investigation of genetic and shared environmental factors on the LBP-physical activity relationship. The AUTBACK group has planned a number of projects, with the main one being the investigation of the influence of physical activity on recurrence of LBP. Data linkage opportunities are available, including with other studies conducted by TRA., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: One model of care that has not been tested for chronic low back pain (LBP) is patient-led goal setting. We aimed to compare the clinical effectiveness and healthcare use of a patient-led goal setting approach (intervention) with simple advice to exercise (control) over 12 months., Methods: An assessor-blinded randomised controlled trial. Intervention was education combined with patient-led goal setting compared with a control group receiving a standardised exercise programme. The primary outcomes were back pain disability and pain intensity. Secondary outcomes were quality of life, kinesiophobia, self-efficacy, depression, anxiety and stress. Outcomes and healthcare use were assessed immediately post-treatment (2 months) and after 4 and 12 months. Analysis was by intention to treat., Results: Seventy-five patients were randomly assigned to either the intervention (n=37) or the control (n=38) group. Using linear mixed model analyses, adjusted mean changes in primary outcomes of disability and pain intensity were greater in the intervention group than in the control group (disability post-treatment: p<0.05). These differences were clinically meaningful. Mean differences in all secondary measures were greater in the intervention group than in the control group (p<0.05). There was no difference in healthcare use between groups over 12 months., Conclusion: A patient-led goal setting intervention was significantly more effective than advice to exercise for improving outcomes in disability, pain intensity, quality of life, self-efficacy and kinesiophobia in chronic LBP. These improvements were maintained at 12 months. Smaller effects were seen in measures of depression, anxiety and stress., Trial Registration Number: ACTRN12614000830695., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

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.

Introduction: Goal setting, led by the patient, is promising as an effective treatment for the management of chronic low back pain (CLBP); however, little is known about current practice. The aims of the study were to explore (1) current goal setting practice in CLBP among physiotherapists; (2) perceived barriers to goal setting in CLBP; and (3) relationship between clinician's attitudes and beliefs and goal setting practice., Method: A cross-sectional observational survey., Results: The majority of respondents used goal setting with the main aim of facilitating self-management. The greatest number of goals were set with 50% therapist/50% patient involvement. The most common perceived barriers to goal setting related to time constraints and lack of skill and confidence. A higher biomedical score for treatment orientation of the therapist was associated with a lower patient involvement score., Conclusion: Goal setting is common practice for CLBP and is perceived as a high priority. It is more often a collaboration between therapist and patient rather than patient-led with treatment orientation of the physiotherapist a predictor of patient involvement. Education of healthcare professionals needs to include better understanding of chronic pain to orient them away from a biomedical treatment approach, as well as to enhance skills in facilitating patient involvement in goal setting.

Question: What influence do physiotherapists' beliefs and attitudes about chronic low back pain have on their clinical management of people with chronic low back pain?, Design: Systematic review with data from quantitative and qualitative studies. Quantitative and qualitative studies were included if they investigated an association between physiotherapists' attitudes and beliefs about chronic low back pain and their clinical management of people with chronic low back pain., Results: Five quantitative and five qualitative studies were included. Quantitative studies used measures of treatment orientation and fear avoidance to indicate physiotherapists' beliefs and attitudes about chronic low back pain. Quantitative studies showed that a higher biomedical orientation score (indicating a belief that pain and disability result from a specific structural impairment, and treatment is selected to address that impairment) was associated with: advice to delay return to work, advice to delay return to activity, and a belief that return to work or activity is a threat to the patient. Physiotherapists' fear avoidance scores were positively correlated with: increased certification of sick leave, advice to avoid return to work, and advice to avoid return to normal activity. Qualitative studies revealed two main themes attributed to beliefs and attitudes of physiotherapists who have a relationship to their management of chronic low back pain: treatment orientation and patient factors., Conclusion: Both quantitative and qualitative studies showed a relationship between treatment orientation and clinical practice. The inclusion of qualitative studies captured the influence of patient factors in clinical practice in chronic low back pain. There is a need to recognise that both beliefs and attitudes regarding treatment orientation of physiotherapists, and therapist-patient factors need to be considered when introducing new clinical practice models, so that the adoption of new clinical practice is maximised. [Gardner T, Refshauge K, Smith L, McAuley J, Hübscher M, Goodall S (2017) Physiotherapists' beliefs and attitudes influence clinical practice in chronic low back pain: a systematic review of quantitative and qualitative studies. Journal of Physiotherapy 63: 132-143]., (Copyright © 2017 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.)

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)., (Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.)

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.

Introduction: Low back pain is the leading worldwide cause of disability, and results in significant personal hardship. Most available treatments, when tested in high-quality randomised, controlled trials, achieve only modest improvements in pain, at best. Recently, treatments that target central nervous system function have been developed and tested in small studies. Combining treatments that target central nervous system function with traditional treatments directed towards functioning of the back is a promising approach that has yet to be tested in adequately powered, prospectively registered, clinical trials. The RESOLVE trial will be the first high-quality assessment of two treatment programs that combine central nervous system-directed and traditional interventions in order to improve chronic low back pain., Aim: To compare the effectiveness of two treatment programs that combine central nervous system-directed and traditional interventions at reducing pain intensity at 18 weeks post randomisation in a randomised clinical trial of people with chronic low back pain., Design: Two-group, randomised, clinical trial with blinding of participants and assessors., Participants and Setting: Two hundred and seventy-five participants with chronic low back pain that has persisted longer than 3 months and no specific spinal pathology will be recruited from the community and primary care in Sydney, Australia., Interventions: Both of the interventions contain treatments that target central nervous system function combined with treatments directed towards functioning of the back. Adherence to the intervention will be monitored using an individual treatment diary and adverse events recorded through passive capture. Participants are informed prior to providing informed consent that some of the treatments are not active. Blinding is maintained by not disclosing any further information. Complete disclosure of the contents of the intervention has been made with the UNSW HREC (HC15357) and an embargoed project registration has been made on the Open Science Framework to meet the Declaration of Helsinki requirement for transparent reporting of trial methods a priori., Intervention a: Participants randomised to Intervention A will receive a 12-session treatment program delivered as 60-minute sessions, scheduled approximately weekly, over a period of 12 to 18 weeks. All treatment sessions are one-on-one. The program includes a home treatment component of 30minutes, five times per week. The intervention comprises discussion of the participant's low back pain experience, graded sensory training, graded motor imagery training and graded, precision-focused and feedback-enriched, functional movement training. Treatment progression is determined by participant proficiency, with mandatory advancement at set time points with respect to a standard protocol., Intervention B: Participants randomised to Intervention B will receive a 12-session treatment program of the same duration and structure as Intervention A. The intervention comprises discussion of the participant's low back pain experience, transcranial direct current stimulation to the motor and pre-frontal cortices, cranial electrical stimulation, and low-intensity laser therapy and pulsed electromagnetic energy to the area of greatest pain. Treatment is delivered according to published recommendations and progressed with respect to a standard protocol., Measurements: The primary outcome is pain intensity at 18 weeks post randomisation. Secondary outcomes will include disability, depression, pain catastrophising, kinesiophobia, beliefs about back pain, pain self-efficacy, quality of life, healthcare resource use, and treatment credibility. Assessment will occur at baseline and at 18, 26 and 52 weeks after randomisation. Treatment credibility will be assessed at baseline and 2 weeks after randomisation only., Analysis: A statistician blinded to group status will analyse the data by intention-to-treat using linear mixed models with random intercepts. Linear contrasts will be constructed to compare the adjusted mean change (continuous variables) in outcome from baseline to each time point between intervention A and intervention B. This will provide effect estimates and 95% confidence intervals for any difference between the interventions., Significance: Preliminary data suggest that combining treatments that target central nervous system function with traditional interventions is a promising approach to chronic low back pain treatment. In the context of modest effects on pain intensity from most available treatments, this approach may lead to improved clinical outcomes for people with chronic low back pain. The trial will determine which, if either, of two treatment programs that combine central nervous system-directed and traditional interventions is more effective at reducing pain intensity in a chronic low back pain cohort. Central nervous system-directed interventions constitute a completely new treatment paradigm for chronic low back pain management. The results have the potential to be far reaching and change current physiotherapy management of chronic low back pain in Australia and internationally., (Copyright © 2016 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.)

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., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Low back pain (LBP) is a major health problem globally, but approaches to prevention are not yet clearly identified because modifiable risk factors are not well established. Although physical activity is one promising modifiable risk factor, it is still not known what types and doses of physical activity are protective or harmful for LBP. The aim of this study is to establish the feasibility of a definitive cohort study that will investigate the effects of different types and doses of physical activity on the risk of developing recurrent LBP while accounting for genetic factors. This will be a pilot longitudinal twin study and twins will be recruited from the Australian Twin Registry, and will be followed over 1 year. Thirty adult complete twin pairs with a history of LBP, but symptom free at recruitment, will be included. Data on physical activity (predictor) will be collected using four questionnaires and an objective measure (accelerometer) at baseline and at 6-month follow-up. Twins will also complete an additional physical activity questionnaire monthly. Data on LBP (outcome) will be collected at baseline and weekly. Data will be collected using short message service (SMS) and email. We will keep records of the recruitment rate, follow-up rate, and completeness of data. Barriers to completing the study will be investigated. The results of this study will inform the design and implementation of a future definitive study, which will help to clarify the effects of different types and doses of physical activity on the risk of developing recurrent LBP.

Study Design: A prospective, single-arm, pre-postintervention study., Objective: The aim of this study was to test the preliminary effectiveness of a patient-led goal-setting intervention on improving disability and pain in chronic low back pain., Summary of Background Data: An effective intervention for the treatment of chronic low back pain remains elusive despite extensive research into the area.An intervention using patient-centered goal setting to drive intervention strategies and encourage self-management for patients suffering chronic low back was developed., Methods: A single group longitudinal cohort pilot study was conducted. Twenty participants (male = nine) experiencing chronic low back pain were involved in a patient-led goal-setting intervention, facilitated by a physiotherapist over a 2-month period with two monthly follow-up sessions after treatment conclusion. Participants, guided by the therapist, identified problem areas of personal importance, defined goals, and developed evidence-based strategies to achieve the goals. Participants implemented the strategies independently between sessions. Primary outcome measures of disability and pain intensity were measured at baseline, 2, and 4 months. Secondary measures of quality of life, stress and anxiety, self-efficacy, and fear of movement were also taken., Results: Significant improvements (repeated analysis of variance P < 0.05) were seen in measures of disability, pain, fear avoidance, quality of life, and self-efficacy over the period of intervention and were maintained for a further 2 months after treatment conclusion., Conclusion: This intervention is novel because the goals set are based on patients' personal preferences, and not on treatment guidelines. Our findings confirm that a patient-centered goal-setting intervention is a potentially effective intervention for the management of chronic low back pain showing significant improvements in both quality of life and pain intensity., Level of Evidence: 4.

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.

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.

Purpose: To investigate whether depression symptomatology is associated with low back pain (LBP) in twins aged 70+ and whether this effect depends on a person's physical activity (PA) status., Methods: This prospective cohort and nested case-control study used a nationally representative sample of twins. Data on depression symptomatology (modified Cambridge Mental Disorders Examination) and self-reported PA were obtained from the Longitudinal Study of Aging Danish Twins using twins without LBP at baseline. Associations between depression symptomatology (highest quartile) at baseline and LBP two years later were investigated using logistic regression analyses adjusted for sex. To examine the moderating effect of PA, we tested its interaction with depression. Associations were analysed using the complete sample of 2446 twins and a matched case-control analysis of 97 twin pairs discordant for LBP at follow-up. Odds ratios (OR) with 95% confidence intervals (CI) were calculated., Results: Using the whole sample, high depression scores were associated with an increased probability of LBP (OR 1.56, 95% CI 1.22-1.99, P ≤ 0.01). There was no statistically significant interaction of light PA and depression symptomatology (OR 0.78, 95% CI 0.46-1.35, P = 0.39) and strenuous PA and depression symptomatology (0.84, 95% CI 0.50-1.41, P = 0.51). The case-control analysis showed similar ORs, although statistically insignificant., Conclusions: High depression symptomatology predicted incident LBP. This effect is supposedly not attributable to genetic or shared environmental factors. Physical activity did not moderate the effect of depression symptomatology on LBP.

Objective: To determine the extent of alignment between clinical outcome measures and patient-derived goals for the management of chronic low back pain (cLBP)., Methods: A customised, patient-led goal setting intervention was implemented facilitated by a physiotherapist, in which participants identified problem areas and developed strategies to address them. Patient goals were compared to the most commonly used outcome measures in cLBP as well as research outcomes recommended by the IMMPACT consortium., Results: From 20 participants, a total of 27 unique goals were identified, the most common goal related to physical activity (49%). Comparison of participant goals to the most common measures used by physiotherapists found none of the goals could be aligned. Comparison of goals and domains with IMPACCT outcome domains found 76% of the goals were aligned with physical functioning and 16% with emotional functioning., Conclusion: This study has identified goals important to patients in cLBP, these were varied, and most did not correspond with current clinical measures., Practice Implications: Clinical outcome measures may not be providing accurate information about the success of treatments that are meaningful to the patient. Clinicians should consider a collaborative approach with cLBP patients to determine treatment interventions that are driven by patient preference., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

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 R(2) 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)., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Introduction: Pain education is a complex intervention developed to help clinicians manage low back pain. Although complex interventions are usually evaluated by their effects on outcomes, such as pain or disability, most do not directly target these outcomes; instead, they target intermediate factors that are presumed to be associated with the outcomes. The mechanisms underlying treatment effects, or the effect of an intervention on an intermediate factor and its subsequent effect on outcome, are rarely investigated in clinical trials. This leaves a gap in the evidence for understanding how treatments exert their effects on outcomes. Mediation analysis provides a method for identifying and quantifying the mechanisms that underlie interventions., Aim: To determine whether the effect of pain education on pain and disability is mediated by changes in self-efficacy, catastrophisation and back pain beliefs., Design: Causal mediation analysis of the PREVENT randomised controlled trial., Participants and Setting: Two hundred and two participants with acute low back pain from primary care clinics in the Sydney metropolitan area., Intervention: Participants will be randomised to receive either 'pain education' (intervention group) or 'sham education' (control group)., Measurements: All outcome measures (including patient characteristics), primary outcome measures (pain and disability), and putative mediating variables (self-efficacy, catastrophisation and back pain beliefs) will be measured prior to randomisation. Putative mediators and primary outcome measures will be measured 1 week after the intervention, and primary outcome measures will be measured 3 months after the onset of low back pain., Analysis: Causal mediation analysis under the potential outcomes framework will be used to test single and multiple mediator models. A sensitivity analysis will be conducted to evaluate the robustness of the estimated mediation effects on the influence of violating sequential ignorability--a critical assumption for causal inference., Discussion and Significance: Mediation analysis of clinical trials can estimate how much the total effect of the treatment on the outcome is carried through an indirect path. Using mediation analysis to understand these mechanisms can generate evidence that can be used to tailor treatments and optimise treatment effects. In this study, the causal mediation effects of a pain education intervention for acute non-specific low back pain will be estimated. This knowledge is critical for further development and refinement of interventions for conditions such as low back pain., (Copyright © 2015 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.)

Importance: Reassurance is a core aspect of daily medical practice, yet little is known on how it can be achieved., Objective: To determine whether patient education in primary care increases reassurance in patients with acute or subacute low back pain (LBP)., Data Sources: Medline, EMBASE, Cochrane Central Register for Controlled Trials, and PsychINFO databases were searched to June 2014., Design: Systematic review and meta-analysis of randomized and nonrandomized clinical trials., Study Selection: To be eligible, studies needed to be controlled trials of patient education for LBP that were delivered in primary care and measured reassurance after the intervention. Eligibility criteria were applied, and studies were selected by 2 independent authors., Main Outcomes and Measures: The primary outcomes were reassurance in the short and long term and health care utilization at 12 months., Data Extraction and Synthesis: Data were extracted by 2 independent authors and entered into a standardized form. A random-effects meta-analysis tested the effects of patient education compared with usual care on measures of reassurance. To investigate the effect of study characteristics, we performed a preplanned subgroup analysis. Studies were stratified according to duration, content, and provider of patient education., Results: We included 14 trials (n=4872) of patient education interventions. Trials assessed reassurance with questionnaires of fear, worry, anxiety, catastrophization, and health care utilization. There is moderate- to high-quality evidence that patient education increases reassurance more than usual care/control education in the short term (standardized mean difference [SMD], -0.21; 95% CI, -0.35 to -0.06) and long term (SMD, -0.15; 95% CI, -0.27 to -0.03). Interventions delivered by physicians were significantly more reassuring than those delivered by other primary care practitioners (eg, physiotherapist or nurse). There is moderate-quality evidence that patient education reduces LBP-related primary care visits more than usual care/control education (SMD, -0.14; 95% CI, -0.28 to -0.00 at a 12-month follow-up). The number needed to treat to prevent 1 LBP-related visit to primary care was 17., Conclusions and Relevance: There is moderate- to high-quality evidence that patient education in primary care can provide long-term reassurance for patients with acute or subacute LBP.

Purpose: To evaluate the association between domestic and recreational physical activity (PA) and low back pain (LBP) after adjusting for genetic and environmental influences., Methods: Twins were recruited through the Australian twin registry. LBP prevalence and domestic (vigorous gardening/heavy yard work) and recreational (light walking, moderate/vigorous) PA were assessed by a validated questionnaire. Associations were analysed using a cross-sectional analysis of the complete sample of 486 twins, including a matched case-control analysis of 69 twin pairs discordant for LBP. Logistic regression and the lincom post-estimation method were used for the analysis. Odds ratios (OR) with 95 % confidence intervals (CIs) were calculated., Results: The case-control analysis showed that LBP was significantly associated with heavy domestic PA (OR 2.88, 95 % CI 1.29-6.43), whereas no significant association was found with any form of recreational PA. The results of the lincom command indicated that being engaged in both heavy domestic and recreational PA (light walking or moderate/vigorous) was associated with a significantly increased probability of LBP compared with being engaged only in recreational PA (light walking or moderate/vigorous, ORs 3.48-4.22). Using the whole sample, we found weaker associations but in the same direction., Conclusions: We found evidence that heavy domestic PA is associated with an increased probability of LBP, and the combination of heavy domestic and recreational PA might increase the probability of LBP more so than heavy domestic or recreational PA alone. Associations being greater when using the co-twin case-control analysis indicate that genetic and environmental factors influence the relationship between PA and LBP, and demonstrate the value of a twin design.

Objectives: Quantitative sensory testing (QST) has been used to elucidate the peripheral and central mechanisms that underlie changes in pain sensitivity associated with low back pain (LBP). However, it remains unclear to what degree peripheral and central changes contribute to the generation and maintenance of LBP. The aim of this study was to compare thermal pain sensitivity, measured using QST, in participants with acute LBP, chronic LBP, and pain-free controls., Materials and Methods: Participant groups with acute LBP (N=20), chronic LBP (N=30), and pain-free controls (N=30) were assessed by thermal QST. The unique contributions of pain-related psychological and QST variables to predict membership to the acute and chronic pain groups were also determined., Results: We found that participants with chronic LBP demonstrated significantly lower cold pain threshold (CPT) in the primary area of pain (low back) as well as in an area anatomically remote from the primary area of pain (forearm) when compared with controls. Participants with acute LBP did not show significantly elevated pain sensitivity. CPT at the remote site was a significant independent predictor of membership to the chronic pain group, after the adjustment for mood and pain catastrophizing. CPT explained 8% of the total variance of 46% related to group membership., Discussion: We found evidence for localized and generalized cold hyperalgesia in chronic, but not acute LBP. We might speculate that hyperalgesia develops as a consequence of long-lasting LBP, but prospective studies are needed to confirm this assumption.

Introduction: Low back pain (LBP) is the leading cause of disability worldwide. Of those patients who present to primary care with acute LBP, 40% continue to report symptoms 3 months later and develop chronic LBP. Although it is possible to identify these patients early, effective interventions to improve their outcomes are not available. This double-blind (participant/outcome assessor) randomised controlled trial will investigate the efficacy of a brief educational approach to prevent chronic LBP in 'at-risk' individuals., Methods/analysis: Participants will be recruited from primary care practices in the Sydney metropolitan area. To be eligible for inclusion participants will be aged 18-75 years, with acute LBP (<4 weeks' duration) preceded by at least a 1 month pain-free period and at-risk of developing chronic LBP. Potential participants with chronic spinal pain and those with suspected serious spinal pathology will be excluded. Eligible participants who agree to take part will be randomly allocated to receive 2×1 h sessions of pain biology education or 2×1 h sessions of sham education from a specially trained study physiotherapist. The study requires 101 participants per group to detect a 1-point difference in pain intensity 3 months after pain onset. Secondary outcomes include the incidence of chronic LBP, disability, pain intensity, depression, healthcare utilisation, pain attitudes and beliefs, global recovery and recurrence and are measured at 1 week post-intervention, and at 3, 6 and 12 months post LBP onset., Ethics/dissemination: Ethical approval was obtained from the University of New South Wales Human Ethics Committee in June 2013 (ref number HC12664). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings., Trial Registration Number: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001180808., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Sensitization of the nervous system can present as pain hypersensitivity that may contribute to clinical pain. In spinal pain, however, the relationship between sensory hypersensitivity and clinical pain remains unclear. This systematic review examined the relationship between pain sensitivity measured via quantitative sensory testing (QST) and self-reported pain or pain-related disability in people with spinal pain. Electronic databases and reference lists were searched. Correlation coefficients for the relationship between QST and pain intensity or disability were pooled using random effects models. Subgroup analyses and mixed effects meta-regression were used to assess whether the strength of the relationship was moderated by variables related to the QST method or pain condition. One hundred and forty-five effect sizes from 40 studies were included in the meta-analysis. Pooled estimates for the correlation between pain threshold and pain intensity were -0.15 (95% confidence interval [CI]: -0.18 to -0.11) and for disability -0.16 (95% CI: -0.22 to -0.10). Subgroup analyses and meta-regression did not provide evidence that these relationships were moderated by the QST testing site (primary pain/remote), pain condition (back/neck pain), pain type (acute/chronic), or type of pain induction stimulus (eg, mechanical/thermal). Fair correlations were found for the relationship between pain intensity and thermal temporal summation (0.26, 95% CI: 0.09 to 0.42) or pain tolerance (-0.30, 95% CI: -0.45 to -0.13), but only a few studies were available. Our study indicates either that pain threshold is a poor marker of central sensitization or that sensitization does not play a major role in patients' reporting of pain and disability. Future research prospects are discussed. [ABSTRACT FROM AUTHOR]