Search

Pre-print of statistical analysis plan for the RESOLVE trial for people with chronic low back pain

Sensitivity analysis of recent meta-analyses of pharmacological interventions for pain in people with low back pain

A randomised clinical trial for chronic low back pain

Additional file 2. Secondary Outcomes

Additional file 1. PRISMA Checklist

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.

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.

© 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.

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.

Background Back pain is a global health problem. Recent research has shown that risk factors that are proximal to the onset of back pain might be important targets for preventive interventions. Rapid communication through social media might be useful for delivering timely interventions that target proximal risk factors. Identifying individuals who are likely to discuss back pain on Twitter could provide useful information to guide online interventions. Methods We used a case-crossover study design for a sample of 742 028 tweets about back pain to quantify the risks associated with a new tweet about back pain. Results The odds of tweeting about back pain just after tweeting about selected physical, psychological, and general health factors were 1.83 (95% confidence interval [CI], 1.80-1.85), 1.85 (95% CI: 1.83-1.88), and 1.29 (95% CI, 1.27-1.30), respectively. Conclusion These findings give directions for future research that could use social media for innovative public health interventions.

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.

Chronic musculoskeletal pain (CMP) refers to ongoing pain felt in the bones, joints and tissues of the body that persists longer than 3 months. For these conditions, it is widely accepted that secondary pathologies or the consequences of persistent pain, including fear of movement, pain catastrophizing, anxiety and nervous system sensitization appear to be the main contributors to pain and disability. While exercise is a primary treatment modality for CMP, the intent is often to improve physical function with less attention to secondary pathologies. Exercise interventions for CMP which address secondary pathologies align with contemporary pain rehabilitation practices and have greater potential to improve patient outcomes above exercise alone. Biopsychosocial treatment which acknowledges and addresses the biological, psychological and social contributions to pain and disability is currently seen as the most efficacious approach to chronic pain. This clinical update discusses key aspects of a biopsychosocial approach concerning exercise prescription for CMP and considers both patient needs and clinician competencies. There is consensus for individualized, supervised exercise based on patient presentation, goals and preference that is perceived as safe and non-threatening to avoid fostering unhelpful associations between physical activity and pain. The weight of evidence supporting exercise for CMP has been provided by aerobic and resistance exercise studies, although there is considerable uncertainty on how to best apply the findings to exercise prescription. In this clinical update, we also provide evidence-based guidance on exercise prescription for CMP through a synthesis of published work within the field of exercise and CMP rehabilitation. 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).

Background Movement restriction has been proposed as an important modulator of changes in sensory and perceptual function and motor imagery performance that are observed in musculoskeletal pain syndromes. There are no empirical data to support this view. Purpose The primary objective of this experiment was to determine the effects of movement restriction on local and widespread sensory, perceptual and motor imagery changes after exercise-induced muscular pain. Further objectives were to investigate whether changes in sensory perception are correlated with pain intensity and tactile acuity or motor imagery performance. Methods In forty healthy volunteers, delayed onset muscle soreness (DOMS) of the non-dominant elbow flexors was induced using eccentric contractions until exhaustion.Participants were then randomised into two groups:a movement restriction group (wearing a sling) or a control group (not wearing a sling). Sensory and perceptual functions were measured using a range of sensory tests and a motor imagery performance task (left/right limb judgements). Results Movement restriction did not modulate any of the measures. We found concurrent mechanical hypoesthesia (p < 0.01), reduced tactile acuity (p = 0.02) and pressure hyperalgesia (p < 0.01) at the painful side. We found evidence of widespread pressure hyperalgesia. Impaired tactile acuity was associated with a decrease in pain threshold to pressure (r = −0.34, p = 0.03). Motor imagery performance was unchanged (p > 0.35) by pain or movement restriction. Conclusion Short-term movement restriction did notinfluence local and widespread sensory changes induced by experimentally induced muscular pain. Refereed/Peer-reviewed

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.