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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

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).

[eng] More than one decade after the global crisis of 2008 had started, many Spanish cities entered a phase of post-crisis, marked by a positive macroeconomic setting. Tourism, as a coping strategy, has contributed to this growth, but it has also led to numerous conflicts, summarized by the emerging discussion about overtourism. In Santa Cruz de Tenerife (Spain), the arrival of short-term rentals is associated with a new crisis on the housing market, as the city shows one of the highest growth rates in rental prices in Spain and a severe shortage on the rental market. This paper analyzes how local stakeholders perceive the ongoing process between crisis, post-crisis and overtourism using qualitative interviews. The conducted material reveals that the housing crisis is linked to the effects of overtourism. However, the causes are multi-faceted and a consequence of the 2008 crisis. This is shown by different aspects, such as housing supply, socio-economic vulnerabilities of residents and political issues. Tourism and housing are both cause and result of this complex relationship between crisis and post-crisis. Hence, coping strategies need to address the underlying structures to overcome the crisis symptoms., [spa] ciudades españolas han entrado en una fase de post-crisis, marcada por un entorno macroeconómico positivo. El turismo ha contribuido a este crecimiento, pero también ha causado conflictos, discutidos bajo el concepto de sobreturismo. En Santa Cruz de Tenerife, se plantea la hipótesis de que la llegada de la vivienda vacacional ha provocado una nueva crisis en el mercado inmobiliario, ya que la ciudad muestra una de las mayores tasas de crecimiento en los precios de alquiler en España y una escasez en el mercado. Este ensayo analiza como los actores locales perciben esta situación entre crisis, postcrisis y sobreturismo mediante entrevistas cualitativas. El material revela que la crisis de la vivienda está vinculada a los efectos del sobreturismo. Sin embargo, las causas son multifacéticas y una consecuencia de la crisis de 2008. Esto se muestra en la producción de viviendas, las vulnerabilidades socioeconómicas y cuestiones políticas. El turismo y la vivienda son a la vez causa y resultado de esta compleja relación entre crisis y post-crisis. Por lo tanto, las estrategias de afrontamiento deben abordar las estructuras subyacentes para superar los síntomas de la crisis.

© Author(s) (or their employer(s)) 2019. 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.

© 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

Background: Worldwide, the incidence of wrist fracture is increasing. There are currently no externally validated prognostic models to inform early decision making for these patients. Objectives: 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. Methods: 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. Results: 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). Conclusion: 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. Level of Evidence: Prognosis, level 1b.

© 2018, © 2018 Taylor & Francis. 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.

OBJECTIVES: Pain sensitivity and psychosocial issues are prognostic of poor outcome in acute neck disorders. However, knowledge of associations between pain sensitivity and ongoing pain and disability in chronic neck pain are lacking. We aimed to investigate associations of pain sensitivity with pain and disability at the 12-month follow-up in people with chronic neck pain. METHODS: The predictor variables were: clinical and quantitative sensory testing (cold, pressure); neural tissue sensitivity; neuropathic symptoms; comorbidities; sleep; psychological distress; pain catastrophizing; pain intensity (for the model explaining disability at 12 months only); and disability (for the model explaining pain at 12 months only). Data were analysed using uni- and multivariate regression models to assess associations with pain and disability at the 12-month follow-up (n = 64 at baseline, n = 51 at follow-up). RESULTS: Univariable associations between all predictor variables and pain and disability were evident (r > 0.3; p < 0.05), except for cold and pressure pain thresholds and cold sensitivity. For disability at the 12-month follow-up, 24.0% of the variance was explained by psychological distress and comorbidities. For pain at 12 months, 39.8% of the variance was explained primarily by baseline disability. CONCLUSIONS: Neither clinical nor quantitative measures of pain sensitivity were meaningfully associated with long-term patient-reported outcomes in people with chronic neck pain, limiting their clinical application in evaluating prognosis.

© 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia 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)

© 2016 Australian Physiotherapy Association 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

© 2017 Australian Physiotherapy Association 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

© 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.

© The Author(s) 2017. 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.

In recent years, there has been increasing interest in studying causal mechanisms in the development and treatment of back pain. The aim of this article is to provide an overview of our current understanding of causal mechanisms in the field. In the first section, we introduce key concepts and terminology. In the second section, we provide a brief synopsis of systematic reviews of mechanism studies relevant to the clinical course and treatment of back pain. In the third section, we reflect on the findings of our review to explain how understanding causal mechanisms can inform clinical practice and the implementation of best practice. In the final sections, we introduce contemporary methodological advances, highlight the key assumptions of these methods, and discuss future directions to advance the quality of mechanism-related studies in the back pain field.

BACKGROUND: Correlations between clinical and quantitative measures of pain sensitivity are poor, making it difficult for clinicians to detect people with pain sensitivity. Clinical detection of pain sensitivity is important because these people have a different prognosis and may require different treatment. OBJECTIVE: The purpose of this study was to investigate the relationship between clinical and quantitative measures of pain sensitivity across individuals with and without neck pain. METHODS: This cross-sectional study included 40 participants with chronic neck pain and 40 age- and sex-matched controls. Participants underwent quantitative sensory testing of cold pain thresholds (CPTs) and pressure pain thresholds (PPTs). Clinical tests for pain sensitivity were the ice pain test and the pressure pain test. All tests were undertaken at standardized local (neck and upper trapezius muscles) and remote (wrist and tibialis anterior muscles) sites. Median and interquartile range (IQR) were calculated for neck pain and control groups, and parametric and nonparametric tests were used to compare groups. Correlation coefficients were calculated between quantitative and clinical measures. RESULTS: There were significant differences for clinical and quantitative measures of cold and pressure sensitivity between the neck pain and control groups (eg, CPT neck pain group: median=22.31°C, IQR=18.58°C; control group: median=5.0°C, IQR=0.74°C). Moderate-to-good correlations were found between the clinical ice pain test and CPT at all sites (.46 to .68) except at the wrist (.29 to .40). Fair correlations were found for the clinical pressure pain test and PPT (-.26 to -.45). Psychological variables contributing to quantitative measures of pain sensitivity included catastrophization, sleep quality, and female sex. LIMITATIONS: Clinical pressure pain tests were not quantitatively standardized in this study. CONCLUSIONS: The ice pain test may be useful as a clinical correlate of CPT a

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 2x1 h sessions of pain biology education or 2x1 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.