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RATIONALE: Fatigue affects almost half of all people living with stroke. Stroke survivors rank understanding fatigue and how to reduce it as one of the highest research priorities. METHODS: We convened an interdisciplinary, international group of clinical and pre-clinical researchers and lived experience experts. We identified four priority areas: (1) best measurement tools for research, (2) clinical identification of fatigue and potentially modifiable causes, (3) promising interventions and recommendations for future trials, and (4) possible biological mechanisms of fatigue. Cross-cutting themes were aphasia and the voice of people with lived experience. Working parties were formed and structured consensus building processes were followed. RESULTS: We present 20 recommendations covering outcome measures for research, development, and testing of new interventions and priority areas for future research on the biology of post-stroke fatigue. We developed and recommend the use of the Stroke Fatigue Clinical Assessment Tool. CONCLUSIONS: By synthesizing current knowledge in post-stroke fatigue across clinical and pre-clinical fields, our work provides a roadmap for future research into post-stroke fatigue.

RATIONALE: Fatigue affects almost half of all people living with stroke. Stroke survivors rank understanding fatigue and how to reduce it as one of the highest research priorities. METHODS: We convened an interdisciplinary, international group of clinical and pre-clinical researchers and lived experience experts. We identified four priority areas: (1) best measurement tools for research, (2) clinical identification of fatigue and potentially modifiable causes, (3) promising interventions and recommendations for future trials, and (4) possible biological mechanisms of fatigue. Cross-cutting themes were aphasia and the voice of people with lived experience. Working parties were formed and structured consensus building processes were followed. RESULTS: We present 20 recommendations covering outcome measures for research, development, and testing of new interventions and priority areas for future research on the biology of post-stroke fatigue. We developed and recommend the use of the Stroke Fatigue Clinical Assessment Tool. CONCLUSIONS: By synthesizing current knowledge in post-stroke fatigue across clinical and pre-clinical fields, our work provides a roadmap for future research into post-stroke fatigue.

OBJECTIVES: An important part of providing pain science education is to first assess baseline knowledge and beliefs about pain, thereby identifying misconceptions and establishing individually-tailored learning objectives. The Concept of Pain Inventory (COPI) was developed to support this need. This study aimed to characterize the concept of pain in care-seeking youth and their parents, to examine its clinical and demographic correlates, and to identify conceptual gaps. MATERIALS AND METHODS: Following an initial interdisciplinary evaluation, a cohort of 127 youth aged 8 to 18 years, and their parents, completed a series of questionnaires. RESULTS: Parents had slightly higher COPI scores than youth did, reflecting parents' greater alignment with contemporary pain science. The moderate positive association with older age among youth ( r =.32) suggests that COPI is sensitive to cognitive development and life experiences. Youth and parent COPI responses were weakly associated ( r =0.24), highlighting the importance of targeting the concept of pain in both groups. For both parents and youth, 'Learning about pain can help you feel less pain' was the least endorsed concept. This conceptual 'gap' is a key point of intervention that could potentially lead to greater engagement with multidisciplinary pain treatment. DISCUSSION: The COPI appears useful for identifying conceptual gaps or 'sticking points'; this may be an important step to pre-emptively address misconceptions about pain through pain science education. Future research should determine the utility of COPI in assessing and treating youth seeking care for pain. The COPI may be a useful tool for tailoring pain science education to youth and their parents.

OBJECTIVES: An important part of providing pain science education is to first assess baseline knowledge and beliefs about pain, thereby identifying misconceptions and establishing individually-tailored learning objectives. The Concept of Pain Inventory (COPI) was developed to support this need. This study aimed to characterize the concept of pain in care-seeking youth and their parents, to examine its clinical and demographic correlates, and to identify conceptual gaps. MATERIALS AND METHODS: Following an initial interdisciplinary evaluation, a cohort of 127 youth aged 8 to 18 years, and their parents, completed a series of questionnaires. RESULTS: Parents had slightly higher COPI scores than youth did, reflecting parents' greater alignment with contemporary pain science. The moderate positive association with older age among youth ( r =.32) suggests that COPI is sensitive to cognitive development and life experiences. Youth and parent COPI responses were weakly associated ( r =0.24), highlighting the importance of targeting the concept of pain in both groups. For both parents and youth, 'Learning about pain can help you feel less pain' was the least endorsed concept. This conceptual 'gap' is a key point of intervention that could potentially lead to greater engagement with multidisciplinary pain treatment. DISCUSSION: The COPI appears useful for identifying conceptual gaps or 'sticking points'; this may be an important step to pre-emptively address misconceptions about pain through pain science education. Future research should determine the utility of COPI in assessing and treating youth seeking care for pain. The COPI may be a useful tool for tailoring pain science education to youth and their parents.

Contemporary conceptualizations of pain emphasize its protective function. The meaning assigned to pain drives cognitive, emotional, and behavioral responses. When pain is threatening and a person lacks control over their pain experience, it can become distressing, self-perpetuating, and disabling. Although the pathway to disability is well established, the pathway to recovery is less researched and understood. This Perspective draws on recent data on the lived experience of people with pain-related fear to discuss both fear and safety-learning processes and their implications for recovery for people living with pain. Recovery is here defined as achievement of control over pain as well as improvement in functional capacity and quality of life. Based on the common-sense model, this Perspective proposes a framework utilizing Cognitive Functional Therapy to promote safety learning. A process is described in which experiential learning combined with "sense making" disrupts a person's unhelpful cognitive representation and behavioral and emotional response to pain, leading them on a journey to recovery. This framework incorporates principles of inhibitory processing that are fundamental to pain-related fear and safety learning.

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: Chronic pain and body perception disturbance are common following stroke. It is possible that an interaction exists between pain and body perception disturbance, and that a change in one may influence the other. We therefore investigated the presence of body perception disturbance in individuals with stroke, aiming to determine if a perceived change in hand size contralateral to the stroke lesion is more common in those with chronic pain than in those without. METHODS: Stroke survivors (N = 523) completed an online survey that included: stroke details, pain features, and any difference in perceived hand size post-stroke. RESULTS: Individuals with stroke who experienced chronic pain were almost three times as likely as those without chronic pain to perceive their hand as now being a different size (OR = 2.895; 95%CI 1.844, 4.547). Further, those with chronic pain whose pain included the hand were almost twice as likely to perceive altered hand size than those whose pain did not include the hand (OR = 1.862; 95%CI 1.170, 2.962). This was not influenced by hemisphere of lesion (p = 0.190). CONCLUSIONS: The results point to a new characteristic of chronic pain in stroke, raising the possibility of body perception disturbance being a rehabilitation target to improve function and pain-related outcomes for stroke survivors.

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: Despite well-established benefits of physical activity for knee osteoarthritis (OA), nine of ten people with knee OA are inactive. People with knee OA who are inactive often believe that physical activity is dangerous, fearing that it will further damage their joint(s). Such unhelpful beliefs can negatively influence physical activity levels. We aim to evaluate the clinical- and cost-effectiveness of integrating physiotherapist-delivered pain science education (PSE), an evidence-based conceptual change intervention targeting unhelpful pain beliefs by increasing pain knowledge, with an individualised walking, strengthening, and general education program. METHODS: Two-arm, parallel-design, multicentre randomised controlled trial involving 198 people aged ≥50 years with painful knee OA who do not meet physical activity guideline recommendations or walk regularly for exercise. Both groups receive an individualised physiotherapist-led walking, strengthening, and OA/activity education program via 4x weekly in-person treatment sessions, followed by 4 weeks of at-home activities (weekly check-in via telehealth), with follow-up sessions at 3 months (telehealth) and 5 and 9 months (in-person). The EPIPHA-KNEE group also receives contemporary PSE about OA/pain and activity, embedded into all aspects of the intervention. Outcomes are assessed at baseline, 12 weeks, 6 and 12 months. Primary outcomes are physical activity level (step count; wrist-based accelerometry) and self-reported knee symptoms (WOMAC Total score) at 12 months. Secondary outcomes are quality of life, pain intensity, global rating of change, self-efficacy, pain catastrophising, depression, anxiety, stress, fear of movement, knee awareness, OA/activity conceptualisation, and self-regulated learning ability. Additional measures include adherence, adverse events, blinding success, COVID-19 impact on activity, intention to exercise, treatment expectancy/perceived credibility, implicit movement/environm

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).

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).

INTRODUCTION: Nine of 10 people with knee osteoarthritis are inactive. Unhelpful pain beliefs may negatively influence physical activity levels. Targeting these unhelpful pain beliefs, through contemporary pain science education (PSE), may provide benefit. OBJECTIVES: To evaluate the feasibility of conducting a clinical trial to determine the effect of adding PSE (vs adding sham ultrasound) to an individualised, physiotherapist-led education and walking program in people with painful knee osteoarthritis. METHODS: Twenty participants were randomised (1:1) into the PSE group or Control group, each receiving 4 in-person weekly treatments, then 4 weeks of at-home activities (weekly telephone check-in). Clinical outcomes and physical activity (7 days of wrist-worn accelerometry) were assessed at baseline, 4 (clinical outcomes only), 8, and 26 weeks. A priori feasibility criteria for recruitment, intervention adherence, viability of wrist-based accelerometry, and follow-up retention were set. Perceived intervention credibility, acceptability, and usefulness from participants and clinicians were assessed (ratings, written/verbal feedback). RESULTS: Most feasibility criteria were met. On average, 7 adults/wk were eligible, with 70% recruited. Treatment compliance was high (in-person: 80% PSE; 100% Control; at-home: 78% PSE; 75% Control). Wrist-based accelerometry had >75% valid wear-time. Sufficient follow-up rates were not achieved (26 weeks: 65%). Participant and clinician feedback highlighted that PSE was too complex and did not match patient expectations of "physiotherapy", that sham ultrasound was problematic (clinician), but that both treatments had high credibility, acceptability, and usefulness. CONCLUSIONS: Progression to a full trial is warranted. Strategies to increase participant retention, refine the PSE content/delivery, and replace/remove the sham intervention are required.

Engaging youth in evidence‐based health education has the capacity to positively impact their experiences of health and illness across the lifespan. In particular, pain science education is now an established part of the treatment arsenal for persistent pain conditions in adults, and there are calls to build educational resources for youth with pain. In this paper, we argue that high‐quality online animated videos are a potentially excellent medium to engage youth at a mass level in pain science education. We present and compare two collaborations between clinician‐scientists and industry to create and disseminate online animated videos for pain science education (“Mysterious Science of Pain” and “Tame the Beast”). We discuss the advantages, disadvantages, and methods of evaluation for each approach, as well as summarizing overall lessons learned. We provide this information as a guiding framework for clinician‐scientists to collaborate with industry in building engaging and impactful health education resources for young people.

Engaging youth in evidence‐based health education has the capacity to positively impact their experiences of health and illness across the lifespan. In particular, pain science education is now an established part of the treatment arsenal for persistent pain conditions in adults, and there are calls to build educational resources for youth with pain. In this paper, we argue that high‐quality online animated videos are a potentially excellent medium to engage youth at a mass level in pain science education. We present and compare two collaborations between clinician‐scientists and industry to create and disseminate online animated videos for pain science education (“Mysterious Science of Pain” and “Tame the Beast”). We discuss the advantages, disadvantages, and methods of evaluation for each approach, as well as summarizing overall lessons learned. We provide this information as a guiding framework for clinician‐scientists to collaborate with industry in building engaging and impactful health education resources for young people.

It has long been thought that severe chronic pain conditions, such as complex regional pain syndrome (CRPS), are not only associated with, but even maintained by a reorganization of the somatotopic representation of the affected limb in primary somatosensory cortex (S1). This notion has driven treatments that aim to restore S1 representations in CRPS patients, such as sensory discrimination training and mirror therapy. However, this notion is based on both indirect and incomplete evidence obtained with imaging methods with low spatial resolution. Here, we used fMRI to characterize the S1 representation of the affected and unaffected hand in humans (of either sex) with unilateral CRPS. The cortical area, location, and geometry of the S1 representation of the CRPS hand were largely comparable with those of both the unaffected hand and healthy controls. We found no differential relation between affected versus unaffected hand map measures and clinical measures (pain severity, upper limb disability, disease duration). Thus, if any map reorganization occurs, it does not appear to be directly related to pain and disease severity. These findings compel us to reconsider the cortical mechanisms underlying CRPS and the rationale for interventions that aim to "restore" somatotopic representations to treat pain.

Background: Persistent pain is a prevalent condition that negatively influences physical, emotional, social and family functioning in adolescents. Pain science education is a promising therapy for adults, yet to be thoroughly investigated for persistent pain in adolescents. There is a need to develop suitable curricula for adolescent pain science education. Methods: An interdisciplinary meeting of 12 clinicians and researchers was held during March 2018 in Adelaide, South Australia. An a priori objective of the meeting was to identify and gain consensus on key learning objectives for adolescent pain science education using a modified-Delphi process. Results and Conclusion: Consensus was reached via a modified Delphi process for seven learning objectives to form the foundation of a curriculum: 1) Pain is a protector; 2) The pain system can become overprotective; 3) Pain is a brain output; 4) Pain is not an accurate marker of tissue state; 5) There are many potential contributors to anyone's pain; 6) We are all bioplastic and; 7) Pain education is treatment. Recommendations are made for promising areas for future research in adolescent pain science education.

OBJECTIVES: The Internet in general, and YouTube in particular, is now one of the most popular sources of health-related information. Pain neuroscience education has become a primary tool for managing persistent pain, based in part on the discovery that information about pain can change pain. Our objective was to examine the availability, characteristics, and content of YouTube videos that address the neuroscience of pain. METHODS: We conducted a systematic review of videos on YouTube using the search terms "pain education", "what is pain", and "pain brain" in January 2018. Videos were included if they were in English, were under 10 minutes long, and included information on the neuroscience of pain. Videos were coded for (i) descriptive characteristics (e.g., number of views, duration on YouTube), (ii) source and style, (iii) whether or not they addressed seven pre-determined target concepts of pain neuroscience education (e.g., 'Pain is not an accurate marker of tissue state'), and (iv) how engaging they were. RESULTS: We found 106 unique videos that met the inclusion criteria. The videos ranged from having four views to over five million views (Mdn = 1,163 views), with the three most highly viewed videos accounting for 75% of the total views. Animated videos were much more highly viewed than non-animated videos. Only a small number of videos had been posted by a clearly-identifiable reputable source such as an academic or medical institution (10%), although a number of videos were posted by healthcare professionals and professional medical societies. For a small number of videos (7%), the source was unclear. We found 17 videos that addressed at least one target concept of pain neuroscience science education, only nine of which were considered to be at least somewhat engaging. The target concept 'Pain is a brain output' was considered to be well addressed by the most videos (N = 11), followed by 'Pain is a protector' (N = 10). We found only one video that adequatel

OBJECTIVES: The Internet in general, and YouTube in particular, is now one of the most popular sources of health-related information. Pain neuroscience education has become a primary tool for managing persistent pain, based in part on the discovery that information about pain can change pain. Our objective was to examine the availability, characteristics, and content of YouTube videos that address the neuroscience of pain. METHODS: We conducted a systematic review of videos on YouTube using the search terms "pain education", "what is pain", and "pain brain" in January 2018. Videos were included if they were in English, were under 10 minutes long, and included information on the neuroscience of pain. Videos were coded for (i) descriptive characteristics (e.g., number of views, duration on YouTube), (ii) source and style, (iii) whether or not they addressed seven pre-determined target concepts of pain neuroscience education (e.g., 'Pain is not an accurate marker of tissue state'), and (iv) how engaging they were. RESULTS: We found 106 unique videos that met the inclusion criteria. The videos ranged from having four views to over five million views (Mdn = 1,163 views), with the three most highly viewed videos accounting for 75% of the total views. Animated videos were much more highly viewed than non-animated videos. Only a small number of videos had been posted by a clearly-identifiable reputable source such as an academic or medical institution (10%), although a number of videos were posted by healthcare professionals and professional medical societies. For a small number of videos (7%), the source was unclear. We found 17 videos that addressed at least one target concept of pain neuroscience science education, only nine of which were considered to be at least somewhat engaging. The target concept 'Pain is a brain output' was considered to be well addressed by the most videos (N = 11), followed by 'Pain is a protector' (N = 10). We found only one video that adequatel

© 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

© Copyright 2019, Mary Ann Liebert, Inc., publishers 2019. Pain is an understudied and undertreated consequence of cancer survival. Pain education is now a recommended treatment approach for persistent non-cancer pain, yet it has not been well applied to the context of adolescent and young adult (AYA) cancer survival. In March 2018, an interdisciplinary meeting was held in Adelaide, South Australia to set a research agenda for pain education in AYA cancer survivors. We identified that AYAs with persistent pain and those with heightened pain-related fear have the potential to benefit from pain education. We identified a number of unique challenges of engaging AYA survivors in pain education, and point towards future research directions.

© Copyright 2019, Mary Ann Liebert, Inc., publishers 2019. Pain is an understudied and undertreated consequence of cancer survival. Pain education is now a recommended treatment approach for persistent non-cancer pain, yet it has not been well applied to the context of adolescent and young adult (AYA) cancer survival. In March 2018, an interdisciplinary meeting was held in Adelaide, South Australia to set a research agenda for pain education in AYA cancer survivors. We identified that AYAs with persistent pain and those with heightened pain-related fear have the potential to benefit from pain education. We identified a number of unique challenges of engaging AYA survivors in pain education, and point towards future research directions.

© 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. Although it is broadly accepted that clinicians should endeavour to reassure patients with low back pain, to do so can present a significant clinical challenge. Guidance for how to provide effective reassurance is scarce and there may be a need to counter patient concerns arising from misinterpretation of spinal imaging findings. `GLITtER' (Green Light Imaging Intervention to Enhance Recovery) was developed as a standardised method of communicating imaging findings in a manner that is reassuring and promotes engagement in an active recovery. This feasibility study is an important step towards definitive testing of its effect. Methods. This feasibility study was a prospective, quasi-randomised, parallel trial with longitudinal follow-up, involving sampling of patients attending a spinal outpatient clinic at a metropolitan hospital. English speaking adults (18-75 years) presenting to the clinic with low back pain and prior spinal imaging were considered for inclusion. Eligible patients were allocated to receive a GLITtER consultation or a standard consultation (as determined by appointment scheduling and clinician availability), and were blinded to their allocation. Full details of the GLITtER intervention are described in accordance with the Tidier template. Follow-up data were collected after 1 and 3 months. The primary outcome of this study was the fulfillment of specific feasibility criteria which were established a priori. Determination of a sample size for a definitive randomised controlled trial was a secondary objective. Results. Two hundred seventy-six patients underwent preliminary screening and 31 patients met the final eligibility criteria for study inclusion. Seventeen participants were allocated to the intervention group and 14 were allocated to the control group. Three month follow-up data were available from 42% of the 31 enrolled participants (N D13, six intervention, seven control). Feasibility indicators for consent, resource burden and

A child's 'concept of pain' refers to how they understand what pain actually is, what function pain serves, and what biological processes are thought to underpin it. We aimed to determine pediatric pain experts' opinions of: (1) the importance and usefulness of assessing a child's concept of pain in clinical and/or research settings; (2) the usefulness of the content of items within currently published adult-targeted resources for assessing a child's concept of pain; and (3) important domains of a child's concept of pain to assess. Forty-nine pediatric pain experts (response rate = 75.4%) completed an online survey. Descriptive statistics and frequency of responses were analyzed. Experts from all included disciplines reported that assessing a child's concept of pain is important and useful both clinically and in a research setting (>80% reported very or extremely useful for each item). Experts considered that the content of 13 items from currently published adult-targeted resources was useful, but the wording was too complex for children aged 8-12 years. Experts considered that all seven of the proposed domains of a child's concept of pain was important to assess. The findings can be used to inform the development of an assessment tool for a child's concept of pain.

A child's 'concept of pain' refers to how they understand what pain actually is, what function pain serves, and what biological processes are thought to underpin it. We aimed to determine pediatric pain experts' opinions of: (1) the importance and usefulness of assessing a child's concept of pain in clinical and/or research settings; (2) the usefulness of the content of items within currently published adult-targeted resources for assessing a child's concept of pain; and (3) important domains of a child's concept of pain to assess. Forty-nine pediatric pain experts (response rate = 75.4%) completed an online survey. Descriptive statistics and frequency of responses were analyzed. Experts from all included disciplines reported that assessing a child's concept of pain is important and useful both clinically and in a research setting (>80% reported very or extremely useful for each item). Experts considered that the content of 13 items from currently published adult-targeted resources was useful, but the wording was too complex for children aged 8-12 years. Experts considered that all seven of the proposed domains of a child's concept of pain was important to assess. The findings can be used to inform the development of an assessment tool for a child's concept of pain.

© 2017 Karran et al. Background Low back pain clinical practice guidelines consistently recommend against the routine ordering of spinal imaging; however, imaging is frequently requested in primary care, without evidence of benefit. Imaging reports frequently identify degenerative features which are likely to be interpreted as 'abnormal', despite their high prevalence in symptom-free individuals. The aim of this study was to investigate whether post-imaging back-related perceptions are influenced by providing prior information about normal findings, and to compare the effect of receiving imaging results with best practice care (without imaging). The impact of introducing novel, 'enhanced' reporting strategies was also explored. Methods This study was a simulated-patient, randomised, multiple-arm experiment. Patient scenarios were presented to volunteer healthy adult participants via an online survey. In the scenarios, 'virtual' patients with low back pain were randomised to one of three groups. Group 1 received imaging and was pre-informed about normal findings. Group 2 received imaging (without pre-information). Group 3 received best practice care: quality information without imaging. Group 1 was further divided to receive either a standard report, or an 'enhanced' report (containing altered terminology and epidemiological information). The primary outcome was back-related perceptions (BRP), a composite score derived from three numeric rating scale scores exploring perceptions of spinal condition, recovery concerns and planned activity. The secondary outcomes were satisfaction and kinesiophobia. Results Full data were available from 660 participants (68% female). Analysis of covariance revealed a significant effect of group after controlling for baseline BRP scores (F(2,74)=10.4,p < 0.001, ηp2=.04)F2,74=10.4,p < 0.001, ηp2=.04. Pairwise comparisons indicated that receiving best practice care resulted in more positive BRPs than receiving imaging results, and receivi

� 2017 Gaikwad et al. Background: It is widely recognized that both doctors and patients report discontent regarding pain management provided and received. The impact of chronic pain on an individual’s life resonates beyond physical and mental suffering; equal or at times even greater impact is observed on an individual’s personal relationships, ability to work, and social interactions. The degree of these effects in each individual varies, mainly because of differences in biological factors, social environment, past experiences, support, and belief systems. Therefore, it is equally possible that these individual patient characteristics could influence their treatment outcome. Research shows that meeting patient expectations is a major challenge for health care systems attempting to provide optimal treatment strategies. However, patient perspectives and expectations in chronic pain management have not been studied extensively. The aim of this study is to investigate the views, perceptions, beliefs, and expectations of individuals who experience chronic pain on a daily basis, and the strategies used by them in managing chronic pain. This paper describes the study protocol to be used in a cross sectional survey of chronic pain patients. Methods and analysis: The study population will comprise of individuals aged ≥18 years, who have experienced pain for ≥3 months with no restrictions of sex, ethnicity, or region of residence. Ethics approval for our study was obtained from Humans research ethics committees, University of Adelaide and University of South Australia. Multinomial logistic regression will be used to estimate the effect of duration and character of pain, on patient’s perception of time to recovery and supplement intake. Logistic regression will also be used for estimating the effect of patient-provider relationship and pain education on patient-reported recovery and pain intensity. Discussion: Knowledge about the perceptions and beliefs of patients with chro

© 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)

© 2017 Tabor et al. Perception is seen as a process that utilises partial and noisy information to construct a coherent understanding of the world. Here we argue that the experience of pain is no different; it is based on incomplete, multimodal information, which is used to estimate potential bodily threat. We outline a Bayesian inference model, incorporating the key components of cue combination, causal inference, and temporal integration, which highlights the statistical problems in everyday perception. It is from this platform that we are able to review the pain literature, providing evidence from experimental, acute, and persistent phenomena to demonstrate the advantages of adopting a statistical account in pain. Our probabilistic conceptualisation suggests a principles-based view of pain, explaining a broad range of experimental and clinical findings and making testable predictions.

© 2017 The Author(s). Background: Delivering efficient and effective healthcare is crucial for a condition as burdensome as low back pain (LBP). Stratified care strategies may be worthwhile, but rely on early and accurate patient screening using a valid and reliable instrument. The purpose of this study was to evaluate the performance of LBP screening instruments for determining risk of poor outcome in adults with LBP of less than 3 months duration. Methods: Medline, Embase, CINAHL, PsycINFO, PEDro, Web of Science, SciVerse SCOPUS, and Cochrane Central Register of Controlled Trials were searched from June 2014 to March 2016. Prospective cohort studies involving patients with acute and subacute LBP were included. Studies administered a prognostic screening instrument at inception and reported outcomes at least 12 weeks after screening. Two independent reviewers extracted relevant data using a standardised spreadsheet. We defined poor outcome for pain to be ≥ 3 on an 11-point numeric rating scale and poor outcome for disability to be scores of ≥ 30% disabled (on the study authors' chosen disability outcome measure). Results: We identified 18 eligible studies investigating seven instruments. Five studies investigated the STarT Back Tool: performance for discriminating pain outcomes at follow-up was 'non-informative' (pooled AUC = 0.59 (0.55-0.63), n = 1153) and 'acceptable' for discriminating disability outcomes (pooled AUC = 0.74 (0.66-0.82), n = 821). Seven studies investigated the Orebro Musculoskeletal Pain Screening Questionnaire: performance was 'poor' for discriminating pain outcomes (pooled AUC = 0.69 (0.62-0.76), n = 360), 'acceptable' for disability outcomes (pooled AUC = 0.75 (0.69-0.82), n = 512), and 'excellent' for absenteeism outcomes (pooled AUC = 0.83 (0.75-0.90), n = 243). Two studies investigated the Vermont Disability Prediction Questionnaire and four further instruments were investigated in single studies only. Conclusions: LBP screening instrument

© 2017 The Author(s). Does feeling back stiffness actually reflect having a stiff back? This research interrogates the long-held question of what informs our subjective experiences of bodily state. We propose a new hypothesis: feelings of back stiffness are a protective perceptual construct, rather than reflecting biomechanical properties of the back. This has far-reaching implications for treatment of pain/stiffness but also for our understanding of bodily feelings. Over three experiments, we challenge the prevailing view by showing that feeling stiff does not relate to objective spinal measures of stiffness and objective back stiffness does not differ between those who report feeling stiff and those who do not. Rather, those who report feeling stiff exhibit self-protective responses: they significantly overestimate force applied to their spine, yet are better at detecting changes in this force than those who do not report feeling stiff. This perceptual error can be manipulated: providing auditory input in synchrony to forces applied to the spine modulates prediction accuracy in both groups, without altering actual stiffness, demonstrating that feeling stiff is a multisensory perceptual inference consistent with protection. Together, this presents a compelling argument against the prevailing view that feeling stiff is an isomorphic marker of the biomechanical characteristics of the back.

© 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 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 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.

© 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 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.

© 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

Crossing the hands over the midline impairs the ability to correctly judge the order of a pair of tactile stimuli, delivered in rapid succession, one to each hand. This impairment, termed crossed-hands deficit, has been attributed to a mismatch between the somatotopic and body-centred frames of reference, onto which somatosensory stimuli are automatically mapped. Whether or not such crossed-hands deficit occurs also when delivering nociceptive stimuli has not been previously investigated. In this study, participants performed a temporal order judgement (TOJ) task in which pairs of either nociceptive or tactile stimuli were delivered, one to each hand, while their arms were either crossed over the body midline or uncrossed. We observed that crossing the hands over the midline significantly decreases the ability to determine the stimulus order when a pair of nociceptive stimuli is delivered to the hands, and that this crossed-hands deficit has a temporal profile similar to that observed for tactile stimuli. These findings suggest that similar mechanisms for integrating somatotopic and body-centred frames of reference underlie the ability to localise both nociceptive and tactile stimuli in space. © 2012 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Illusions that induce a feeling of ownership over an artificial body or body-part have been used to explore the complex relationships that exist between the brain's representation of the body and the integrity of the body itself. Here we discuss recent findings in both healthy volunteers and clinical populations that highlight the robust relationship that exists between a person's sense of ownership over a body part, cortical processing of tactile input from that body part, and its physiological regulation. We propose that a network of multisensory and homeostatic brain areas may be responsible for maintaining a 'body-matrix'. That is, a dynamic neural representation that not only extends beyond the body surface to integrate both somatotopic and peripersonal sensory data, but also integrates body-centred spatial sensory data. The existence of such a 'body-matrix' allows our brain to adapt to even profound anatomical and configurational changes to our body. It also plays an important role in maintaining homeostatic control over the body. Its alteration can be seen to have both deleterious and beneficial effects in various clinical populations.

Numerous clinical conditions, including complex regional pain syndrome, are characterized by autonomic dysfunctions (e.g. altered thermoregulation, sometimes confined to a single limb), and disrupted cortical representation of the body and the surrounding space. The presence, in patients with complex regional pain syndrome, of a disruption in spatial perception, bodily ownership and thermoregulation led us to hypothesize that impaired spatial perception might result in a spatial-dependent modulation of thermoregulation and bodily ownership over the affected limb. In five experiments involving a total of 23 patients with complex regional pain syndrome of one arm and 10 healthy control subjects, we measured skin temperature of the hand with infrared thermal imaging, before and after experimental periods of either 9 or 10 min each, during which the hand was held on one or the other side of the body midline. Tactile processing was assessed by temporal order judgements of pairs of vibrotactile stimuli, delivered one to each hand. Pain and sense of ownership over the hand were assessed by self-report scales. Across experiments, when kept on its usual side of the body midline, the affected hand was 0.5 ± 0.3°C cooler than the healthy hand (P < 0.02 for all, a common finding in cold-type complex regional pain syndrome), and tactile stimuli delivered to the healthy hand were prioritized over those delivered to the affected hand. Simply crossing both hands over the midline resulted in (i) warming of the affected hand (the affected hand became 0.4 ± 0.3°C warmer than when it was in the uncrossed position; P = 0.01); (ii) cooling of the healthy hand (by 0.3 ± 0.3°C; P = 0.02); and (iii) reversal of the prioritization of tactile processing. When only the affected hand was crossed over the midline, it became warmer (by 0.5 ± 0.3°C; P = 0.01). When only the healthy hand was crossed over the midline, it became cooler (by 0.3 ± 0.3°C; P = 0.01). The temperature change of either hand

The ability to determine precisely the location of sensory stimuli is fundamental to how we interact with the world; indeed, to our survival. Crossing the hands over the body midline impairs this ability to localize tactile stimuli. We hypothesized that crossing the arms would modulate the intensity of pain evoked by noxious stimulation of the hand. In two separate experiments, we show (1) that the intensity of both laser-evoked painful sensations and electrically-evoked nonpainful sensations were decreased when the arms were crossed over the midline, and (2) that these effects were associated with changes in the multimodal cortical processing of somatosensory information. Critically, there was no change in the somatosensory-specific cortical processing of somatosensory information. Besides studies showing relief of phantom limb pain using mirrors, this is the first evidence that impeding the processes by which the brain localises a noxious stimulus can reduce pain, and that this effect reflects modulation of multimodal neural activities. By showing that the neural mechanisms by which pain emerges from nociception represent a possible target for analgesia, we raise the possibility of novel approaches to the treatment of painful clinical conditions. Crossing the arms over the midline impairs multimodal processing of somatosensory stimuli and induces significant analgesia to noxious hand stimulation. © 2011 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.