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Background context : Low back pain is a major cause of morbidity and disability worldwide and is responsible for vast societal impact. Rates of surgical intervention for lumbar spine disorders continue to rise but poor outcomes remain common. Understanding how the social determinants of health (SDH) influence spinal surgical outcomes stands to inform appropriately tailored care practices and lead to better patient outcomes. Purpose : To determine the relationships between the SDH and pain, opioid use, disability and work absenteeism following lumbar spine surgery. Study design : Systematic review and narrative synthesis. Methods : We searched Embase, the Cochrane Library, Medline, and Web of Science from inception to 21/4/2020. Studies eligible for inclusion involved participants receiving lumbar spine surgery and investigated the relationship between at least one SDH and post-surgical pain, opioid use, disability or work absenteeism. We evaluated the risk of bias of included studies and used the PROGRESS-Plus framework to organise a narrative synthesis of findings. Results : Relevant data was extracted from twenty-three studies involving 30,987 adults from 12 countries. 107 relationships between the SDH and post-surgical outcomes were evaluated, 67 in multivariate analyses. Education was investigated in 23 analyses (14 studies): 70% revealed significant independent relationships between lower education and poorer outcomes. Socioeconomic status was investigated in nine analyses (four studies): 67% revealed independent relationships between lower socioeconomic status and poorer outcomes. Gender was investigated in 40 analyses (22 studies): indications that male versus female sex was associated with poorer outcomes were equivocal. Place of residence, race/ethnicity, and social capital were infrequently investigated. Conclusions : Low educational attainment and low income status are clear independent contributors to poorer outcomes following lumbar spine surgery. Occupational factors and work context are likely to be influential. Further research is critical to guide best-practice spinal surgery through a health equity lens. Study registration : PROSPERO registration number CRD42015015778

Refereed/Peer-reviewed Complex regional pain syndrome (CRPS) is a distressing and disabling pain condition. Many people with CRPS and the health professionals who treat them seek information about the condition via the Internet. The credibility, accuracy and comprehensiveness of online CRPS information remains unknown. The aim of this study was to determine the credibility, accuracy and comprehensiveness of information presented on freely accessible websites that aim to educate people about CRPS. Keyword searches were conducted on the Australian Google site, with 'trustworthy' websites included and critically appraised. Primary outcomes were recognised metrics of credibility (JAMA benchmark credibility criteria) and website accuracy (according to European CRPS guidelines). Comprehensiveness was assessed using the proportion of European CRPS guidelines covered by the websites. In all, 30 websites with 819 recommendations were critically appraised. Five (17%) websites met all credibility criteria; of the recommendations, 349 (43%) were accurate, 252 (31%) were inaccurate and 218 (26%) were unclear. For comprehensiveness, an average of 17% of general guidelines, 15% of therapeutic guidelines and 6% of medication/supplement guidelines were covered. Online information about CRPS available to Australians has low credibility, accuracy and comprehensiveness. Many website recommendations are inaccurate or unclear, and many websites endorse inappropriate treatments. There is an urgent need for accurate and comprehensive sources of CRPS information online.

Objective To determine if impairment in motor imagery processes is present in Achilles tendinopathy (AT), as demonstrated by a reduced ability to quickly and accurately identify the laterality (left-right judgement) of a pictured limb. Additionally, this study aimed to use a novel data pooling approach to combine data collected at 3 different sites via meta-analytical techniques that allow exploration of heterogeneity. Design Multi-site case-control study. Methods Three independent studies with similar protocols were conducted by separate research groups. Each study-site evaluated left/right judgement performance for images of feet and hands using Recognise© software and compared performance between people with AT and healthy controls. Results from each study-site were independently collated, then combined in a meta-analysis. Results In total, 126 participants (40 unilateral, 22 bilateral AT cases, 61 controls) were included. There were no differences between AT cases and controls for hand image accuracy and reaction time. Contrary to the hypothesis, there were no differences in performance between those with AT and controls for foot image reaction time, however there were conflicting findings for foot accuracy, based on four separate analyses. There were no differences between the affected and unaffected sides in people with unilateral AT. Conclusions Impairments in motor imagery performance for hands were not found in this study, and we found inconsistent results for foot accuracy. This contrasts to studies in persistent pain of limbs, face and knee osteoarthritis, and suggests that differences in pathoetiology or patient demographics may uniquely influence proprioceptive representation.

The purpose of the current study was to determine whether auditory prepulse inhibition (PPI) and/or prepulse facilitation (PPF) were altered in people with fibromyalgia (FM) when compared with controls. Eyeblink responses were recorded from 29 females with FM and 27 controls, while they listened to 3 blocks of auditory stimuli that delivered pulses with either PPI or PPF. Using a linear mixed model, our main findings were that there was a GROUP*CONDITION interaction (F4, 1084 = 4.01, P= .0031) indicating that the difference in amplitude between FM group and control group changed depending on the condition (PPI or PPF). Post hoc tests revealed no differences between the groups in response to PPI. The FM group showed a greater reactivity of response to the PPF conditioned stimulus than the control group did (t(39.7) = 2.03, P= .0494). Augmentation of PPF, as demonstrated by the FM group is thought to be linked to alterations in information processing mediated by an autonomically driven general orienting process. Activities that decrease autonomic drive or rebalance autonomic and parasympathetic tone such as vagal stimulation might be pursued as effective interventions for people with FM. Perspective This article presents evidence of preservation of neural circuitry that underpins response suppression and evidence of neural circuit disturbance mediated by autonomic drive-in people with FM. These results are important because intact circuitry underpins the effectiveness of therapies and may be harnessed, and rebalancing autonomic drive may be indicated.

Cognitive flexibility can be thought of as the ability to effectively adapt one's cognitive and behavioural strategies in response to changing task or environmental demands. To substantiate the common inference that self-report and neuropsychological tests of cognitive flexibility provide ‘different windows into the same room’, we undertook a systematic review and meta-analysis to determine whether self-report and neuropsychological tests of cognitive flexibility are related in healthy adults. Ten databases and relevant grey literature were searched from inception. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were adhered to. Twenty-one articles satisfied our inclusion criteria. A multi-level random-effects meta-analysis revealed no relationship (0.05, 95% CI = −0.00 to 0.10). Random-effects meta-analyses raised the possibility that the Cognitive Flexibility Scale and the Trail Making Test – part B (time) may be related (0.19, 95% CI = 0.06 to 0.31). We conclude that the relationship between self-report and neuropsychological tests of cognitive flexibility is not large enough to be considered convincing evidence for the two assessment approaches sharing construct validity. These results have clear implications for assessing and interpreting cognitive flexibility research and clinical practice Refereed/Peer-reviewed

Refereed/Peer-reviewed

Objectives: Hamstring injuries in athletes can lead to significant time away from competition as a result of persistent posterior thigh pain. These cases are often difficult to treat as the state of the tissues alone cannot explain symptoms. In non-athletic populations with persistent pain, disruptions to tactile, proprioceptive, and spatial cortical representations exist, which has led to promising brain-based treatments.Here, we explored whether athletes with persistent posterior thigh pain also display impairments in these cortical representations.Design: Cross-sectional study.Methods: Fourteen male professional athletes with persistent posterior thigh pain (‘Patients’) and 14pain-free age, sport, body mass index and level-matched controls (‘Controls’) participated. The tactile cortical representation was assessed using two-point discrimination (TPD) threshold and accuracy of tactile localisation; the proprioceptive cortical representation was assessed using a left/right judgement task; spatial processing was assessed using an auditory detection task. Results: TPD thresholds were similar for Patients and Controls (p = 0.70). Patients were less accurate at localising tactile stimuli delivered to their affected leg, slower to make left/right judgements when the lower limb image corresponded to the side of their affected leg, and less accurate at detecting auditory stimuli delivered near their affected leg, when compared to their healthy leg or to the leg of Controls(p < 0.01 for all). Conclusions: Leg-specific tactile, proprioceptive, and spatial processing deficits exist in athletes with persistent posterior thigh pain. That these processing deficits exist despite rehabilitation and normal tissue healing time suggests they may play a role in the persistence of posterior thigh pain. Refereed/Peer-reviewed

Background There is evidence that people with persistent shoulder pain exhibit findings consistent with the presence of sensorimotor dysfunction. Sensorimotor impairments can manifest in a variety of ways, and further developing our understanding of sensorimotor dysfunction in shoulder pain may improve current models of care. The Fremantle Back Awareness Questionnaire (FreBAQ) has been developed to assess disturbed body perception specific to the back. The purpose of the present study was to develop a shoulder-specific self-perception questionnaire and evaluate the questionnaire in people with persistent shoulder pain. Methods The Fremantle Shoulder Awareness Questionnaire (FreSHAQ-J) was developed by modifying the FreBAQ. One hundred and twelve consecutive people with persistent shoulder pain completed the FreSHAQ-J. Thirty participants completed the FreSHAQ-J again two-weeks later to assess test-retest reliability. Rasch analysis was used to assess the psychometric properties of the FreSHAQ-J. Associations between FreSHAQ-J total score and clinical status was explored using correlational analysis. Results The FreSHAQ-J has acceptable category order, unidimensionality, no misfitting items, and excellent test-retest reliability. The FreSHAQ-J was moderately correlated with disability and pain catastrophization. Conclusions The FreSHAQ-J fits the Rasch measurement model well and is suitable for use with people with shoulder pain. Given the relationship between the FreSHAQ-J score and clinical status, change in body perception may be worth assessing when managing patients with shoulder pain.

Refereed/Peer-reviewed OBJECTIVE: To synthesize results of somatosensory processing tests in people with upper- and lower-limb tendinopathy, compared to controls. DESIGN: Systematic review with meta-analysis. LITERATURE SEARCH: Four electronic databases (MEDLINE, CINAHL Plus, SPORTDiscus, and Embase) were searched. STUDY SELECTION CRITERIA: Included studies measured a domain of sensory processing and compared a tendinopathy group to a healthy control group. DATA SYNTHESIS: Meta-analysis was conducted for outcomes with homogeneous data from at least 2 studies. Upper- and lower-limb conditions were compared and outcomes were examined by measurement site (local, regional, or remote to location of pain) RESULTS: Of the 30 studies included, 18 investigated lateral elbow tendinopathy. The most commonly assessed outcome measures were pressure pain threshold (PPT) and thermal pain threshold. There was moderate evidence for local and regional reduction of PPT in upper-limb tendinopathies, but not at remote sites. In lower-limb tendinopathies,there was conflicting evidence regarding reduced PPT at local sites and limited evidence of normal PPT at remote sites. There was moderate evidence of sensitization of thermal pain threshold at local sites in upper-limb tendinopathies and limited evidence of no difference in thermal pain threshold in lower-limb tendinopathies. Findings across other domains were variable CONCLUSION: Sensory processing was different between upper-limb tendinopathy and lower-limb tendinopathy. Upper-limb tendinopathies showed signs consistent with primary and secondary hyperalgesia, but lower-limb tendinopathies did not. There was mixed evidence for primary hyperalgesia and limited evidence against secondary hyperalgesia.

Study design Multiround wiki-based Delphi expert panel survey. Objective To provide proof of concept for an alternative method for creating sets of nationally-agreed point-of-care clinical indicators, and obtain consensus among end-user groups on "appropriate care" for the assessment, diagnosis, acute, and ongoing care of people with low back pain (LBP). Summary of background data The provision of inappropriate and low value care for LBP is a significant healthcare and societal burden. Vague clinical practice guideline (CPG) recommendations can be difficult to apply and measure in real world clinical practice, and a likely barrier to "appropriate care." Methods Draft "appropriate care" clinical indicators for LBP were derived from CPG recommendations published between 2011 and 2017. Included CPGs were independently appraised by two reviewers using the Appraisal of Guidelines for Research and Evaluation instrument. Headed by a Clinical Champion, a 20-member Expert Panel reviewed and commented on the draft indicators over a three-round modified e-Delphi process using a collaborative online wiki. At the conclusion of each review round, the research team and the Clinical Champion synthesized and responded to experts' comments and incorporated feedback into the next iteration of the draft indicators. Results From seven CPGs and six qualitative meta-syntheses, 299 recommendations and themes were used to draft 42 "appropriateness" indicators. In total, 17 experts reviewed these indicators over 18 months. A final set of 27 indicators comprising screening and diagnostic processes (n = 8), assessment (n = 3), acute (n = 5), and ongoing care (n = 9), and two which crossed the acute-ongoing care continuum. Most indicators were geared toward recommended care (n = 21, 78%), with the remainder focused on care to be avoided. Conclusion These 27 LBP clinical indicators can be used by healthcare consumers, clinicians, researchers, policy makers/funders, and insurers to guide and monitor the provision of "appropriate care" for LBP.Level of Evidence: 4.

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.

Background Reduced tactile acuity has been observed in several chronic pain conditions and has been proposed as a clinical indicator of somatosensory impairments related to the condition. As some interventions targeting these impairments have resulted in pain reduction, assessing tactile acuity may have significant clinical potential. While two-point discrimination threshold (TPDT) is a popular method of assessing tactile acuity, large measurement error has been observed (impeding responsiveness) and its validity has been questioned. The recently developed semi-automated ‘imprint Tactile Acuity Device’ (iTAD) may improve tactile acuity assessment, but clinimetric properties of its scores (accuracy score, response time and rate correct score) need further examination. Aims Experiment 1: To determine inter-rater reliability and measurement error of TPDT and iTAD assessments. Experiment 2: To determine internal consistencies and floor or ceiling effects of iTAD scores, and investigate effects of age, sex, and anthropometry on performance. Methods Experiment 1: To assess inter-rater reliability (ICC(2,1)) and measurement error (coefficient of variation (CoV)), three assessors each performed TPDT and iTAD assessments at the neck in forty healthy participants. Experiment 2: To assess internal consistency (ICC(2,k)) and floor or ceiling effects (skewness z-scores), one hundred healthy participants performed the iTAD’s localisation and orientation tests. Balanced for sex, participants were equally divided over five age brackets (18–30, 31–40, 41–50, 51–60 and 61–70). Age, sex, body mass index (BMI) and neck surface area were assessed to examine their direct (using multiple linear regression analysis) and indirect (using sequential mediation analysis) relationship with iTAD scores. Results Mean ICC(2,1) was moderate for TPDT (0.70) and moderate-to-good for the various iTAD scores (0.65–0.86). The CoV was 25.3% for TPDT and ranged from 6.1% to 16.5% for iTAD scores. Internal consistency was high for both iTAD accuracy scores (ICC(2,6) = 0.84; ICC(2,4) = 0.86). No overt floor or ceiling effects were detected (all skewness z-scores Discussion Although reliability was similar, iTAD scores demonstrated less measurement error than TPDT indicating a potential for better responsiveness to treatment effects. Further, unlike previously reported for TPDT, iTAD scores appeared independent of anthropometry, which simplifies interpretation. Additionally, the iTAD assesses multiple aspects of tactile processing which may provide a more comprehensive evaluation of tactile acuity. Taken together, the iTAD shows promise in measuring tactile acuity, but patient studies are needed to verify clinical relevance.

Background Blinding of participants and therapists in trials of physical interventions is a significant and ongoing challenge. There is no widely accepted sham protocol for dry needling. Purpose The purpose of this review was to summarize the effectiveness and limitations of blinding strategies and types of shams that have been used in dry needling trials. Data Sources Twelve databases were searched from inception to February 2016. Study Selection Trials that compared active dry needling with a sham that simulated dry needling were included. Data Extraction The main domains of data extraction were participant/therapist details, intervention details, blinding strategies, blinding assessment outcomes, and key conclusions of authors. Reported blinding strategies and sham types were synthesized descriptively, with available blinding effectiveness data synthesized using a chance-corrected measurement of blinding (blinding index). Data Synthesis The search identified 4894 individual publications with 27 trials eligible for inclusion. In 22 trials, risk of methodological bias was high or unclear. Across trials, blinding strategies and sham types were heterogeneous. Notably, no trials attempted therapist blinding. Sham protocols have focused on participant blinding using strategies related to group standardization and simulation of tactile sensations. There has been little attention given to the other senses or cognitive strategies to enhance intervention credibility. Nonpenetrating sham types may provide effective participant blinding. Limitations Trials were clinically and methodologically diverse, which limited the comparability of blinding effectiveness across trials. Reported blinding evaluations had a high risk of chance findings with power clearly achieved in only 1 trial. Conclusions Evidence-based consensus on a sham protocol for dry needling is required. Recommendations provided in this review may be used to develop sham protocols so that future protocols are more consistent and potentially more effective.

Purpose: To understand the process of change at an individual level, this study used a single-case experimental design to evaluate how change in potential mediators related to change in disability over time, during an exposure-based behavioural intervention in four people with chronic low back pain and high pain-related fear. A second aim was to evaluate whether the change (sequential or simultaneous) in mediators and disability occurred at the same timepoint for all individuals. Results: For all participants, visual and statistical analyses indicated that changes in disability and proposed mediators were clearly related to the commencement of Cognitive Functional Therapy. This was supported by standard outcome assessments at pre-post timepoints. Cross-lag correlation analysis determined that, for all participants, most of the proposed mediators (pain intensity, pain controllability, and fear) were most strongly associated with disability at lag zero, suggesting that mediators changed concomitantly and not before disability. Importantly, these changes occurred at different rates and patterns for different individuals, highlighting the individual temporal variability of change. Conclusion: This study demonstrated the interplay of factors associated with treatment response, highlighting ‘how change unfolded’ uniquely for each individual. The findings that factors underpinning treatment response and the outcome changed simultaneously, challenge the traditional understanding of therapeutic change. Refereed/Peer-reviewed

BackgroundDespite 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.MethodsTwo-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/environmental bias, implicit motor imagery, two-point discrimination, and pain sensitivity to activity. Cost-utility analysis of the EPIPHA-KNEE intervention will be undertaken, in addition to evaluation of cost-effectiveness in the context of primary trial outcomes.DiscussionWe will determine whether the integration of PSE into an individualised OA education, walking, and strengthening program is more effective than receiving the individualised program alone. Findings will inform the development and implementation of future delivery of PSE as part of best practice for people with knee OA.Trial registrationAustralian New Zealand Clinical Trials Registry:ACTRN12620001041943(13/10/2020).

Objectives: (1) Validate thresholds for minimal, low, moderate, and high fear of movement on the 11-item Tampa Scale of Kinesiophobia (TSK-11), and (2) Establish a patient-driven minimal clinically important difference (MCID) for Achilles tendinopathy (AT) symptoms of pain with heel raises and tendon stiffness.Methods: Four hundred and forty-two adults with chronic AT responded to an online survey, including psychosocial questionnaires and symptom-related questions (severity and willingness to complete heel raises and hops). Kinesiophobia subgroups (Minimal ≤ 22, Low 23–28, Moderate 29–35, High ≥ 36 scores on the TSK-11), pain MCID subgroups (10-, 20-, 30-, >30-points on a 0- to 100-point scale), and stiffness MCID subgroups (5, 10, 20, >20 min) were described as median [interquartile range] and compared using non-parametric statistics.Results: Subgroups with higher kinesiophobia reported were less likely to complete three heel raises (Minimal = 93%, Low = 74%, Moderate = 58%, High = 24%). Higher kinesiophobia was associated with higher expected pain (Minimal = 20.0 [9.3–40.0], Low = 43.0 [20.0–60.0], Moderate = 50.0 [24.0–64.0], High = 60.5 [41.3–71.0]) yet not with movement-evoked pain (Minimal = 25.0 [5.0–43.0], Low = 31.0 [18.0–59.0], Moderate = 35.0 [20.0–60.0], High = 43.0 [24.0–65.3]). The most common pain MCID was 10 points (39% of respondents). Half of respondents considered a 5-min (35% of sample) or 10-min (16%) decrease in morning stiffness as clinically meaningful.Conclusions: Convergent validity of TSK-11 thresholds was supported by association with pain catastrophizing, severity of expected pain with movement, and willingness to complete tendon loading exercises. Most participants indicated that reducing their pain severity to the mild range would be clinically meaningful.

Background Chronic low back pain (CLBP) is a global health problem associated with an increasing burden on individuals, health care systems, and society. Common treatments for people with CLBP produce, on average, small short-term improvements in pain and function compared with minimal care. The RESOLVE trial randomly allocated 276 people with CLBP to a new complex treatment strategy, pain education integrated with graded sensorimotor precision training (RESOLVE), or a sham control. The RESOLVE treatment was developed within a theoretical framework to target possible treatment mechanisms associated with CLBP development and persistence. Objective This protocol describes the planned evaluation of these proposed treatment mechanisms. Improved understanding of the mechanisms underpinning the RESOLVE treatment may guide its refinement and implementation. Methods We will use causal mediation analysis to evaluate the proposed treatment mechanisms, including pain self-efficacy, back beliefs, pain catastrophizing, kinesiophobia, back perception, tactile acuity, and movement coordination. The primary outcomes are pain intensity and function at 18 weeks following allocation. Data were collected blind to allocation and hypotheses at baseline (mediators, outcomes, confounders), end of treatment (mediators), and at 18 weeks following allocation (outcomes). We will test the robustness of our findings by conducting planned sensitivity analyses. Results Ethical approval was granted by the University of New South Wales Human Research Ethics Committee (HC15357). A total of 276 participants have been recruited from primary care practices and the community in Sydney, Australia. Conclusions The RESOLVE treatment constitutes a new paradigm for CLBP management with potentially wide-reaching implications. This mechanistic evaluation will provide evidence for the hypothesized treatment mechanisms and help explain why the treatment strategy did or did not have an effect on patient-reported outcomes. These results will help guide the treatment refinement and implementation. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN12615000610538; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368619&isReview=true International Registered Report Identifier (IRRID) DERR1-10.2196/26053

Patients with complex regional pain syndrome suffer from chronic neuropathic pain and also show a decrease in sensorimotor performance associated with characteristic central and peripheral neural system parameters. In the brain imaging domain, these comprise altered functional sensorimotor representation for the affected hand side. With regard to neurophysiology, a decrease in intracortical inhibition for the sensorimotor cortex contralateral to the affected hand has been repetitively verified, which might be related to increased primary somatosensory cortex functional activation for the affected limb. Rare longitudinal intervention studies in randomized controlled trials have demonstrated that a decrease in primary somatosensory cortex functional MRI activation coincided with pain relief and recovery in sensorimotor performance. By applying a randomized wait-list control crossover study design, we tested possible associations of clinical, imaging and neurophysiology parameters in 21 patients with complex regional pain syndrome in the chronic stage (>6 months). In more detail, we applied graded motor imagery over 6 weeks to relieve movement pain of the affected upper limb. First, baseline parameters were tested between the affected and the non-affected upper limb side and age-matched healthy controls. Second, longitudinal changes in clinical and testing parameters were associated with neurophysiological and imaging parameters. During baseline short intracortical inhibition, as assessed with transcranial magnetic stimulation, was decreased only for hand muscles of the affected hand side. During movement of the affected limb, primary somatosensory cortex functional MRI activation was increased. Hand representation area size for somatosensory stimulation in functional MRI was smaller on the affected side with longer disease duration. Graded motor imagery intervention but not waiting, resulted in a decrease of movement pain. An increase of somatosensory hand representation size over graded motor imagery intervention was related to movement pain relief. Over graded motor imagery intervention, pathological parameters like the increased primary somatosensory cortex activation during fist movement or decreased short intracortical inhibition were modified in the same way as movement pain and hand performance improved. No such changes were observed during the waiting period. Overall, we demonstrated characteristic changes in clinical, behaviour and neuropathology parameters applying graded motor imagery in patients with upper limb complex regional pain syndrome, which casts light on the effects of graded motor imagery intervention on biomarkers for chronic neuropathic pain., In this randomized wait-list control crossover study, Lotze et al test possible associations of clinical, imaging and neurophysiology parameters in CRPS patients in the chronic stage over 6 weeks of graded motor imagery. Lotze et al here describe the value of biomarkers assessed for monitoring interventions and predict treatment outcome., Graphical Abstract Graphical Abstract

Objectives Dry needling is widely used in physiotherapy. Lack of blinding in clinical trials means that dry needling effects and mechanisms remain unclear, with blinding issues accepted as an unavoidable barrier to better evidence. The authors aimed to overcome this barrier by designing a protocol to double-blind dry needling trials. Design A prospectively registered randomised experiment tested a novel blinding protocol for blinding effectiveness. Setting University physiotherapy clinic. Participants Therapists (n = 15) and asymptomatic volunteers (‘recipients’) (n = 45) were randomly allocated to real and/or sham interventions. Interventions The protocol involved custom-made needles and cognitive and multisensory blinding techniques. Main outcome measures The primary outcome was guesses about allocation. The a priori criterion for successful blinding was ≤50% correct guesses (random chance). Secondary analyses explored blinding patterns using blinding indices. Results Correct guesses were not different from 50% for therapists [41% (95%CI 30 to 50), n = 120 guesses] or recipients [49% (95%CI 38 to 60), n = 90 guesses]. Blinding indices supported the primary result but revealed that recipients were better at detecting real dry needling than sham. Conclusion Both therapists and recipients were successfully blinded, which contrasts with the widely held assumption that double-blinding is impossible for needling interventions. The authors recommend that any future trials can, and therefore should, blind therapists. However, secondary analyses revealed that recipients receiving real dry needling were less blinded than sham recipients, which may still create bias in clinical trials and suggests further work is needed to improve recipient blinding. Nonetheless, the current findings offer an opportunity to gain better evidence concerning the effects and mechanisms of dry needling. Study registration: https://osf.io/rkzeb/ .

Letter to the Editor-in-Chief in response to JOSPT article “Education With Therapeutic Alliance Did Not Improve Symptoms in Patients With Chronic Low Back Pain and Low Risk of Poor Prognosis Compar...

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.

The Wisconsin Card Sorting Test (WCST) is a popular neurocognitive task used to assess cognitive flexibility, and aspects of executive functioning more broadly, in research and clinical practice. Despite its widespread use and the development of an updated WCST manual in 1993, confusion remains in the literature about how to score the WCST, and importantly, how to interpret the outcome variables as indicators of cognitive flexibility. This critical review provides an overview of the changes in the WCST, how existing scoring methods of the task differ, the key terminology and how these relate to the assessment of cognitive flexibility, and issues with the use of the WCST across the literature. In particular, this review focuses on the confusion between the terms ‘perseverative responses’ and ‘perseverative errors’ and the inconsistent scoring of these variables. To our knowledge, this critical review is the first of its kind to focus on the inherent issues surrounding the WCST when used as an assessment of cognitive flexibility. We provide recommendations to overcome these and other issues when using the WCST in future research and clinical practice. Refereed/Peer-reviewed

Over the last 15–20 years, clinicians have been encouraged to shift their management of chronic musculoskeletal pain from a biomedical/biomechanical approach to a more biopsychosocial approach. To perform such shift, the information provided to the patient with chronic musculoskeletal pain has had to evolve from the biomechanics and pathoanatomy of involved structures toward an explanation of the physiological and psychological processes involved in the pain experience [1–3]. The latter has become known as pain neuroscience education (PNE), and the aim is to help patients reconceptualize their pain [4]. But is educating patients with chronic pain enough? Can we just talk our patients out of pain? Should Pain Neuroscience Education be our only tool?

IntroductionChronic pain is a distressing condition and often poorly treated and managed. Psychological therapies are considered first-line intervention for people with chronic pain. Common psychological therapies require extensive clinician training and specialist qualifications. One approach that does not need lengthy training nor specialist qualification, but has empirical support in other health domains, is behavioural activation (BA). BA seeks to increase engagement in behaviours that are valued by the person and progress through behaviours that can increase mood and develop skills that build satisfying routines. BA can help people to manage their condition through scheduling behaviours, promoting routine and mastery over their condition. The extent to which BA has been used to support people living with chronic pain is not clear.Methods and analysisThis scoping review aims to identify published studies describing the application of BA to support people living with chronic pain. To map the evidence regarding BA and chronic pain, including the study type and the associated evidence, a scoping review was adopted. The search will be conducted in bibliographic databases, clinical trial registries and grey literature. No date limits will be applied to the search strategy. Screening of titles and abstracts, and full-text screening, will be independently undertaken by two investigators using Covidence software. Any disagreement between investigators will be resolved by a third investigator. Data from included publications will be extracted using a customised data extraction tool.Ethics and disseminationThe scoping review is an analysis of existing data and therefore ethics approval is not required. The findings of this scoping review will further our understanding of how BA has been used to support people living with chronic pain and inform future training and education programmes in this area.

Complex regional pain syndrome (CRPS) is a neuropathic pain condition that is difficult to treat. For behavioral interventions, graded motor imagery (GMI) showed relevant effects, but underlying neural substrates in patient groups have not been investigated yet. A previous study investigating differences in the representation of a left/right hand judgment task demonstrated less recruitment of subcortical structures, such as the putamen, in CRPS patients than in healthy controls. In healthy volunteers, the putamen activity increased after a hand judgment task training. In order to test for longitudinal effects of GMI training, we investigated 20 CRPS patients in a wait-list crossover design with 3 evaluation time points. Patients underwent a 6 week GMI treatment and a 6 week waiting period in a randomized group assignment and treatment groups were evaluated by a blinded rater. When compared to healthy matched controls at baseline, CRPS patients showed less functional activation in areas processing visual input, left sensorimotor cortex, and right putamen. Only GMI treatment, but not the waiting period showed an effect on movement pain and hand judgment task performance. Regression analyses revealed positive associations of movement pain with left anterior insula activation at baseline. Right intraparietal sulcus activation change during GMI was associated with a gain in performance of the hand judgment task. The design used here is reliable for investigating the functional representation of the hand judgment task in an intervention study. Perspective: Twenty chronic CRPS patients underwent a 6 week GMI intervention in a randomized wait-list crossover design. functional MRI was tested pre and post for the hand lateralization task which improved over GMI but not over WAITING. Performance gain was positively related to right parietal functional MRI activation. Refereed/Peer-reviewed

Refereed/Peer-reviewed Clinicians have an increasing number of evidence-based interventions to treat pain in youth. Mediation analysis offers a way of investigating how interventions work, by examining the extent to which an intermediate variable, or mediator, explains the effect of an intervention. This systematic review examined studies that used mediation analysis to investigate mechanisms of interventions on pain-relevant outcomes for youth (3–18 years) with acute or chronic pain, and provides recommendations for future mediation research in this field. We searched five electronic databases for clinical trials or observational longitudinal studies that included a comparison group and conducted mediation analyses of interventions on youth and assessed pain outcomes. We found six studies (N = 635), which included a total of 53 mediation models examining how interventions affect pain-relevant outcomes for youth. Five studies were secondary analyses of randomized controlled trials of psychological interventions for chronic pain; one was a longitudinal observational study of morphine for acute pain. The pain conditions studied were irritable bowel syndrome, functional abdominal pain, juvenile fibromyalgia, mixed chronic pain, and post-operative pain. Fourteen putative mediators were tested, of which three partially mediated treatment effect; seven did not significantly mediate treatment effect and four had mixed results. Methodological and reporting limitations were common. There are substantial gaps in the field with respect to investigating, and therefore understanding, how paediatric interventions work.

BackgroundAchilles tendinopathy (AT) rehabilitation traditionally includes progressive tendon loading exercises. Recent evidence suggests a biopsychosocial approach that incorporates patient education on psychosocial factors and mechanisms of pain can reduce pain and disability in individuals with chronic pain. This is yet to be examined in individuals with AT.ObjectiveThis study aims to compare the effects on movement-evoked pain and self-reported function of pain education as part of a biopsychosocial approach with pathoanatomical education for people with AT when combined with a progressive tendon loading exercise program.MethodsA single-site, randomized, double-blind, placebo-controlled clinical trial will be conducted in a university-based hospital in a laboratory setting and/or by telehealth. A total of 66 participants with chronic (>3 months) midportion or insertional AT will be randomized for the Tendinopathy Education of the Achilles (TEAch) study. All participants will complete progressive Achilles tendon loading exercises over 12 weeks and will be encouraged to continue with self-selected exercises as tolerated. All participants will complete 6-7 one-to-one sessions with a physical therapist to progress exercises in a standardized manner over 8 weeks. During the last 4 weeks of the intervention, participants will be encouraged to maintain their home exercise program. Participants will be randomized to 1 of 2 types of education (pain education or pathoanatomic), in addition to exercise. Pain education will focus on the biological and psychological mechanisms of pain within a biopsychosocial framing of AT. Pathoanatomic education will focus on biological processes within a more traditional biomedical framework of AT. Evaluation sessions will be completed at baseline and 8-week follow-up, and self-reported outcome measures will be completed at the 12-week follow-up. Both groups will complete progressive Achilles loading exercises in 4 phases throughout the 12 weeks and will be encouraged to continue with self-selected exercises as tolerated. Primary outcomes are movement-evoked pain during heel raises and self-reported function (patient-reported outcome measure information system—Physical Function). Secondary outcomes assess central nervous system nociceptive processing, psychological factors, motor function, and feasibility.ResultsInstitutional review board approval was obtained on April 15, 2019, and study funding began in July 2019. As of March 2020, we randomized 23 out of 66 participants. In September 2020, we screened 267 individuals, consented 68 participants, and randomized 51 participants. We anticipate completing the primary data analysis by March 2022.ConclusionsThe TEAch study will evaluate the utility of pain education for those with AT and the effects of improved patient knowledge on pain, physical function, and clinical outcomes.International Registered Report Identifier (IRRID)DERR1-10.2196/19111

Objective Complex physical interventions are widely used in physiotherapy, despite doubts over the validity of clinical trial results due to lack of credible shams. Credible shams are critically needed, so too, therefore, is a process by which they can be developed. The authors used a novel methodology to develop and test blinding protocols for dry needling, a complex physical intervention for which blinding is particularly difficult. Design The research design was a practical three-day workshop influenced by Participatory Action Research, which uses iteration and reflection to solve a problem. Participants Five multidisciplinary experts (researchers, clinicians, technician, magician) were invited. Healthy volunteers (‘recipients’, n = 17) and accredited physiotherapists (n = 6) were recruited to enable testing of blinding strategies. Main outcome measures Primary outcomes were expert opinion on the potential to blind recipients/therapists for (1) individual blinding strategies, and (2) entire blinding protocols. Secondary outcomes included recipient/therapist blinding effectiveness and acceptability. Results Experts iteratively developed 11 blinding protocols involving 22 blinding strategies. Experts rated 18 of the blinding strategies to ‘definitely have potential’ and identified four categories: knowledge of the sham, clinical interaction, disinformation, and sensation. Recipient and therapist blinding became more successful as the protocols evolved. Conclusions Credible shams capable of simultaneous recipient and therapist blinding have been regarded to be impossible in dry needling. The preliminary success of the devised protocols suggest that our novel approach may be a crucial step in sham development. Improvements in expert rankings and blinding effectiveness as the protocols progressed support the value of this workshop approach.

Objective Low back pain (LBP) is one of the most disabling and costly conditions worldwide. It remains unclear why many individuals experience persistent and recurrent symptoms after an acute episode whereas others do not. A longitudinal cohort study was established to address this problem. We aimed to; (1) evaluate whether promising and potentially modifiable biological, psychological, social and behavioural factors, along with their possible interactions, predict LBP outcome after an acute episode; (2) compare these factors between individuals with and without acute LBP; and (3) evaluate the time-course of changes in these factors from LBP onset. This paper outlines the methodology and compares baseline characteristics between acute LBP and control, and LBP participants with and without follow-up. Results 133 individuals with acute LBP and 74 pain-free individuals participated. Bio-psycho-social and behavioural measures were collected at baseline and 3-monthly for 12 months (LBP) or 3 months (control). Pain and disability were recorded fortnightly. Baseline characteristics were mostly similar between those who did and did not return for follow-up. Initial analyses of this cohort have revealed important insights into the pathways involved in acute-to-chronic LBP. These and future findings will provide new targets for treatment and prevention of persistent and recurrent LBP.

The social determinants of health (SDH) are known to differentially impact outcomes from many noncommunicable diseases; however, their potential role in low back pain (LBP) is poorly defined. This review endeavours to comprehensively inform the field of their relevance. Our research question was: "How do the broad range of SDH and chronic LBP (CLBP) relate?" The primary aim of this review was to synthesise evidence of relationships between SDH and the frequency or severity of CLBP. Secondary aims were to identify relationships between SDH and LBP-related disability, work absenteeism, and opioid prescription. We included studies involving adult participants that evaluated relationships between one or more of the SDH and CLBP frequency or LBP outcomes (beyond 3 months). Two reviewers screened studies, extracted data, and assessed risk of bias. We synthesized the results narratively and applied PROGRESS to organise our findings. Database searches identified 7018 records. Forty-one studies were included, containing data from 2,161,617 adults from 17 countries. Twenty-four percent and 19% of the relationships included were classified as having a high risk of bias due to confounding and missing data, respectively. We reported 166 relationships representing the majority of the PROGRESS domains. An array of independent and interdependent relationships between the SDH and CLBP were identified with the strongest evidence for associations related to educational attainment and socioeconomic status. Our findings suggest that greater recognition of the contribution of SDH to disparities in LBP outcomes is warranted and this has the potential to usefully inform strategies to impact burden.

Supplemental Digital Content is Available in the Text. This feasibility study of contemporary pain science education to increase activity levels in people with painful knee osteoarthritis supports progression to a larger trial., 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.

Refereed/Peer-reviewed We tested the hypotheses that rendering sensory input about hand location imprecise increases a classically conditioned pain expectancy effect, increases generalization of the effect to novel locations and reduces extinction of the effect. Forty healthy volunteers performed movements with their right hand along predefined paths. Each path passed through 2 locations that were defined as either i) the conditioned stimulus (CS+; paired with a painful unconditioned stimulus), or ii) unpaired (CS-). During acquisition phase, participants watched their hand as they moved it. Participants were randomly allocated to an Imprecise group, for whom visual feedback of the hand was offset 30 to 50 mm from its true location, or a Precise group, for whom vision was not disrupted. In the test phase, participants moved their hands to 5 locations--the CS+, CS- locations that lay between the 2 ("generalization stimuli"). Our primary hypothesis was supported--pain expectancy was greater at the CS+ location in the Imprecise group than in the Precise group (6.9 [SD = 1.9] vs 5.4 [SD = 2.5], P= .02). Pain expectancies generalized to novel locations similarly in both groups and there was no difference in extinction between groups. Our primary hypothesis was supported but our subsequent hypotheses were not. Perspective: We conditioned pain expectancy at a certain location of one hand, even though most participants were unaware of the contingency. Conditioned pain expectancy was greater when sensory information about location was less precise. This adds support to the possibility that associative learning may play a role in the progression of an acute pain episode to a more generalized pain disorder.

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 ).

Objective This proof-of-concept pilot study aimed to investigate if a visual illusion that altered the size and muscularity of the back could be embodied and alter perception of the back. Methods The back visual illusions were created using the MIRAGE multisensory illusion system. Participants watched real-time footage of a modified version of their own back from behind. Participants undertook one experimental condition, in which the image portrayed a muscled, fit-looking back (Strong), and two control conditions (Reshaped and Normal) during a lifting task. Embodiment, back perception as well as pain intensity and beliefs about the back during lifting were assessed. Results Two participants with low back pain were recruited for this study: one with altered body perception and negative back beliefs (Participant A) and one with normal perception and beliefs (Participant B). Participant A embodied the Strong condition and pain and fear were less and both perceived strength and confidence were more than for the Normal or the Reshaped condition. Participant B did not embody the Strong condition and reported similar levels of pain, fear strength and confidence across all three conditions. Discussion An illusion that makes the back look strong successfully induced embodiment of a visually modified back during a lifting task in a low back pain patient with altered body perception. Both participants tolerated the illusion, there were no adverse effects, and we gained preliminary evidence that the approach may have therapeutic potential.