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

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

Background: Worldwide, the incidence of wrist fracture is increasing. There are currently no externally validated prognostic models to inform early decision making for these patients., Objectives: To develop and validate a prognostic model from a comprehensive range of candidate prognostic factors that can identify patients who are at risk of developing persistent pain following wrist or hand fracture., Methods: We developed and validated a prognostic model using secondary data derived from a prospective cohort study (n = 715), with recruitment sites in 3 metropolitan hospitals in Sydney, Australia. The primary outcome was persistent pain 4 months following the injury. The current study used a backward stepwise regression analysis to develop the model in 2 hospitals (n = 408) and externally validate it in a third hospital (n = 307). To determine the accuracy of the model, we assessed calibration and discrimination in accordance with the PROGnosis RESearch Strategy framework., Results: Complete data were available for 95% of the cohort. Of 14 candidate variables, the final model contained 2 prognostic factors: patient age and pain intensity reported at initial presentation. The area under the receiver operating characteristic curve was 0.63 (95% confidence interval: 0.56, 0.69) in the development sample and 0.61 (95% confidence interval: 0.51, 0.70) in the validation sample. The model systematically overestimated risk (intercept, -1.13; slope, 0.73)., Conclusion: We developed and externally validated a prognostic model to predict persistent pain 4 months after a wrist or hand fracture. Future studies are needed to assess whether the accuracy of this model can be improved by updating and validating it in local settings., Level of Evidence: Prognosis, level 1b. J Orthop Sports Phys Ther 2019;49(1):28-35. Epub 12 Sep 2018. doi:10.2519/jospt.2019.8342.

Objectives: Pain sensitivity and psychosocial issues are prognostic of poor outcome in acute neck disorders. However, knowledge of associations between pain sensitivity and ongoing pain and disability in chronic neck pain are lacking. We aimed to investigate associations of pain sensitivity with pain and disability at the 12-month follow-up in people with chronic neck pain., Methods: The predictor variables were: clinical and quantitative sensory testing (cold, pressure); neural tissue sensitivity; neuropathic symptoms; comorbidities; sleep; psychological distress; pain catastrophizing; pain intensity (for the model explaining disability at 12 months only); and disability (for the model explaining pain at 12 months only). Data were analysed using uni- and multivariate regression models to assess associations with pain and disability at the 12-month follow-up (n = 64 at baseline, n = 51 at follow-up)., Results: Univariable associations between all predictor variables and pain and disability were evident (r > 0.3; p < 0.05), except for cold and pressure pain thresholds and cold sensitivity. For disability at the 12-month follow-up, 24.0% of the variance was explained by psychological distress and comorbidities. For pain at 12 months, 39.8% of the variance was explained primarily by baseline disability., Conclusions: Neither clinical nor quantitative measures of pain sensitivity were meaningfully associated with long-term patient-reported outcomes in people with chronic neck pain, limiting their clinical application in evaluating prognosis., (Copyright © 2018 John Wiley & Sons, Ltd.)

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

Chronic musculoskeletal pain (CMP) refers to ongoing pain felt in the bones, joints and tissues of the body that persists longer than 3 months. For these conditions, it is widely accepted that secondary pathologies or the consequences of persistent pain, including fear of movement, pain catastrophizing, anxiety and nervous system sensitization appear to be the main contributors to pain and disability. While exercise is a primary treatment modality for CMP, the intent is often to improve physical function with less attention to secondary pathologies. Exercise interventions for CMP which address secondary pathologies align with contemporary pain rehabilitation practices and have greater potential to improve patient outcomes above exercise alone. Biopsychosocial treatment which acknowledges and addresses the biological, psychological and social contributions to pain and disability is currently seen as the most efficacious approach to chronic pain. This clinical update discusses key aspects of a biopsychosocial approach concerning exercise prescription for CMP and considers both patient needs and clinician competencies. There is consensus for individualized, supervised exercise based on patient presentation, goals and preference that is perceived as safe and non-threatening to avoid fostering unhelpful associations between physical activity and pain. The weight of evidence supporting exercise for CMP has been provided by aerobic and resistance exercise studies, although there is considerable uncertainty on how to best apply the findings to exercise prescription. In this clinical update, we also provide evidence-based guidance on exercise prescription for CMP through a synthesis of published work within the field of exercise and CMP rehabilitation., (Copyright © 2017 John Wiley & Sons, Ltd.)

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

Background: Marketing communication and brand identity is a fundamental principle of advertising and end-user engagement. Health researchers have begun to apply this principle to trial recruitment in primary care. The aim of this study was to evaluate whether a Teaser Campaign using a series of postcards in advance of a conventional mail-out increases the number of primary care clinics that engage with a clinical trial., Methods: Embedded randomised recruitment trial across primary care clinics (general practitioners and physiotherapists) in the Sydney metropolitan area. Clinics in the Teaser Campaign group received a series of branded promotional postcards in advance of a standard letter inviting them to participate in a clinical trial. Clinics in the Standard Mail group did not receive the postcards., Results: From a total of 744 clinics that were sent an invitation letter, 46 clinics in the Teaser Campaign group and 40 clinics in the Standard Mail group responded (11.6% total response rate). There was no between-group difference in the odds of responding to the invitation letter (odds ratio = 1.18, 95% confidence interval = 0.75-1.85, p = 0.49). For physiotherapy clinics and general practice clinics, the odds ratios were 1.43 (confidence interval = 0.82-2.48, p = 0.21) and 0.77 (confidence interval = 0.34-1.75, p  = 0.54), respectively., Conclusion: A Teaser Campaign using a series of branded promotional postcards did not improve clinic engagement for a randomised controlled trial in primary care.

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

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

Background: Low back pain (LBP) is a major health problem. Globally it is responsible for the most years lived with disability. The most problematic type of LBP is chronic LBP (pain lasting longer than 3 mo); it has a poor prognosis and is costly, and interventions are only moderately effective. Targeting interventions according to risk profile is a promising approach to prevent the onset of chronic LBP. Developing accurate prognostic models is the first step. No validated prognostic models are available to accurately predict the onset of chronic LBP. The primary aim of this study was to develop and validate a prognostic model to estimate the risk of chronic LBP., Methods and Findings: We used the PROGRESS framework to specify a priori methods, which we published in a study protocol. Data from 2,758 patients with acute LBP attending primary care in Australia between 5 November 2003 and 15 July 2005 (development sample, n = 1,230) and between 10 November 2009 and 5 February 2013 (external validation sample, n = 1,528) were used to develop and externally validate the model. The primary outcome was chronic LBP (ongoing pain at 3 mo). In all, 30% of the development sample and 19% of the external validation sample developed chronic LBP. In the external validation sample, the primary model (PICKUP) discriminated between those who did and did not develop chronic LBP with acceptable performance (area under the receiver operating characteristic curve 0.66 [95% CI 0.63 to 0.69]). Although model calibration was also acceptable in the external validation sample (intercept = -0.55, slope = 0.89), some miscalibration was observed for high-risk groups. The decision curve analysis estimated that, if decisions to recommend further intervention were based on risk scores, screening could lead to a net reduction of 40 unnecessary interventions for every 100 patients presenting to primary care compared to a "treat all" approach. Limitations of the method include the model being restricted to using prognostic factors measured in existing studies and using stepwise methods to specify the model. Limitations of the model include modest discrimination performance. The model also requires recalibration for local settings., Conclusions: Based on its performance in these cohorts, this five-item prognostic model for patients with acute LBP may be a useful tool for estimating risk of chronic LBP. Further validation is required to determine whether screening with this model leads to a net reduction in unnecessary interventions provided to low-risk patients.

Background: Correlations between clinical and quantitative measures of pain sensitivity are poor, making it difficult for clinicians to detect people with pain sensitivity. Clinical detection of pain sensitivity is important because these people have a different prognosis and may require different treatment., Objective: The purpose of this study was to investigate the relationship between clinical and quantitative measures of pain sensitivity across individuals with and without neck pain., Methods: This cross-sectional study included 40 participants with chronic neck pain and 40 age- and sex-matched controls. Participants underwent quantitative sensory testing of cold pain thresholds (CPTs) and pressure pain thresholds (PPTs). Clinical tests for pain sensitivity were the ice pain test and the pressure pain test. All tests were undertaken at standardized local (neck and upper trapezius muscles) and remote (wrist and tibialis anterior muscles) sites. Median and interquartile range (IQR) were calculated for neck pain and control groups, and parametric and nonparametric tests were used to compare groups. Correlation coefficients were calculated between quantitative and clinical measures., Results: There were significant differences for clinical and quantitative measures of cold and pressure sensitivity between the neck pain and control groups (eg, CPT neck pain group: median=22.31°C, IQR=18.58°C; control group: median=5.0°C, IQR=0.74°C). Moderate-to-good correlations were found between the clinical ice pain test and CPT at all sites (.46 to .68) except at the wrist (.29 to .40). Fair correlations were found for the clinical pressure pain test and PPT (-.26 to -.45). Psychological variables contributing to quantitative measures of pain sensitivity included catastrophization, sleep quality, and female sex., Limitations: Clinical pressure pain tests were not quantitatively standardized in this study., Conclusions: The ice pain test may be useful as a clinical correlate of CPT at all sites except the wrist, whereas the pressure pain test is less convincing as a clinical correlate of PPT., (© 2015 American Physical Therapy Association.)

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