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Background: Low health literacy is associated with worse pain and poorer self-management. This study (1) examined the level of health literacy and associations with lifestyle habits, health status, chronic pain, and radiographic knee osteoarthritis; and (2) explored experiences illuminating health literacy among individuals with knee pain., Methods: A convergent parallel mixed-methods design was used, including 221 individuals. Health literacy was assessed by HLS-EU-Q16 and eHEALS. The questionnaire included questions on lifestyle habits, health status, and pain distribution. Radiographic knee osteoarthritis was assessed with x-rays. Associations were analysed using logistic regression analyses. Individual semi-structured interviews were conducted (n = 19) and analysed with qualitative content analysis., Results: The result showed that 71% reported sufficient health literacy. Higher education, healthy lifestyle habits, better general health, and absence of widespread pain were associated with sufficient health literacy. Experiences regarding health literacy influencing the decision-making process toward a decision on action comprised: (1) searching for information actively or passively; (2) processing of the information included being informed, critical, and interpretive; and (3) taking a stand on the information based on trustfulness and motivation., Conclusion: Seven out of 10 reported sufficient health literacy. Despite this, unhealthy lifestyles were common, suggesting that having sufficient HL is not enough for a behavioural change and the decision-making process, including different phases such as searching, processing, and taking a stand on health information is important to consider. More research on health literacy is needed to gain knowledge of how best to develop health promotion in individuals with knee pain., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Approximately 20% of total knee arthroplasty patients experience persistent postsurgical pain one year after surgery. No qualitative studies have explored previous stories of painful or stressful life experiences in patients experiencing persistent postsurgical pain after total knee replacement. This study aimed to explore stories of previous painful or stressful experiences in life in a cohort of patients that reported no improvement in pain one year after total knee arthroplasty., Methods: The study employed an explorative-descriptive qualitative design. Data was collected through semi-structured interviews five to seven years after surgery, with patients who reported no improvement in pain-related interference with walking 12 months after total knee replacement. The data was analyzed using qualitative content analysis., Results: The sample consisted of 13 women and 10 men with a median age of 67 years at the time of surgery. Prior to surgery, six reported having at least one chronic illness and 16 reported having two or more painful sites. Two main themes were identified in the data analysis: Painful years - the burden of living with long lasting pain, and the burden of living with psychological distress., Conclusions: The participants had severe longlasting knee pain as well as longlasting pain in other locations, in addition to experiences of psychologically stressful life events before surgery. Health personnel needs to address the experience and perception of pain and psychological struggles, and how it influences patients' everyday life including sleeping routines, work- and family life as well as to identify possible vulnerability for persistent postsurgical pain. Identifying and assessing the challenges enables personalized care and support, such as advice on pain management, cognitive support, guided rehabilitation, and coping strategies both pre-and post-surgery., (© 2023. The Author(s).)

Background: Unhealthy alcohol use represents a significant risk for morbidity and mortality among people living with HIV (PLWH), in part through its impact on HIV management. Chronic pain, a common comorbidity, exacerbates suboptimal engagement in the HIV care continuum and has reciprocal detrimental effects on alcohol outcomes. There are no integrated, accessible approaches that address these comorbid conditions among PLWH to date. This paper describes a research study protocol of an integrated telehealth intervention to reduce unhealthy drinking and chronic pain among PLWH (Motivational and Cognitive-Behavioral Management for Alcohol and Pain [INTV]). Methods: Two-hundred and fifty PLWH with unhealthy drinking and chronic pain will be recruited nationally via online advertisement. Informed consent and baseline assessments occur remotely, followed by 15 days of ecological momentary assessment to assess alcohol use, chronic pain, functioning, and mechanisms of behavior change. Next, participants will be randomized to either the INTV or Control (CTL) condition. Individuals in both conditions will meet with a health counselor through videoconferencing following randomization, and those in the INTV condition will receive 6 additional sessions. At 3- and 6-months post-baseline, participants will complete outcome assessments. It is hypothesized that the INTV condition will result in reduced unhealthy alcohol use and pain ratings compared to the CTL condition. Conclusion: This protocol paper describes a randomized controlled trial which tests the efficacy of a novel, integrated telehealth approach to reduce unhealthy alcohol use and chronic pain for PLWH, two common comorbid conditions that influence the HIV treatment cascade. ClinicalTrials.gov identifier: NCT05503173. Highlights: Unhealthy alcohol use and chronic pain are common in people living with HIV. An integrated telehealth intervention may improve alcohol, pain, and HIV outcomes. Ecological momentary assessment will examine processes underlying behavior change. [ABSTRACT FROM AUTHOR]

Background: Pain is a common experience in adolescence, with up to 44% of adolescents reporting chronic pain. For a significant minority, severe pain becomes an ongoing disabling problem. Treatment of adolescent chronic pain aims to reduce the impact of pain on adolescents' lives. Efficient, accurate assessment of the impact of pain is essential to treatment. The 'Bath Adolescent Pain Questionnaire' (BAPQ) is a psychometrically robust multidimensional self-report measure of adolescent functioning. Whilst widely used, the paper-based format of the BAPQ can present completion difficulties for adolescents experiencing chronic pain. To increase the accessibility and clinical utility of the BAPQ, an electronic version of the measure is needed. This study assesses the usability and feasibility of a computerized version of this measure (BAPQ-C) in an adolescent chronic pain population.Methods: Fourteen adolescents (13 females; 13-16 years) were recruited from a hospital-based residential pain management programme. Participants completed a qualitative 'thinking aloud task' whilst completing the BAPQ-C. and, an acceptability questionnaire regarding the BAPQ-C. Data were analysed using thematic analysis, a widely used qualitative method of data analysis .Results: Two themes labelled 'engagement and technological appeal' and 'accessibility and independence' were generated. Themes revealed numerous factors contributing to participants' preference for the BAPQ-C compared with the paper version of the BAPQ. Participants reported that the BAPQ-C was 'quicker' and 'easier' to complete than the BAPQ. Functional aspects of the BAPQ-C which included use of a touch screen rather than a pen and paper, font colours/styles, the zoom function and the spellchecker, provided participants with improved access. This subsequently increased participants' independence and confidence when completing the measure.Conclusion: The BAPQ-C is a feasible multidimensional tool for the assessment of functioning in adolescents who experience chronic pain. It was well-received by participants who were able to complete the measure more quickly, independently and confidently than the paper-based BAPQ. Increased speed, ease and accuracy of completion make the BAPQ-C an ideal tool for use in busy clinical and research settings. Findings highlight the potential benefits of adopting the BAPQ-C when assessing the impact of chronic pain on adolescents in clinic and home-based settings. [ABSTRACT FROM AUTHOR]

Background: Integrating spiritual aspects into treatment plans can release essential resources for coping with chronic pain. However, some spiritual aspects may also induce distress and hinder the coping process. There is a lack of evidence regarding how to perform the clinical tasks of exploring spiritual aspects and of instruments assessing related competencies. Therefore, we developed a web-based learning module to provide education on the subject alongside corresponding assessment instruments. The module presents the InSpiRe (Integration of Spirituality and/or Religion in patient encounters) protocol. The instruments encompass cognitive, affective, and behavioral dimensions., Methods: This paper aims to determine (i) the learning effects associated with completing the web-based spiritual-care learning module and (ii) the reliability and validity of the instruments employed. To address these aims, we conducted a pre-test/post-test trial with N = 32 randomly selected fourth-year medical students. During the pre-test, we assessed the students' knowledge, attitudes, and self-efficacy regarding exploring spiritual aspects. For this purpose, we developed a short-answer knowledge test, an attitude questionnaire, and a self-efficacy scale. Additionally, the students explored spiritual aspects with a simulated patient portraying a person with chronic pain. Three trained raters evaluated the students' performances using a self-developed scale. In the intervention phase, the students completed the 45-minute learning module on a personal computer. The module presented InSpiRe-related content as text and step-by-step video demonstrations, including hints that denote critical actions. The subsequent post-test was identical to the pre-test., Results: The internal consistency was suitable for all respective instruments, and there was an indication of solid validity of the performance test. After completing the spiritual care learning module, the students showed statistically significant increases in knowledge scores and significant positive shifts in their attitudes and levels of self-efficacy regarding exploring spiritual aspects. They also attained significantly higher performance scores in the same regard., Conclusions: Completing the spiritual-care module is associated with meaningful learning effects on cognitive, affective, and behavioral dimensions related to exploring spiritual aspects, as demonstrated in the post-test conducted shortly after the intervention. Due to good reliability and validity scores, the self-developed instruments can be applied appropriately., (© 2024. The Author(s).)

Background: The global increase in forcibly displaced populations highlights the importance of understanding their health needs. Chronic pain is prevalent among refugees, poses significant personal and public health challenges, and complicates their integration into new home countries. Understanding refugees' pain post-migration and how it is being managed is crucial for ensuring adequate and timely interventions and fostering health equity. This paper explores the associations between pain levels and the use of painkillers, healthcare services, and long-term impairment among Syrian refugees with chronic pain, one year after their resettlement in Norway., Methods: This cross-sectional study is based on survey data collected from 353 quota refugees in 2018-19, one year after resettlement in Norway. The primary outcomes were the use of painkillers, the use of healthcare services, and long-term impairment, according to reported chronic pain levels. Associations between these outcomes and chronic pain levels were studied using Poisson regression, adjusted by sociodemographic variables and trauma experience., Results: Of the 353 adults included, 52% were women, and the median age was 36 years. A total of 5% reported very mild/mild, 10% moderate, and 12% strong/very strong chronic pain over the last four weeks. Significant associations were found between all chronic pain levels and use of non-prescription painkillers (adjusted relative risks (aRR) (95% CI)); mild (3.1 (2.0-4.7)), moderate (1.8 (1.1-2.8)), strong (1.7 (1.1-2.6)), and prescription painkillers; mild (4.6 (2.2-9.5)), moderate (5.6 (3.2-10.0)), strong (6.7 (3.9-11.3)), compared to those without chronic pain. Use of emergency rooms, specialist care, and hospitalization were significantly associated with strong chronic pain, with aRR (95% CI) of 2.0 (1.2-3.5), 3.9 (2.1-7.0) and 2.4 (1.3-4.4), respectively. Long-term impairment was strongly associated with chronic pain across all pain levels; mild (8.6 (5.6-13.49)), moderate (6.7 (4.3-10.5)) and strong (6.6 (4.3-10.4))., Conclusion: Despite their young age, more than a quarter of the Syrian refugees in our study reported chronic pain one year after resettlement in Norway. High levels of pain were related to the use of medication, healthcare services, and long-term impairment. Understanding the dynamics of pain among refugees is crucial to ensure adequate and timely management., (© 2024. The Author(s).)

Background: Chronic pain is a major health issue and rapid population ageing exacerbates the burden to health systems in countries like Germany. Nonpharmacological interventions (NPIs) are essential in pain care and the prioritization of active NPIs is emphasized in guidelines. This paper examines the utilization of NPIs for chronic pain management in community-dwelling older adults with a certified need of care in Berlin, Germany., Methods: Cross-sectional data was collected through standardized face-to-face surveys with older adults (≥65 years), using validated instruments (e.g., Brief Pain Inventory), and structured lists for NPI utilization. Categorization into active and passive NPIs was performed through a literature-based, iterative process by an interdisciplinary team. For not normally distributed data, non-parametric tests were used as appropriate. Logistic regression was conducted for multivariate analysis., Results: In total, 250 participants were included in this analysis (aged 65-104, x̅ = 81.8, 68.8% female). Most (92%) use NPIs for chronic pain management: 85.6% use active NPIs, 50.4% active movement and only 5.6% use solely passive approaches. Most common NPIs are distraction, thermotherapy/compresses, and physiotherapy. The odds of utilizing physiotherapy are three times higher for those with high educational status when compared to those with low education while those with low educational status had higher odds of using thermotherapy/compresses., Conclusions: In our sample, most community-dwelling older adults with a certified need of care use active NPIs for chronic pain management with about half using active movement approaches. Considering the high vulnerability of this population, physiotherapy (in the form of therapeutic exercise) is a particularly appropriate intervention, and it was the third most frequent NPI in our sample. However, there is a social gradient in the utilization of physiotherapy for chronic pain management which might be rooted in issues around awareness, appeal, and access to such measures. It is important to take socioeconomic differences into account when planning the care for older chronic pain patients but also when designing research or user-friendly guidelines for this target group., Trial Registration: Ethical approval from the Ethics Committee of Charité - Universitätsmedizin Berlin (EA1/368/14) and study registration with the Central Study Register (ZSR no. 20009093)., (© 2024. The Author(s).)

Background: Providing individualized care based on the context and preferences of the patient is important. Knowledge on both prognostic risk stratification and blended eHealth care in musculoskeletal conditions is increasing and seems promising. Stratification can be used to match patients to the most optimal content and intensity of treatment as well as mode of treatment delivery (i.e. face-to-face or blended with eHealth). However, research on the integration of stratified and blended eHealth care with corresponding matched treatment options for patients with neck and/or shoulder complaints is lacking. Methods: This study was a mixed methods study comprising the development of matched treatment options, followed by an evaluation of the feasibility of the developed Stratified Blended Physiotherapy approach. In the first phase, three focus groups with physiotherapists and physiotherapy experts were conducted. The second phase investigated the feasibility (i.e. satisfaction, usability and experiences) of the Stratified Blended Physiotherapy approach for both physiotherapists and patients in a multicenter single-arm convergent parallel mixed methods feasibility study. Results: In the first phase, matched treatment options were developed for six patient subgroups. Recommendations for content and intensity of physiotherapy were matched to the patient's risk of persistent disabling pain (using the Keele STarT MSK Tool: low/medium/high risk). In addition, selection of mode of treatment delivery was matched to the patient's suitability for blended care (using the Dutch Blended Physiotherapy Checklist: yes/no). A paper-based workbook and e-Exercise app modules were developed as two different mode of treatment delivery options, to support physiotherapists. Feasibility was evaluated in the second phase. Physiotherapists and patients were mildly satisfied with the new approach. Usability of the physiotherapist dashboard to set up the e-Exercise app was considered 'OK' by physiotherapists. Patients considered the e-Exercise app to be of 'best imaginable' usability. The paper-based workbook was not used. Conclusion: Results of the focus groups led to the development of matched treatment options. Results of the feasibility study showed experiences with integrating stratified and blended eHealth care and have informed amendments to the Stratified Blended Physiotherapy approach for patients with neck and/or shoulder complaints ready to use within a future cluster randomized trial. [ABSTRACT FROM AUTHOR]

This response letter addresses the comments received on our paper. The main points of our response include: Clarification of the definitions of primary and secondary indexes; Justification for the use of the RoB2 tool for quality assessment; Measures to improve sensitivity analysis and data consistency; Explanation and improvement plans regarding the timing of Prospero registration. We have provided detailed explanations of the study design and outlined specific measures for future improvements to enhance research transparency and quality. [ABSTRACT FROM AUTHOR]

Background: Cognitive-Behavior Therapy (CBT) is the validated non-pharmacological treatment for chronic pain in pediatric patients. While some suggested CBT were comparable to the usual care in reducing children's functional abdominal pain. This meta-analysis was designed to systematically review the literature for RCTs that investigated the efficacy of CBT in children with functional abdominal pain (FAP). Methods: PubMed, Embase, and the Cochrane library were searched for papers published up to October 2022. Studies applying different CBT delivery methods (in-person, web-based, phone-based) were included in this meta-analysis to evaluate the comprehensive effectiveness of CBT compared with usual care. Weighted and standardized mean difference with the 95% confidence intervals were used for the synthesis of the results. Primary outcome was the decrease of functional disability inventory (FDI) and the secondary outcomes were the decrease of severity in pain intensity, depression, anxiety, gastrointestinal symptoms, and improvement in physical quality of life (QoL). Results: A total of 10 RCTs with 1187 children were included in the final analysis. The results showed that CBT resulted in better effect in reducing functional disability inventory (SMD=-2.282, 95%CI: -4.537 to -0.027, P = 0.047), pain intensity (SMD=-0.594, 95%CI: -1.147 to -0.040, P = 0.036), and improving QoL (SMD = 14.097, 95%CI: 0.901 to 27.292, P = 0.036) compared with the control groups. Comparable effects were observed in the severity of depression (SMD=-0.493, 95%CI: -1.594 to 0.608, P = 0.380), anxiety (SMD=-0.062, 95%CI: -0.640 to 0.517, P = 0.835), and gastrointestinal symptoms (SMD=-1.096 95%CI: -2.243 to 0.050, P = 0.061) between CBT and usual treatment. Conclusions: We observed the differences in post-treatment FAP and pain intensity for children receiving CBT compared with children receiving treatment as usual. CBT in the setting of FAP demonstrates promising developments and highlights the need for future research. [ABSTRACT FROM AUTHOR]

Introduction: Nutrition-related factors linked to pain chronicity and disability include weight status and dietary behaviours. Dietary patterns associated with concurrent pain episodes, however, remain poorly characterised. This paper outlines the protocol for a feasibility study that aims to characterise pain-related dietary and lifestyle behaviours in people experiencing chronic musculoskeletal pain. Methods: The study will recruit participants who experience musculoskeletal pain on 5 or more days of the week for at least 3 months. Participants will attend two in-person clinic visits where physical measurements and a series of pain and lifestyle questionnaires will be completed. Visits will be conducted pre and post a 2-week self-monitoring period where participants will self-report concurrent diet, sleep, mood, and pain on four days and will wear a wrist-worn activity monitor (GENEActiv). Key feasibility metrics will evaluate participant recruitment, enrolment and retention rates, and compliance with the study data collection protocol. Discussion: There remains a lack of evidence behind dietary advice as an adjunct pain management tool. Upon completion of the protocol, feasibility outcomes will identify challenges to guide the design and delivery of a dietary intervention for chronic musculoskeletal pain. [ABSTRACT FROM AUTHOR]

Background: The health care is likely to break down unless we are able to increase the level of functioning for the growing number of patients with complex, chronic illnesses. Hence, novel high-capacity and cost-effective treatments with trans-diagnostic effects are warranted. In accordance with the protocol paper, we aimed to examine the acceptability, satisfaction, and effectiveness of an interdisciplinary micro-choice based concentrated group rehabilitation for patients with chronic low back pain, long COVID, and type 2 diabetes. Methods: Patients with low back pain > 4 months sick-leave, long COVID, or type 2 diabetes were included in this clinical trial with pre-post design and 3-month follow-up. The treatment consisted of three phases: (1) preparing for change, (2) the concentrated intervention for 3–4 days, and (3) integrating change into everyday life. Patients were taught and practiced how to monitor and target seemingly insignificant everyday micro-choices, in order to break the patterns where symptoms or habits contributed to decreased levels of functioning or increased health problems. The treatment was delivered to groups (max 10 people) with similar illnesses. Client Satisfaction Questionnaire (CSQ-8)) (1 week), Work and Social Adjustment Scale (WSAS), Brief Illness Perception Questionnaire (BIPQ), and self-rated health status (EQ-5D-5L) were registered at baseline and 3-month follow-up. Results: Of the 241 included participants (57% women, mean age 48 years, range 19–84), 99% completed the concentrated treatment. Treatment satisfaction was high with a 28.9 (3.2) mean CSQ-8-score. WSAS improved significantly from baseline to follow-up across diagnoses 20.59 (0.56) to 15.76 (0.56). BIPQ improved from: 22.30 (0.43) to 14.88 (0.47) and EQ-5D-5L: 0.715 (0.01) to 0.779 (0.01)), all P<0.001. Conclusions: Across disorders, the novel approach was associated with high acceptability and clinically important improvements in functional levels, illness perception, and health status. As the concentrated micro-choice based treatment format might have the potential to change the way we deliver rehabilitation across diagnoses, we suggest to proceed with a controlled trial. Trial registration: ClinicalTrials.gov NCT05234281 [ABSTRACT FROM AUTHOR]

Background: Considerable disparities in chronic pain management have been identified. Persons in rural, lower income, and minoritized communities are less likely to receive evidence-based, nonpharmacologic care. Telehealth delivery of nonpharmacologic, evidence-based interventions for persons with chronic pain is a promising strategy to lessen disparities, but implementation comes with many challenges. The BeatPain Utah study is a hybrid type 1 effectiveness-implementation pragmatic clinical trial investigating telehealth strategies to provide nonpharmacologic care from physical therapists to persons with chronic back pain receiving care in ommunity health centers (CHCs). CHCs provide primary care to all persons regardless of ability to pay. This paper outlines the use of implementation mapping to develop a multifaceted implementation plan for the BeatPain study. Methods: During a planning year for the BeatPain trial, we developed a comprehensive logic model including the five-step implementation mapping process informed by additional frameworks and theories. The five iterative implementation mapping steps were addressed in the planning year: (1) conduct needs assessments for involved groups; (2) identify implementation outcomes, performance objectives, and determinants; (3) select implementation strategies; (4) produce implementation protocols and materials; and (5) evaluate implementation outcomes. Results: CHC leadership/providers, patients, and physical therapists were identified as involved groups. Barriers and assets were identified across groups which informed identification of performance objectives necessary to implement two key processes: (1) electronic referral of patients with back pain in CHC clinics to the BeatPain team and (2) connecting patients with physical therapists providing telehealth. Determinants of the performance objectives for each group informed our choice of implementation strategies which focused on training, education, clinician support, and tailoring physical therapy interventions for telehealth delivery and cultural competency. We selected implementation outcomes for the BeatPain trial to evaluate the success of our implementation strategies. Conclusions: Implementation mapping provided a comprehensive and systematic approach to develop an implementation plan during the planning phase for our ongoing hybrid effectiveness-implementation trial. We will be able to evaluate the implementation strategies used in the BeatPain Utah study to inform future efforts to implement telehealth delivery of evidence-based pain care in CHCs and other settings. Trial registration: ClinicalTrials.gov Identifier: NCT04923334. Registered June 11, 2021. [ABSTRACT FROM AUTHOR]

Objectives: Low back pain (LBP) is the number one cause of disability world-wide. It is also the most expensive area in healthcare. Patient-centered innovations are needed. This paper uses medical storytelling to illustrate the common problems that often lead to unnecessary suffering for patients, and costs to society. We present innovative solutions, including narrative interventions., Methods: We use medical storytelling to present a scenario in which hypothetical twin patients with identical LBP episodes enter the healthcare system, with one twin managed in an appropriate manner, and the other inappropriately., Results: One twin becomes a chronic LBP sufferer, while the other experiences quick resolution, despite identical conditions. Recommendations are made to de-implement inappropriate action and to implement a more productive approach., Conclusions: Many patients with LBP descend into chronic pain. This is rarely inevitable based on clinical factors. Much of chronic LBP results from how the condition is handled within the healthcare system. Medical narrative may be one innovation to illustrate the problem of current LBP management, recommend solutions and foster changes in clinical behavior., Practical Implications: The starkly different outcomes for each identical twin are illustrated. Recommendations are made for reframing the situation to de-implement the inappropriate and to implement a more appropriate approach., (© 2023. Chiropractic and Osteopathic College of Australasia, European Academy of Chiropractic, The Royal College of Chiropractors, Nordic Institute of Chiropractic and Clinical Biomechanics and BioMed Central Ltd.)

Background: Chronic pain is a highly prevalent health problem especially in rural regions. There is a dearth of comprehensive pain management programs particularly in rural areas.Aim: The objectives of this paper are to describe the evolution of an interprofessional chronic pain team employing a patient-centered model of care with a biopsychosocial approach, and health services metrics.Method: This descriptive case study approach includes an overview of the Chronic Pain Management Program (CPMP) services at St. Joseph Care Group in Thunder Bay, NW Ontario; the process involved in the development of an interprofessional chronic pain team employing a patient-centered model of care with a biopsychosocial approach; and metrics of the program's operations.Results: Established in 1998, CPMP has evolved to become inter-professional, providing consultations and management, with partial funding by the Ontario Ministry of Health and Long term Care that has allowed expansion of services. The CPMP currently provides three distinct program streams as follows: a) Intensive 6-week, four half-days/week, outpatient program that offers an interdisciplinary team approach in groups and individual format; b) PACE-IT (Pain Assessment Collaborative Education Inter-professional Therapy), 8-week long, half-day/ week, interprofessional treatment program, in person; and c) Individual format for one-on-one services for patients not fitting in either the 6-Week or PACE-IT programs. In addition, Additional services provide virtual consultations and didactic videoteleconference sessions on opioid stewardship and pain management to health providers. Health services outcomes, research, and educational opportunities across the Northwestern Ontario Region, challenges and future needs are discussed.Conclusion: The CPMP's model of care can serve as a foundation for expert chronic pain care delivery across rural Canada, and as template for similar institutionally-based and publicly funded pain clinics. [ABSTRACT FROM AUTHOR]

Background: Databases have become an important tool in understanding trends and correlations in health care by collecting demographic and clinical information. Analysis of data collected from large cohorts of patients can have the potential to generate insights into factors identifying treatments and the characteristics of subgroups of patients who respond to certain types of care. The Care Response (CR) database was designed to capture patient-reported outcome measures (PROMs) for chiropractic patients internationally. Although several papers have been published analysing some of the data, its contents have not yet been comprehensively documented. The primary aim of this study was to describe the information in the CR database. The secondary aim was to determine whether there was suitable information available to better understand subgroups of chiropractic patients and responsiveness to care. This would be achieved by enabling correlations among patient demographics, diagnoses, and therapeutic interventions with machine learning approaches. Methods: Data in all available fields were requested with no date restriction. Data were collected on 12 April 2022. The output was manually scanned for scope and completeness. Tables were created with categories of information. Descriptive statistics were applied. Results: The CR database collects information from patients at the first clinical visit, 14, 30, and 90 days subsequently. There were 32,468 patient responses; 3210 patients completed all fields through the 90 day follow up period. 45% of respondents were male; 54% were female; the average age was 49. There was little demographic information, and no information on diagnoses or therapeutic interventions. We received StartBack, numerical pain scale, patient global impression of change, and Bournemouth questionnaire data, but no other PROMs. Conclusions: The CR database is a large set of PROMs for chiropractic patients internationally. We found it unsuitable for machine learning analysis for our purposes; its utility is limited by a lack of demographic information, diagnoses, and therapeutic interventions. However, it can offer information about chiropractic care in general and patient satisfaction. It could form the basis for a useful clinical tool in the future, if reformed to be more accessible to researchers and expanded with more information collected. [ABSTRACT FROM AUTHOR]

Background: Low back pain (LBP) is a multifactorial disorder associated with a high range of physical and psychological burden on the society. Patient-led goal-setting approach has shown potential effects for improving chronic LBP. However, there are few studies investigating its benefits when combined with a supplementary intervention. This paper, therefore, presents a protocol for a randomized control trial (RCT) to study the effect of a patient-led goal-setting approach combined with pain neuroscience education (PNE) or manual therapy (MT) among patients with chronic LBP. Methods: A total of 105 patients suffering from chronic LBP will be recruited via flyers displayed in hospitals and universities, and those meeting the study's criteria will randomly be allocated into a patient-led goal-setting approach with the PNE group, and/or with the MT program group, and/or a control group. The primary outcomes will be the pain intensity and disability. Secondary outcomes include quality of life, depression, anxiety and stress, fear avoidance beliefs, kinesophobia, pain self-efficacy, catastrophic pain, neurophysiology of pain, and central sensitivity. All the outcomes will be recorded at 2 months after receiving the treatment as post-test sessions and after 4 and 12 months as follow-up sessions. The Ethics Committee in Research at Sport Sciences Research Institute of Iran approved the protocol of this trial (IR.SSRC.REC.1400.084). Written, informed consent to participate will be obtained from all participants. All methods will be conducted in accordance with the ethical standards of the Declaration of Helsinki and in accordance with relevant guidelines and regulations. We will disseminate the findings through peer-reviewed publications and conference presentations and send them to the participants. Discussion: This trial will demonstrate which supplementary intervention can better improve the impact of a patient-led goal-setting approach to treat LBP. If successful, the results will potentially have implications for athletic trainers, physiotherapists, and health care practitioners. Trial registration: IRCT Iranian Registry of Clinical Trials IRCT20210927052616N1. Registered on November 03, 2021. [ABSTRACT FROM AUTHOR]

Background: Pain predominant multisymptom illness (pain-CMI) refers to symptom-based conditions where pain is a primary symptom. There is initial evidence that health coaching may be efficacious in treating pain-CMI because it can be tailored to the veteran's goals and emphasizes long-term behavior change, which may indirectly impact the maintaining factors of pain-CMI (e.g., catastrophizing, poor pain control, and limited activity). This paper describes the study protocol and rationale of a randomized controlled trial that will compare the efficacy of remote-delivered health coaching in reducing disability and pain impairment for veterans with pain-CMI to remote-delivered supportive psychotherapy., Methods: This randomized controlled trial will consist of two treatment arms: remote-delivered health coaching and remote-delivered supportive psychotherapy, the active control. Each treatment condition will consist of twelve, weekly one-on-one meetings with a study provider. In addition to the baseline assessment, participants will also complete 6-week (mid-treatment), 12-week (post-treatment), and 24-week (follow-up) assessments that consist of questionnaires that can be completed remotely. The primary aims for this study are to determine whether health coaching reduces disability and pain impairment as compared to supportive psychotherapy. We will also examine whether health coaching reduces physical symptoms, catastrophizing, limiting activity, and increasing pain control as compared to supportive psychotherapy., Discussion: This study will contribute to the existing literature on pain-CMI and report the effectiveness of a novel, remote-delivered behavioral intervention., (© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Background and Objective: The diagnosis of rare diseases (RDs) is often challenging due to their rarity, variability and the high number of individual RDs, resulting in a delay in diagnosis with adverse effects for patients and healthcare systems. The development of computer assisted diagnostic decision support systems could help to improve these problems by supporting differential diagnosis and by prompting physicians to initiate the right diagnostic tests. Towards this end, we developed, trained and tested a machine learning model implemented as part of the software called Pain2D to classify four rare diseases (EDS, GBS, FSHD and PROMM), as well as a control group of unspecific chronic pain, from pen-and-paper pain drawings filled in by patients., Methods: Pain drawings (PDs) were collected from patients suffering from one of the four RDs, or from unspecific chronic pain. The latter PDs were used as an outgroup in order to test how Pain2D handles more common pain causes. A total of 262 (59 EDS, 29 GBS, 35 FSHD, 89 PROMM, 50 unspecific chronic pain) PDs were collected and used to generate disease specific pain profiles. PDs were then classified by Pain2D in a leave-one-out-cross-validation approach., Results: Pain2D was able to classify the four rare diseases with an accuracy of 61-77% with its binary classifier. EDS, GBS and FSHD were classified correctly by the Pain2D k-disease classifier with sensitivities between 63 and 86% and specificities between 81 and 89%. For PROMM, the k-disease classifier achieved a sensitivity of 51% and specificity of 90%., Conclusions: Pain2D is a scalable, open-source tool that could potentially be trained for all diseases presenting with pain., (© 2023. The Author(s).)

Background: The Chronic Pain Network (CPN) is a pan-Canadian research network focused on innovating and improving the quality and delivery of pain prevention, assessment, management and research for all Canadians. An important focus of the CPN is to work in collaboration with patient partners. Patient partners, researchers and clinicians work together in all aspects of the research network including on funded research projects and in the governance of the Network. Given this focus, the CPN identified the importance of evaluating their patient engagement work to understand its functioning and impact. Methods: The objective of this exploratory evaluation case study was to understand the impacts of patient engagement on the CPN. The CPN worked with an external evaluation team which established an arms-length approach to the evaluation. Interviews were conducted with CPN members, including patient partners, leadership, funded researchers and committee co-chairs, at three discrete time points to trace the evolution of the patient engagement program within the Network. Key Network documents were also collected and reviewed. Data were analyzed following each set of interviews using content analysis guided by the principles of constant comparison and qualitative description. A final round of analysis was conducted using the Engage with Impact Toolkit, an impact measurement framework, to identify impacts of engagement. Results: Impacts of patient engagement were identified at the individual, network, funded research project and research community levels. These impacts were observed in the following areas: (1) building community; (2) developing knowledge, skills and resources; (3) increasing confidence; (4) influencing priorities and decisions; (5) enabling additional opportunities; (6) promoting culture change; and, (7) coping with experiences of living with chronic pain. Conclusions: While not without challenges, the patient engagement efforts of the CPN demonstrates the impact engaging patient partners can have on a national research network and related policy activities. Understanding the approaches to, and impacts of, patient engagement on health research networks can illuminate the value of having patient partners engaged in all aspects of a research network and should serve as encouragement to others who look to take on similar work. Plain English summary: The Chronic Pain Network (CPN) is one of a group of research networks that was funded by the Canadian Institutes of Health Research (CIHR) to support patient-oriented research in chronic diseases. From the beginning of its work, the CPN has included patients as partners. Patient partners are co-chairs of all Network governance committees, funded projects are required to include patient partners in their work and there is a committee dedicated to engagement, the Patient Engagement (PE) committee. The PE Committee determined that it was important to evaluate how the CPN was engaging with patient partners and collaborated with the Public and Patient Engagement Collaborative (PPEC) to evaluate this work. The PPEC, along with members of the PE Committee, identified understanding the impact of patient engagement as an important part of the evaluation. This paper provides a description of the impacts of patient engagement on the people who were involved in the CPN, on the CPN's work and way of being, and on the broader pain research community. Based on the results from three sets of interviews and review of Network documents, we share impacts identified in seven areas: (1) building community; (2) developing knowledge, skills and resources; (3) increasing confidence; (4) influencing priorities and decisions; (5) enabling additional opportunities; (6) promoting culture change; and, (7) coping with experiences of living with chronic pain. This research shows us the impact that engaging patient partners can have on a national research network, and the areas where greater focus could, perhaps, lead to even greater impacts in future networks. [ABSTRACT FROM AUTHOR]

Background: Neurostimulation is an effective therapy for treating and management of refractory chronic pain. However, the complex nature of pain and infrequent in-clinic visits, determining subject's long-term response to the therapy remains difficult. Frequent measurement of pain in this population can help with early diagnosis, disease progression monitoring, and evaluating long-term therapeutic efficacy. This paper compares the utilization of the common subjective patient-reported outcomes with objective measures captured through a wearable device for predicting the response to neurostimulation therapy. Method: Data is from the ongoing international prospective post-market REALITY clinical study, which collects long-term patient-reported outcomes from 557 subjects implanted by Spinal Cord Stimulator (SCS) or Dorsal Root Ganglia (DRG) neurostimulators. The REALITY sub-study was designed for collecting additional wearables data on a subset of 20 participants implanted with SCS devices for up to six months post implantation. We first implemented a combination of dimensionality reduction algorithms and correlation analyses to explore the mathematical relationships between objective wearable data and subjective patient-reported outcomes. We then developed machine learning models to predict therapy outcome based on the subject's response to the numerical rating scale (NRS) or patient global impression of change (PGIC). Results: Principal component analysis showed that psychological aspects of pain were associated with heart rate variability, while movement-related measures were strongly associated with patient-reported outcomes related to physical function and social role participation. Our machine learning models using objective wearable data predicted PGIC and NRS outcomes with high accuracy without subjective data. The prediction accuracy was higher for PGIC compared with the NRS using subjective-only measures primarily driven by the patient satisfaction feature. Similarly, the PGIC questions reflect an overall change since the study onset and could be a better predictor of long-term neurostimulation therapy outcome. Conclusions: The significance of this study is to introduce a novel use of wearable data collected from a subset of patients to capture multi-dimensional aspects of pain and compare the prediction power with the subjective data from a larger data set. The discovery of pain digital biomarkers could result in a better understanding of the patient's response to therapy and their general well-being. [ABSTRACT FROM AUTHOR]

Background: This review aims to synthesise evidence on the economic impact of psychological interventions and therapies when applied to a broad range of physical health conditions., Methods: The following bibliographic databases were searched for relevant articles: MEDLINE (Ovid), EMBASE (Ovid) and PsycINFO (Ebsco). As this review was intended to update an earlier review, the date range for the search was restricted to between January 2012 and September 2018. Reference lists from the review articles were also searched for relevant articles. Study quality was evaluated using the Scottish Intercollegiate Network Guidelines (SIGN) appraisal checklists for both economic studies and Randomised Controlled Trials (RCTs). When the economic analyses did not provide sufficient detail for quality evaluation, the original RCT papers were sought and these were also evaluated. Half of the papers were quality rated by a second author. Initial agreement was high and all disagreements were resolved by discussion., Results: This yielded 1408 unique articles, reduced to 134 following screening of the title and abstract. The full texts of the remaining articles were reviewed by at least one team member and all exclusions were discussed and agreed by the team. This left 46 original research articles, alongside five systematic reviews. Fifty-seven per cent of the articles were deemed to be of high quality, with the remainder of acceptable quality. Fifteen different medical conditions were covered, with chronic pain (10 articles) and cancer (9 articles) being the two most investigated health conditions. Three quarters of the papers reviewed showed evidence for the cost-effectiveness of psychological interventions in physical health, with the clearest evidence being in the field of chronic pain and cancer., Conclusions: This paper provides a comprehensive integration of the research on the cost-effectiveness of psychological therapies in physical health. Whilst the evidence for cost-effectiveness in chronic pain and cancer is encouraging, some health conditions require further study. Clearly, as the primary research is international, and was therefore conducted across varying health care systems, caution must be exercised when applying the results to counties outside of those covered. Despite this, the results are of potential relevance to service providers and funders., (© 2022. The Author(s).)

Background: The role of pain sensitivity in the development and maintenance of chronic pain states, impaired executive functioning, and patient recovery is being investigated. Conditioned pain modulation (CPM) is widely used to measure musculoskeletal pain associated with central sensitization (CS). Despite the recommendations of many reviews and clinical practice guidelines that exercise programs reduce pain and disability, the overall confidence in these results is considered "critically low." The "active ingredient" of exercise programs and the dominant factor influencing CPM remain largely unknown. The objectives of this trial are to determine: • If different exercises cause different results on the CPM in a subgroup of people with chronic low back pain (CLBP) who are labeled as having CS pain, • If a program of exercise interventions for 12 weeks would alter executive functioning, quality of life (QoL), disability, and pain in persons with CLBP. • The relationship between patient characteristics, executive functions, CPM, and QoL Methods: The trial is a randomized, controlled, multi-center study with four experimental groups and one healthy control group. Both the researchers and the people in the study will be blinded to the results. This paper describes the protocol for a trial examining the effects of 12-week individualized, twice-weekly exercise sessions lasting 30 to 60 min in persons with CLBP, who are positive for CS. Participants will be randomized to receive either patient education with motor control exercises (MCE), superficial strengthening (SS), aerobic exercises (AE), or patient education alone. Another group comprised of healthy volunteers will serve as controls. The primary outcomes are changes in CPM outcomes as measured by the cold pressor test (CPT). The secondary objectives are to evaluate executive functioning, pain, disability, quality of life, and spine muscle strength. The outcomes will be measured at 3 months and at a 6-month follow-up. Discussion: The outcomes of the study will help in gaining more information and evidence about exercise-induced analgesia from the perspective of CPM. Measuring exercise outcomes will aid in scientifically prescribing exercise prescriptions in people with CLBP. The study outcomes will also assist in identifying the characteristics of individuals who will respond or respond indifferently to exercises. Investigating the relationship between the study's various outcomes could provide information for future trials. Trial registration: Clinical Trials Registry of India (CTRI) identifier: CTRI/2022/03/041143. Registered on 16 March 2022. [ABSTRACT FROM AUTHOR]

Objective: This study evaluated the quality of randomized controlled trials (RCTs) on chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS)., Methods: We searched PubMed, Web of Science, and Embase for RCTs (original articles) on CP/CPPS published from database establishment to 2021. The RCT quality assessment was performed using the Consolidated Standards of Reporting of Trials (CONSORT) statement and the improved Jadad scale., Results: In total, 77 RCTs were included. According to the evaluation, 26 (33.77%) papers presented the description of the specific random methods, only 6 (7.79%) papers described the allocation concealment methods, and 26 (33.77%) articles referred to the "blind method". Of the RCTs, 34 (44.16%) papers recorded the number of patients who withdrew from the study, and 67 (87.01%) papers reported adverse reactions. However, few reports mentioned the sample size calculation, clinical trial registration, or information about the relevant research programs and funding. In addition, 19 (24.68%) reports had Jadad scale scores of ≥ 4 points, and 58 (75.32%) reports had Jadad scale scores of ≤ 3 points., Conclusion: To date, the quality of RCT reports on CP/CPPS needs to be further improved, and the results of the RCTs should be accepted and utilized cautiously. It is suggested that researchers should follow the CONSORT statement and the improved Jadad scale to standardize the design and implementation of RCTs to improve the quality of RCTs and provide reliable evidence for the treatment of CP/CPPS., (© 2022. The Author(s).)

Background: Participatory approaches to developing health interventions with end-users are recommended to improve uptake and use. We aimed to explore the experiences of co-designing an online-delivered pain management programme (iSelf-help) for people with persistent pain. Methods: A modified participatory action research (PAR) framework was used to co-design contents and delivery of iSelf-help. The PAR team included: (1) a patient advisory group consisting of people living with persistent pain (n = 8), (2) pain management service clinicians (n = 2), (3) health researchers (n = 3), (4) digital health experts (n = 2), (5) a health literacy expert, and (6) two Māori health researchers and our community partner who led the cultural appropriateness of iSelf-help for Māori (the Indigenous population of New Zealand). The iSelf-help co-design processes and activities of the 'PAR' team is reported in another paper. In this paper, all PAR team members were invited to share their experiences of the co-design process. Individual interviews were held with 12 PAR team members. Interview transcripts were analysed using the General Inductive Approach. Results: Five common themes were identified from the interviews: (1) Shared understanding and values of the co-design process, (2) Mismatched expectations with content creation, (3) Flexibility to share power and decision making, (4) Common thread of knowledge, and (5) Shared determination. Sustaining these themes was an overarching theme of "A coalition of the willing". Conclusions: PAR team members valued the shared determination and responsibility to co-design iSelf-help. They also acknowledged the complexities and challenges during the process related to mismatched expectations, power sharing and establishing a common thread of knowledge. Successful co-design requires a shared commitment and responsibility as a coalition to meet the aspirations of end-users, within the boundaries of time and budget. Plain English summary: Persistent non-cancer pain affects one in five people globally. Māori (the Indigenous population of New Zealand) experience a higher persistent pain prevalence than non-Māori. People living with persistent pain in New Zealand experience significant challenges in accessing specialised pain services, such as long-waiting times for referral, delays in getting a persistent pain diagnosis, lack of specialised health professionals in pain management and services that do not provide culturally responsive care. In an increasingly digital world, one way of addressing such access barriers is to provide pain services remotely. Using a participatory action research (PAR) framework, we co-designed an online version of an existing hospital-based pain management programme. The PAR 'team' included patients living with persistent pain, who have previously completed the pain management programme and other stakeholders including pain management clinicians, health researchers, technology design experts, and a health literacy expert. The PAR 'team' also included two Māori researchers, and our Māori community partner who led the cultural adaptation process of the online programme with Māori community members living with persistent pain. We invited all the PAR team members asking their experiences of co-designing an online pain management programme (iSelf-help) that is culturally adapted for Māori. Our results from interviewing 12 PAR team members suggest the shared values and determination to co-design the online programme enabled team members' journey as a coalition to be successful, however, along the way, the process was complex and challenging at times both within and between the various teams. The key factors that caused such complexity were the mismatched expectations and understandings of the project, negotiating power sharing between the various teams and establishing a common thread of knowledge. We conclude that successful co-design requires a shared commitment and responsibility as a coalition to meet the aspirations of end-users, within the limits of time and budget. [ABSTRACT FROM AUTHOR]

Background: Neck and shoulder complaints are common in primary care physiotherapy. These patients experience pain and disability, resulting in high societal costs due to, for example, healthcare use and work absence. Content and intensity of physiotherapy care can be matched to a patient's risk of persistent disabling pain. Mode of care delivery can be matched to the patient's suitability for blended care (integrating eHealth with physiotherapy sessions). It is hypothesized that combining these two approaches to stratified care (referred to from this point as Stratified Blended Approach) will improve the effectiveness and cost-effectiveness of physiotherapy for patients with neck and/or shoulder complaints compared to usual physiotherapy.Methods: This paper presents the protocol of a multicenter, pragmatic, two-arm, parallel-group, cluster randomized controlled trial. A total of 92 physiotherapists will be recruited from Dutch primary care physiotherapy practices. Physiotherapy practices will be randomized to the Stratified Blended Approach arm or usual physiotherapy arm by a computer-generated random sequence table using SPSS (1:1 allocation). Number of physiotherapists (1 or > 1) will be used as a stratification variable. A total of 238 adults consulting with neck and/or shoulder complaints will be recruited to the trial by the physiotherapy practices. In the Stratified Blended Approach arm, physiotherapists will match I) the content and intensity of physiotherapy care to the patient's risk of persistent disabling pain, categorized as low, medium or high (using the Keele STarT MSK Tool) and II) the mode of care delivery to the patient's suitability and willingness to receive blended care. The control arm will receive physiotherapy as usual. Neither physiotherapists nor patients in the control arm will be informed about the Stratified Blended Approach arm. The primary outcome is region-specific pain and disability (combined score of Shoulder Pain and Disability Index & Neck Pain and Disability Scale) over 9 months. Effectiveness will be compared using linear mixed models. An economic evaluation will be performed from the societal and healthcare perspective.Discussion: The trial will be the first to provide evidence on the effectiveness and cost-effectiveness of the Stratified Blended Approach compared with usual physiotherapy in patients with neck and/or shoulder complaints.Trial Registration: Netherlands Trial Register: NL8249 . Officially registered since 27 December 2019. Date of first enrollment: 30 September 2020. Study status: ongoing, data collection. [ABSTRACT FROM AUTHOR]

Background: Health is a fundamental aspect of many scientific disciplines and its definition and measurement is the analytical core of many empirical studies. Comprehensive measures of health, however, are typically precluded in survey research due to financial and temporal restrictions. Self-rated health (SRH) as a single indicator of health, on the other hand, exhibits a lack of measurement invariance by age and is biased due to non-health influences. In the three-item Minimum European Health Module (MEHM), SRH is complemented with questions on chronic health conditions and activity limitations, thus providing a compromise between single indicators and comprehensive measures. Methods: Using data from the German Ageing Survey (2008 & 2014; n = 12,037), I investigated the feasibility to combine the MEHM into a generic health indicator and judged its utility in comparison to SRH as a benchmark. Additionally, I explored the option of an extended version of the MEHM by adding information on multimorbidity and the presence and intensity of chronic pain. Results: The analyses showed that both versions of the MEHM had a good internal consistency and each represented a single latent variable that can be computed using generalized structural equation modeling. The utility of this approach showed great promise as it significantly reduced age-specific reporting behavior and some non-health biases present in SRH. Conclusions: Using the MEHM to measure generic (physical) health is a promising approach with a wide array of applications. Further research could extend these analyses to additional age groups, other countries, and establish standardized weights for greater comparability. [ABSTRACT FROM AUTHOR]

Background: Although chronic pain is common in children with cerebral palsy (CP), little is known about short-term pain fluctuations and their impact on children's well-being. High-quality cohort studies are needed to understand the clinical course of pain in this population. We aimed to determine the feasibility of conducting a multicentre cohort study. In this pilot study we assessed: 1) study processes, 2) resource and 3) management indicators including recruitment and follow-up rates, data completeness, participant characteristics, and successes and barriers in the study conduct., Methods: A multi-centre pilot cohort study was conducted with 10 Canadian children/youth with CP attending one of two children's rehabilitation centers. We collected self-reported pain intensity (Faces Pain Scale-Revised [FPS-R], Numeric Rating Scale [NRS]); pain interference (PROMIS PI); pain location (pain diagram); physical and psychological well-being (KIDSCREEN-27), sleep characteristics, preceding months' interventions, and some clinical characteristics at baseline. Average pain intensity was reported weekly for five weeks. Well-being, sleep and interventions were measured at baseline and again at five weeks. We used feasibility indicators to evaluate:1) study processes (e.g. recruitment, attrition rates); 2) resources (e.g. data completion, budgetary challenges); and 3) management (e.g. data optimization, variability of participants and pain scores)., Results: Between March and May 2019, 24 children and their parents/guardians were contacted and 20 met eligibility criteria. Of those, 10 agreed to in-person screening (50%) and were subsequently enrolled. The follow-up rate was 90% and self-reported missing data was minimal. Ninety percent of participants chose e-questionnaire follow-ups versus mailed paper questionnaires. Sixty percent required reminders to complete e-follow-ups. Participants were aged 8-17 years, five were female, GMFCS levels I-IV (none with level V), 90% had spastic CP and 80% reported having pain in the preceding week. Pain intensity (FPS-R) between participants ranged from 0-8/10 at baseline and 0-6/10 across all four weekly follow-ups., Conclusions: This pilot study demonstrates the feasibility of conducting a multicentre cohort study to identify short-term pain trajectories and measure their association with well-being in children and youth with CP. Additional strategies to improve recruitment and accessibility for those with GMFCS levels V should be implemented in future studies., (© 2021. The Author(s).)

Chronic pain easily leads to concomitant mood disorders, and the excitability of anterior cingulate cortex (ACC) pyramidal neurons (PNs) is involved in chronic pain-related anxiety. However, the mechanism by which PNs regulate pain-related anxiety is still unknown. The GABAergic system plays an important role in modulating neuronal activity. In this paper, we aimed to study how the GABAergic system participates in regulating the excitability of ACC PNs, consequently affecting chronic inflammatory pain-related anxiety. A rat model of CFA-induced chronic inflammatory pain displayed anxiety-like behaviors, increased the excitability of ACC PNs, and reduced inhibitory presynaptic transmission; however, the number of GAD65/67 was not altered. Interestingly, intra-ACC injection of the GABA A R agonist muscimol relieved anxiety-like behaviors but had no effect on chronic inflammatory pain. Intra-ACC injection of the GABA A R antagonist picrotoxin induced anxiety-like behaviors but had no effect on pain in normal rats. Notably, chemogenetic activation of GABAergic neurons in the ACC alleviated chronic inflammatory pain and pain-induced anxiety-like behaviors, enhanced inhibitory presynaptic transmission, and reduced the excitability of ACC PNs. Chemogenetic inhibition of GABAergic neurons in the ACC led to pain-induced anxiety-like behaviors, reduced inhibitory presynaptic transmission, and enhanced the excitability of ACC PNs but had no effect on pain in normal rats. We demonstrate that the GABAergic system mediates a reduction in inhibitory presynaptic transmission in the ACC, which leads to enhanced excitability of pyramidal neurons in the ACC and is associated with chronic inflammatory pain-related anxiety., (© 2021. The Author(s).)

Background: Critically ill patients with COVID-19 are an especially susceptible population to develop post-intensive care syndrome (PICS) due to acute respiratory distress syndrome (ARDS). Patients can suffer acute severe pain and may have long-term mental, cognitive, and functional health deterioration after discharge. However, few controlled trials are evaluating interventions for the prevention and treatment of PICS. The study hypothesis is that a specific care program based on early therapeutic education and psychological intervention improves the quality of life of patients at risk of developing PICS and chronic pain after COVID-19. The primary objective is to determine whether the program is superior to standard-of-care on health-related quality of life at 6 months after hospital discharge. The secondary objectives are to determine whether the intervention is superior to standard-of-care on health-related quality of life, incidence of chronic pain and degree of functional limitation, incidence of anxiety, depression, and post-traumatic stress syndrome at 3 and 6 months after hospital discharge., Methods: The PAINCOVID trial is a unicentric randomized, controlled, patient-blinded superiority trial with two parallel groups. The primary endpoint is the health-related quality of life at 6 months after hospital discharge, and randomization will be performed with a 1:1 allocation ratio. This paper details the methodology and statistical analysis plan of the trial and was submitted before outcome data were available. The estimated sample size is 84 patients, 42 for each arm. Assuming a lost to follow-up rate of 20%, a sample size of 102 patients is necessary (51 for each arm)., Discussion: This is the first randomized clinical trial assessing the effectiveness of an early care therapeutic education, and psychological intervention program for the management of PICS and chronic pain after COVID-19. The intervention will serve as proof of the need to implement early care programs at an early stage, having an incalculable impact given the current scenario of the pandemic., Trial Registration: This study is being conducted in accordance with the tenets of the Helsinki Declaration and has been approved by the authors' institutional review board Comité Ético de Investigación Clínica del Hospital Clínic de Barcelona (approval number: HCB/2020/0549) and was registered on May 9, 2020, at clinicaltrials.gov ( NCT04394169 )., (© 2021. The Author(s).)

Background: The National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) was developed to accurately assess the pain, urinary symptoms, and quality of life related to chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). This study aimed to evaluate the cross-cultural adaptations of the NIH-CPSI., Method: PubMed, Embase, CINAHL, and SciELO databases were searched from their established year to September 2020. Cross-cultural adaptations and the quality control of measurement properties of adaptations were conducted by two reviewers independently according to the Guidelines for the Process of Cross-Cultural Adaptation of Self-Report Measures and the Quality Criteria for Psychometric Properties of Health Status Questionnaire., Results: Area total of 21 papers with 16 adaptations, and six studies of the original version of the NIH-CPSI were enrolled in the systematic review. Back translation was the weakest process for the quality assessment of the cross-cultural adaptations of the NIH-CPSI. Internal consistency was analyzed for most of the adaptations, but none of them met the standard. Only 11 adaptations reported test reliability, then only the Arabic-Egyptian, Chinese-Mainland, Danish, Italian, Persian, and Turkish adaptations met the criterion. Most adaptations reported the interpretability, but only the Danish adaptation reported the agreement. The other measurement properties, including responsiveness, and floor as well as ceiling effects were not reported in any of the adaptations., Conclusions: The overall quality of the NIH-CPSI cross-cultural adaptations was not organized as expected. Only the Portuguese-Brazilian, Italian, and Spanish adaptations reached over half the process for the cross-cultural adaptation. Only the Turkish adaptations finished half of the measurement properties of cross-cultural adaptations.

Background: Shared decision-making requires doctors to be competent in exchanging views with patients to identify the appropriate course of action. In this paper we focus on the potential of a course in argumentation as a promising way to empower doctors in presenting their viewpoints and addressing those of patients. Argumentation is the communication process in which the speaker, through the use of reasons, aims to convince the interlocutor of the acceptability of a viewpoint. The value of argumentation skills for doctors has been addressed in the literature. Yet, there is no research on what a course on argumentation might look like. In this paper, we present the content and format of a training session in argumentation for doctors and discuss some insights gained from a pilot study that examined doctors' perceived strengths and limitations vis-à-vis this training. Methods: The training session (eight hours) combined different aspects from prominent theories of argumentation and was designed to strengthen doctors' argumentative discussion skills. A convenient, self-selected sample of 17 doctors who were experts in the field of chronic pain participated in the training and evaluated it via a feedback form and semi-structured interviews. Results: The participants found that the training session gave a structure to types of communication they use to interact with their patients, and taught them techniques that can increase their effectiveness. Moreover, it provided tools to help address some of the challenges of modern doctor-patient interactions, including dealing with patients' unrealistic expectations and medically inaccurate beliefs, and reaching agreement when there are differences of opinion. Conclusions: This study enriches the research in the field of medical education. In line with the findings of studies that explore the value of argumentation in different fields, argumentative discussion skills can be applied by doctors to express their views and to account for the views of patients without patronizing the interaction. In this paper, we provide a basis to reflect on the value of argumentation in enhancing patients' right to autonomy and self-determination in interactions with their doctors. [ABSTRACT FROM AUTHOR]

Background: Low back pain is common and a significant number of patients experience chronic low back pain. Current treatment options offer small to moderate effects. Patients with vertebral bone marrow lesions visualized as Modic changes on magnetic resonance imaging may represent a subgroup within the low back pain population. There is evidence for inflammatory mediators being involved in development of Modic changes; hence, suppression of inflammation could be a treatment strategy for these patients. This study examines the effect of anti-inflammatory treatment with the TNF-α inhibitor infliximab in patients with chronic low back pain and Modic changes., Methods/design: The BackToBasic trial is a multicenter, double blind, randomized controlled trial conducted at six hospitals in Norway, comparing intravenous infusions with infliximab with placebo. One hundred twenty-six patients aged 18-65 with chronic low back pain and type 1 Modic changes will be recruited from secondary care outpatients' clinics. The primary outcome is back pain-specific disability at day 154 (5 months). The study is designed to detect a difference in change of 10 (SD 18) in the Oswestry Disability Index at day 154/ 5 months. The study also aims to refine MRI-assessment, investigate safety and cost-effectiveness and explore the underlying biological mechanisms of Modic changes., Discussion: Finding treatments that target underlying mechanisms could pose new treatment options for patients with low back pain. Suppression of inflammation could be a treatment strategy for patients with low back pain and Modic changes. This paper presents the design of the BackToBasic study, where we will assess the effect of an anti-inflammatory treatment versus placebo in patients with chronic low back pain and type 1 Modic changes. The study is registered at ClinicalTrials.gov under the identifier NCT03704363 . The EudraCT Number: 2017-004861-29.

Chronic pain surrounding the temporomandibular joints and masticatory muscles is often the primary chief complaint of patients with temporomandibular disorders (TMD) seeking treatment. Yet, the neuro-pathophysiological basis underlying it remains to be clarified. Neuroimaging techniques have provided a deeper understanding of what happens to brain structure and function in TMD patients with chronic pain. Therefore, we performed a systematic review of magnetic resonance imaging (MRI) studies investigating structural and functional brain alterations in TMD patients to further unravel the neurobiological underpinnings of TMD-related pain. Online databases (PubMed, EMBASE, and Web of Science) were searched up to August 3, 2019, as complemented by a hand search in reference lists. A total of 622 papers were initially identified after duplicates removed and 25 studies met inclusion criteria for this review. Notably, the variations of MRI techniques used and study design among included studies preclude a meta-analysis and we discussed the findings qualitatively according to the specific neural system or network the brain regions were involved in. Brain changes were found in pathways responsible for abnormal pain perception, including the classic trigemino-thalamo-cortical system and the lateral and medial pain systems. Dysfunction and maladaptive changes were also identified in the default mode network, the top-down antinociceptive periaqueductal gray-raphe magnus pathway, as well as the motor system. TMD patients displayed altered brain activations in response to both innocuous and painful stimuli compared with healthy controls. Additionally, evidence indicates that splint therapy can alleviate TMD-related symptoms by inducing functional brain changes. In summary, MRI research provides important novel insights into the altered neural manifestations underlying chronic pain in TMD.

Background: Complex Regional Pain Syndrome (CRPS) presents as chronic, continuous pain and sensory, autonomic, and motor abnormalities affecting one or more extremities. People with CRPS can also show changes in their perception of and attention to the affected body part and sensory information in the affected side of space. Prism Adaptation (PA) is a behavioural intervention targeted at reducing attention deficits in post-stroke hemispatial neglect. PA also appears to reduce pain and other CRPS symptoms; however, these therapeutic effects have been demonstrated only in small unblinded studies. This paper describes the protocol for an ongoing double-blind, randomized, sham-controlled clinical trial that will evaluate the efficacy of PA treatment for CRPS. The secondary aims of the study are to examine the relationships between neuropsychological changes (such as spatial attention, space and body representation, and motor spatial performance) and clinical manifestations of CRPS, as well as symptom improvement., Methods: Forty-two participants with upper-limb CRPS type I will undergo 2 weeks of twice-daily PA treatment or sham treatment. The primary outcome measures are current pain intensity and CRPS severity score, measured immediately before and after the treatment period. Secondary outcome measures include the results of self-report questionnaires about pain, movement, symptoms interference, and body representation; clinical assessments of sensory, motor, and autonomic functions; and computer-based psychophysical tests of neuropsychological functions. Data are collected in four research visits: 4 weeks and 1 day before treatment, and 1 day and 4 weeks after the end of treatment. Additional follow-up through postal questionnaires is conducted 3 and 6 months post-treatment., Discussion: It is hypothesised that participants undergoing PA treatment, compared to those receiving sham treatment, will show greater reduction in pain and CRPS severity score, and improvements on other clinical and neuropsychological measures. Also, more pronounced neuropsychological symptoms are predicted to correlate with more severe clinical CRPS symptoms. This study will provide the first randomized double-blind evaluation of the therapeutic effects of PA that could be implemented as a rehabilitation method for CRPS, and will contribute to the understanding of how neuropsychological changes in body representation and attention pertain to the manifestation and treatment of CRPS., Trial Registration: (27/03/2017): ISRCTN46828292 (ISRCTN - ISRCTN46828292: Treatment of complex regional pain syndrome (CRPS) with sensory-motor adaptation).

Background: Chronic musculoskeletal pain (MSP) affects more than 40% of adults aged 50 years and older and is the leading cause of disability in the USA. Older adults with chronic MSP are at risk for analgesic-related side effects, long-term opioid use, and functional decline. Recognizing the burden of chronic MSP, reducing the transition from acute to chronic pain is a public health priority. In this paper, we report the protocol for the Brief EducaTional Tool to Enhance Recovery (BETTER) trial. This trial compares two versions of an intervention to usual care for preventing the transition from acute to chronic MSP among older adults in the emergency department (ED).Methods: Three hundred sixty patients from the ED will be randomized to one of three arms: full intervention (an interactive educational video about pain medications and recovery-promoting behaviors, a telecare phone call from a nurse 48 to 72 h after discharge from the ED, and an electronic communication containing clinical information to the patient's primary care provider); video-only intervention (the interactive educational video but no telecare or primary care provider communication); or usual care. Data collection will occur at baseline and at 1 week and 1, 3, 6, and 12 months after study enrollment. The primary outcome is a composite measure of pain severity and interference. Secondary outcomes include physical function, overall health, opioid use, healthcare utilization, and an assessment of the economic value of the intervention.Discussion: This trial is the first patient-facing ED-based intervention aimed at helping older adults to better manage their MSP and reduce their risk of developing chronic pain. If effective, future studies will examine the effectiveness of implementation strategies.Trial Registration: ClinicalTrials.gov NCT04118595 . Registered on 8 October 2019. [ABSTRACT FROM AUTHOR]

Background: Despite its increasing clinical significance and diagnostic challenges, little is known about functional abdominal pain disorders (FAPDs) in Central-Eastern Europe. In this paper, the prevalence and potential sociodemographic correlates of FAPDs among Hungarian adolescents are explored.Methods: A cross-sectional, nationwide, questionnaire study in a representative sample of 657 adolescents has been conducted. With a response rate of 80.2%, 522/527 (99.1%) questionnaires were eligible for data analysis (N = 267, 51.1% girls, mean age 14.8, SD 2.4 years). The questionnaire included sociodemographic variables (age, sex, place of residence, marital status of the parents, family income, religion, educational level of parents), questions regarding self-reported specific learning disorders and the Questionnaire for Paediatric Gastrointestinal Symptoms Rome ΙΙΙ Edition.Results: The prevalence of FAPDs was 11.9% (N = 62). FAPDs were significantly associated with female sex. Living in a county town showed a negative correlation with FAPD. Adolescents with self-reported arithmetic learning disorders had an 8.7-fold likelihood of FAPD (OR, 8.7; 95% CI (3.5-21.9). Adolescent girls reported pain in all subtypes of FAPDs more frequently than adolescent boys except functional abdominal pain syndrome. The most prevalent FAPD was abdominal migraine (N = 32, 6.1%), followed by irritable bowel syndrome (N = 24, 4.6%).Conclusions: The prevalence of FAPDs in Hungary is similar to that reported worldwide, however, contrary to international data, abdominal migraine is the most frequently encountered FAPD in Hungary. In addition to well-known correlates of FAPDs, such as female sex and place of residence, arithmetic learning disorders have also been identified as correlating with the prevalence of FAPDs. Our results suggest culture-specific differences in the distribution of FAPDs, and confirm the significance of school performance indicators such as specific learning disorders as a correlate of FAPDs. [ABSTRACT FROM AUTHOR]

Background: Weight stigma is defined as negative misconception and stereotypes associated with weight, and it is commonly experienced during pregnancy. Weight stigma during pregnancy may be sourced from trusted close relationships including family members, partners, and friends. Social support is a necessary psychosocial factor for optimal health and wellbeing throughout pregnancy, and weight stigma sourced from these integral relationships may negatively affect health outcomes. The purpose of this study was to assess the impact of weight stigma from close others on maternal health outcomes. Methods: A survey was administered via Qualtrics to pregnant women (≥ 13 weeks, residence within the United States or Canada, ≥ 18 years old, singleton pregnancy). During pregnancy, participants completed questionnaires identifying whether they had experienced weight stigma from a close relationship (i.e., family, partners, or friends), how often, and relationship quality scales for each source. At three months postpartum, they were surveyed about their pregnancy outcomes including gestational diabetes, gestational hypertension, preeclampsia, chronic pain, anxiety/depression. They also completed the Edinburgh Postpartum Depression Scale (EPDS), and a linear regression was performed with frequency of weight stigma. Logistic regressions were performed between frequency of weight stigma and health outcomes. If significant, relationship quality was tested as a potential mediator. Significance was accepted as p < 0.05. Results: 463 participants completed both surveys of which 86% had experienced weight stigma from close others. Frequency of weight stigma was significantly associated with chronic pain (β = 0.689, p < 0.001), and anxiety/depression (β = 0.404, p = 0.005). The relationship between frequency of weight stigma in pregnancy and chronic pain was mediated by quality of all relationships. Family relationship quality mediated between frequency of weights stigma and anxiety/depression. Frequency of weight stigma was significantly associated with depression symptom severity measured by the EPDS (β = 0.634, p < 0.001). Conclusion: These findings underscore the issue of weight stigma and show that experiencing this from trusted close others is associated with poor health outcomes like chronic pain. Advocacy efforts to mitigate weight stigma in pregnancy and strengthen close relationships to improve maternal health and wellbeing is warranted. [ABSTRACT FROM AUTHOR]

Background : Chronic overlapping pain conditions (COPCs), pain-related conditions that frequently occur together, may occur in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and could impact illness severity. This study aimed to identify comorbid COPCs in patients with ME/CFS and evaluate their impact on illness severity. Methods: We used data from 923 participants in the Multi-Site Clinical Assessment of ME/CFS study, conducted in seven U.S. specialty clinics between 2012 and 2020, who completed the baseline assessment (595 ME/CFS and 328 healthy controls (HC)). COPCs included chronic low back pain (cLBP), chronic migraine/headache (cMHA), fibromyalgia (FM), interstitial cystitis/irritable bladder (IC/IB), irritable bowel syndrome (IBS), temporomandibular disorder (TMD). Illness severity was assessed through questionnaires measuring symptoms and functioning. Multivariate analysis of variance and analysis of covariance models were used for analyses. Log-binomial regression analyses were used to compute prevalence of COPCs and prevalence ratios (PR) between groups with 95% confidence intervals. Both unadjusted and adjusted results with age and sex are presented. Results : 76% of participants with ME/CFS had at least one COPCs compared to 17.4% of HC. Among ME/CFS participants, cMHA was most prevalent (48.1%), followed by FM (45.0%), cLBP (33.1%), and IBS (31.6%). All individual COPCs, except TMD, were significantly more frequent in females than males. The unadjusted PR (ME/CFS compared to HC) was highest for FM [147.74 (95% confidence interval (CI) = 20.83-1047.75], followed by cLBP [39.45 (12.73-122.27)], and IC/IB [13.78 (1.88-101.24)]. The significance and order did not change after age and sex adjustment. The COPC comorbidities of cLBP and FM each had a significant impact on most health measures, particularly in pain attributes (Cohen's d effect size 0.8 or larger). While the impact of COPC comorbidities on non-pain attributes and quality of life measures was less pronounced than that on pain, statistically significant differences between ME/CFS participants with and without COPCs were still evident. Conclusions: More than 75% of ME/CFS participants had one or more COPCs. Multiple COPCs further exacerbated illness severity, especially among females with ME/CFS. Assessment and management of COPCs may help improve the health and quality of life for patients with ME/CFS. [ABSTRACT FROM AUTHOR]

Background: Numerous studies have examined associations between overweight and obesity and risk of low back pain (LBP), but the exact magnitude of these associations is not yet clear. The purpose of this work was to assess such sex-specific associations in a community-based setting in Norway, taking into account potential relationships with other risk factors. Methods: A cohort study was conducted combining data from two waves of the Trøndelag Health Study, HUNT3 (2006–2008) and HUNT4 (2017–2019). Separate analyses were performed of risk of chronic LBP in HUNT4 among 14,775 individuals without chronic LBP in HUNT3, and of recurrence or persistence in HUNT4 among 5034 individuals with chronic LBP in HUNT3. Relative risks were estimated in generalised linear models for overweight and obesity compared to normal weight. Body size classification was based on values of BMI computed from measurements of height and weight. Chronic LBP was defined as LBP persisting at least 3 months during last year. Results: After adjustment for age, smoking, physical activity in leisure time and work activity, analysis of risk among women produced relative risks 1.11 (95% CI 1.00–1.23) for overweight, 1.36 (95% CI 1.20–1.54) for obesity class I and 1.68 (95% CI 1.42–2.00) for obesity classes II-III. Relative risks among men were 1.10 (95% CI 0.94–1.28) for overweight, 1.36 (95% CI 1.13–1.63) for obesity class I and 1.02 (95% CI 0.70–1.50) for obesity classes II-III, the last estimate being based on relatively few individuals. Analyses of recurrence or persistence indicated similar relationships but with smaller magnitude of relative risks and no drop in risk among obesity classes II-III in men. The change in BMI from HUNT3 to HUNT4 hardly differed between individuals with and without chronic LBP in HUNT3. Conclusions: Risk of chronic LBP increases with higher values of BMI in both sexes, although it is uncertain whether this applies to very obese men. Very obese women carry a particularly large risk. Probabilities of recurrence or persistence of chronic LBP among those already afflicted also increase with higher values of BMI. Adjustment for other factors does not influence relationships with overweight and obesity to any major extent. [ABSTRACT FROM AUTHOR]

Introduction: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pain condition creating a wide range of urologic and pain symptoms. There is currently limited evidence to understand the mechanisms of IC/BPS. There have been recent studies suggesting that altered function in brain motor areas, particularly the supplementary motor cortex (SMA), relates to altered bladder sensorimotor control and may play an important role in IC/BPS. This study aims to provide evidence that non-invasive stimulation targeting the motor cortex may help reduce IC/BPS pain, as well as better understand the neural mechanism by which this stimulation targets neuromuscular dysfunction. This study is a two-group quadruple-blinded randomized controlled trial (RCT) of active vs. sham repetitive transmagnetic stimulation (rTMS). In addition, our study will also include functional magnetic resonance imaging (fMRI), pelvic floor electromyography (EMG), pelvic exam, and outcome measures and questionnaires to further study outcomes. Ethics and dissemination: All aspects of the study were approved by the Institutional Review Board of the University of Southern California (protocol HS-20–01021). All participants provided informed consent by the research coordinator/assistants. The results will be submitted for publication in peer-reviewed journals and disseminated at scientific conferences. Trial registration: ClinicalTrials.gov NCT04734847. Registered on February 1, 2021. [ABSTRACT FROM AUTHOR]

Background: Obesity leads to the increase of pain at different parts of the body and it is a potential marker for complications of chronic diseases. This paper aims to assess changes in the body pain among overweight and obese housewives who participated in the My Body is Fit and Fabulous at home (MyBFF@home) study., Methods: Housewives aged 18 to 59 years old from the MyBFF@home study were selected and pain was measured using the Visual Analogue Scale (VAS) questionnaire. VAS measured the pain intensity at different parts of the body (score of 0-10). Data were collected at base line, 3 months and 6 months among the housewives in both the control and intervention group. Pain scores and other variables (age, Body Mass Index (BMI) and waist circumference) were analysed using SPSS version 22., Results: A total of 328 housewives completed the VAS questionnaires at baseline, while 185 (56.4%) of housewives completed the VAS at 3 months and 6 months. A decreasing trend of mean pain score in both groups after 6 months was observed. However, the intervention group showed a consistent decreasing trend of pain score mainly for back pain. In the control group, there was a slight increment of score in back pain from baseline towards the 6 months period. Older housewives in both groups (aged 50 years and above) had a higher mean score of leg pain (2.86, SD: 2.82) compared to the other age group. Higher BMI was significantly associated with pain score in both groups., Conclusion: There were some changes in the level of body pain among the housewives before and after the intervention. Older obese women had a higher pain score compared to younger obese women. Pain was associated with BMI and change in BMI appears to be beneficial in reducing body pain among overweight and obese individuals.

Background: Chronic pain has become a major health problem across the world, especially in older adults. Unfortunately, the effectiveness of medical interventions is modest. Some have argued that assessment strategies should be improved if the impact of medical interventions is to be improved. Ecological momentary assessment using smartphones is now considered the gold standard in monitoring in health settings, including chronic pain. However, to the best of our knowledge, there is no randomized controlled trial to show that telemonitoring using a smartphone app can indeed improve the effectiveness of medical treatments in adults with chronic pain. The goal of this study will be to explore the effects of using a smartphone app for telemonitoring adults with chronic pain., Methods: The study will be a randomized controlled trial with three groups: treatment as usual (TAU), TAU+app, and TAU+app+alarms. All groups will receive the adequate treatment for their pain, which will be prescribed the first day of study according to clinical guidelines. Assessment in the TAU group will be the usual at the Pain Clinic, that is, a paper-and-pencil evaluation at the onset of treatment (beginning of study) and at follow up (end of study, 30 days later). The other two groups (TAU+app and TAU+app+alarms) will be assessed daily using Pain Monitor, a smartphone app developed by our multidisciplinary team. Telemonitoring will only be made in the TAU+app+alarms group. For this group, physicians at the Pain Clinic may decide to adjust pain treatment in response to alarms. Telemonitoring is not the usual practice at the Pain Clinic and will not occur in the other two groups (TAU and TAU+app), so no changes in treatment are expected in these groups after the first appointment. The total sample size will be 150, with 50 patients in each group. The assessment protocol will be the same in all groups and will include pain intensity and side effects of the medication (primary outcomes), together with several pain-related variables like pain interference, activity level, use of rescue medication, pain catastrophizing, and pain acceptance, among others., Discussion: We believe that the present trial has important clinical implications. We think that telemonitoring using ecological momentary assessment is crucial to improve current interventions for pain. The armamentarium of available treatments for pain is large, so physicians can turn to different treatments or dosages in the presence of an undesired event. The use of the app for telemonitoring can allow for this rapid detection of unwanted events, thus improving patient safety (i.e., withdrawal of treatment causing side effects) and augmenting treatment effectiveness (i.e., changing an ineffective treatment or dosage). In a time when smartphones are a mainstream technology, we should take advantage of them in the promotion of health care., Trial Registration: ClinicalTrials.gov, NCT03247725 . Registered on 25 July 2017.

Background: The U.S. opioid epidemic has been driven by the high volume of opioids prescribed by healthcare providers. U.S. states have recently enacted four types of laws designed to curb high-risk prescribing practices, such as high-dose and long-term opioid prescribing, associated with opioid-related mortality: (1) mandatory Prescription Drug Monitoring Program (PDMP) enrollment laws, which require prescribers to enroll in their state's PDMP, an electronic database of patients' controlled substance prescriptions, (2) mandatory PDMP query laws, which require prescribers to query the PDMP prior to prescribing an opioid, (3) opioid prescribing cap laws, which limit the dose and/or duration of opioid prescriptions, and (4) pill mill laws, which strictly regulate pain clinics to prevent nonmedical opioid prescribing. Some pain experts have expressed concern that these laws could negatively affect pain management among patients with chronic non-cancer pain. This paper describes the protocol for a mixed-methods study analyzing the independent effects of these four types of laws on opioid prescribing patterns and chronic non-cancer pain treatment, accounting for variation in implementation and enforcement of laws across states., Methods: Many states have enacted multiple opioid prescribing laws at or around the same time. To overcome this issue, our study focuses on 18 treatment states that each enacted a single law of interest, and no other potentially confounding laws, over a 4-year period (2 years pre-/post-law). Qualitative interviews with key leaders in each of the 18 treatment states will characterize the timing, scope, and strength of each state law's implementation and enforcement. This information will inform the design and interpretation of synthetic control models analyzing the effects of each of the two types of laws on two sets of outcomes: measures of (1) high-risk opioid prescribing and (2) non-opioid treatments for chronic non-cancer pain., Discussion: Study of mandatory PDMP enrollment, mandatory PDMP query, opioid prescribing cap, and pill mill laws is timely given a dynamic policy environment in which numerous states pass, revise, implement, and enforce varied laws to address opioid prescribing each year. Findings will inform enactment, implementation, and enforcement of these laws in additional states.

Background: This paper reports on the feasibility, acceptability, and effectiveness of an innovative implementation strategy named "systems consultation" aimed at improving adherence to clinical guidelines for opioid prescribing in primary care. While clinical guidelines for opioid prescribing have been developed, they have not been widely implemented, even as opioid abuse reaches epidemic levels., Methods: We tested a blended implementation strategy consisting of several discrete implementation strategies, including audit and feedback, academic detailing, and external facilitation. The study compares four intervention clinics to four control clinics in a randomized matched-pairs design. Each systems consultant aided clinics on implementing the guidelines during a 6-month intervention consisting of monthly site visits and teleconferences/videoconferences. The mixed-methods evaluation employs the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Quantitative outcomes are compared using time series analysis. Qualitative methods included focus groups, structured interviews, and ethnographic field techniques., Results: Seven clinics were randomly approached to recruit four intervention clinics. Each clinic designated a project team consisting of six to eight staff members, each with at least one prescriber. Attendance at intervention meetings was 83%. More than 80% of staff respondents agreed or strongly agreed with the statements: "I am more familiar with guidelines for safe opioid prescribing" and "My clinic's workflow for opioid prescribing is easier." At 6 months, statistically significant improvements were noted in intervention clinics in the percentage of patients with mental health screens, treatment agreements, urine drug tests, and opioid-benzodiazepine co-prescribing. At 12 months, morphine-equivalent daily dose was significantly reduced in intervention clinics compared to controls. The cost to deliver the strategy was $7345 per clinic. Adaptations were required to make the strategy more acceptable for primary care. Qualitatively, intervention clinics reported that chronic pain was now treated using approaches similar to those employed for other chronic conditions, such as hypertension and diabetes., Conclusions: The systems consultation implementation strategy demonstrated feasibility, acceptability, and effectiveness in a study involving eight primary care clinics. This multi-disciplinary strategy holds potential to mitigate the prevalence of opioid addiction and ultimately may help to improve implementation of clinical guidelines across healthcare., Trial Registration: ClinicalTrials.gov (NCT02433496). https://clinicaltrials.gov/ct2/show/NCT02433496 Registered May 5, 2015.

Background: Whiplash-associated disorders (WAD) are an enormous and costly burden to Australian society. Up to 50% of people who experience a whiplash injury will never fully recover. Whiplash is resistant to treatment and no early management approach has yet been shown to prevent chronic pain. The early presence of central sensitization is associated with poor recovery. Pregabalin's effects on central sensitization indicate the potential to prevent or modulate these processes after whiplash injury and to improve health outcomes, but this has not been investigated. This paper describes the protocol for a feasibility study for a randomised controlled trial of pregabalin plus evidence-based advice compared to placebo plus evidence-based advice for individuals with acute whiplash injury who are at risk of poor recovery., Methods: This double blind, placebo-controlled randomised feasibility study will examine the feasibility and potential effectiveness of pregabalin and evidence-based advice (intervention) compared to placebo and evidence-based advice (control) for individuals with acute whiplash injury at risk of poor recovery. Thirty participants (15 per group) aged 18-65 years with Grade II WAD, within 48 hours of injury and currently experiencing at least moderate pain (NRS: ≥ 5/10) will be recruited from Emergency Departments of public hospitals in Queensland, Australia. Pregabalin will be commenced at 75 mg bd and titrated up to 300 mg bd as tolerated for 4 weeks followed by 1 week of weaning., Results: The feasibility of trial procedures will be tested, as well as the potential effect of the intervention on the outcomes. The primary outcome of neck pain intensity at 3 months from randomisation will be compared between the treatment groups using standard analysis of variance techniques., Discussion: Feasibility and potential effectiveness data will inform an appropriately powered full trial, which if successful, will provide an effective and cost-effective intervention for a costly and treatment resistant condition. It will also have implications for the early management of other traumatic conditions beyond whiplash., Trial Registration: Clinical Trials Primary Registry: Australian and New Zealand Clinical Trials Registry., Clinical Trial Registration Number: ACTRN12617000059369 . Date of Registration: 11/01/2017. Primary Trial Sponsor: The University of Queensland, Brisbane QLD 4072 Australia.

Background: Individuals with persistent low back pain commonly have a broad range of other health concerns including co-occurring musculoskeletal pain, which significantly affect their quality of life, symptom severity, and treatment outcomes. The purpose of this review is to get a better understanding of prevalence and patterns of co-occurring musculoskeletal pain complaints in those with persistent low back pain and its potential association with age, sex, and back-related disability as it might affect prognosis and management., Methods: This systematic review protocol has been designed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols. We will perform a comprehensive search, with no date limit, in the following bibliographic databases: MEDLINE and Embase (via Ovid), CINAHL, and Scopus for citation tracking, based on the following domains: back pain, co-occurring musculoskeletal pain, combined with a focus group that emphasizes study design. Appropriate papers will be screened against the eligibility criteria by three reviewers independently, data extracted by two independent author pairs and disagreement resolved by consensus meetings or other reviewers if required. Assessment of methodological quality and risk of bias will be conducted using a modified version of the Risk of Bias Tool for Prevalence Studies developed by Hoy and colleagues. The overall risk of bias will be determined for each included study based on the raters' consensus of the responses to the items in this tool. In case of sufficiently homogenous studies, meta-analysis will be performed., Discussion: Given the lack of standard terms used to define co-occurring musculoskeletal pain, the search strategy will include the broader term "back pain," different terms for the "other co-occurring pain," and specific study designs combined with several exclusion terms. The results of this proposed review will identify the prevalence and patterns of co-occurring musculoskeletal pain among those with persistent low back pain, which is likely to inform clinical management, research, and policy in management of musculoskeletal disorders., Systematic Review Registration: PROSPERO CRD42017068807.