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BackgroundIn contrast to prior research, our study presents longitudinal comparisons of the EQ-5D-5L and Patient-Reported Outcomes Measurement Information System (PROMIS) preference (PROPr) scores. This fills a gap in the literature, providing a much-needed understanding of these preference-based measures and their applications in healthcare research. Furthermore, our study provides equations to estimate one measure from the other, a tool that can significantly facilitate comparisons across studies.MethodsWe administered a health survey to 4,098 KnowledgePanel® members living in the United States. A subset of 1,256 (82% response rate) with back pain also completed the six-month follow-up survey. We then conducted thorough cross-sectional and longitudinal analyses of the two measures, including product-moment correlations between scores, associations with demographic variables, and health conditions. To estimate one measure from the other, we used ordinary least squares (OLS) regression with the baseline data from the general population.ResultsThe correlation between the EQ-5D-5L and PROPr scores was 0.69, but the intraclass correlation was only 0.34 because the PROPr had lower (less positive) mean scores on the 0 (dead) to 1 (perfect health) continuum than the EQ-5D-5L. The associations between the two preference measures and demographic variables were similar at baseline. The product-moment correlation between unstandardized beta coefficients for each preference measure regressed on 22 health conditions was 0.86, reflecting similar patterns of unique associations. Correlations of change from baseline to 6 months in the two measures with retrospective perceptions of change were similar. Adjusted variance explained in OLS regressions predicting one measure from the other was 48%. On average, the predicted values were within a half-standard deviation of the observed EQ-5D-5L and PROPr scores. The beta-binomial regression model slightly improved over the OLS model in predicting the EQ-5D-5L from the PROPr but was equivalent to the OLS model in predicting the PROPr.ConclusionDespite substantial mean differences, the EQ-5D-5L and PROPr have similar cross-sectional and longitudinal associations with other variables. We provide the OLS regression equations for use in cost-effectiveness research and meta-analyses. Future studies are needed to compare these measures with different conditions and interventions to provide more information on their relative validity.

ObjectivePeople commonly cope with chronic low back pain (cLBP) by ignoring and distraction. Can mindful interoceptive exposure to the pain sensation itself and its phenomenological components be an alternative approach?MethodsSingle-arm feasibility study in patients with cLBP using a 2-minute attention exercise guided by a smartphone app several times per day over 8 weeks. We assessed feasibility, pre/post pain, function, and psychological parameters using mixed methods: standard questionnaires, ecological momentary assessment, and exit interviews that included micro-phenomenology technique and subsequent reflexive thematic qualitative analysis.ResultsWe enrolled 31 participants, mostly female, mean age 48, the majority had pain for >5 years; 29 completed. Mean pain intensity [0-10] improved from 4.8 ±1.7 to 3.1 ±1.9 (p < .0001); mean PEG scores (intensity and interference with daily life; range 0-30) improved from 13.7 ±6.2 to 8.4 ±6.6 (p < .0001); pain impact (9 items incl physical function) 22.3 ±8.7 to 19.7 ±8.1 (p = .0010). Twenty-one of 29 improved PEG score ≥30%. There were significant improvements in PCS Rumination and MAIA Not-Worrying. Participants became aware of their usual habit of avoidance and the challenge of and resistance to focusing on pain. They were surprised how pain sensations varied over time, and that pain intensity and the threat value of pain could diminish by focusing on it. They described a variety of 3D pain shapes (e.g., football, pool ball, rod, nail, brick, stars) with a range of colors, transparency, temperature, and density that for some changed with mindful attention. Most struggled to find appropriate words for sensory awareness and attention regulation and found that the threat value of their pain diminished.ConclusionsMindful interoceptive exposure to the sensations of their cLBP using a 2-minute attention exercise with a phone app-rather than ignoring and distracting from it-may be a beneficial intervention for cLBP.Trial registrationClinicalTrials.gov #NCT06186193.

BackgroundTools, such as the STarTBack Screening Tool (SBT), have been developed to identify risks of progressing to chronic disability in low back pain (LBP) patients in the primary care population. However, less is known about predictors of change in function after treatment in the specialty care population.ObjectiveWe pursued a retrospective observational cohort study involving LBP patients seen in a multidisciplinary specialty clinic to assess which features can predict change in function at follow-up.MethodsThe SBT was administered at initial visit, and a variety of patient characteristics were available in the chart including the presence of chronic overlapping pain conditions (COPCs). Patient Reported Outcomes Measurement Information System-10 (PROMIS-10) global physical health (PH) and global mental health (MH) were measured at baseline and at pragmatic time points during follow-up. Linear regression was used to estimate adjusted associations between available features and changes in PROMIS scores.Results241 patients were followed for a mean of 17.0 ± 7.5 months. Mean baseline pain was 6.7 (SD 2.1), PROMIS-10 global MH score was 44.8 (SD 9.3), and PH score was 39.4 (SD 8.6). 29.7% were low-risk on the SBT, 41.8% were medium-risk, and 28.5% were high-risk. Mean change in MH and PH scores from baseline to the follow-up questionnaire were 0.86 (SD 8.11) and 2.39 (SD 7.52), respectively. Compared to low-risk patients, high-risk patients had a mean 4.35 points greater improvement in their MH score (p= 0.004) and a mean 3.54 points greater improvement in PH score (p= 0.006). Fewer COPCs also predicted greater improvement in MH and PH.ConclusionsSBT and the presence of COPC, which can be assessed at initial presentation to a specialty clinic, can predict change in PROMIS following treatment. Effort is needed to identify other factors that can help predict change in function after treatment in the specialty care setting.

BACKGROUND: Quality of life (QOL) is a critical factor in decision-making for advanced breast cancer (ABC). There is a need to improve how QOL and treatment-related side effects (SEs) that impact it are clinically assessed. We examined healthcare professionals (HCPs) and patients perspectives on the importance of QOL discussions and the impact of SEs on QOL in clinical settings. PATIENTS AND METHODS: A cross-sectional online survey was conducted (7/2020-5/2021) among oncologists, nurses, and patients with HR+/HER2- ABC in 7 countries. RESULTS: The survey was completed by 502 HCPs and 467 patients. Overall, 88% of oncologists and 49% of patients recalled QOL discussions at follow-up. In the first- through fourth-line (1L, 2L, 3L, and 4L) settings, respectively, 48%, 57%, 79%, and 85% of oncologists reported QOL was very important; 73% and 45% of patients receiving 1L and 2L treatment and 40% receiving 3L+ treatment indicated QOL was important. Patients reported that insomnia, anxiety, back pain, fatigue, diarrhea, hot flashes, low sexual interest, and loss of appetite had a moderate/severe impact on QOL. Of patients experiencing certain SEs, ≥64% did not discuss them with HCPs until there was a moderate/severe impact on QOL. In patients receiving a CDK4/6 inhibitor, SEs, including insomnia, diarrhea, back pain, and fatigue, had a moderate/severe impact on QOL. CONCLUSIONS: This survey discovered disconnects between HCPs and patients with ABC on the importance of QOL discussions and the impact of SEs on QOL. These data support the use of ABC-specific QOL questionnaires that closely monitor SEs impacting QOL.

ObjectiveOne aim of the Back Pain Consortium (BACPAC) Research Program is to develop an integrated model of chronic low back pain that is informed by combined data from translational research and clinical trials. We describe efforts to maximize data harmonization and accessibility to facilitate Consortium-wide analyses.MethodsConsortium-wide working groups established harmonized data elements to be collected in all studies and developed standards for tabular and nontabular data (eg, imaging and omics). The BACPAC Data Portal was developed to facilitate research collaboration across the Consortium.ResultsClinical experts developed the BACPAC Minimum Dataset with required domains and outcome measures to be collected by use of questionnaires across projects. Other nonrequired domain-specific measures are collected by multiple studies. To optimize cross-study analyses, a modified data standard was developed on the basis of the Clinical Data Interchange Standards Consortium Study Data Tabulation Model to harmonize data structures and facilitate integration of baseline characteristics, participant-reported outcomes, chronic low back pain treatments, clinical exam, functional performance, psychosocial characteristics, quantitative sensory testing, imaging, and biomechanical data. Standards to accommodate the unique features of chronic low back pain data were adopted. Research units submit standardized study data to the BACPAC Data Portal, developed as a secure cloud-based central data repository and computing infrastructure for researchers to access and conduct analyses on data collected by or acquired for BACPAC.ConclusionsBACPAC harmonization efforts and data standards serve as an innovative model for data integration that could be used as a framework for other consortia with multiple, decentralized research programs.

In 2019, the National Health Interview survey found that nearly 59% of adults reported pain some, most, or every day in the past 3 months, with 39% reporting back pain, making back pain the most prevalent source of pain, and a significant issue among adults. Often, identifying a direct, treatable cause for back pain is challenging, especially as it is often attributed to complex, multifaceted issues involving biological, psychological, and social components. Due to the difficulty in treating the true cause of chronic low back pain (cLBP), an over-reliance on opioid pain medications among cLBP patients has developed, which is associated with increased prevalence of opioid use disorder and increased risk of death. To combat the rise of opioid-related deaths, the National Institutes of Health (NIH) initiated the Helping to End Addiction Long-TermSM (HEAL) initiative, whose goal is to address the causes and treatment of opioid use disorder while also seeking to better understand, diagnose, and treat chronic pain. The NIH Back Pain Consortium (BACPAC) Research Program, a network of 14 funded entities, was launched as a part of the HEAL initiative to help address limitations surrounding the diagnosis and treatment of cLBP. This paper provides an overview of the BACPAC research program's goals and overall structure, and describes the harmonization efforts across the consortium, define its research agenda, and develop a collaborative project which utilizes the strengths of the network. The purpose of this paper is to serve as a blueprint for other consortia tasked with the advancement of pain related science.

Back pain is the single leading cause of disability worldwide. Despite the prevalence and morbidity of lower back pain, we still lack a gold-standard treatment that restores the physiological function of degenerated intervertebral discs. Recently, stem cells have emerged as a promising strategy for regenerative therapy for degenerative disc disease. In this study, we review the etiology, pathogenesis, and developing treatment strategies for disc degeneration in low back pain with a focus on regenerative stem cell therapies. A systematic search of PubMed/MEDLINE/Embase/Clinical Trials.gov databases was conducted for all human subject abstracts or studies. There was a total of 10 abstracts and 11 clinical studies (1 RCT) that met the inclusion criteria. The molecular mechanism, approach, and progress of the different stem cell strategies in all studies are discussed, including allogenic bone marrow, allogenic discogenic cells, autologous bone marrow, adipose mesenchymal stem cells (MSCs), human umbilical cord MSC, adult juvenile chondrocytes, autologous disc derived chondrocytes, and withdrawn studies. Clinical success with animal model studies is promising; however, the clinical outcomes of stem cell regenerative therapy remain poorly understood. In this systematic review, we found no evidence to support its use in humans. Further studies on efficacy, safety, and optimal patient selection will establish whether this becomes a viable, non-invasive therapeutic option for back pain.

ObjectiveTo crosswalk the National Institutes of Health (NIH) Pain Consortium's Research Task Force proposed Impact Stratification Score (ISS) to the PEG (Pain Intensity, Interference With Enjoyment of Life, Interference With General Activity) Scale.DesignCross-sectional data collected in 2021. Ordinary least squares regression analyses of ISS and PEG.SettingAmazon Mechanical Turk workers.Participants1931 adults with back pain with an average age of 41 (range, 19-77); 48% were female, 16% Hispanic, 7% non-Hispanic Black, 5% non-Hispanic Asian, and 71% non-Hispanic White (N=1931).InterventionsNot applicable.Main outcome measuresThe Patient-Reported Outcomes Measurement Information System (PROMIS)-29+2 v2.1 survey that includes the ISS, and the 3-item PEG.ResultsThe ISS and PEG had a correlation coefficient of 0.74. The ISS accounted for 55% of the adjusted variance in the PEG and the standardized average deviation between observed and predicted scores (normalized mean absolute error) was 0.53. Likewise, the PEG explained 55% of the variance in the ISS with a normalized mean absolute error of 0.52.ConclusionsThis study provides a crosswalk between the ISS and PEG that can be used to predict one from the other. The regression equations can facilitate comparisons in studies that use different measures.

Low back pain and depression have been globally recognized as key public health problems and they are considered co-morbid conditions. This study explores both cross-sectional and longitudinal comorbid associations between back pain and major depression in the adult population in the United States. We used data from the Midlife in the United States survey (MIDUS), linking MIDUS II and III with a sample size of 2358. Logistic regression and Poisson regression models were used. The cross-sectional analysis showed significant associations between back pain and major depression. The longitudinal analysis indicated that back pain at baseline was prospectively associated with major depression at follow-up (PR 1.96, CI: 1.41, 2.74), controlling for health behavioral and demographic variables. Major depression at baseline was also prospectively associated with back pain at follow-up (PR 1.48, CI: 1.04, 2.13), controlling for a set of related confounders. These findings of a bidirectional comorbid association fill a gap in the current understanding of these comorbid conditions and could have clinical implications for the management and prevention of both depression and low back pain.

BACKGROUND: Examining workplace psychosocial risk factors for back pain becomes increasingly important because of the changing nature of work and rising healthcare costs. Some psychosocial risk factors for back pain, such as work and family imbalance, exposure to a hostile work environment, and job insecurity, are understudied for the working population in the United States. METHODS: Data used in this study came from the Quality of Work Life Survey (QWL), a supplementary module of the General Social Survey conducted in the United States. Data from the 2002, 2006, 2010, 2014, and 2018 QWL surveys were used in these analyses, giving a total sample size of 6661. Five domains of workplace psychosocial risk factors for back pain were examined, including job strain, low social support, work-family imbalance, exposure to a hostile work environment (harassment and discrimination), and job insecurity. The adjusted odds ratio (aOR) of each psychosocial risk factor for back pain with 95% confidence intervals (CI) was estimated using a multivariable logistic regression model after controlling for job physical factors, occupation, and demographic and socioeconomic characteristics. RESULTS: Significant associations were found between back pain and several psychosocial factors including job strain (aOR 1.19; CI 1.00,1.41), work-family imbalance (aOR,1.42; CI 1.22,1.64), harassment (aOR 1.40; CI 1.15,1.71), and discrimination (aOR 1.20 CI 1.00,1.44). CONCLUSION: This study contributes to the understanding of the relationship between a variety of workplace psychosocial factors and back pain. Our findings suggest directions in future longitudinal research to examine emerging workplace psychosocial factors for back pain.

BackgroundChronic back pain (CBP) is a condition that places a considerable burden on society, with several million people affected in the United States alone. Treatment options to address this problem and relieve CBP are constantly evolving, and one of the most promising treatment modalities for CBP that is refractory to conservative treatment options is endoscopic rhizotomy (ER).MethodsA thorough search of the PubMed (MEDLINE) database was conducted to assess the full progression of ER from its earliest uses to present day in a historical narrative review of ER, with treatment of facetogenic pain as a model pathology.ResultsER allows for direct visualization and ablation of sensory branches of the dorsal ramus to provide pain relief in up to 80% of patients faced with refractory CBP. This technique has been built upon since the early 20th century, and the novel endoscopic approach continues to gain popularity among physicians. Benefits of ER include superior postoperative median pain-free duration compared with traditional percutaneous radiofrequency ablation, as well as direct visualization of regional anatomy. Patient selection criteria for the procedure and a modest list of contraindications allow the use of ER as a viable treatment option for a significant population of patients suffering from CBP. Potential barriers to ER include high cost of the procedure, longer intraoperative time, and expensive proprietary equipment.ConclusionsER is an effective treatment for refractory CBP with notable advantages. As the technology and popularity of this procedure progress, improvements in the cost, training, and intraoperative time may make it a favorable alternative to the current standard of care.

BackgroundIn 2014, the National Institutes of Health Pain Consortium Research Task Force recommended that patients with chronic low back pain (CLBP) be stratified by its impact on their lives. They proposed the Impact Stratification Score (ISS) to help guide therapy and facilitate study comparability. The ISS has been evaluated as a continuous measure, but not for use as a stratification or classification scheme.ObjectivesIdentify the characteristics of successful schemes to inform the use of the ISS for stratification or classification.Study designScoping review of the peer-reviewed literature.MethodsSearch of PubMed, CINAHL, and APA PsycInfo to identify patient self-report-based classification schemes applicable to CLBP. Data were captured on the methods used for each scheme's development, the domains covered, their scoring criteria and what the classification has successfully measured. The study was reviewed and approved by the RAND Human Subjects Protection Committee (2019-0651-AM02).ResultsThe search identified 87 published articles about the development and testing of 5 classification schemes: 1) The Subgroups for Targeted Treatment (STarT) Back Screening Tool, 2) Multiaxial Assessment of Pain, 3) Graded Chronic Pain Scale, 4) Back Pain Classification Scale, and 5) Chronic Pain Risk Score. All have been shown to be predictive of future outcomes and the STarT Back has been found useful in identifying effective classification-specific treatment. Each scheme had a different classification scoring structure, was developed using different methods, and 3 included domains not found in the ISS.LimitationsExpanding the search to other databases may have identified more classification schemes. Our minimum number of publications inclusion criterion eliminated dozens of cluster analyses, some of which may have eventually been replicated.ConclusionsThe methods used to develop these successful classification schemes, especially those that use straightforward scoring schemes, should be considered for use in the development of a scheme based on the ISS.

OBJECTIVES: Although chiropractic spinal manipulative therapy (CSMT) and prescription benzodiazepines are common treatments for radicular low back pain (rLBP), no research has examined the relationship between these interventions. We hypothesise that utilisation of CSMT for newly diagnosed rLBP is associated with reduced odds of benzodiazepine prescription through 12 months follow-up. DESIGN: Retrospective cohort study. SETTING: National, multicentre 73-million-patient electronic health records-based network (TriNetX) in the USA, queried on 30 July 2021, yielding data from 2003 to the date of query. PARTICIPANTS: Adults aged 18-49 with an index diagnosis of rLBP were included. Serious aetiologies of low back pain, structural deformities, alternative neurological lesions and absolute benzodiazepine contraindications were excluded. Patients were assigned to cohorts according to CSMT receipt or absence. Propensity score matching was used to control for covariates that could influence the likelihood of benzodiazepine utilisation. OUTCOME MEASURES: The number, percentage and OR of patients receiving a benzodiazepine prescription over 3, 6 and 12 months follow-up prematching and postmatching. RESULTS: After matching, there were 9206 patients (mean (SD) age, 37.6 (8.3) years, 54% male) per cohort. Odds of receiving a benzodiazepine prescription were significantly lower in the CSMT cohort over all follow-up windows prematching and postmatching (p

ObjectivesBack pain and poor mental health are interrelated issues in older men. Evidence suggests that socioeconomic status moderates this relationship, but less is known about the role of subjective social status (SSS). This study examined if the association between back pain and mental health is moderated by SSS.MethodWe used a sample of community-dwelling older men (≥65 years) from the Osteoporotic Fractures in Men Study (N = 5994). Participants self-reported their back pain severity and frequency over the past 12 months. SSS was assessed with the MacArthur Scale of SSS. Mental health was assessed with the SF-12 Mental Component Summary (MCS).ResultsSevere back pain was associated with lower SF-12 MCS scores (p = .03). Back pain frequency was not associated with SF-12 MCS scores. SSS moderated the back pain and mental health relationship. Among men with higher national or community SSS, the association between back pain severity and SF-12 MCS scores was not significant. However, among men with lower national or community SSS, more severe back pain was associated with lower SF-12 MCS scores (p's < .001). Among those with lower national or community SSS, greater back pain frequency was also associated with lower SF-12 MCS scores (p's < .05).ConclusionWhere one ranks oneself within their nation or community matters for the back pain and mental health relationship. Higher SSS may be a psychosocial resource that buffers the negative associations of severe and frequent back pain on mental health in older men.

INTRODUCTION: There are limited available research and guidance regarding the use of spinal manipulative therapy (SMT) in patients with low back-related symptoms following lumbar spine surgery, a condition called persistent spinal pain syndrome type 2 (PSPS-2). This publication outlines a review protocol to identify and synthesise individual participant data (IPD) to examine associations between patient, clinical and surgical variables and SMT application in adults with PSPS-2. METHODS AND ANALYSIS: PubMed, OVID, Web of Science, Scopus, PEDro, Index to Chiropractic Literature and KoreaMed will be searched from inception to 1 January 2022 without language restrictions. Case reports, series, observational studies and cases from grey literature of adults receiving SMT for PSPS-2 will be included. Two investigators will independently screen citations, abstracts and full-text articles. A risk-of-bias assessment will be performed in duplicate to rate cases according to exposure and outcome ascertainment and data completeness. Data extraction will be performed in duplicate and missing IPD will be requested from corresponding authors. Multiple binary logistic regression will be used to identify independent predictors of the use of lumbar-SMT, lumbar-manual-thrust SMT and SMT within 1-year postsurgery. Patient, clinical and surgical variables will be summarised using descriptive statistics, while SMT-related outcomes (lumbar-SMT, lumbar-manual-thrust SMT and 1-year surgery-to-SMT interval) will be described using adjusted ORs with 95% CIs. ETHICS AND DISSEMINATION: This study was deemed not human subjects research by the University Hospitals institutional review board. The results of this review will be disseminated at conferences and/or published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42021250039.

BackgroundGiven the risks of opioids, clinicians are under growing pressure to treat pain with non-opioid medications. Yet non-opioid analgesics such as non-steroidal anti-inflammatory drugs (NSAIDs) have their own risks: patients with kidney disease or gastrointestinal diseases can experience serious adverse events. We examined the likelihood that patients with back pain diagnoses and contraindications to NSAIDs and opioids received an opioid prescription in primary care.MethodsWe identified office visits for back pain from 2012 to 2017 and sampled the first office visit per patient per year (N = 24,543 visits). We created indicators reflecting contraindications for NSAIDs (kidney, liver, cardiovascular/cerebrovascular, and gastrointestinal diseases; concurrent or chronic use of anticoagulants/antiplatelets, chronic corticosteroid use) and opioids (depression, anxiety, substance use (SUD) and bipolar disorders, and concurrent benzodiazepines) and estimated four logistic regression models, with the one model including all patient visits and models 2-4 stratifying for previous opioid use. We estimated the population attributable risk for each contraindication.ResultsIn our model with all patients-visits, patients received an opioid prescription at 4% of visits. The predicted probability (PP) of receiving an opioid was 4% without kidney disease vs. 7% with kidney disease; marginal effect (ME): 3%; 95%CI: 1-4%). For chronic or concurrent anticoagulant/antiplatelet prescriptions, the PPs were 4% vs. 6% (ME: 2%; 95%CI: 1-3%). For concurrent benzodiazepines, the PPs were 4% vs. 11% (ME: 7%, 95%CI: 5-9%) and for SUD, the PPs were 4% vs. 5% (ME: 1%, 95%CI: 0-3%). For the model including patients with previous long-term opioid use, the PPs for concurrent benzodiazepines were 25% vs. 24% (ME: -1%; 95%CI: - 18-16%). The population attributable risk (PAR) for NSAID and opioid contraindications was small. For kidney disease, the PAR was 0.16% (95%CI: 0.08-0.23%), 0.44% (95%CI: 0.30-0.58%) for anticoagulants and antiplatelets, 0.13% for substance use (95%CI: 0.03-0.22%) and 0.20% for concurrent benzodiazepine use (95%CI: 0.13-0.26%).ConclusionsPatients with diagnoses of kidney disease and concurrent use of anticoagulants/antiplatelet medications had a higher probability of receiving an opioid prescription at a primary care visit for low back pain, but these conditions do not explain a large proportion of the opioid prescriptions.

ObjectiveEvaluate the Impact Stratification Score (ISS) measure of low back pain impact that assesses physical function, pain interference, and pain intensity.DesignSecondary analyses of a prospective comparative effectiveness trial of active-duty military personnel with low back pain.SettingA Naval hospital at a military training site (Pensacola, Florida) and two military medical centers: 1) Walter Reed National Military Medical Center (Bethesda, Maryland); and 2) San Diego Naval Medical Center.SubjectsThe 749 active-duty military personnel had an average age of 31 years, 76% were male, and 67% were white.MethodsParticipants completed questionnaires at baseline, 6 weeks later, and 12 weeks later. Measures included the ISS, Roland-Morris Disability Questionnaire (RMDQ), PROMIS-29 v1.0 satisfaction with social role participation scale, and single-item ratings of average pain, feeling bothered by low back pain in the past week, and a rating of change in low back pain.ResultsInternal consistency reliability for the ISS was 0.92-0.93 at the three time points. The ISS correlated 0.75 to 0.84 with the RMDQ, 0.51 to 0.78 with the single-item ratings, and -0.64 to -0.71 with satisfaction with social role participation. The ISS was responsive to change on the three single items. The area under the curve for the ISS predicting improvement on the rating of change from baseline to 6 weeks later was 0.83.ConclusionsThis study provides support for the reliability and validity of the ISS as a patient-reported summary measure for acute, subacute, and chronic low back pain. The ISS is a useful indicator of low back impact.

ObjectiveThe purpose of this study was to compare the crowdsourcing platform Amazon Mechanical Turk (MTurk) with in-person recruitment and web-based surveys as a method to (1) recruit study participants and (2) obtain low-cost data quickly from chiropractic patients with chronic low back pain in the United States.MethodsIn this 2-arm quasi-experimental study, we used in-person clinical sampling and web-based surveys from a separate study (RAND sample, n = 1677, data collected October 2016 to January 2017) compared with MTurk (n = 310, data collected November 2016) as a sampling and data collection tool. We gathered patient-reported health outcomes and other characteristics of adults with chronic low back pain receiving chiropractic care. Parametric and nonparametric tests were run. We assessed statistical and practical differences based on P values and effect sizes, respectively.ResultsCompared with the RAND sample, the MTurk sample was statistically significantly younger (mean age 35.4 years, SD 9.7 vs 48.9, SD 14.8), made less money (24% vs 17% reported less than $30,000 annual income), and reported worst mental health than the RAND sample. Other differences were that the MTurk sample had more men (37% vs 29%), fewer White patients (87% vs 92%), more Hispanic patients (9% vs 5%), fewer people with a college degree (59% vs 68%), and patients were more likely to be working full time (62% vs 58%). The MTurk sample was more likely to have chronic low back pain (78% vs 66%) that differed in pain frequency and duration. The MTurk sample had less disability and better global health scores. In terms of efficiency, the surveys cost $2.50 per participant in incentives for the MTurk sample. Survey development took 2 weeks and data collection took 1 month.ConclusionOur results suggest that there may be differences between crowdsourcing and a clinic-based sample. These differences range from small to medium on demographics and self-reported health. The low incentive costs and rapid data collection of MTurk makes it an economically viable method of collecting data from chiropractic patients with low back pain. Further research is needed to explore the utility of MTurk for recruiting clinical samples, such as comparisons to nationally representative samples.

IntroductionVertebral endplates, innervated by the basivertebral nerve (BVN), are a source of chronic low back pain correlated with Modic changes. A randomized trial comparing BVN ablation to standard care (SC) recently reported results of an interim analysis. Here, we report the results of the full randomized trial, including the 3-month and 6-month between-arm comparisons, 12-month treatment arm results, and 6-month outcomes of BVN ablation in the former SC arm.MethodsProspective, open label, 1:1 randomized controlled trial of BVN ablation versus SC in 23 US sites with follow-up at 6 weeks, 3, 6, 9, and 12 months. SC patients were re-baselined and followed up for 6 months post BVN ablation. The primary endpoint was the between-arm comparison of mean Oswestry Disability Index (ODI) change from baseline. Secondary endpoints were Visual Analog Scale (VAS), Short Form (SF-36), EuroQual Group 5 Dimension 5-Level Quality of Life (EQ-5D-5L), responder rates, and rates of continued opioid use.Results140 were randomized. Results from BVN ablation (n=66) were superior to SC (n=74) at 3 months for the primary endpoint (mean ODI reduction, difference between arms of -20.3 (CI -25.9 to -14.7 points; p

BackgroundBlinding aims to minimize biases from what participants and investigators know or believe. Randomized controlled trials, despite being the gold standard to evaluate treatment effect, do not generally assess the success of blinding. We investigated the extent of blinding in back pain trials and the associations between participant guesses and treatment effects.MethodsWe did a review with PubMed/OvidMedline, 2000-2019. Eligibility criteria were back pain trials with data available on treatment effect and participants' guess of treatment. For blinding, blinding index was used as chance-corrected measure of excessive correct guess (0 for random guess). For treatment effects, within- or between-arm effect sizes were used. Analyses of investigators' guess/blinding or by treatment modality were performed exploratorily.ResultsForty trials (3899 participants) were included. Active and sham treatment groups had mean blinding index of 0.26 (95% confidence interval: 0.12, 0.41) and 0.01 (-0.11, 0.14), respectively, meaning 26% of participants in active treatment believed they received active treatment, whereas only 1% in sham believed they received sham treatment, beyond chance, that is, random guess. A greater belief of receiving active treatment was associated with a larger within-arm effect size in both arms, and ideal blinding (namely, "random guess," and "wishful thinking" that signifies both groups believing they received active treatment) showed smaller effect sizes, with correlation of effect size and summary blinding indexes of 0.35 (p = 0.028) for between-arm comparison. We observed uniformly large sham treatment effects for all modalities, and larger correlation for investigator's (un)blinding, 0.53 (p = 0.046).ConclusionParticipants in active treatments in back pain trials guessed treatment identity more correctly, while those in sham treatments tended to display successful blinding. Excessive correct guesses (that could reflect weaker blinding and/or noticeable effects) by participants and investigators demonstrated larger effect sizes. Blinding and sham treatment effects on back pain need due consideration in individual trials and meta-analyses.

BackgroundPatients with acute low back pain frequently request diagnostic imaging, and clinicians feel pressure to acquiesce to such requests to sustain patient trust and satisfaction. Spinal imaging in patients with acute low back pain poses risks from diagnostic evaluation of false-positive findings, patient labeling and anxiety, and unnecessary treatment (including spinal surgery). Watchful waiting advice has been an effective strategy to reduce some low-value treatments, and some evidence suggests a watchful waiting approach would be acceptable to many patients requesting diagnostic tests.MethodsWe will use key informant interviews of clinicians and focus groups with primary care patients to refine a theory-informed standardized patient-based intervention designed to teach clinicians how to advise watchful waiting when patients request low-value spinal imaging for low back pain. We will test the effectiveness of the intervention in a randomized clinical trial. We will recruit 8-10 primary care and urgent care clinics (~ 55 clinicians) in Sacramento, CA; clinicians will be randomized 1:1 to intervention and control groups. Over a 3- to 6-month period, clinicians in the intervention group will receive 3 visits with standardized patient instructors (SPIs) portraying patients with acute back pain; SPIs will instruct clinicians in a three-step model emphasizing establishing trust, empathic communication, and negotiation of a watchful waiting approach. Control physicians will receive no intervention. The primary outcome is the post-intervention rate of spinal imaging among actual patients with acute back pain seen by the clinicians adjusted for rate of imaging during a baseline period. Secondary outcomes are use of targeted communication techniques during a follow-up visit with an SP, clinician self-reported use of watchful waiting with actual low back pain patients, post-intervention rates of diagnostic imaging for other musculoskeletal pain syndromes (to test for generalization of intervention effects beyond back pain), and patient trust and satisfaction with physicians.DiscussionThis trial will determine whether standardized patient instructors can help clinicians develop skill in negotiating a watchful waiting approach with patients with acute low back pain, thereby reducing rates of low-value spinal imaging. The trial will also examine the possibility that intervention effects generalize to other diagnostic tests.Trial registrationClinicalTrials.gov NCT04255199 . Registered on January 20, 2020.

IntroductionBack and neck pain are the leading causes of disability worldwide. Doctors of chiropractic (DCs) are trained to manage these common conditions and can provide non-pharmacological treatment aligned with international clinical practice guidelines. Although DCs practice in over 90 countries, chiropractic care is rarely available within integrated healthcare delivery systems. A lack of DCs in private practice, particularly in low-income communities, may also limit access to chiropractic care. Improving collaboration between medical providers and community-based DCs, or embedding DCs in medical settings such as hospitals or community health centres, will improve access to evidence-based care for musculoskeletal conditions.Methods and analysesThis scoping review will map studies of DCs working with or within integrated healthcare delivery systems. We will use the recommended six-step approach for scoping reviews. We will search three electronic data bases including Medline, Embase and Web of Science. Two investigators will independently review all titles and abstracts to identify relevant records, screen the full-text articles of potentially admissible records, and systematically extract data from selected articles. We will include studies published in English from 1998 to 2020 describing medical settings that have established formal relationships with community-based DCs (eg, shared medical record) or where DCs practice in medical settings. Data extraction and reporting will be guided by the Proctor Conceptual Model for Implementation Research, which has three domains: clinical intervention, implementation strategies and outcome measurement. Stakeholders from diverse clinical fields will offer feedback on the implications of our findings via a web-based survey.Ethics and disseminationEthics approval will not be obtained for this review of published and publicly accessible data, but will be obtained for the web-based survey. Our results will be disseminated through conference presentations and a peer-reviewed publication. Our findings will inform implementation strategies that support the adoption of chiropractic care within integrated healthcare delivery systems.

BACKGROUND: Spinal cord stimulation (SCS) activates the dorsal column fibers using electrical stimuli. Current SCS systems function in fixed-output mode, delivering the same stimulus regardless of spinal cord (SC) activation. OBJECTIVE: To present long-term outcomes of a novel closed-loop SCS system that aims to maintain the SC activation near a set target level and within a therapeutic window for each patient. SC activation is measured through the evoked compound action potential (ECAP) generated by each stimulus pulse. METHODS: Fifty patients with lower back and/or leg pain who were successfully trialed received a permanent system (Evoke; Saluda Medical, Sydney, Australia). Ratings of pain (visual analog scale), quality of life, function, sleep, and medication use were collected at baseline and at each visit. SC activation levels were reported in summary statistics. The therapeutic window for each individual patient was defined as the range of ECAP amplitudes between sensation threshold and uncomfortably strong stimulation. RESULTS: At 12 mo, the proportion of patients with ≥50% relief was 76.9% (back), 79.3% (leg), and 81.4% (overall), and the proportion with ≥80% pain relief was 56.4% (back), 58.6% (leg), and 53.5% (overall). Patients spent a median of 84.9% of their time with stimulation in their therapeutic window, and 68.8% (22/32) eliminated or reduced their opioid intake. Statistically significant improvements in secondary outcomes were observed. CONCLUSION: The majority of patients experienced more than 80% pain relief with stable SC activation, as measured by ECAP amplitude at 12 mo, providing evidence for the long-term effectiveness of the Evoke closed-loop SCS system.

Vertebral endplate bone marrow lesions, visualized on magnetic resonance imaging (MRI) as Modic changes (MC), are associated with chronic low back pain (cLBP). Since guidelines recommend against routine spinal MRI for cLBP in primary care, MC may be underdiagnosed. Serum biomarkers for MC would allow early diagnosis, inform clinical care decisions, and supplement treatment monitoring. We aimed to discover biomarkers in the blood serum that correlate with MC pathophysiological processes. For this single-site cross-sectional study, we recruited 54 subjects with 38 cLBP patients and 16 volunteers without a history of LBP. All subjects completed an Oswestry Disability Index (ODI) questionnaire and 10-cm Visual Analog Score (VAS) for LBP (VASback) and leg pain. Lumbar T1-weighted and fat-saturated T2-weighted MRI were acquired at 3T and used for MC classification in each endplate. Blood serum was collected on the day of MRI. Biomarkers related to disc resorption and bone marrow fibrosis were analyzed with enzyme-linked immune-absorbent assays. The concentration of biomarkers between no MC and any type of MC (AnyMC), MC1, and MC2 were compared. The Area Under the Curve (AUC) of the Receiver Operating Characteristics were calculated for each biomarker and for bivariable biomarker models. We found that biomarkers related to type III and type IV collagen degradation and formation tended to correlate with the presence of MC (p = 0.060-0.088). The bivariable model with the highest AUC was PRO-C3 + C4M and had a moderate diagnostic value for AnyMC in cLBP patients (AUC = 0.73, specificity = 78.9%, sensitivity = 73.7%). In conclusion, serum biomarkers related to the formation and degradation of type III and type IV collagen, which are key molecules in bone marrow fibrosis, correlated with MC presence. Bone marrow fibrosis may be an important pathophysiological process in MC that should be targeted in larger biomarker and treatment studies.

BackgroundPrescription opioids account for 40% of all U.S. opioid overdose deaths, and national efforts have intensified to reduce opioid prescriptions. Little is known about the relationship between peripheral artery disease (PAD) and high-risk opioid use. The objectives of this study were to evaluate this relationship and to assess the impact of PAD treatment on opiate use.MethodsIn this retrospective cohort study, the Truven Health MarketScan database (Truven Health Analytics, Ann Arbor, Mich), a deidentified national private insurance claims database, was queried to identify patients with PAD (two or more International Classification of Diseases, Ninth Revision diagnosis codes of PAD ≥2 months apart, with at least 2 years of continuous enrollment) from 2007 to 2015. Critical limb ischemia (CLI) was defined as the presence of rest pain, ulcers, or gangrene. The primary outcome was high opioid use, defined as two or more opioid prescriptions within a 1-year period. Multivariable analysis was used to determine risk factors for high opioid use.ResultsA total of 178,880 patients met the inclusion criteria, 35% of whom had CLI. Mean ± standard deviation follow-up time was 5.3 ± 2.1 years. An average of 24.7% of patients met the high opioid use criteria in any given calendar year, with a small but significant decline in high opioid use after 2010 (P < .01). During years of high opioid use, 5.9 ± 5.5 yearly prescriptions were filled. A new diagnosis of PAD increased high opioid use (21.7% before diagnosis vs 27.3% after diagnosis; P

ObjectivesThe purpose of this article is to describe how we designed patient survey instruments to ensure that patient data about preferences and experience could be included in appropriateness decisions. These actions were part of a project that examined the appropriateness of spinal manipulation and mobilization for chronic low back pain and chronic neck pain.MethodsWe conducted focus groups, cognitive interviews, a literature review of measures in prior chiropractic and complementary and integrative health research, and a pilot study to develop questionnaires of patient preferences, experiences, values, and beliefs.ResultsQuestionnaires were administered online to 2024 individuals from 125 chiropractic clinics. The survey included 3 long questionnaires and 5 shorter ones. All were administered online. The baseline items had 2 questionnaires that respondents could complete in different sittings. Respondents completed shorter biweekly follow-ups every 2 weeks and a final questionnaire at 3 months. The 2 initial questionnaires had 81 and 140 items, the 5 biweekly follow-up questionnaires had 37 items each, and the endline questionnaire contained 121 items. Participants generally responded positively to the survey items, and 91% of the patients who completed a baseline questionnaire completed the endpoint survey 3 months later. We used "legacy" measures, and we also adapted measures and developed new measures for this study. Preliminary assessment of reliability and validity for a newly developed scale about coping behaviors indicates that the items work well together in a scale.ConclusionsThis article documents the challenges and the efforts involved in designing data collection tools to facilitate the inclusion of patient data into appropriateness decisions.

Clinical guidelines discourage prescribing opioids for chronic pain, but give minimal advice about how to discuss opioid tapering with patients. We conducted focus groups and interviews involving 21 adults with chronic back or neck pain in different stages of opioid tapering. Transcripts were qualitatively analyzed to characterize patients' tapering experiences, build a conceptual model of these experiences, and identify strategies for promoting productive discussions of opioid tapering. Analyses revealed 3 major themes. First, owing to dynamic changes in patients' social relationships, emotional state, and health status, patients' pain and their perceived need for opioids fluctuate daily; this finding may conflict with recommendations to taper by a certain amount each month. Second, tapering requires substantial patient effort across multiple domains of patients' everyday lives; patients discuss this effort superficially, if at all, with clinicians. Third, patients use a variety of strategies to manage the tapering process (eg, keeping an opioid stash, timing opioid consumption based on planned activities). Recommendations for promoting productive tapering discussions include understanding the social and emotional dynamics likely to impact patients' tapering, addressing patient fears, focusing on patients' best interests, providing anticipatory guidance about tapering, and developing an individualized tapering plan that can be adjusted based on patient response. Perspective: This study used interview and focus group data to characterize patients' experiences with opioid tapering and identify communication strategies that are likely to foster productive, patient-centered discussions of opioid tapering. Findings will inform further research on tapering and help primary care clinicians to address this important, often challenging topic.

Mr. M., an uninsured, 44-year-old Puerto Rican man with chronic back pain, diabetes, hypertension, asthma, and a history of incarceration presented to a free clinic with acute exacerbation of back pain triggered by carrying heavy loads of trash at work. A premedical student acting as his health care advocate accompanied him. Mr. M. was hesitant to seek health care because he had no health insurance and mistrusted institutions as a result of his extensive negative experiences with the criminal justice system. He was visibly nervous in the unfamiliar institutional environment of the clinic, which had no Latino staff and was located in a middle-class neighborhood far from his home. The advocate reassured him in Spanish that the doctor was trustworthy and urged him to speak frankly about his health problems, including his challenges in obtaining medication. Embarrassed, Mr. M. reported that during recent back-pain exacerbations he occasionally resorted to purchasing one or two 5-mg oxycodone tablets in the open-air drug market operating on the inner-city block where he lived. The physician gave Mr. M. ibuprofen and a prescription for five 5-mg oxycodone tablets, enrolled him in the clinic’s diabetes and hypertension programs, and scheduled a follow-up visit. Mr. M. never filled the prescription and did not return to the clinic, despite repeated entreaties by the advocate both in person and over the phone. Mr. M.’s pain had eased, and he claimed to be managing his diabetes, hypertension, and asthma by splitting medication with insured family members. To stretch their supply, they rationed their doses for use only on the days when they “felt symptoms.” Finally, 8 months later, Mr. M. admitted that he had not dared fill his prescription or return to the clinic for fear of being rearrested after admitting to the doctor that he had purchased oxycodone illegally.

Vertebral augmentation is among the current standards of care to reduce pain in patients with vertebral fractures (VF), yet a lack of consensus regarding efficacy and safety of percutaneous vertebroplasty and kyphoplasty raises questions on what basis clinicians should choose one therapy over another. Given the lack of consensus in the field, the American Society for Bone and Mineral Research (ASBMR) leadership charged this Task Force to address key questions on the efficacy and safety of vertebral augmentation and other nonpharmacological approaches for the treatment of pain after VF. This report details the findings and recommendations of this Task Force. For patients with acutely painful VF, percutaneous vertebroplasty provides no demonstrable clinically significant benefit over placebo. Results did not differ according to duration of pain. There is also insufficient evidence to support kyphoplasty over nonsurgical management, percutaneous vertebroplasty, vertebral body stenting, or KIVA®. There is limited evidence to determine the risk of incident VF or serious adverse effects (AE) related to either percutaneous vertebroplasty or kyphoplasty. No recommendation can be made about harms, but they cannot be excluded. For patients with painful VF, it is unclear whether spinal bracing improves physical function, disability, or quality of life. Exercise may improve mobility and may reduce pain and fear of falling but does not reduce falls or fractures in individuals with VF. General and intervention-specific research recommendations stress the need to reduce study bias and address methodological flaws in study design and data collection. This includes the need for larger sample sizes, inclusion of a placebo control, more data on serious AE, and more research on nonpharmacologic interventions. Routine use of vertebral augmentation is not supported by current evidence. When it is offered, patients should be fully informed about the evidence. Anti-osteoporotic medications reduce the risk of subsequent vertebral fractures by 40-70%. © 2018 American Society for Bone and Mineral Research.

• Risk stratification is an approach which is recommended in numerous guidelines for the management of back pain. • This review found that risk stratification with matched treatment may be just as worthwhile as usual care for acute back pain, however the evidence is very uncertain. • Further research is required to confirm the utility of risk stratification for acute back pain. Risk stratification is an approach which has been recommended across a number of international guidelines for the management of back pain. To assess whether the use of risk stratification with a matched treatment pathway improves clinical outcomes, when compared with usual care or other interventions, in adults with acute back pain. A comprehensive search was conducted of the databases Medline, Embase, PEDro, CINAHL and Cochrane Library in November 2022. Studies of adults with back pain of less than 3 months' duration and who had been stratified according to their level of risk of a poor functional outcome and provided with a treatment matched to their level of risk were included. Participants with specific and/or serious spinal pathologies were excluded. Five trials involving 3519 participants were included. Meta-analysis found very-low certainty evidence that the use of a risk stratification approach with matched treatment may lead to a very small reduction in pain levels at 3–6 months compared with usual care (MD -0.62, 95 % CI -0.88, -0.36). These results did not achieve clinical significance. No difference was found for the use of risk stratification compared to usual care for disability (MD -1.52, 95 % CI -4.15, 1.11). The use of risk stratification with matched treatment may be just as worthwhile as usual care for acute back pain, however the evidence is very uncertain. Further high quality research is required to confirm whether risk stratification is a useful approach for this population. CRD42022379987 [ABSTRACT FROM AUTHOR]

Back pain is the #1 cause of years lived with disability worldwide, yet surprisingly little is known regarding the biology underlying this symptom. We conducted a genome-wide association study (GWAS) meta-analysis of chronic back pain (CBP). Adults of European ancestry were included from 15 cohorts in the Cohorts for Heart and Aging Research in Genomic Epidemiology (CHARGE) consortium, and from the UK Biobank interim data release. CBP cases were defined as those reporting back pain present for ≥3-6 months; non-cases were included as comparisons ("controls"). Each cohort conducted genotyping using commercially available arrays followed by imputation. GWAS used logistic regression models with additive genetic effects, adjusting for age, sex, study-specific covariates, and population substructure. The threshold for genome-wide significance in the fixed-effect inverse-variance weighted meta-analysis was p

The zygapophysial joint, a diarthrodial joint commonly referred to as the facet joint, plays a pivotal role in back pain, a condition that has been a leading cause of global disability since 1990. Along with the intervertebral disc, the facet joint supports spinal motion and aids in spinal stability. Highly susceptible to early development of osteoarthritis, the facet is responsible for a significant amount of pain in the low-back, mid-back, and neck regions. Current noninvasive treatments cannot offer long-term pain relief, while invasive treatments can relieve pain but fail to preserve joint functionality. This review presents an overview of the facet in terms of its anatomy, functional properties, problems, and current management strategies. Furthermore, this review introduces the potential for regeneration of the facet and particular engineering strategies that could be employed as a long-term treatment.

Study designResearch.ObjectiveThe goal of this study was to investigate whether Propionibacteria acnes infection of the intervertebral disc can be detected noninvasively by nuclear magnetic resonance (NMR) spectroscopy.Summary of background dataMicrobiological studies of surgical samples suggest that a significant subpopulation of back pain patients may have occult disc infection with P. acnes bacteria. This hypothesis is further supported by a double-blind clinical trial showing that back pain patients with Modic type 1 changes may respond to antibiotic treatment. Because significant side effects are associated with antibiotic treatment, there is a need for a noninvasive method to detect whether specific discs in back pain patients are infected with P acnes bacteria.MethodsP. acnes bacteria were obtained from human patients. NMR detection of a propionic acid (PA) in the bacteria extracts was conducted on 500 MHz high-resolution spectrometer, whereas in vivo NMR spectroscopy of an isolated bovine disk tissue infected with P. acnes was conducted on 7 T magnetic resonance imaging scanner.ResultsNMR spectra of P. acnes metabolites revealed a distinct NMR signal with identical chemical shits (1.05 and 2.18 ppm) as PA (a primary P. acne metabolite). The 1.05 ppm signal does not overlap with other bacteria metabolites, and its intensity increases linearly with P. acnes concentration. Bovine disks injected with P. acnes bacteria revealed a very distinct NMR signal at 1.05 ppm, which linearly increased with P. acnes concentration.ConclusionThe 1.05 ppm NMR signal from PA can be used as a marker of P. acnes infection of discs. This signal does not overlap with other disc metabolites and linearly depends on P. acnes concentration. Consequently, NMR spectroscopy may provide a noninvasive method to detect disc infection in the clinical setting.Level of evidenceN/A.

Prior data in women suggest that incident clinically undiagnosed radiographic vertebral fractures (VFs) often are symptomatic, but misclassification of incident clinical VF may have biased these estimates. There are no comparable data in men. To evaluate the association of incident clinically undiagnosed radiographic VF with back pain symptoms and associated activity limitations, we used data from the Osteoporotic Fractures in Men (MrOS) Study, a prospective cohort study of community-dwelling men aged ≥65 years. A total of 4396 men completed spine X-rays and symptom questionnaires at baseline and visit 2, about 4.6 years later. Incident clinical VFs during this interval were defined by self-reported clinical diagnosis plus community imaging showing a centrally adjudicated ≥1 increase in semiquantitative (SQ) grade in any thoracic or lumbar vertebra versus baseline study X-rays. Incident radiographic VFs (≥1 increase in SQ grade between baseline and visit 2 study X-rays) were categorized as radiographic-only (not clinically diagnosed) or radiographic plus clinical (also clinically diagnosed). Multivariable-adjusted log binomial regression was used to calculate prevalence ratios (PRs) and 95% confidence intervals (CIs). Men with incident radiographic plus clinical VF were most likely to have back pain symptoms and associated activity limitation at follow-up. However, versus men without incident VF, those with incident radiographic-only VF also were significantly more likely at follow-up to report any back pain (70% versus 59%; PR, 1.2 [95% CI, 1.1 to 1.3]), severe back pain (8% versus 4%; PR, 1.9 [95% CI, 1.1 to 3.3]), bother from back pain most/all the time (22% versus 13%; PR, 1.7 [95% CI, 1.3 to 2.2]), and limited usual activity from back pain (34% versus 18%; PR, 1.9 [95% CI, 1.5 to 2.4]). Clinically undiagnosed, incident radiographic VFs were associated with an increased likelihood of back pain symptoms and associated activity limitation. Results suggest incident radiographic-only VFs often were symptomatic, and were associated with both new and worsening back pain. Preventing these fractures may reduce back pain and related disability in older men. © 2017 American Society for Bone and Mineral Research.

BackgroundMusculoskeletal pain is associated with increased fall risk among older men. However, the association of back pain, the most prevalent type of pain in this population, and fall risk is unknown.MethodsWe conducted a prospective investigation among 5,568 community-dwelling U.S. men at least 65 years of age from the Osteoporotic Fractures in Men Study (MrOS). Baseline questionnaires inquired about back pain and its location (such as low back), severity, and frequency in the past year. During 1 year of follow-up, falls were summed from self-reports obtained every 4 months. Outcomes were recurrent falls (≥2 falls) and any fall (≥1 fall). Associations of back pain and fall risk were estimated with risk ratios (RRs) and 95% confidence intervals (CIs) from multivariable log-binomial regression models adjusted for age, dizziness, arthritis, knee pain, urinary symptoms, self-rated health, central nervous system medication use, and instrumental activities of daily living.ResultsMost (67%) reported any back pain in the past year. During follow-up, 11% had recurrent falls and 25% fell at least once. Compared with no back pain, any back pain was associated with elevated recurrent fall risk (multivariable RR = 1.3, 95% CI: 1.1, 1.5). Multivariable RRs for 1, 2, and 3+ back pain locations were, respectively, 1.2 (95% CI: 1.0, 1.5), 1.4 (1.1, 1.8), and 1.7 (95% CI: 1.3, 2.2). RRs were also elevated for back pain severity and frequency. Back pain was also associated with risk of any fall.ConclusionsAmong older men, back pain is independently associated with increased fall risk.

ContextAlthough physical function is an important patient outcome, little is known about changes in physical function in older adults receiving chemotherapy (CTX).ObjectivesIdentify subgroups of older patients based on changes in their level of physical function; determine which demographic and clinical characteristics were associated with subgroup membership; and determine if these subgroups differed on quality-of-life (QOL) outcomes.MethodsLatent profile analysis was used to identify groups of older oncology patients (n = 363) with distinct physical function profiles. Patients were assessed six times over two cycles of CTX using the Physical Component Summary score from the Short Form 12. Differences, among the groups, in demographic and clinical characteristics and QOL outcomes were evaluated using parametric and nonparametric tests.ResultsThree groups of older oncology patients with distinct functional profiles were identified: Well Below (20.4%), Below (43.8%), and Above (35.8%) normative Physical Component Summary scores. Characteristics associated with membership in the Well Below class included the following: lower annual income, a higher level of comorbidity, being diagnosed with depression and back pain, and lack of regular exercise. Compared with the Above class, patients in the other two classes had significantly poorer QOL outcomes.ConclusionAlmost 65% of older oncology patients reported significant decrements in physical function that persisted over two cycles of CTX. Clinicians can assess for those characteristics associated with poorer functional status to identify high-risk patients and initiate appropriate interventions.

ImportanceHospital-employed physicians provide primary care within the hospital or within community-based office practices. Yet, little is understood regarding the influence of hospital location and ownership on the delivery of low-value care.ObjectiveTo assess the association of hospital location and hospital ownership with the provision of low-value health services.Design, setting, and participantsThis study compared low-value service use after primary care visits at hospital-based outpatient practices from January 1, 1997, to December 31, 2011, vs community-based office practices and at hospital-owned vs physician-owned community-based office practices from January 1, 1997, to December 31, 2013. Logistic regression models adjusted for patient and health care professional characteristics and year, and weighted results were used to reflect population estimates. Results were also stratified by symptom acuity and whether a generalist physician (eg, general internist or family practitioner) was the patient's primary care provider. This study used nationally representative data from the National Ambulatory Medical Care Survey (January 1, 1997, to December 31, 2013) and the National Hospital Ambulatory Medical Care Survey (January 1, 1997, to December 31, 2011) on outpatient visits to generalist physicians. Participants were patients seen with 3 common primary care conditions, namely, upper respiratory tract infection, back pain, and headache.Main outcomes and measuresThe use of antibiotics (for upper respiratory tract infection), computed tomography or magnetic resonance imaging (for back pain and headache), radiographs (for upper respiratory tract infection and back pain), and specialty referrals (for all 3 conditions).ResultsThis study identified 31 162 visits for upper respiratory tract infection, back pain, and headache, representing an estimated 739 million US primary care visits from 1997 to 2013. Compared with visits with community-based physicians, patients in visits to hospital-based physicians were younger (mean age, 44.5 vs 49.1 years; P

Study designProspective case series.ObjectiveEvaluate lumbar paraspinal muscle (PSM) cross-sectional area and intervertebral disc (IVD) height changes induced by a 6-month space mission on the International Space Station. The long-term objective of this project is to promote spine health and prevent spinal injury during space missions and here on Earth.Summary of background dataNational Aeronautics and Space Administration (NASA) crewmembers have a 4.3 times higher risk of herniated IVDs, compared with the general and military aviator populations. The highest risk occurs during the first year after a mission. Microgravity exposure during long-duration spaceflights results in approximately 5 cm lengthening of body height, spinal pain, and skeletal deconditioning. How the PSMs and IVDs respond during spaceflight is not well described.MethodsSix NASA crewmembers were imaged supine with a 3 Tesla magnetic resonance imaging. Imaging was conducted preflight, immediately postflight, and then 33 to 67 days after landing. Functional cross-sectional area (FCSA) measurements of the PSMs were performed at the L3-4 level. FCSA was measured by grayscale thresholding within the posterior lumbar extensors to isolate lean muscle on T2-weighted scans. IVD heights were measured at the anterior, middle, and posterior sections of all lumbar levels. Repeated measures analysis of variance was used to determine significance at P

BackgroundThe Emergency Department (ED) is a frequent site of antibiotic use; poor adherence with evidence-based guidelines and broad-spectrum antibiotic overuse is common. Our objective was to determine rates and predictors of inappropriate antimicrobial use in patients with uncomplicated urinary tract infections (UTI) compared to the 2010 International Clinical Practice Guidelines (ICPG).MethodsA single center, prospective, observational study of patients with uncomplicated UTI presenting to an urban ED between September 2012 and February 2014 that examined ED physician adherence to ICPG when treating uncomplicated UTIs. Clinician-directed antibiotic treatment was compared to the ICPG using a standardized case definition for non-adherence. Binomial confidence intervals and student's t-tests were performed to evaluate differences in demographic characteristics and management between patients with pyelonephritis versus cystitis. Regression models were used to analyze the significance of various predictors to non-adherent treatment.Results103 cases met the inclusion and exclusion criteria, with 63.1 % receiving non-adherent treatment, most commonly use of a fluoroquinolone (FQ) in cases with cystitis (97.6 %). In cases with pyelonephritis, inappropriate antibiotic choice (39.1 %) and no initial IV antibiotic for pyelonephritis (39.1 %) where recommended were the most common characterizations of non-adherence. Overall, cases of cystitis were no more/less likely to receive non-adherent treatment than cases of pyelonephritis (OR 0.9, 95 % confidence interval 0.4-2.2, P = 0.90). In multivariable analysis, patients more likely to receive non-adherent treatment included those without a recent history of a UTI (OR 3.8, 95 % CI 1.3-11.4, P = 0.02) and cystitis cases with back or abdominal pain only (OR 11.4, 95 % CI 2.1-63.0, P = 0.01).ConclusionsPatients with cystitis with back or abdominal pain only were most likely to receive non-adherent treatment, potentially suggesting diagnostic inaccuracy. Physician education on evidence-based guidelines regarding the treatment of uncomplicated UTI will decrease broad-spectrum use and drug resistance in uropathogens.

PurposeLow back pain (LBP) is the most disabling condition worldwide. Although LBP relates to different spinal pathologies, vertebral bone marrow lesions visualized as Modic changes on MRI have a high specificity for discogenic LBP. This review summarizes the pathobiology of Modic changes and suggests a disease model.MethodsNon-systematic literature review.ResultsChemical and mechanical stimulation of nociceptors adjacent to damaged endplates are likely a source of pain. Modic changes are adjacent to a degenerated intervertebral disc and have three generally interconvertible types suggesting that the different Modic change types represent different stages of the same pathological process, which is characterized by inflammation, high bone turnover, and fibrosis. A disease model is suggested where disc/endplate damage and the persistence of an inflammatory stimulus (i.e., occult discitis or autoimmune response against disc material) create predisposing conditions. The risk to develop Modic changes likely depends on the inflammatory potential of the disc and the capacity of the bone marrow to respond to it. Bone marrow lesions in osteoarthritic knee joints share many characteristics with Modic changes adjacent to degenerated discs and suggest that damage-associated molecular patterns and marrow fat metabolism are important pathogenetic factors. There is no consensus on the ideal therapy. Non-surgical treatment approaches including intradiscal steroid injections, anti-TNF-α antibody, antibiotics, and bisphosphonates have some demonstrated efficacy in mostly non-replicated clinical studies in reducing Modic changes in the short term, but with unknown long-term benefits. New diagnostic tools and animal models are required to improve painful Modic change identification and classification, and to clarify the pathogenesis.ConclusionModic changes are likely to be more than just a coincidental imaging finding in LBP patients and rather represent an underlying pathology that should be a target for therapy.

BackgroundBack pain and falls are common health conditions among older U.S. women. The extent to which back pain is an independent risk factor for falls has not been established.MethodsWe conducted a prospective study among 6,841 community-dwelling U.S. women at least 65 years of age from the Study of Osteoporotic Fractures (SOF). Baseline questionnaires inquired about any back pain, pain severity, and frequency in the past year. During 1 year of follow-up, falls were summed from self-reports obtained every 4 months. Two outcomes were studied: recurrent falls (≥2 falls) and any fall (≥1 fall). Associations of back pain and each fall outcome were estimated with risk ratios (RRs) and 95% confidence intervals (CIs) from multivariable log-binomial regression. Adjustments were made for age, education, smoking status, fainting history, hip pain, stroke history, vertebral fracture, and Geriatric Depression Scale.ResultsMost (61%) women reported any back pain. During follow-up, 10% had recurrent falls and 26% fell at least once. Any back pain relative to no back pain was associated with a 50% increased risk of recurrent falls (multivariable RR = 1.5, 95% CI: 1.3, 1.8). Multivariable RRs for recurrent falls were significantly elevated for all back pain symptoms, ranging from 1.4 (95% CI: 1.1, 1.8) for mild back pain to 1.8 (95% CI: 1.4, 2.3) for activity-limiting back pain. RRs of any fall were also significantly increased albeit smaller than those for recurrent falls.ConclusionsOlder community-dwelling women with a recent history of back pain are at increased risk for falls.

ObjectiveTo evaluate ultrashort time to echo (UTE) magnetic resonance (MR) morphology of the cartilaginous endplates (CEP) in cadaveric lumbar spines with bony vertebral endplate (VEP) lesions, to determine inter-reader agreement as well as associations between the CEP morphology and VEP lesions as well as other abnormalities.Materials and methodsMR imaging of cadaveric lumbar spines from 10 donors was performed at 3T using a UTE MR sequence. Two musculoskeletal radiologists identified the location of vertebral endplate lesions in consensus. The morphology of the CEP overlying the lesions and in the adjacent normal regions was assessed individually. A total of 55 vertebral lesions and 55 normal regions were assessed. The presence of osteophytosis, morphological changes of the anterior and posterior longitudinal ligament, and intervertebral disc signal and morphology was also assessed. Agreement between observers was determined using Cohen's kappa analysis, and association between CEP and vertebral endplate lesions was determined using the chi square test.ResultsFifty-five vertebral endplate lesions were identified and the morphology of CEP evaluated by two readers was in substantial agreement with Cohen's kappa of 0.78. The presence of vertebral endplate abnormality was associated with the presence of osteophytes (39 out of 55 levels), altered morphology and signal of the anterior longitudinal ligament (23 out of 55 levels) and intervertebral discs (30 out of 55 levels).ConclusionUTE MRI enables evaluation of the CEP with substantial inter-reader agreement. Abnormal changes of the CEP may facilitate formation of lesions of vertebral endplate over time and are associated with degenerative changes of the lumbar spine.

BACKGROUND: Many physicians believe that advanced practice clinicians (APCs [nurse practitioners and physician assistants]) provide care of relatively lower value. OBJECTIVE: To compare use of low-value services among U.S. APCs and physicians. DESIGN: Service use after primary care visits was evaluated for 3 conditions after adjustment for patient and provider characteristics and year. Patients with guideline-based red flags were excluded and analyses stratified by office- versus hospital-based visits, acute versus nonacute presentations, and whether clinicians self-identified as the patients primary care provider (PCP). SETTING: National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS), 1997 to 2011. PATIENTS: Patients presenting with upper respiratory infections (URIs), back pain, or headache. MEASUREMENTS: Use of guideline-discordant antibiotics (for URIs), radiography (for URIs and back pain), computed tomography (CT) or magnetic resonance imaging (MRI) (for headache and back pain), and referrals to other physicians (for all 3 conditions). RESULTS: 12 170 physician and 473 APC office-based visits and 13 359 physician and 2947 APC hospital-based visits were identified. Although office-based clinicians saw similar patients, hospital-based APCs saw younger patients (mean age, 42.6 vs. 45.0 years; P < 0.001), and practiced in urban settings less frequently (49.7% vs. 81.7% of visits; P < 0.001) than hospital-based physicians. Unadjusted and adjusted results revealed that APCs ordered antibiotics, CT or MRI, radiography, and referrals as often as physicians in both settings. Stratification suggested that self-identified PCP APCs ordered more services than PCP physicians in the hospital-based setting. LIMITATION: NHAMCS reflects hospital-based APC care; NAMCS samples physician practices and likely underrepresents office-based APCs. CONCLUSION: APCs and physicians provided an equivalent amount of low-value health services, dispelling physicians perceptions that APCs provide lower-value care than physicians for these common conditions. PRIMARY FUNDING SOURCE: U.S. Health Services and Research Administration, Ryoichi Sasakawa Fellowship Fund, and National Institutes of Health.

Background: Restoration of height or angle has been reported following vertebroplasty (VP). The purpose of the study was to investigate the predictive value of the preoperative lateral fulcrum radiograph (LFR) of success in one-level VP for painful osteoporotic vertebral fracture. Methods: From January 2017 to January 2018, 71 patients (mean age, 76 years) receiving VP were retrospectively analyzed. Painful vertebra was defined as pseudarthrosis or edematous change in magnetic resonance imaging (MRI) scan. Fulcrum flexibility (FF) and fulcrum restoration index (FRI) of the vertebral wedge angle (VWA), regional kyphotic angle (RKA), and anterior vertebral body height (AVBH) were investigated. Back pain was evaluated using a visual analogue scale. Results: The 30 males and 41 females were followed for an average of 21 months. The sensitivity of LFR and MRI to detect pseudarthrosis was 92% and 97%, respectively. Preoperative FF of VWA, RKA, and AVBH was 52.4%, 58.3%, and 60%, respectively, indicating similar potential restoration ability. Postoperative average FRI for VWA, RKA, and AVBH was 1.29 ± 2.98, 0.46 ± 1.16, and 1.04 ± 1.68, respectively. Final average FRI was 0.94 ± 2.96, −0.03 ± 2.25, and 0.6 ± 2.04, respectively. VWA and AVBH had better immediate restoration, and VWA had better final maintenance. All parameters progressive lost significant levels of restoration to similar degrees but without increase in back pain. Conclusion: LFR can help with evaluation for pseudarthrosis and the restoration effect of VP. VP had better immediate restoration of VWA and AVBH and better final VWA maintenance. [ABSTRACT FROM AUTHOR]

BackgroundSacroiliac joint (SI) pain is increasingly being recognized as a source of low back pain. Injections and percutaneous type procedures are performed to treat symptomatic joints. However, there are limited studies available assessing the anatomy of the SI joint in vivo among patients with pain.ObjectivesThe purpose of this study was to provide more precise information on the dimensions and orientation of the SI joint using a new technique for the radiographic evaluation of this joint.Study designObservational study.SettingEmergency departmentMethodsThree dimensional computed tomographic (CT) reconstructions of the pelvis were formatted from 100 SI joints in 50 patients who had clinically indicated abdominal/pelvic scans. These images were manipulated to evaluate the SI joint in multiple planes and measure its dimensions, area, and relationship to anatomic landmarks such as the anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS).ResultsOf the 50 patients, 23 were men and 27 women. Their mean age was 47.6 years (± 18.1). The SI joint consists of a superior limb which measures 39.7 mm (± 4.8) in length, and an inferior limb which measures 54.3 mm (± 5.1), oriented at an angle of 100.1° (± 8.1) to one another. The mean area of the joint was 1276.8 mm2 (± 189.8). The horizontal distance from the ASIS to the front of the superior SI joint is 75.4 mm (± 8.4). The horizontal distance from the PSIS to the back of the superior SI joint is 43.9 mm (± 5.6). The joint stretches 7.5 mm (± 5.9) cephalad and 38.1 mm (± 6.4) caudal to the PSIS, and 35.4 mm (± 8.8) cephalad and 10.2 mm (± 11.4) caudal to the ASIS.LimitationsCT scans were performed with patients lying supine, while most SI joint procedures are performed with a patient prone. However it is doubtful that the bony anatomic landmarks would change appreciable in this largely immobile joint. These patients were seen in the emergency department for a variety of conditions related to abdominal and pelvic pain, and not exclusively for SI joint pain.ConclusionsTreatment of the SI joint by surgeons and interventionalists is hampered by the limited number of anatomic studies in the literature. Our study presents the SI joint as a 2-limbed structure, sitting from slightly above the level of the PSIS rostrally to slightly below the level of the ASIS caudally. Palpation of these landmarks may assist in directing physicians to the joint. To begin an interventional pain procedure, with a patient lying prone, this data supports tilting the x-ray image intensifier 10 degrees caudal past the vertical anteroposterior (AP) view for optimal approach of the SI joint's inferior limb. The needle entry should be about 44.1 mm (1.75 inches) caudal to the PSIS. The image intensifier should have a 12 degree left lateral oblique view for injection of the right SI joint, and a 12 degree right lateral oblique view for the left SI joint.

ObjectiveAnxiety is linked to a number of medical conditions, yet few studies have examined how symptom severity relates to medical comorbidity.PurposeThe current study assessed associations between severity of anxiety and depression and the presence of medical conditions in adults diagnosed with anxiety disorders.MethodNine-hundred eighty-nine patients diagnosed with panic, generalized anxiety, social anxiety, and posttraumatic stress disorders reported on the severity of anxiety and depressive symptoms and on diagnoses of 11 medical conditions.ResultsSeverity of anxiety and depressive symptoms was strongly associated with having more medical conditions over and above control variables, and the association was as strong as that between BMI and disease. Odds of having asthma, heart disease, back problems, ulcer, migraine headache and eyesight difficulties also increased as anxiety and depressive symptom severity increased. Anxiety symptoms were independently associated with ulcer, whereas depressive symptoms were independently associated with heart disease, migraine, and eyesight difficulties.ConclusionsThese findings add to a growing body of research linking anxiety disorders with physical health problems and indicate that anxiety and depressive symptoms deserve greater attention in their association with disease.