Two field experiments with psychologically threatened undergraduates in introductory physics tested whether mindfulness promotes adaptive meaning-making about learning setbacks (Experiment 1) and unpleasant learning emotions (Experiment 2). Participants were randomly assigned to receive five consecutive days of 20-minute audio guided mindfulness training or to a no-training audiobook control (Experiment 1) or an active relaxation training (Experiment 2). In Experiment 1 (N=149), students completed experience sampling and longitudinal surveys assessing interpretations of difficult physics experiences. In Experiment 2 (N=303), students completed daily diaries of interpretations of negative physics emotions for 15 consecutive weekdays before, during, and after training. In both experiments, preregistered analyses showed that mindfulness students reported more adaptive interpretations, and in Experiment 2, meaning-making changes mediated improvements in both challenge-type stress appraisals and physics motivation. Though mindfulness is about non-elaborative observation of the present, our findings suggest its practice can be used to internalize adaptive meaning-making about learning struggles.

Importance:Back pain is among the most common, disabling, and costly conditions managed in primary care in the US, but current treatment options often do not provide adequate relief. Mindfulness-based interventions have demonstrated effectiveness in individuals with chronic low back pain (CLBP); however, mindfulness remains underused in part because it is not integrated into most outpatient care models. Objective:To assess whether persons with CLBP participating in a mindfulness group medical visit intervention experience significantly improved pain intensity and interference compared with those receiving usual care. Design, Setting, and Participants:This randomized clinical trial, Optimizing Pain Treatment in Medical Settings Using Mindfulness (OPTIMUM), using a pragmatic approach (designed to evaluate interventions under typical conditions of care) was conducted from May 7, 2021, to November 6, 2024. Adults with CLBP attending primary care clinics in Massachusetts, Pennsylvania, and North Carolina were included. Intervention:Participants were randomized 1:1 to the OPTIMUM intervention, an 8-week telehealth-delivered mindfulness group medical visit program delivered as part of primary care (intervention), or usual care (controls). Main Outcomes and Measures:The primary analysis assessed the between-group difference in the primary outcome of change from baseline to month 6 in the Pain, Enjoyment of Life and General Activity (PEG) scale score. A mean minimal clinically important difference (MCID) in PEG score of at least 1 was considered. Secondary analyses evaluated the between-group differences in change from baseline to week 8 and month 12 in PEG score. Results:Of 451 participants (mean [SD], 52.1 [14.7] years; 318 [70.5%] female), 224 were randomized to the intervention group and 227 to the control group. All reported moderate pain interference at baseline. In intention-to-treat analyses, the intervention participants had a statistically significant improvement in PEG score from baseline compared with controls at the 6-month primary time point (mean change, -1.21 [95% CI, -1.50 to -0.92] vs -0.59 [95% CI, -0.86 to -0.31]; between-group difference, -0.62 [95% CI, -1.02 to -0.23]; P = .002) and at 8 weeks (mean change, -1.16 [95% CI, -1.44 to -0.88] vs -0.27 [95% CI, -0.53 to -0.003]; between-group difference, -0.89 [95% CI, -1.27 to -0.51]; P < .001) and 12 months (mean change, -1.52 [95% CI, -1.81 to -1.23] vs -0.78 [95% CI, -1.05 to -0.50]; between-group difference, -0.74 [95% CI, -1.14 to -0.34]; P < .001). The MCID was not met at any time point. Conclusions and Relevance:In this randomized clinical trial, a telehealth-delivered mindfulness group medical visit program for persons with CLBP resulted in significant improvements in pain intensity and interference compared with usual care; however, these changes did not meet the prespecified mean 1-point MCID between groups. The program incorporated primary care clinicians, was accessible, and is potentially scalable as a nonpharmacologic treatment for CLBP. Trial Registration:ClinicalTrials.gov Identifier: NCT04129450.

Background:Chronic low back pain (cLBP) is a prevalent and debilitating condition. Gaining insight into the daily experiences of those with cLBP is crucial for developing effective management. Pain and activity are typically assessed at a single time point and often rely on retrospective self-reports, which can be prone to recall bias and may not reflect the day-to-day variability of these experiences. As a part of the University of Pittsburgh LB3P Mechanistic Research Center, this study used ecological momentary assessment (EMA) and wearable devices to collect real-time data in a large cohort of adults with cLBP. The primary aims were to collect and characterize pain and activity profiles of individuals with cLBP. Methods:This study enrolled 1007 adults with cLBP who met the National Institutes of Health defined criteria. Over 7 days, participants were assessed in their own environment. EMA was gathered in real-time via a custom mobile app, prompting participants three times daily to provide their perceptions of current pain intensity (0-10), pain interference (0-10), and activity level (very light to vigorous). Time of falling asleep and waking was also reported. Participants wore ActiGraph GT9X devices on their wrist and waist. A custom back sensor was also adhered to the skin over the lumbar (L5) segment. Activity counts, wear time, and step counts were calculated, utilizing algorithms provided by ActiGraph. Sensor data were filtered to include at least 4 days of 10 or more hours each. Activity counts were categorized into sedentary, light, and moderate-to-very-vigorous based on Freedson Adult cutpoints. Results:Out of 1007 participants, 989 submitted EMA data (58.8 ± 16.5 years old; 40% male and 60% female; mean pain intensity at enrollment of 5.4 (SD 2.1) and a median of 5 (interquartile range [IQR] 3) on a 0-10 scale; mean PROMIS Pain Interference T-score at enrollment of 60.5 (SD 7.5) and a median of 61.2 (IQR 9.6)). The median reported pain intensity level from the EMA was 1 (IQR = 3), while pain interference was 3 (IQR = 3). More than half of the participants reported a median pain intensity of either 0 or 1 (54.0%) and a median pain interference between 0 and 3 (57.4%). Most participants self-reported their activity levels as moderate (36%) or light (33%). Based on pain ratings during each day, most participants had their pain intensity (30%) and pain interference (40%) peaking in the evening. ActiGraph data from 884 wrist-worn and 785 waist-worn devices were analyzed. Wrist data showed a median of 1 765 325 (IQR 796 995) activity counts/day and 9575 (IQR 4228) steps/day. Waist data showed 358 390 (IQR 223 758) activity counts/day and 4114 (IQR 3146) steps/day. The percentage of daily sedentary activity was 47.3% for wrist and 72.8% for waist. The back sensor data from 586 participants showed a median of 340 345 (IQR = 223 399) activity counts/day and a median of 3695 (IQR = 2743) steps/day. The percentage of time spent in daily sedentary activity was 82.6%. Both ActiGraph devices and the back sensor indicated that the majority of the time was spent in sedentary activity level, which is lower than the activity level reported in the EMA. Conclusions:Despite having cLBP with self-reported moderate pain levels, participants generally reported periods of relatively low levels of pain intensity and interference in their EMA. In addition, their EMA-reported activity levels differed from the sensor data. Participants self-reported higher levels of activity compared to the activity levels calculated by the wearable sensors. This suggests that participants overestimated their activity levels on EMA, or that the activity level cut-points may need to be re-evaluated for the cLBP population. Additionally, sensors placed on different body locations showed varying activity and step counts. The activity counts calculated from the waist ActiGraph and the back sensor from this cohort were lower than the average activity counts in the US adult population. Further research is needed to better quantify these differences for people with cLBP to develop a more comprehensive understanding of the pain experience.

Importance Back pain is among the most common, disabling, and costly conditions managed in primary care in the US, but current treatment options often do not provide adequate relief. Mindfulness-based interventions have demonstrated effectiveness in individuals with chronic low back pain (CLBP); however, mindfulness remains underused in part because it is not integrated into most outpatient care models. Objective To assess whether persons with CLBP participating in a mindfulness group medical visit intervention experience significantly improved pain intensity and interference compared with those receiving usual care. Design, Setting, and Participants This randomized clinical trial, Optimizing Pain Treatment in Medical Settings Using Mindfulness (OPTIMUM), using a pragmatic approach (designed to evaluate interventions under typical conditions of care) was conducted from May 7, 2021, to November 6, 2024. Adults with CLBP attending primary care clinics in Massachusetts, Pennsylvania, and North Carolina were included. Intervention Participants were randomized 1:1 to the OPTIMUM intervention, an 8-week telehealth-delivered mindfulness group medical visit program delivered as part of primary care (intervention), or usual care (controls). Main Outcomes and Measures The primary analysis assessed the between-group difference in the primary outcome of change from baseline to month 6 in the Pain, Enjoyment of Life and General Activity (PEG) scale score. A mean minimal clinically important difference (MCID) in PEG score of at least 1 was considered. Secondary analyses evaluated the between-group differences in change from baseline to week 8 and month 12 in PEG score. Results Of 451 participants (mean [SD], 52.1 [14.7] years; 318 [70.5%] female), 224 were randomized to the intervention group and 227 to the control group. All reported moderate pain interference at baseline. In intention-to-treat analyses, the intervention participants had a statistically significant improvement in PEG score from baseline compared with controls at the 6-month primary time point (mean change, −1.21 [95% CI, −1.50 to −0.92] vs −0.59 [95% CI, −0.86 to −0.31]; between-group difference, −0.62 [95% CI, −1.02 to −0.23]; P = .002) and at 8 weeks (mean change, −1.16 [95% CI, −1.44 to −0.88] vs −0.27 [95% CI, −0.53 to −0.003]; between-group difference, −0.89 [95% CI, −1.27 to −0.51]; P < .001) and 12 months (mean change, −1.52 [95% CI, −1.81 to −1.23] vs −0.78 [95% CI, −1.05 to −0.50]; between-group difference, –0.74 [95% CI, −1.14 to −0.34]; P < .001). The MCID was not met at any time point. Conclusions and Relevance In this randomized clinical trial, a telehealth-delivered mindfulness group medical visit program for persons with CLBP resulted in significant improvements in pain intensity and interference compared with usual care; however, these changes did not meet the prespecified mean 1-point MCID between groups. The program incorporated primary care clinicians, was accessible, and is potentially scalable as a nonpharmacologic treatment for CLBP. Trial Registration ClinicalTrials.gov Identifier: NCT04129450

OBJECTIVE:Chronic low back pain (cLBP) is a common condition that impacts quality of life and function. There are many evidence-based treatments to address cLBP; however, treatment effects are modest, perhaps in part due to individual variation in treatment response. The Biomarkers for Evaluating Spine Treatments (BEST) trial was designed as the collaborative centerpiece of the Back Pain Consortium (BACPAC) research program. This consortium was sponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) as part of the Helping to End Addiction Long-term (HEAL) Initiative. DESIGN:The BEST trial was a sequential multiple assignment randomized trial (SMART) designed with the primary goal of identifying in whom different treatments show optimal response. The primary focus of the study was to use patient features, including biomarkers and phenotypic measures, to identify subsets of persons with cLBP who respond best to specific common treatments. METHODS:Four interventions were chosen for the trial: Enhanced Self-Care, Acceptance and Commitment Therapy, Duloxetine, and Evidence-Based Exercise and Manual Therapy. Following a run-in period and baseline assessment, participants were randomized to 1 of the 4 treatments for the first 12-week intervention period. Participants were reassessed and based on their self-reported response to initial treatment, continued that initial treatment, were augmented with an additional randomly assigned treatment, or were switched to a new treatment. CONCLUSION:This trial was designed to deliver rich phenotypic data that will both potentially aid in the discovery of phenotypic characteristics that predict treatment response and provide a greater mechanistic understanding of cLBP. CLINICAL TRIAL REGISTRATION NUMBER:The Biomarkers for Evaluating Spine Treatments (BEST) trial is registered on ClinicalTrials.gov (Registration number: NCT05396014; https://clinicaltrials.gov/study/NCT05396014).

ABSTRACT Background The chronic low back pain (cLBP) literature rarely includes comprehensive characterization of demographic and biomedical factors in a large sample of individuals. The University of Pittsburgh Mechanistic Research Center, entitled, “Low Back Pain: Biological, Biomechanical, Behavioral Phenotypes (LB 3 P),” is part of the National Institutes of Health's Helping to End Addiction Long‐term Initiative. The LB 3 P conducted a prospective, observational cohort study to identify phenotypes of people with cLBP. Here, we report demographic and biomedical characteristics of a large cohort of individuals with cLBP, stratified by sex and age, collected at the in‐person enrollment visit. Methods The key eligibility criteria were adults with cLBP, English speakers, and identified in the electronic health record of our medical center. Recruitment strategies were through clinical partners who invited their patients to join the study and research registries. Participants completed demographic and biomedical surveys. Descriptive statistics were computed for the sample overall, and for the subgroups (male/female and age < 60/≥ 60). Results N = 1007 individuals (60% female) were enrolled, with an average age of 59 ± 17 years. Most participants were non‐Hispanic (90%), White (75%), and 53% attained college or higher education. 54% were married or had a partner, 43% were employed, 38% retired, 41% had an annual household income < $50 000, 20% had been off work for more than 30 days due to low back pain (LBP), 16% had applied for or received disability, and 6% were on worker's compensation. The majority were obese (average BMI of 31.5 kg/m 2 ), 61% had back pain for > 5 years, and pain had been ongoing every or nearly every day in 76% of the sample. The participants reported a high prevalence of osteoarthritis (58%), anxiety (40%), depression (40%), vision impairment (35%), and balance problems/falls (31%). Among the chronic overlapping pain conditions, the most common were migraine or headache (29%), irritable bowel syndrome (16%), and temporomandibular joint dysfunction (12%). Previous low back surgery was reported by 25%. The most frequently reported LBP treatments during the previous month were exercise routine done on their own (58%), physical therapy, occupational therapy, or chiropractic care (33%), mindfulness, meditation, or relaxation (22%), and diet or nutrition counseling (21%). Medication intake during the last month was 43% for nonsteroidal anti‐inflammatory drugs, 18% for gabapentin, 13% for opioid, and 10% for antidepressants. Conclusions Describing comprehensive demographic and biomedical characteristics of individuals with cLBP stratified by sex and age will serve as a reference for clinicians and research planning, particularly with respect to comorbid conditions and utilization of treatment for cLBP. These data will be useful in future efforts to comprehensively phenotype cLBP.

Background:Chronic low back pain (cLBP) is complex, disabling, and costly to patients and to society. Patients' social circumstances, beliefs, and behaviors interact in a dynamic way with biomedical factors and have the potential to amplify or reduce suffering. It is important to assess the experience of pain via patient-reported outcomes (PROs). The University of Pittsburgh Mechanistic Research Center, entitled, "Low Back Pain: Biological, Biomechanical, Behavioral Phenotypes (LB 3 P)," is part of the National Institutes of Health's Helping to End Addiction Long-term Initiative. LB3P conducted a prospective, observational cohort study to identify phenotypes of over 1000 participants with cLBP. This article reports key information from the PROs and selected demographic variables obtained at the in-person LB3P study enrollment visit. Methods:The LB3P study participants completed numerous PROs, including the minimum data set assessments of the NIH Research Task Force on back pain and the NIH HEAL Initiative's Common Data Elements. PROs were organized into five conceptual domains: (1) Pain Characteristics and Qualities, (2) Pain-related Psychosocial Factors, (3) General Psychosocial Factors, (4) General Health and Lifestyle Factors, and (5) Social Determinants of Health (SDoH). Patient Acceptance of Symptom Status, which consists of yes/no responses to 10 questions about whether the level of each of the 10 symptoms is satisfactory, was also assessed. Results:PRO measures were collected from 1007 LB3P participants with cLBP. The means and standard deviations, or medians and interquartile ranges, and percentages for the PRO variables collected at the in-person enrollment visit are presented for the overall group and stratified by sex at birth (females and males) and by age (< 60 years old and ≥ 60 years old). For the participants overall, and across sex and age groups, pain intensity and interference were moderate on average. Neuropathic pain, assessed via PainDETECT, was present in 18% of the overall sample, and in 22.5% of those younger than 60. On average, fatigue, depressive and anxiety symptoms, memory and concentration, self-efficacy, and positive outlook were within normal limits, as indicated by PROMIS T-scores. However, PROMIS Physical function was below normal, with T-scores in the mild to moderate range of impairment. When participants were asked to rate the acceptability of their symptom status in 10 areas of function, the most frequently reported areas of dissatisfaction were: pain intensity and interference, physical function, sleep, and fatigue. In the area of SDoH, nearly half (44%) of participants reported having been exposed to traumatic experiences. In the overall group, 36% reported difficulty paying for basic needs such as food, medical care, and heating, while 51% of those in the < 60 group reported this level of financial strain. Conclusions:The LB3P cLBP observational cohort exhibited moderate levels of pain intensity, pain interference with life activities, and pain-related disability. Participants reported mild to moderate levels of pain-related psychosocial factors, and general mental health challenges such as depression and anxiety were relatively rare. Many participants reported a history of exposure to traumatic experiences and having current financial challenges. The LB3P PRO results provide reference values for a community sample of persons with cLBP.

Background:Chronic low back pain (cLBP) is a multifactorial condition that can have various contributing factors, including biological, biomechanical, and behavioral. Recent evidence suggests that systemic inflammation may contribute to cLBP, impacting pain sensitivity and individuals' functional status. Circulatory pro- and anti-inflammatory cytokines are widely used to determine individuals' systemic inflammatory status. The University of Pittsburgh Mechanistic Research Center, part of the National Institutes of Health's (NIH) Helping to End Addiction Long-term Initiative, conducted a prospective, observational study to identify phenotypes in a large cohort of individuals with cLBP. The present work reports the quantification of key circulatory cytokines in this cLBP cohort. Methods:A total of 1007 individuals with cLBP were enrolled. Plasma samples were available from 936 participants, and concentrations of pro-inflammatory (IL-6, IFN-γ, TNF, IL-15, Leptin) and anti-inflammatory (IL-1ra, IL-10) cytokines were measured via immunoassays. Pain and functional status were assessed using validated self-reported numeric pain ratings scale and the Oswestry Disability Index. Descriptive statistics of analyzed cytokines were reported across the overall population, stratified by age (< 60 and ≥ 60 years old) and sex, and by pain levels as mild (0-5), moderate (6, 7), and severe (8-10), and ODI, categorized as minimal disability (0%-20%), moderate (21%-40%), and severe disability (> 40%). Results:The values of circulating cytokines assessed in this study aligned with those reported in the literature for other painful inflammatory conditions and, in most cases, exceeded those documented for healthy populations. IL-6, IL-1ra, and Leptin demonstrated higher concentrations with higher pain and disability severity. TNF showed higher concentration in participants with higher disability severity. Concentration levels of IFN-γ, IL-15, and IL-10 exhibited no differences across pain or ODI categories. Notably, TNF levels were higher in older adults (≥ 60 years), whereas Leptin levels were higher in females than in males. Conclusion:This study provides a snapshot of key circulating cytokines in a large cLBP cohort, revealing differences in pro- and anti-inflammatory cytokines across pain and disability for the overall population and in sex and age subgroups. Additional longitudinal and mechanistic studies are required to clarify how cytokines could serve as diagnostic, prognostic, or phenotyping markers, ultimately informing targeted, inflammation-focused therapies that may reshape current treatment approaches.

Background:Chronic low back pain (cLBP) presents as a heterogeneous condition, making diagnosis and treatment challenging. Lumbar spine intervertebral kinematics may provide an objective assessment of patients with cLBP that may be used to inform treatment decisions and evaluate the efficacy of interventions. The purpose of this study was to provide a quantitative description of intervertebral motion in the lumbar spine during flexion/extension (F/E) and lateral bending (LB) in individuals with cLBP. Methods:Data from 125 individuals is included in this analysis (M: 53; F: 72; n = 66 < 60 years of age; average BMI: 25.7 ± 3.6 kg/m2). Dynamic biplane radiography (DBR) and a validated volumetric model-based tracking system were used to assess intervertebral motion at every lumbar level (L1-L2 through L5-S1) during active F/E and LB movements in individuals with cLBP. The outcome measures were the intervertebral translation and rotation range of motion (ROM), the contribution of each motion segment to lumbar motion, the anterior-posterior slip per degree of flexion (SPDF), and trial-to-trial repeatability as assessed by the standard deviation in continuous kinematics waveforms over 3 trials of each movement. Outcomes were calculated for the entire group as well as for the subgroups of men, women, individuals less than 60 years of age, and individuals 60 or more years of age. Results:The mean intervertebral F/E ROM progressively increased from 6.8° ± 3.1° at the L1-L2 through the L4-L5 motion segments, then decreased from 9.7° ± 5.2° at L4-L5 to 8.4° ± 4.9° at L5-S1. However, substantial variability among individuals was observed, and only 7 participants (5.6%) followed this ROM pattern. The mean intervertebral LB ROM increased from 8.8° ± 3.2° at L1-L2 to 9.1° ± 4.2° at L2-L3 and then progressively decreased from the L2-L3 through the L5-S1 motion segments to 2.7° ± 1.8°. However, only 13 participants (10.4%) followed this ROM pattern. On average, the L1-L2, L2-L3, and L5-S1 motion segments were the main contributors to F/E when the torso was near the upright neutral position. L2-L3, L3-L4, and L4-L5 were the main contributors to midrange flexion and extension, and L3-L4, L4-L5, and L5-S1 were the main contributors to lumbar motion when the trunk was near full flexion. L1-L2 and L2-L3 were the main contributors to lumbar LB near the neutral position and through the midrange. The contributions from L4-L5 and L5-S1 peaked at the neutral position and at maximum bending. SPDF was similar in the L1-L2, L2-L3, and L3-L4 motion segments, but less in the L4-L5 motion segment. L5-S1 SPDF was characterized by high variability among individuals as compared to other motion segments. The average trial-to-trial repeatability in intervertebral rotation in the primary plane of motion over all points on the kinematics waveform ranged from 0.3° to 0.7° across all motion segments during F/E and LB. Conclusion:This study demonstrates the heterogeneity in lumbar spine intervertebral kinematics in individuals with cLBP. Further research is needed to identify mechanistic links between kinematics and other biological, behavioral, and clinical features in individuals with cLBP and to identify which kinematic characteristics are useful metrics for informing treatment approaches for patients with cLBP.

Chronic low back pain is globally prevalent and associated with significant impairment in quality of life. Furthermore, people from historically marginalized communities are less likely to receive treatment, contributing to health inequities. Group mindfulness-based interventions improve pain and function, and virtual delivery has been demonstrated to be feasible. Little is known about how participants experience the virtual delivery of mindfulness-based interventions, especially participants from historically marginalized communities. This study explored participant perspectives of a virtual mindfulness-based group medical visit for people with chronic low back pain. Participants were recruited from the intervention arm of OPTIMUM, a study of virtual medical group visits using an adapted Mindfulness-Based Stress Reduction program for chronic low back pain. Semi-structured exit interviews were examined, and reflexive thematic analysis was used to compose key themes. Interviews from 59 participants (mean 56 years, 69.5% women; 45.8% Black or African American) were examined. Two major themes were derived from analysis. The first theme was 'effects of the external environment,' ie, the physical location from which the participant engaged with the session. The subthemes were comfort, social demands in the home setting, and sharing personal spaces. The second theme was 'navigating the virtual platform.' Subthemes were ease, struggle, and levels of support. Patient experiences varied substantially during the virtual mindfulness-based group medical visit intervention and this variation was influenced by social determinants of health. The key themes bring attention to the effects of the external environment and the technology itself on participation for people from historically marginalized communities. Basic tenets of mindfulness, such as present state awareness and equanimity, can provide a structure within which to navigate virtual participation amid home environments. Future studies are needed to explore differences in virtual and in-person mindfulness programs and to adapt virtual mindfulness programs. NCT04129450.

Background:Quantitative Sensory Testing (QST), also known as psychophysical testing, includes standardized methods for assessing humans' perceptions of different types of sensory stimuli and their associated pain thresholds. QST results can be used to estimate altered or atypical sensory processing and thus can be useful for determining pain mechanisms such as nociplastic or central nervous system-mediated pain. The University of Pittsburgh Mechanistic Research Center, entitled, "Low Back Pain: Biological, Biomechanical, Behavioral Phenotypes (LB3P)," is part of the National Institutes of Health's Helping to End Addiction Long-term Initiative. LB3P conducted a prospective, observational cohort study to identify phenotypes of over 1000 participants with cLBP. QST was conducted on these participants as part of comprehensive data collection. This article reports on the results of the QST procedures performed at the initial in-person enrollment visit. Methods:Four QST procedures were administered to participants of the LB3P study at their enrollment visit: (1) Pressure Pain Thresholds (PPT) over the participant-reported site of lumbar pain (paraspinals) and a control site (trapezius) using an analog algometer; (2) Temporal Summation (TS) over the lumbar pain and control sites (forearm) using a Neuropen with a 40-g monofilament; (3) Conditioned Pain Modulation (CPM) using a cold water (5°C) immersion tank; and (4) Cold Water Tolerance time. A subset of LB3P participants was excluded from the CPM and cold-water immersion procedures due to medical comorbidities such as cardiovascular disease and diabetic neuropathy. Means and standard deviations (SDs) were calculated from three trials of PPT and TS, two trials of CPM, and one trial of cold-water immersion time. TS was calculated by subtracting the numeric pain scores (0-10 scale) of the first from the 10th pinpricks. CPM was calculated by subtracting the mean trapezius algometer readings during the PPT procedure from those of the trapezius PPT during cold-water immersion. Results:The final cohort of QST participants was 999 adults. The mean/SD of lumbar and trapezius PPTs was 4.6 (2.4) and 4.4 (1.9) kg/cm2, respectively. The mean/SD of lumbar and forearm TS was 1.6 (2.0) and 1.2 (1.8). Lingering pain after the 10th pinprick (after-sensations) was reported by 19.3% and 15.6% of participants after a series of 10 pinpricks was applied to the lumbar pain site and control site, respectively. The mean/SD CPM was 0.9 (1.2) with a wide range of CPM values from -2.9 to 5.9. The cold-water tolerance test resulted in a bimodal distribution, with 83% of participants having an average immersion time of 30 s and the remaining 17% reaching the maximum immersion time of 180 s. Conclusions:QST data were collected from a large cohort of individuals with cLBP who participated in the LB3P observational study. The QST results provide reference values for persons living with cLBP.

OBJECTIVES:Loneliness is one of the most robust risk factors for morbidity and accelerated mortality among older adults, and effective interventions are needed. However, interventions to reduce loneliness have shown limited success, especially in this population. Indeed, research suggests that simply increasing social contact might not combat loneliness; instead, addressing the cognitive and emotional mechanisms of loneliness might be more effective. Here, in two randomized controlled trials (RCT), we explored whether mindfulness training could reduce loneliness. METHODS:This study tested an 8-week Mindfulness-Based Stress Reduction (MBSR) program on loneliness in older adults across two RCTs. Study 1 compared MBSR to a waitlist (WL) control, and Study 2 compared MBSR to the Health Enhancement Program (HEP). RESULTS:From baseline to follow-up, MBSR significantly reduced loneliness compared to WL in Study 1 (b = -1.680, SE = 0.273, 95% CI [-3.325, -0.034], p = .045, β = -0.402). In Study 2, MBSR and HEP both reduced loneliness (main effect of time: b = -3.598, SE = 0.957, 95% CI [-5.481, -0.1.716], p < .001, β = -0.378), with no significant difference between conditions. Baseline depressive symptoms, perceived stress, sex, age, or homework did not reliably moderate effects on reducing loneliness. DISCUSSION:These findings suggest that both MBSR and HEP may be promising approaches to addressing loneliness in older adults with effects lasting for months.

BACKGROUND:Chronic low back pain (cLBP) is extremely common and is one of the Chronic Overlapping Pain Conditions (COPCs), 10 conditions thought to have similar underlying pathophysiology. Little is known about the prevalence and co-occurrence of cLBP with other commonly accepted conditions referred to as COPCs. METHODS:We assessed participants enrolled in a pragmatic trial of mindfulness-based stress reduction for cLBP to determine the prevalence of co-occurring COPCs using a validated COPC screener. We compared psychosocial and physical functioning among participants with only cLBP and participants with cLBP and additional COPCs using Student's t-tests, chi-squared tests and multivariable linear regression. RESULTS:Among 285 enrollees (age range: 18-88 years, mean age: 52.2 years, SD = 15.3), 272 (95%) reported pain outside the upper and lower back region. One hundred and twenty-nine people (45%) had one COPC, and 68 (24%) had two or more COPCs not including cLBP. The most common COPCs were irritable bowel syndrome (n = 56, 20%); myalgia encephalomyelitis/chronic fatigue syndrome (n = 54, 19%); and fibromyalgia (n = 42, 15%). CONCLUSION:We found strong differences when comparing people with cLBP alone to those with cLBP and COPCs. People with COPCs reported more pain symptoms, higher levels of anxiety, depression, fatigue and scored worse across measures of physical functioning and pain symptoms. An additional COPC was associated with a 7.6-point increase in fatigue scores (95% CI: 5.6, 9.7) on a T-score metric (mean = 50, SD = 10). SIGNIFICANCE STATEMENT:Compared to people with low back pain alone, individuals with additional chronic pain experienced more severe pain symptoms, more anxiety, depression and fatigue. In this sample of people with cLBP, overlapping pain conditions were common, affecting 45% of people. REGISTRATION NUMBER AND REGISTRY NAME:Clinicaltrials.gov identifier NCT04129450.

Background:The integrative medicine (IM) clinic is an innovative care model that may increase access to guideline-concordant nonpharmacologic treatment use in healthcare delivery systems for prevalent conditions such as low back pain (LBP). Objective:To describe the use and effectiveness of IM services for LBP in IM clinics. Research Design:Prospective cohort study. Subjects:Adult patients with LBP enrolled at seventeen IM clinics. Measures:Patterns of IM service use were assessed over 12 months. Changes in clinical outcomes were assessed between index visit and 12-month follow-up using linear mixed-effects models. Primary (pain interference, physical function) and secondary (pain intensity, anxiety, depression, fatigue, sleep disturbance, social participation) outcomes were obtained from the PROMIS-29 instrument. Results:We identified 660 participants with LBP (mean age = 51.6 years, 75% female). Over the 12-month study period, common IM services were IM consults (56%), acupuncture (44%), chiropractic care (24%), physical therapy (19%), and massage (17%). Over two-thirds (70%) of participants received at least one guideline-concordant nonpharmacologic treatment. Participants with follow-up outcome data (n = 443, 67%) reported a modest reduction in pain interference with life activities in the short- and long-term (2-month mean difference [MD] = -1.47, 95%CI = -2.98, -0.64; 12-month MD = -1.98, 95%CI = -3.12, -0.88). By contrast, improvements in physical function were not statistically or clinically significant (2-month MD = 0.37, 95%CI = -0.28, 1.01; 12-month MD = 0.69, 95%CI = -0.31, 1.69). At 12 months, small improvements were observed on all secondary outcomes (pain intensity, anxiety, depression, and social participation) except fatigue and sleep disturbance. Conclusions:Most patients with LBP receiving care at IM clinics received at least one guideline-recommended nonpharmacologic treatment. However, improvements on clinical outcomes were relatively small. Additional multi-site studies are needed to explore the optimal implementation approach.

Background:Despite the wide utilization of physical tests and pain assessments to evaluate individuals with chronic low back pain (cLBP), there is limited information about their feasibility in terms of test duration, the ability of individuals with cLBP to perform these tests, and associated adverse events. The literature also lacks reports on comprehensive characterization of physical tests to serve as a reference for clinicians and researchers. The objectives of the present work are to assess the feasibility of a comprehensive battery of physical tests and pain assessments germane to individuals with cLBP and characterize the tests' values in the context of a large cohort. Methods:This cross-sectional analysis uses enrollment data from a large observational study conducted by the University of Pittsburgh Mechanistic Research Center-"Low Back Pain: Biological, Biomechanical, Behavioral Phenotypes (LB3P)." LB3P is part of the National Institutes of Health's Helping to End Addiction Long-term Initiative. Individuals with cLBP were screened by trained clinicians who assessed their safety to partake in up to 37 physical tests based on pre-existing medical conditions. Testers could elect not to administer tests based on their clinical judgment and participants could refuse to partake in tests. The reasons for not performing tests were recorded. The feasibility of the tests was assessed by the time to complete each test, percentages and reasons for tests not done, and adverse events related to test performance. Descriptive statistics for the physical tests were computed for the sample overall, and for the subgroups (male/female and age < 60/≥ 60) to serve as reference values for individuals with cLBP. Results:The testing protocol took on average 130 min. In total, 8.9% of tests were not done. About one third of tests not done were screened out due to medical conditions identified during the safety screening, and two-thirds due to the tester's clinical judgment or participant refusal. Only four adverse events occurred, and they resolved without sequelae. The tests most often omitted were those requiring maximal and submaximal physical effort or could elevate blood pressure in those with hypertension, such as muscle strength testing of the hip, abdomen, and thigh, or hand immersion in cold water. From the 1007 participants enrolled in the study, those who did not complete one or more tests tended to be older, obese, less educated, and experienced more disability and back pain for a longer time. The descriptive statistics of the 37 tests are reported stratified by sex and age. Conclusions:The results support the safety and feasibility of a comprehensive battery of physical tests and pain assessments in individuals with cLBP. This study also provides novel information on the test's performance frequency, reasons for not being completed, duration, and descriptive results in individuals with cLBP. This comprehensive characterization provides reference values for comparison in future research planning and clinical practice.

Background:Chronic low back pain (cLBP) requires precise phenotyping for tailored treatments. This study introduces a mobile health (mHealth) system for cLBP assessment, aiming to collect extensive biomechanical and behavioral data from in-clinic and seven-day at-home assessments from 1000 individuals with cLBP to accommodate accurate phenotyping. Methods:Using a user-centered design approach, an integrated mHealth system was developed, comprising two mobile applications: a clinician-facing in-clinic app and a participant-facing at-home app. The in-clinic app aids physical therapists in conducting in-clinic assessments, while the at-home app allows cLBP patients to manage and submit responses to ecological momentary assessments (EMA). Usability evaluations were conducted using the mHealth App Usability Questionnaire (MAUQ) and qualitative open-ended questions asking about ease of use, learnability, overall impression and satisfaction, and reflective questions. Scores from MAUQ were summarized using median and interquartile range (IQR). The usability results were used to iteratively refine the system's design and functionality. Results:Three physical therapists and 337 out of 522 cLBP patients participated in the usability evaluations. The evaluations demonstrated positive feedback for both apps. For the in-clinic app, the first iteration median MAUQ score was 6 (IQR 1) and the second iteration median MAUQ score was also 6 (IQR 2). For the at-home app, the median MAUQ scores were consistently high across five iterations (median score of 7 (IQR 1) for all iterations). These scores indicated good usability, meaning they were easy to use, efficient, and satisfying. Iterative modifications based on the feedback focused on enhancing navigation consistency, responsiveness, and user interface, resulting in overall improved usability. Conclusion:The in-clinic app was successfully used by physical therapists for the assessments of 1000 cLBP patients, receiving positive feedback. Similarly, 989 cLBP patients used the at-home app to complete and submit their EMA, finding it easier to comply with the assessment.

The OPTIMUM trial is a multisite pragmatic randomized clinical trial of an adapted Mindfulness Based Stress Reduction (MBSR) program for people with chronic low back pain in primary care settings provided via telehealth group medical visits. Researchers conducted fifty-nine exit interviews at the end of the intervention to inform the ongoing conduct of the trial and to better understand patients’ experiences. This manuscript describes a pragmatic approach to the qualitative analysis of exit interviews within a pragmatic clinical trial. The analysis included three important pivots. First, researchers conducted a process evaluation using a rapid approach called the Lightning Report method. Second, team-based approaches to qualitative analysis were utilized to pair experienced and inexperienced qualitative researchers. Third, based upon principles from Big Qual methodology, a codebook was developed and applied to provide an aerial overview of the data in preparation for more in-depth exploration. Based upon these pivots, the process evaluation provided actionable results in a timely fashion, team members increased analytical skills, and multiple analyses are being applied to the data set. By describing the pragmatic decisions to pivot approaches to qualitative analysis, this manuscript contributes to existing literature regarding rapid qualitative analysis methods for process evaluation in pragmatic clinical trials, team-based mentorship in large trials, and applications from Big Qual for large data sets.

Chronic low back pain (cLBP) is a prevalent condition with profound impacts on functioning and quality of life. While multiple evidence-based treatments exist, they all have modest average treatment effectsx2013potentially due to individual variation in treatment response and the diverse etiologies of cLBP. This multi-site sequential, multiple-assignment randomized trial (SMART) investigated four treatment modalities with two stages of randomization and aimed to enroll 630 protocol completers. The primary objective was to develop a precision medicine approach by estimating optimal treatment or treatment combinations based on patient characteristics and initial treatment response. The analysis strategy focuses on estimating interpretable dynamic treatment regimes and identifying subgroups most responsive to specific interventions. Broad eligibility criteria were implemented to enhance generalizability and recruitment, most notably that participants could be eligible to enroll even if they could not be assigned to one (but no more) of the study interventions. Enrolling participants with restrictions on the treatment they could be assigned necessitated modifications to standard minimization methods for balancing covariates. The BEST trial represents one of the largest SMARTs focused on clinical decision-making to date and the largest in cLBP. By collecting an extensive array of biomarker and phenotypic measures, this trial may identify potential treatment mechanisms and establish a more evidence-based approach to individualizing cLBP treatment in clinical practice.

Objective Chronic low back pain (cLBP) is a significant public health problem in the United States. A method to identify treatments that are most likely effective for an individual patient based on their unique characteristics is needed.Methods The Biomarkers for Evaluating Spine Treatments (BEST) Trial is a sequential, multiple assignment, randomized trial designed to estimate an optimal treatment or combination of treatments to reduce pain intensity and interference at 24 weeks in individuals with cLBP.Results We describe the patient-reported characteristics of the BEST Trial at the Baseline visit. Data collection for extensive required phenotyping is reported. We analyzed the run-in period of the BEST Trial to evaluate predictors of run-in failure. The BEST Trial enrolled 1019 participants and randomized 805 participants (61.6% female, mean age 50.4, 12.5% Black or African American) to the first stage of treatment. We collected extensive required phenotyping on all 805 randomized BEST Trial participants, and additional optional phenotyping on 510 (63.4%) participants.Conclusions The BEST Trial successfully enrolled a racially and geographically diverse sample of chronic low back pain patients and completed rich phenotypic assessments to inform our primary goal of identifying in whom different treatments show optimal response. We demonstrated the feasibility of collecting extensive phenotypic assessments in a multi-site clinical trial of cLBP.Clinical trial registration number The Biomarkers for Evaluating Spine Treatments (BEST) Trial is registered on ClinicalTrials.gov. Registration number: NCT05396014 (https://clinicaltrials.gov/study/NCT05396014).