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The lack of racial and ethnic diversity in the biomedical workforce is pronounced and those from underrepresented backgrounds encounter more challenges than their majority counterparts. The extent of the impact of the COVID-19 pandemic on early-career investigators from underrepresented backgrounds is not yet fully understood. To examine the impact of the pandemic on underrepresented early-career biomedical researchers, this study evaluated differences in productivity, research, and psychological well-being by gender and career status.This was a cross-sectional analysis of preintervention data, collected in September-October 2020, from 220 participants enrolled in the Building Up a Diverse Biomedical Research Workforce study. Participants were from 25 academic medical centers in the United States and were underrepresented early-career researchers. The primary outcomes were agreement on a 5-point Likert scale with pandemic impact statements (e.g., "The COVID-19 pandemic has impacted my ability to conduct research"). Thematic analysis was conducted on responses to 2 open-ended questions assessing the pandemic's impact.Most participants were female (79.9%), of non-Hispanic/Latinx/Spanish origin Black/African American (33.2%) or Hispanic/Latinx/Spanish origin (34.1%), and early-career faculty (53.4%). Over half of participants agreed or strongly agreed that the COVID-19 pandemic impacted their ability to work (55.7%) and conduct research (70.7%). Themes from qualitative analysis suggested lower research productivity, concerns about the academic job market and funding, and psychological distress due to the pandemic. Women were more likely to attribute lost productivity and psychological distress to homeschooling and childcare responsibilities. Postdoctoral fellows were concerned about more competition for fewer academic positions.In this study of early-career underrepresented biomedical researchers, the impact of the COVID-19 pandemic was widely felt by participants, varying by gender and career status. For those postdoctoral fellows and early-career faculty who are underrepresented, it is critical for institutions to offer flexibility in their positions.

Objective We assessed whether race or ethnicity was associated with the incidence of high-impact chronic low back pain (cLBP) among adults consulting a primary care provider for acute low back pain (aLBP). Methods In this secondary analysis of a prospective cohort study, patients with aLBP were identified through screening at seventy-seven primary care practices from four geographic regions. Incidence of high-impact cLBP was defined as the subset of patients with cLBP and at least moderate disability on Oswestry Disability Index [ODI >30]) at 6 months. General linear mixed models provided adjusted estimates of association between race/ethnicity and high-impact cLBP. Results We identified 9,088 patients with aLBP (81.3% White; 14.3% Black; 4.4% Hispanic). Black/Hispanic patients compared to White patients, were younger and more likely to be female, obese, have Medicaid insurance, worse disability on ODI, and were at higher risk of persistent disability on STarT Back Tool (all P Conclusions We observed an increased incidence of high-impact cLBP among Black and Hispanic patients compared to White patients. This disparity was partly explained by racial/ethnic differences in socioeconomic and back-related risk factors. Interventions that target these factors to reduce pain-related disparities should be evaluated. ClinicalTrials.gov Identifier NCT02647658.

OBJECTIVE This study aimed to explore a) if high pain interference has a negative effect on response to computerized cognitive behavioral therapy (cCBT) for anxiety and depression and b) whether high optimism can buffer the negative effects of pain interference on cCBT outcomes. METHODS We performed a secondary analysis of data on 403 participants from the randomized controlled clinical trial "Online Treatment for Mood and Anxiety Disorders in Primary Care." It examined the impact of cCBT, with and without access to an Internet support group, on health-related quality of life (HRQoL), mood, and anxiety symptoms. RESULTS High versus low pain interference had a negative effect on response to cCBT for physical HRQoL regardless of high or low optimism level (between group difference = -3.46 [-5.89 to -1.03], p = .005, or -4.06 [-6.28 to -1.85], p < .001, respectively). However, in the context of low optimism/high pain interference only negatively impacted the effect of cCBT on mental HRQoL (3.68 [0.63 to 6.73], p = .018) and anxiety symptoms (-2.61 [-4.87 to -0.35], p = .024). Although the pattern of effects was similar for depressive symptoms, the between-group differences were not significant. CONCLUSIONS High optimism may buffer against the negative effects of pain interference on treatment response from cCBT. Primary care patients who report high pain interference yet also lack optimism may not receive as much benefit from cCBT as other groups. Furthermore, this study found an unexpected positive effect of low optimism on treatment response. For depressed and anxious patients with low pain interference, low optimism enhanced the impact of cCBT on mental HRQoL.Trial Registration:ClinicalTrials.gov Identifier: NCT01482806.

Underrepresented minorities have higher attrition from the professoriate and have experienced greater negative impacts of the COVID-19 pandemic. The purpose of this study was to compare the impact of COVID-19 on the lives of 196 early-career physician-scientists versus PhD researchers who are underrepresented in biomedical research. Participants in the Building Up study answered questions on the impact of the COVID-19 pandemic on their personal and professional lives, and a mixed-methods approach was used to conduct the analysis. While most participants experienced increases in overall stress (72% of PhD researchers vs 76% of physician-scientists), physician-scientists reported that increased clinical demands, research delays, and the potential to expose family members to SARS-CoV-2 caused psychological distress, specifically. PhD researchers, more than physician-scientists, reported increased productivity (27% vs 9%), schedule flexibilities (49% vs 25%), and more quality time with friends and family (40% vs 24%). Future studies should consider assessing the effectiveness of programs addressing COVID-19-related challenges experienced by PhD researchers and physician-scientists, particularly those from underrepresented backgrounds.

The Building Up Trial is a cluster-randomized trial that aims to address the issue of the leaky career pathway for underrepresented (UR) faculty in biomedical fields. Regulatory approval and recruitment for the Building Up Trial took place during the COVID-19 pandemic and the anti-racism movement. The pandemic and anti-racism movement personally and professionally impacted the target population and made recruitment challenging at both the institution and participant level. The target sample size for this study was 208 postdoctoral fellows or early-career faculty across 26 predominately white institutions. Challenges and adaptations are described. The Building Up Trial was delayed by 3 months. In total, 225 participants from 26 institutions were enrolled. Participants are predominately female (80%), Hispanic/Latinx (34%) or non-Hispanic/Latinx Black (33%), and early-career faculty (53%). At the institution level, obtaining Institutional Review Board (IRB) approval through a single Institutional Review Board (sIRB) posed the biggest challenge. We adapted to COVID-19-related challenges through simplifying sIRB forms, modifying study practices, and increasing communication with institutions. Recruiting UR postdoctoral fellows and faculty during the COVID-19 pandemic and anti-racism movement was challenging but not impossible. Studies should be prepared to modify study and recruitment policies to overcome additional barriers posed by the pandemics.

Background Chronic pain and heavy drinking are conditions that commonly co-occur among primary care patients. Despite the availability of behavioral interventions that target these conditions individually, engagement and adherence to treatment remain a challenge, and there have been no interventions designed to address both of these conditions together for patients presenting to primary care. This study seeks to incorporate the perspectives of patients regarding symptoms, treatment experiences, views on behavior change, and technology use to develop a tailored, integrated mobile health intervention that addresses both pain and heavy drinking among patients in primary care. Methods Twelve participants with moderate or greater chronic pain intensity and heavy drinking were recruited from primary care clinics in a large urban safety-net hospital. One-on-one interviews were recorded and transcribed. Codes were developed from interview transcripts, followed by thematic analysis in which specific meanings were assigned to codes. Participants also completed a series of Likert-based rating scales to evaluate components of the proposed intervention to supplement qualitative interviews. Results A number of themes were identified that had implications for intervention tailoring including: ambivalence about changing drinking, low expectations about pain treatment success, desire for contact with a designated provider, common use of smartphones but lack of familiarity with functions as a potential barrier to use, and strategies to maintain engagement and adherence. Evaluative ratings indicated that the proposed intervention content was perceived as helpful and the proposed structure, layout and design of the mobile intervention was acceptable to patients. Conclusions Results supported the view that a mobile health intervention delivered via smartphone with electronic coaching is an acceptable method of addressing chronic pain and heavy drinking among patients in primary care. The interviews highlight the need to utilize an intervention approach that addresses motivation to change drinking, sets realistic expectations for change, provides careful attention to training/education of the use of technology components, and fosters engagement through the use of reminders, feedback, and personalized activities.

Purpose:The need to diversify the biomedical research workforce is well documented. The importance of fostering the careers of fledgling underrepresented background (URB) biomedical researchers is evident in light of the national and local scarcity of URB scientists in biomedical research. The Career Education and Enhancement for Health Care Research Diversity (CEED) program at the University of Pittsburgh Institute for Clinical Research Education (ICRE) was designed to promote career success and help seal the “leaky pipeline” for URB researchers. In this study, we aimed to quantify CEED’s effect on several key outcomes by comparing CEED Scholars to a matched set of URB ICRE trainees not enrolled in CEED using data collected over 10 years.Method:We collected survey data on CEED Scholars from 2007 to 2017 and created a matched set of URB trainees not enrolled in CEED using propensity score matching in a 1:1 ratio. Poisson regression was used to compare the rate of publications between CEED and non-CEED URB trainees after adjusting for baseline number of publications.Results:CEED has 45 graduates. Seventy-six percent are women, 78% are non-White, and 33% are Hispanic/Latino. Twenty-four CEED Scholars were matched to non-CEED URB trainees. Compared to matched URB trainees, CEED graduates had more peer-reviewed publications (p=0.0261) and were more likely to be an assistant professor (p=0.0145).Conclusions:Programs that support URB researchers can help expand and diversify the biomedical research workforce. CEED has been successful despite the challenges of a small demographic pool.

IntroductionUS military veterans have disproportionately high rates of diabetes and diabetes-related morbidity in addition to being at risk of comorbid stress-related conditions. This study aimed to examine the effects of a technology-supported mindfulness intervention integrated into usual diabetes care and education on psychological and biobehavioral outcomes.Research design and methodsVeterans (N=132) with type 1 or 2 diabetes participated in this two-arm randomized controlled efficacy trial. The intervention arm received a one-session mindfulness intervention integrated into a pre-existing program of diabetes self-management education and support (DSMES) plus one booster session and 24 weeks of home practice supported by a mobile application. The control arm received one 3-hour comprehensive DSMES group session. The primary outcome was change in diabetes distress (DD). The secondary outcomes were diabetes self-care behaviors, diabetes self-efficacy, post-traumatic stress disorder (PTSD), depression, mindfulness, hemoglobin A1C (HbA1C), body weight, and blood pressure. Assessments were conducted at baseline, 12 weeks, and 24 weeks. Participant satisfaction and engagement in home practice were assessed in the intervention group at 12 and 24 weeks.ResultsIntention-to-treat group by time analyses showed a statistically significant improvement in DD in both arms without significant intervention effect from baseline to 24 weeks. Examination of distal effects on DD between weeks 12 and 24 showed significantly greater improvement in the intervention arm. Improvement in DD was greater when baseline HbA1C was ConclusionsA technology-supported mindfulness intervention integrated with DSMES showed stronger distal effects on DD compared with DSMES control. Examination of longer-term outcomes, underlying mechanisms, and the feasibility of virtual delivery is warranted.Trial registration numberNCT02928952.

Objective To describe key peripheral and central nervous system (CNS) conditions in a group of older adults with chronic low back pain (CLBP) and their association with pain severity and self-reported and performance-based physical function. Design Cross-sectional. Setting Outpatient VA clinics. Subjects Forty-seven community-dwelling veterans with CLBP (age 68.0 ± 6.5 years, range = 60–88 years, 12.8% female, 66% white) participated. Methods Data were collected on peripheral pain generators—body mass index, American College of Rheumatology hip osteoarthritis criteria, neurogenic claudication (i.e., spinal stenosis), sacroiliac joint (SIJ) pain, myofascial pain, leg length discrepancy (LLD), and iliotibial band pain; and CNS pain generators—anxiety (GAD-7), depression (PHQ-9), insomnia (Insomnia Severity Index), maladaptive coping (Fear Avoidance Beliefs Questionnaire, Cognitive Strategies Questionnaire), and fibromyalgia (fibromyalgia survey). Outcomes were pain severity (0 to 10 scale, seven-day average and worst), self-reported pain interference (Roland Morris [RM] questionnaire), and gait speed. Results Approximately 96% had at least one peripheral CLBP contributor, 83% had at least one CNS contributor, and 80.9% had both peripheral and CNS contributors. Of the peripheral conditions, only SIJ pain and LLD were associated with outcomes. All of the CNS conditions and SIJ pain were related to RM score. Only depression/anxiety and LLD were associated with gait speed. Conclusions In this sample of older veterans, CLBP was a multifaceted condition. Both CNS and peripheral conditions were associated with self-reported and performance-based function. Additional investigation is required to determine the impact of treating these conditions on patient outcomes and health care utilization.

Mindfulness-based stress reduction (MBSR) is an evidence-based non-pharmacological approach for chronic low back pain (cLBP), yet it is not readily available or reimbursable within primary care clinics. Primary care providers (PCPs) who wish to avoid prescribing opioids and other medications typically have few options for their cLBP patients. We present the protocol of a pragmatic clinical trial entitled OPTIMUM (Optimizing Pain Treatment In Medical settings Using Mindfulness). OPTIMUM is offered online via telehealth and includes medical group visits (MGV) with a PCP and a mindfulness meditation intervention modeled on MBSR for persons with cLBP. In diverse health-care settings in the US, such as a safety net hospital, federally qualified health centers, and a large academic health system, 450 patients will be assigned randomly to the MGV + MBSR or to usual PCP care alone. Participants will complete self-report surveys at baseline, following the 8-week program, and at 6- and 12-month follow-up. Health care utilization data will be obtained through electronic health records and via brief monthly surveys completed by participants. The primary outcome measure is the PEG (Pain, enjoyment, and general activity) at the 6-month follow-up. Additionally, we will assess psychological function, healthcare resource use, and opioid prescriptions. This trial, which is part of the NIH HEAL Initiative, has the potential to enhance primary care treatment of cLBP by combining PCP visits with a non-pharmacological treatment modeled on MBSR. Because it is offered online and integrated into primary care, it is expected to be scalable and accessible to underserved patients. Clinical Trials.gov : NCT 04129450.

ObjectiveMindfulness is a nonpharmacologic mind-body therapy that has been shown to be effective in older adults with chronic low back pain (cLBP). There are few first-person accounts in the literature that describe the older adult experience and perspective while learning mindfulness and meditation to treat pain. The objective of this study was to investigate dominant themes present in the experiences of older adults applying mindfulness and meditation to cope with cLBP.DesignQualitative analysis of four focus groups.SubjectTwenty-five adults age 65 years or older who had completed an eight-week mindfulness program.MethodsThe focus groups met for a comprehensive discussion session about their experience with mindfulness and meditation. The audio for each session was recorded, and the discussions were transcribed. Codebook development, qualitative coding, and thematic analysis were performed. The coders each coded all four transcripts, following which they met to adjudicate all coding differences until they were in complete agreement on coding.ResultsSeveral key themes were brought up by older adults utilizing mindfulness as a means of coping with pain, which included overcoming fear of pain (“Before [learning mindfulness], I used to dread pain”), pain awareness (“You’re focusing more on being aware than the pain; now that’s what helps me”), and pain significance (“It becomes insignificant”).ConclusionsThe themes identify several ways mindfulness impacts older adults with cLBP, including decreased negative emotions related to chronic pain such as fear of pain, a different perspective or change in awareness about pain, and reducing the significance of pain.

The teledementia clinic is a new model of care that expands the reach of specialized geriatric and dementia care using clinical video telehealth (CVT) to rural veterans, who frequently lack access to specialty care. The clinic is a Veterans Affairs (VA) Geriatric Research, Education, and Clinical Center clinical demonstration project. It is located in the Pittsburgh VA Healthcare System tertiary referral hospital and serves veterans in affiliated rural community-based outpatient clinics (CBOCs). Rural CBOC primary care providers refer clinic patients, or referral is according to previous cognitive impairment diagnosis in a VAPHS geriatric clinic. Patients undergo interprofessional dementia assessment by a geriatrician, geropsychologist, geriatric psychiatrist or neurologist, and social worker using CVT technology. Metrics for clinic evaluation included rural patients served and savings in travel time, distance, and costs. Assessments collected depended upon individual presentation and included cognitive tests, geriatric depression scales, functional assessment, and the Zarit Burden Interview. A patient satisfaction survey was created and administered. In the first year, 95 individuals were served in 156 clinic visits and 251 interprofessional provider encounters. Of patients served, 61 lived in rural ZIP codes, 72 were diagnosed with dementia, 19 were diagnosed with mild cognitive impairment, and four were found to have primarily psychiatric diagnoses rather than cognitive impairment. The average Functional Assessment Staging of Alzheimer's Disease Scale score was 4.3 ± 1.3. This clinic model demonstrates that CVT technology is a feasible means of providing interprofessional dementia evaluations and follow-up to rural presidents.

BackgroundChronic low back pain (cLBP) is a major health problem and the most common pain condition among those aged 60 years or older in the US. Despite the development of pharmacological and nonpharmacological interventions, cLBP outcomes have not improved and disability rates continue to rise. This study aims to test auricular point acupressure (APA) as a non-invasive, nonpharmacological self-management strategy to manage cLBP and to address current shortcomings of cLBP treatment.Methods/designFor this prospective randomized controlled study, participants will be randomly assigned to three groups: (1)APAgroup (active points related to cLBP), (2) Comparison group-1 (non-active points, unrelated to cLBP), and (3) Comparison group-2 (enhanced educational control, an educational booklet on cLBP will be given and the treatment used by participants for their cLBP will be recorded). The ecological momentary assessment smartphone app will be used to collect real-time cLBP outcomes and adherence to APA practice. Treatment and nonspecific psychological placebo effects will be measured via questionnaires for all participants. This proposed trial will evaluate the APA sustained effects for cLBP at 12-month follow-up. Monthly telephone follow-up will be used to collect study outcomes. Blood will be collected during study visits at baseline, post APA treatment, and follow-up study visits at 1, 3, 6, 9 and 12 months post completion of treatment for a total of seven assessments. Appointments will start between 9 and 11 am to control for circadian variation in cytokine levels.DiscussionThis study is expected to provide vital information on the efficacy, sustainability, and underlying mechanism of APA on cLBP necessary for APA to gain acceptance from both healthcare providers and patients, which would provide a strong impetus for including APA as part of cLBP management in clinical and home settings.Trial registrationClinicalTrials.gov, ID:NCT03589703. Registered on 22 May 2018.

Integrative and complementary non-pharmacological treatments have proven efficacious in treating both the physiological and psychological symptoms of chronic pain conditions but the potential of many combined therapies is unknown. This study examined the effects of a combined intervention of mindfulness meditation followed by aerobic walking exercise in chronic low back pain (cLBP) patients. We hypothesized that meditation before exercise would reduce disability and pain by increasing mindfulness prior to physical activity. Thirty-eight adults completed either meditation and exercise treatment (MedExT) (n=18) or an audiobook control condition (n=20). Over a 4-week period, participants in the MedExT group performed 12-17 minutes of guided meditation followed by 30 minutes of moderate intensity walking exercise 5 days per week. Measures of disability, pain, mindfulness and anxiety were taken at baseline and post-intervention. Ratings of pain were also assessed by participant self-report, before and after each intervention session. Following MedExT, participants showed significant improvement in our primary outcome of disability compared to the control group (p

Objective . To present the sixth in a series of articles designed to deconstruct chronic low back pain (CLBP) in older adults. This article focuses on the evaluation and management of lumbar spinal stenosis (LSS), the most common condition for which older adults undergo spinal surgery. Methods . The evaluation and treatment algorithm, a table articulating the rationale for the individual algorithm components, and stepped-care drug recommendations were developed using a modified Delphi approach. The Principal Investigator, a five-member content expert panel and a nine-member primary care panel were involved in the iterative development of these materials. The illustrative clinical case was taken from the clinical practice of a contributor’s colleague (SR). Results . We present an algorithm and supportive materials to help guide the care of older adults with LSS, a condition that occurs not uncommonly in those with CLBP. The case illustrates the importance of function-focused management and a rational approach to conservative care. Conclusions . Lumbar spinal stenosis exists not uncommonly in older adults with CLBP and management often can be accomplished without surgery. Treatment should address all conditions in addition to LSS contributing to pain and disability.

Key Points Question Is obesity associated with prescription opioids for pain diagnoses among patients seeking primary care in the United States? Findings In this cross-sectional study of electronic health records of 565 930 patients, osteoarthritis, other joint disorders, and other back disorders were the most important pain diagnoses associated with the increased prescribing of opioids to patients with obesity. Meaning The findings suggest that population-level efforts to prevent and treat obesity may reduce the prevalence and severity of joint and back disorders and the associated use of prescription opioids., Importance Prior studies have identified an association between obesity and prescription opioid use in the US. However, the pain conditions that are factors in this association remain unestablished. Objective To investigate the association between obesity and pain diagnoses recorded by primary care clinicians as reasons for prescription of opioids. Design, Setting, and Participants A cross-sectional study including 565 930 patients aged 35 to 64 years with a body mass index (BMI) measurement recorded in 2016 was conducted. Electronic health records of patients seen by primary care clinicians in the US in the multipayer athenahealth network from January 1, 2015, to December 31, 2017, were reviewed, and data were analyzed from March 1 to September 15, 2019. Main Outcomes and Measures Any prescription of opioids in the 365 days before or after the first BMI measurement in 2016 were identified. All International Classification of Diseases, Ninth Revision, and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, claims within 7 days before each opioid prescription were captured and classified using a pain diagnosis typologic system. Weight was categorized as underweight (BMI, 18.5-19.9), normal weight (BMI, 20.0-24.9), overweight (BMI, 25.0-29.9), obese I (BMI, 30-34.9), obese II (BMI, 35.0-39.9), obese III (BMI, 40.0-49.9), and obese IV (BMI, 50.0-80.0). Results Among 565 930 patients, 329 083 (58.1%) were women. A total of 125 093 patients (22.1%) were aged 35 to 44 years, 199 384 patients (35.2%) were 45 to 54 years, and 241 453 patients (42.7%) were 55 to 64 years. A total of 177 631 patients (31.4%) were overweight and 273 135 patients (48.2%) were obese at baseline. Over 2 years, 93 954 patients (16.6%) were prescribed opioids. The risk of receiving prescription opioids increased progressively with BMI (adjusted relative risk for overweight: 1.08; 95% CI, 1.06-1.10; obese I: 1.24; 95% CI, 1.22-1.26; obese II: 1.33; 95% CI, 1.30-1.36; obese III: 1.48; 95% CI, 1.45-1.51; and obese IV, 1.71; 95% CI, 1.65-1.77). The percentage of patients with opioid prescriptions attributable to an overweight or obese BMI was 16.2% (95% CI, 15.0%-17.4%). Prescription opioids for management of osteoarthritis (relative risk for obese vs normal weight, 1.90; 95% CI, 1.77-2.05) and other joint disorders (relative risk, 1.63; 95% CI, 1.55-1.72) both had stronger associations with obesity than the mean for any pain diagnosis (relative risk, 1.33; 95% CI, 1.31-1.36). Osteoarthritis, other joint disorders, and other back disorders comprised a combined 53.4% of the absolute difference in prescription of opioids by obesity. Conclusions and Relevance Joint and back disorders appear to be the most important diagnoses in explaining the increased receipt of opioid prescriptions among patients with obesity. Addressing the opioid crisis will require attention to underlying sources of demand for prescription opioids, including obesity, through its associations with pain., This cross-sectional study investigates the association of obesity with prescription opioids for pain diagnoses among US adults seeking primary care.

Nonspecific factors that accompany healthcare treatments, such as patients’ attitudes and expectations, are important parts of the experience of care and can influence outcomes. However, no precise, concise, and generalizable instruments to measure these factors exist. We report on the development and calibration of new item banks, titled the Healing Encounters and Attitudes Lists (HEAL), that assess nonspecific factors across a broad range of treatments and conditions. The instrument development methodology of the Patient-Reported Outcomes Measurement Information System (PROMIS®) was used. Patient focus groups and clinician interviews informed our HEAL conceptual model. Literature searches of eight databases yielded over 500 instruments and resulted in an initial item pool of several thousand items. After qualitative item analysis, including cognitive interviewing, 296 items were included in field testing. The calibration sample included 1657 respondents, 1400 obtained through an Internet panel and 257 from conventional and integrative medicine clinics. Following exploratory and confirmatory factor analyses, the HEAL item banks were calibrated using item response theory. The final HEAL item banks were Patient–Provider Connection (57 items), Healthcare Environment (25 items), Treatment Expectancy (27 items), Positive Outlook (27 items), and Spirituality (26 items). Short forms were also developed from each item bank. A six-item short form, Attitudes toward Complementary and Alternative Medicine (CAM), was also created. HEAL item banks provided substantial information across a broad range of each construct. HEAL item banks showed initial evidence of predictive and concurrent validity, suggesting that they are suitable for measuring nonspecific factors in treatment.

Objective To present the third in a series of articles designed to deconstruct chronic low back pain (CLBP) in older adults. The series presents CLBP as a syndrome, a final common pathway for the expression of multiple contributors rather than a disease localized exclusively to the lumbosacral spine. Each article addresses one of 12 important contributors to pain and disability in older adults with CLBP. This article focuses on fibromyalgia syndrome (FMS). Methods A modified Delphi approach was used to create the evaluation and treatment algorithm, the table discussing the rationale behind each of the algorithm components, and the stepped-care drug recommendations. The team involved in the creation of these materials consisted of a principal investigator, a 5-member content expert panel, and a 9-member primary care panel. The evaluation and treatment recommendations were based on availability of medications and other resources within the Veterans Health Administration (VHA) facilities. However, non-VHA panelists were also involved in the development of these materials, which can be applied to both VA and civilian settings. The illustrative clinical case was taken from the clinical practice of the principal investigator. Results Following expert consultations and a review of the literature, we developed an evaluation and treatment algorithm with supporting materials to aid in the care of older adults with CLBP who have concomitant FMS. A case is presented that demonstrates the complexity of pain evaluation and management in older patients with CLBP and concomitant FMS. Conclusions Recognition of FMS as a common contributor to CLBP in older adults and initiating treatment targeting both FMS and CLBP may lead to improved outcomes in pain and disability.

Background.Auricular point acupressure (APA) is a promising treatment for pain management. Few studies have investigated the physiological mechanisms of APA analgesics.Method.In this pilot randomized clinical trial (RCT), a 4-week APA treatment was used to manage chronic low back pain (CLBP). Sixty-one participants were randomized into a real APA group (n=32) or a sham APA group (n=29). Blood samples, pain intensity, and physical function were collected at baseline and after 4 weeks of treatment.Results.Subjects in the real APA group reported a 56% reduction of pain intensity and a 26% improvement in physical function. Serum blood samples showed (1) a decrease in IL-1β, IL-2, IL-6, and calcitonin gene-related peptide [CGRP] and (2) an increase in IL-4. In contrast, subjects in the sham APA group (1) reported a 9% reduction in pain and a 2% improvement in physical function and (2) exhibited minimal changes of inflammatory cytokines and neuropeptides. Statistically significant differences in IL-4 and CGRP expression between the real and sham APA groups were verified.Conclusion.These findings suggest that APA treatment affects pain intensity through modulation of the immune system, as reflected by APA-induced changes in serum inflammatory cytokine and neuropeptide levels.

Objective We hypothesized that among community-dwelling older adults without dementia with advanced chronic knee osteoarthritis (OA) pain: 1) higher levels of self-reported pain would be associated with decreased executive cognitive function and decreased physical function; and 2) decreased cognitive function would be associated with decreased physical function. Methods Substudy on 79 older adults who were participants in a Veterans Affairs clinical trial of periosteal stimulation therapy for advanced painful knee OA. Participants were ≥60 years, had radiographic evidence of Kellgren–Lawrence 3 or 4 knee OA on a standing anterior–posterior X-ray, had pain of at least moderate intensity and of at least 3 months' duration, and knee pain severity greater than pain severity in other parts of the body. Measures included computerized cognitive tests of executive function, pain, and physical function (gait speed and stair climbing). Results As pain scores worsened, gait speed and stair climbing worsened ( P = 0.007 and P = 0.035, respectively). Lower performance on the executive function tests was also significantly associated with decreased gait speed and stair climbing ( P = 0.002 and P = 0.014, respectively). We did not find a significant relationship between pain and cognitive function. We explored the relationship between pain and physical function adjusted for executive functioning and found that pain was no longer associated with gait speed ( P = 0.06). Conclusion Worse pain scores and executive function scores were associated with worse physical function in older adults with painful knee OA. This suggests that slower gait speed in patients could be an indication to clinicians to monitor their patient's cognitive function. Executive function in particular affected the relationship between gait speed and pain, suggesting a possible mediating relationship.

This prospective, randomized clinical trial (RCT) pilot study was designed to (1) assess the feasibility and tolerability of an easily administered, auricular point acupressure (APA) intervention and (2) provide an initial assessment of effect size as compared to a sham treatment. Thirty-seven subjects were randomized to receive either the real or sham APA treatment. All participants were treated once a week for 4 weeks. Self-report measures were obtained at baseline, weekly during treatment, at end-of-intervention (EOI), and at a 1-month follow-up. A dropout rate of 26% in the real APA group and 50% in the sham group was observed. The reduction in worst pain from baseline to EOI was 41% for the real and 5% for the sham group with a Cohen’s effect size of 1.22P<0.00. Disability scores on the Roland Morris Disability Questionnaire (RMDQ) decreased in the real group by 29% and were unchanged in the sham group (+3%)P<0.00. Given the high dropout rate, results must be interpreted with caution; nevertheless, our results suggest that APA may provide an inexpensive and effective complementary approach for the management of back pain in older adults, and further study is warranted.

The push to evaluate pain in patients as exemplified by the fifth vital sign has exposed serious deficits in practitioner education and training in pain assessment and management because patient report of pain level has become commonplace in clinical practice. The rapid increase in prescription opioid medications suggests that practitioners are trying to address their patients' pain by prescribing opioids. However, the increase in prescription opioids has also been associated with an increase in prescription opioid-related unintended deaths. In clinical practice, the fifth vital sign has proven to be more complex to assess, evaluate, and manage than originally anticipated. Expanding pain education and training is critical to remedying some of the issues the routine report of pain by patients has uncovered.

To describe estimates of the number and characteristics of persons who had used mindfulness meditation in the U.S.Data from 108,131 adults from the 2012 National Health Interview Survey were weighted to produce national estimates representative of the U.S.Persons who used mindfulness meditation were identified by their response to the question "During the past 12 months, did you use mindfulness meditation?"An estimated 2,029,720 adults had used mindfulness meditation. Compared with those who did not meditate, more meditators endorsed moderate exercise (79.6% vs. 54.8%; p 0.0001). More meditators had low-back and neck pain and headache (36.7% vs. 28.9 [p = 0.0002]; 26.4% vs. 14.7% [p0.0001]; 19.1% vs. 12.1% [p0.0001], respectively). More meditators reported being nervous or feeling sad at least a little of the time (60.4% vs. 37.8% and 34% vs. 23.5%, respectively; p0.0001) and being frequently stressed (56.4% vs. 29.0%; p0.0001).Mindfulness meditation was used by an estimated 2,029,720 adults in the United States in 2012. More meditators than nonmeditators reported more pain and reported feeling nervous or sad and being stressed, suggesting a reason for using mindfulness meditation.

Objectives. This prospective, randomized clinical trial (RCT) was designed to investigate the feasibility and effects of a 4-week auricular point acupressure (APA) for chronic low back pain (CLBP).Methods. Participants were randomized to either true APA (true acupoints with taped seeds on the designated ear points for CLBP) or sham APA (sham acupoints with taped seeds but on different locations than those designated for CLBP). The duration of treatment was four weeks. Participants were assessed before treatment, weekly during treatment, and 1 month following treatment.Results. Participants in the true APA group who completed the 4-week APA treatment had a 70% reduction in worst pain intensity, a 75% reduction in overall pain intensity, and a 42% improvement in disability due to back pain from baseline assessment. The reductions of worst pain and overall pain intensity in the true APA group were statistically greater than participants in the sham group(P<0.01)at the completion of a 4-week APA and 1 month followup.Discussion. The preliminary findings of this feasibility study showed a reduction in pain intensity and improvement in physical function suggesting that APA may be a promising treatment for patients with CLBP.

Objective. This article presents an evidence-based algorithm to assist primary care providers with the diagnosis and management of lateral hip and thigh pain in older adults. It is part of a series that focuses on coexisting pain patterns and contributors to chronic low back pain (CLBP) in the aging population. The objective of the series is to encourage clinicians to take a holistic approach when evaluating and treating CLBP in older adults. Methods. A content expert panel and a primary care panel collaboratively used the modified Delphi approach to iteratively develop an evidence-based diagnostic and treatment algorithm. The panelists included physiatrists, geriatricians, internists, and physical therapists who treat both civilians and Veterans, and the algorithm was developed so that all required resources are available within the Veterans Health Administration system. An illustrative patient case was chosen from one of the author’s clinical practices to demonstrate the reasoning behind principles presented in the algorithm. Results. An algorithm was developed which logically outlines evidence-based diagnostic and therapeutic recommendations for lateral hip and thigh pain in older adults. A case is presented which highlights the potential complexities of identifying the true pain generator and the importance of implementing proper treatment. Conclusions. Lateral hip and thigh pain in older adults can contribute to and coexist with CLBP. Distinguishing the true cause(s) of pain from potentially a myriad of asymptomatic degenerative changes can be challenging, but a systematic approach can assist in identifying and treating some of the most common causes.

Primary care patients with Panic Disorder (PD) and Generalized Anxiety Disorder (GAD) experience poorer than expected clinical outcomes, despite the availability of efficacious pharmacologic and non-pharmacologic treatments. A barrier to recovery from PD/GAD may be the co-occurrence of pain. To evaluate whether pain intensity interfered with treatment response for PD and/or GAD in primary care patients who had received collaborative care for anxiety disorders. A secondary data analysis of a randomized, controlled effectiveness trial comparing a telephone-delivered collaborative care intervention for primary care patients with severe PD and/or GAD to their doctor’s “usual” care. Patients had to have a diagnosis of PD and/or GAD and a severe level of anxiety symptoms. The 124 patients randomized at baseline to the collaborative care intervention were analyzed. Participants were divided into two pain intensity groups based on their response to the SF-36 Bodily Pain scale (none or mild pain vs. at least moderate pain). Pain was assessed using the Bodily Pain scale of the SF-36. Anxiety symptoms were measured with the Hamilton Anxiety Rating Scale (HRS-A), Panic Disorder Severity Scale (PDSS) and Generalized Anxiety Disorder Severity Scale (GADSS). Measures were collected over 12 months. At baseline, patients with at least moderate pain were significantly more likely to endorse more anxiety symptoms on the HRS-A than patients with no pain or mild pain (P

Chronic low back pain (CLBP) is widespread among older adults (≥ 65 years) and is often treated inadequately. With a rapidly growing aging population, CLBP will increase and so will the demand for treatment. We believe that mind-body therapies can help to meet this demand. We present the methodology of a randomized, controlled clinical trial of 300 individuals with CLBP aged 65 years or older. The specific aims are, 1) to determine the effectiveness of a mindfulness meditation program in increasing function and reducing pain among older adults with CLBP, and 2) to evaluate the impact of mindfulness meditation on neuropsychological performance in older adults with CLBP. The intervention program is modeled on the Mindfulness-Based Stress Reduction Program (MBSR) and the control is adapted from the 10 Keys™ to Healthy Aging. We will measure self-reported and objectively measured physical function and include a variety of measures to assess pain intensity and pain interference and psychological function. Our primary hypothesis is that the MBSR program will be more effective than the 10 Keys ™ program in increasing function and decreasing pain. The proposed study represents the first large, well-controlled, comprehensive examination of the effects of a mind-body program on older adults with chronic pain.

Objective. To describe the methodology of the first NIH-funded clinical trial for seniors with comorbid depression and chronic low back pain. Methods. Randomized controlled effectiveness trial using stepped care methodology. Participants are ≥60 years old. Phase 1 (6 weeks) is open treatment with venlafaxine xr 150 mg/day and supportive management (SM). Response is 2 weeks of PHQ-9 ≤5 and at least 30% improvement in the average numeric rating scale for pain. Nonresponders progress to phase 2 (14 weeks) in which they are randomized to high-dose venlafaxine xr (up to 300 mg/day) with problem solving therapy for depression and pain (PST-DP) or high-dose venlafaxine xr and continued SM. Primary outcomes are the univariate pain and depression response and both observed and self-reported disability. Survival analytic techniques will be used, and the clinical effect size will be estimated with the number needed to treat. We hypothesize that self-efficacy for pain management will mediate response for subjects randomized to venlafaxine xr and PST-DP. Results. Not applicable. Conclusions. The results of this trial will inform the care of these complex patients and further understanding of comorbid pain and depression in late life.

While the adverse impact of stress on health states has been established, effective stress reduction programs are largely underused in clinical settings. In an area with little published information, this study identifies themes that describe the process of applying mindfulness methods to cope with psychosocial stressors in participants of the Mindfulness-Based Stress Reduction (MBSR) program. The study design is a qualitative investigation with a phenomenological approach using participant feedback from 11 MBSR 8-week programs. Participants were 74 adults from the greater Pittsburgh area. Content analysis was used to inductively generate thematic categories. Four themes were identified that described the process and results of learning mindfulness to adapt to psychosocial stressors. We categorized participants’ feedback into interrelated themes of awareness (subdivided into self-discovery—“step back from my thoughts in order to view them more clearly”, and being in the present), coping—“pause, take a breath”, serenity—“increased feeling of calm, centeredness”, and change in perspective—“different understanding interpersonally and intrapersonally.” In addition, a brief section describes specific health benefits identified by participants. Participants found the mindfulness-based approach effective for stress reduction. The learning process allowed them to routinely apply mindfulness strategies that provided multiple benefits.

Older adults with persistent pain are not simply a chronologically older version of younger pain patients. Pain-related disability in older adults may be driven by pain 'homeostenosis', that is, diminished ability to effectively respond to the stress of persistent pain. Some of the comorbidities of ageing that can contribute to pain homeostenosis include cognitive and physical impairments, increased sensitivity to suprathreshold pain stimuli, medical and psychological comorbidities, altered pharmacokinetics and pharmacodynamics, and social isolation. A key distinction between older and younger individuals with persistent pain is the normal and pathological ageing-associated brain changes. These may alter the expression and experience of pain with impaired descending inhibition and dysfunction of pain gating mechanisms. Cognizance of these brain changes is needed to guide appropriate evaluation and treatment approaches. This paper reviews data that support these ageing-associated phenomena. Specifically, we discuss age-related changes in the brain (both normal and pathological) and in pain physiology; changes in experience and expression of pain that occur with dementia and contribute to pain homeostenosis; and unique aspects of age and pain-associated psychological function and their contribution to disability. We also present data demonstrating changes in brain morphology and neuropsychological performance that accompany persistent non-malignant pain in older adults and the treatment implications of these brain changes. Finally, preliminary data are presented on the efficacy of mindfulness meditation, a treatment that has been examined explicitly in older adults and targets optimizing brain function and descending inhibition.

Knowledge of baseline risk of urinary tract infection can help clinicians make informed diagnostic and therapeutic decisions. We conducted a meta-analysis to determine the pooled prevalence of urinary tract infection (UTI) in children by age, gender, race, and circumcision status.MEDLINE and EMBASE databases were searched for articles about pediatric urinary tract infection. Search terms included urinary tract infection, cystitis, pyelonephritis, prevalence and incidence. We included articles in our review if they contained data on the prevalence of UTI in children 0-19 years of age presenting with symptoms of UTI. Of the 51 articles with data on UTI prevalence, 18 met all inclusion criteria. Two evaluators independently reviewed, rated, and abstracted data from each article.Among infants presenting with fever, the overall prevalence (and 95% confidence interval) of UTI was 7.0% (CI: 5.5-8.4). The pooled prevalence rates of febrile UTIs in females aged 0-3 months, 3-6 months, 6-12 months, and12 months was 7.5%, 5.7%, 8.3%, and 2.1% respectively. Among febrile male infants less than 3 months of age, 2.4% (CI: 1.4-3.5) of circumcised males and 20.1% (CI: 16.8-23.4) of uncircumcised males had a UTI. For the 4 studies that reported UTI prevalence by race, UTI rates were higher among white infants 8.0% (CI: 5.1-11.0) than among black infants 4.7% (CI: 2.1-7.3). Among older children (19 years) with urinary symptoms, the pooled prevalence of UTI (both febrile and afebrile) was 7.8% (CI: 6.6-8.9).Prevalence rates of UTI varied by age, gender, race, and circumcision status. Uncircumcised male infants less than 3 months of age and females less than 12 months of age had the highest baseline prevalence of UTI. Prevalence estimates can help clinicians make informed decisions regarding diagnostic testing in children presenting with signs and symptoms of urinary tract infection.

The objectives of this pilot study were to assess the feasibility of recruitment and adherence to an eight-session mindfulness meditation program for community-dwelling older adults with chronic low back pain (CLBP) and to develop initial estimates of treatment effects. It was designed as a randomized, controlled clinical trial. Participants were 37 community-dwelling older adults aged 65 years and older with CLBP of moderate intensity occurring daily or almost every day. Participants were randomized to an 8-week mindfulness-based meditation program or to a wait-list control group. Baseline, 8-week and 3-month follow-up measures of pain, physical function, attention, and quality of life were assessed. Eighty-nine older adults were screened and 37 found to be eligible and randomized within a 6-month period. The mean age of the sample was 74.9 years, 21/37 (57%) of participants were female and 33/37 (89%) were white. At the end of the intervention 30/37 (81%) participants completed 8-week assessments. Average class attendance of the intervention arm was 6.7 out of 8. They meditated an average of 4.3 days a week and the average minutes per day was 31.6. Compared to the control group, the intervention group displayed significant improvement in the Chronic Pain Acceptance Questionnaire Total Score and Activities Engagement subscale (P = .008, P = .004) and SF-36 Physical Function (P = .03). An 8-week mindfulness-based meditation program is feasible for older adults with CLBP. The program may lead to improvement in pain acceptance and physical function.

Importance Treatment of chronic low back pain (LBP) in older adults is limited by the adverse effects of analgesics. Effective nonpharmacologic treatment options are needed. Objective To determine the effectiveness of a mind-body program at increasing function and reducing pain in older adults with chronic LBP. Design, Setting, and Participants This single-blind, randomized clinical trial compared a mind-body program (n = 140) with a health education program (n = 142). Community-dwelling older adults residing within the Pittsburgh metropolitan area were recruited from February 14, 2011, to June 30, 2014, with 6-month follow-up completed by April 9, 2015. Eligible participants were 65 years or older with functional limitations owing to their chronic LBP (≥11 points on the Roland and Morris Disability Questionnaire) and chronic pain (duration ≥3 months) of moderate intensity. Data were analyzed from March 1 to July 1, 2015. Interventions The intervention and control groups received an 8-week group program followed by 6 monthly sessions. The intervention was modeled on the Mindfulness-Based Stress Reduction program; the control program, on the “10 Keys” to Healthy Aging. Main Outcomes and Measures Follow-up occurred at program completion and 6 months later. The score on the Roland and Morris Disability Questionnaire was the primary outcome and measured functional limitations owing to LBP. Pain (current, mean, and most severe in the past week) was measured with the Numeric Pain Rating Scale. Secondary outcomes included quality of life, pain self-efficacy, and mindfulness. Intent-to-treat analyses were conducted. Results Of 1160 persons who underwent screening, 282 participants enrolled in the trial (95 men [33.7%] and 187 women [66.3%]; mean [SD] age,74.5 [6.6] years). The baseline mean (SD) Roland and Morris Disability Questionnaire scores for the intervention and control groups were 15.6 (3.0) and 15.4 (3.0), respectively. Compared with the control group, intervention participants improved an additional −1.1 (mean, 12.1 vs 13.1) points at 8 weeks and −0.04 (mean, 12.2 vs 12.6) points at 6 months (effect sizes, −0.23 and −0.08, respectively) on the Roland and Morris Disability Questionnaire. By 6 months, the intervention participants improved on the Numeric Pain Rating Scale current and most severe pain measures an additional −1.8 points (95% CI, −3.1 to −0.05 points; effect size, −0.33) and −1.0 points (95% CI, −2.1 to 0.2 points; effect size, −0.19), respectively. The changes in Numeric Pain Rating Scale mean pain measure after the intervention were not significant (−0.1 [95% CI, −1.1 to 1.0] at 8 weeks and −1.1 [95% CI, −2.2 to −0.01] at 6 months; effect size, −0.01 and −0.22, respectively). Conclusions and Relevance A mind-body program for chronic LBP improved short-term function and long-term current and most severe pain. The functional improvement was not sustained, suggesting that future development of the intervention could focus on durability. Trial Registration clinicaltrials.gov Identifier:NCT01405716

Objective. As part of a series of articles designed to deconstruct chronic low back pain (CLBP) in older adults, this article focuses on maladaptive coping—a significant contributor of psychological distress, increased pain, and heightened disability in older adults with CLBP. Methods. A modified Delphi technique was used to develop a maladaptive coping algorithm and table providing the rationale for the various components of the algorithm. A seven-member content expert panel and a nine-member primary care panel were involved in the iterative development of the materials. While the algorithm was developed keeping in mind resources available within the Veterans Health Administration (VHA) facilities, panelists were not exclusive to the VHA, and therefore, materials can be applied in both VHA and civilian settings. The illustrative clinical case was taken from one of the contributors’ clinical practice. Results. We present a treatment algorithm and supporting table to be used by providers treating older adults who have CLBP and engage in maladaptive coping strategies. A case of an older adult with CLBP and maladaptive coping is provided to illustrate the approach to management. Conclusions. To promote early engagement in skill-focused treatments, providers can routinely evaluate pain coping strategies in older adults with CLBP using a treatment algorithm.

OBJECTIVES: To examine the efficacy of periosteal stimulation therapy (PST, osteopuncture) for the treatment of chronic pain associated with advanced knee osteoarthritis. DESIGN: Randomized, controlled clinical trial. SETTING: Outpatient pain clinic. PARTICIPANTS: Eighty-eight community-dwelling older adults with moderate knee pain or greater for 3 months or longer and Kellgren-Lawrence (K-L) grade 2 through 4 radiographic severity (80% had K-L 4). INTERVENTION: Participants were randomized to receive PST or control PST once a week for 6 weeks. MEASUREMENTS: Pain severity and self-reported function (Western Ontario and McMasters University Osteoarthritis Index (WOMAC)) and physical performance (Short Physical Performance Battery (SPPB)) were assessed at baseline, after the last PSTsession (post), and 3 months later (follow-up). Pain severity was also assessed monthly using the multidimensional pain inventory short form. RESULTS: Pain was reduced significantly more in the PST group than in the control PST group at post (P 5.003; mean WOMAC pain subscale baseline 9.4 vs 6.4) and 1 month later (Po.001), but by 2 months, pain levels had regressed to pre-intervention levels. The group-by-time interaction for the WOMAC function scale was significant at post (P 5.04) but not at follow-up (P 5.63). No significant group differences were found for the SPPB. Neither analgesic use nor global improvement differed between groups. There were four treatment dropouts. CONCLUSION: PST affords short-term modest pain reduction for older adults with advanced knee OA. Future research should test the effectiveness of booster treatments in sustaining analgesic benefits and of combining PST with therapeutic exercise in ameliorating disability risk. JA m Geriatr Soc 55:1541‐1547, 2007.

Pittsburgh, Pennsylvania, USA ABSTRACT Study Design. We conducted a structured review of eight mind-body interventions for older adults with chronic nonmalignant pain. Objectives. To evaluate the feasibility, safety, and evidence for pain reduction in older adults with chronic nonmalignant pain in the following mind-body therapies: biofeedback, progressive muscle relaxation, meditation, guided imagery, hypnosis, tai chi, qi gong, and yoga. Methods. Relevant studies in the MEDLINE, PsycINFO, AMED, and CINAHL databases were located. A manual search of references from retrieved articles was also conducted. Of 381 articles retrieved through search strategies, 20 trials that included older adults with chronic pain were reviewed. Results. Fourteen articles included participants aged 50 years and above, while only two of these focused specifically on persons aged ≥ 65 years. An additional six articles included persons aged ≥ 50 years. Fourteen articles were controlled trials. There is some support for the efficacy of progressive muscle relaxation plus guided imagery for osteoarthritis pain. There is limited support for meditation and tai chi for improving function or coping in older adults with low back pain or osteoarthritis. In an uncontrolled biofeedback trial that stratified by age group, both older and younger adults had significant reductions in pain following the intervention. Several studies included older adults, but did not analyze benefits by age. Tai chi, yoga, hypnosis, and progressive muscle relaxation were significantly associated with pain reduction in these studies. Conclusion. The eight mind-body interventions reviewed are feasible in an older population. They are likely safe, but many of the therapies included modifications tailored for older adults. There is not yet sufficient evidence to conclude that these eight mind-body interventions reduce chronic nonmalignant pain in older adults. Further research should focus on larger, clinical trials of mind- body interventions to answer this question.

The purpose of this study was to report sleep quality from 4 weeks of auricular point acupressure that was designed for chronic low back pain and determine the relationship between pain intensity and sleep quality. Participants were randomized into the APA group (n = 30) or the sham-APA group (n = 31). At baseline assessment, 87% of the participants reported poor sleep quality. Participants who received APA had decreased daytime disturbance and improved global Pittsburgh Sleep Quality Index scores at end of intervention (EOI) and 1-month follow up compared to participants in the sham-APA group. For the APA group, both the sleep duration and wake after sleep onset decreased gradually during the 4-week APA (0.56% and 0.23% daily change, respectively).

Importance Treatment of chronic low back pain (LBP) in older adults is limited by the adverse effects of analgesics. Effective nonpharmacologic treatment options are needed. Objective To determine the effectiveness of a mind-body program at increasing function and reducing pain in older adults with chronic LBP. Design, setting, and participants This single-blind, randomized clinical trial compared a mind-body program (n = 140) with a health education program (n = 142). Community-dwelling older adults residing within the Pittsburgh metropolitan area were recruited from February 14, 2011, to June 30, 2014, with 6-month follow-up completed by April 9, 2015. Eligible participants were 65 years or older with functional limitations owing to their chronic LBP (≥ 11 points on the Roland and Morris Disability Questionnaire) and chronic pain (duration ≥ 3 months) of moderate intensity. Data were analyzed from March 1 to July 1, 2015. Interventions The intervention and control groups received an 8-week group program followed by 6 monthly sessions. The intervention was modeled on the Mindfulness-Based Stress Reduction program; the control program, on the ”10 Keys” to Healthy Aging. Main outcomes and measures Follow-up occurred at program completion and 6 months later. The score on the Roland and Morris Disability Questionnaire was the primary outcome and measured functional limitations owing to LBP. Pain (current, mean, and most severe in the past week) was measured with the Numeric Pain Rating Scale. Secondary outcomes included quality of life, pain self-efficacy, and mindfulness. Intent-to-treat analyses were conducted. Results Of 1160 persons who underwent screening, 282 participants enrolled in the trial (95 men [33.7%] and 187 women [66.3%]; mean [SD] age, 74.5 [6.6] years). The baseline mean (SD) Roland and Morris Disability Questionnaire scores for the intervention and control groups were 15.6 (3.0) and 15.4 (3.0), respectively. Compared with the control group, intervention participants improved an additional –1.1 (mean, 12.1 vs 13.1) points at 8 weeks and –0.04 (mean, 12.2 vs 12.6) points at 6 months (effect sizes, –0.23 and –0.08, respectively) on the Roland and Morris Disability Questionnaire. By 6 months, the intervention participants improved on the Numeric Pain Rating Scale current and most severe pain measures an additional –1.8 points (95% CI, –3.1 to –0.05 points; effect size, –0.33) and –1.0 points (95% CI, –2.1 to 0.2 points; effect size, –0.19), respectively. The changes in Numeric Pain Rating Scale mean pain measure after the intervention were not significant (–0.1 [95% CI, –1.1 to 1.0] at 8 weeks and –1.1 [95% CI, –2.2 to –0.01] at 6 months; effect size, –0.01 and –0.22, respectively). Conclusions and relevance A mind-body program for chronic LBP improved short-term function and long-term current and most severe pain. The functional improvement was not sustained, suggesting that future development of the intervention could focus on durability.