[Evidence-based interventions to treat chronic low back pain: treatment selection for a personalized medicine approach : German version]. / Evidenzbasierte Interventionen zur Behandlung von chronischem Schmerz im unteren Rücken ­ Therapieauswahl für einen personalisierten Behandlungsansatz : Deutsche Fassung.

INTRODUCTION: Chronic low back pain (cLBP) is highly prevalent in the United States and globally, resulting in functional impairment and lowered quality of life. While many treatments are available for cLBP, clinicians have little information about which specific treatment(s) will work best for individual patients or subgroups of patients. The Back Pain Research Consortium, part of the National Institutes of Health Helping to End Addiction Long-termSM (HEAL) Initiative, will conduct a collaborative clinical trial, which seeks to develop a personalized medicine algorithm to optimize patient and provider treatment selection for patients with cLBP. OBJECTIVE: The primary objective of this article is to provide an update on evidence-based cLBP interventions and describe the process of reviewing and selecting interventions for inclusion in the clinical trial. METHODS: A working group of cLBP experts reviewed and selected interventions for inclusion in the clinical trial. The primary evaluation measures were strength of evidence and magnitude of treatment effect. When available in the literature, duration of effect, onset time, carryover effect, multimodal efficacy, responder subgroups, and evidence for the mechanism of treatment effect or biomarkers were considered. CONCLUSION: The working group selected 4 leading, evidence-based treatments for cLBP to be tested in the clinical trial and for use in routine clinical treatment. These treatments include (1) duloxetine, (2) acceptance and commitment therapy, (3) a classification-based exercise and manual therapy intervention, and (4) a self-management approach. These interventions each had a moderate to high level of evidence to support a therapeutic effect and were from different therapeutic classes.

Biobehavioral Assessments in BACPAC: Recommendations, Rationale, and Methods.

The Biobehavioral Working Group of BACPAC was charged to evaluate a range of psychosocial, psychophysical, and behavioral domains relevant to chronic low back pain, and recommend specific assessment tools and procedures to harmonize biobehavioral data collection across the consortium. Primary references and sources for measure selection were the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials, the Minimum Data Set from the National Institutes of Health (NIH) Research Task Force on Standards for Chronic Low Back Pain, the Patient-Reported Outcomes Measurement Information System, and NeuroQOL. The questionnaire's recommendations supplemented the NIH HEAL Common Data Elements and BACPAC Minimum Data Set. Five domains were identified for inclusion: Pain Characteristics and Qualities; Pain-Related Psychosocial/Behavioral Factors; General Psychosocial Factors; Lifestyle Choices; and Social Determinants of Health/Social Factors. The Working Group identified best practices for required and optional Quantitative Sensory Testing of psychophysical pain processing for use in BACPAC projects.

Theoretical Schemas to Guide Back Pain Consortium (BACPAC) Chronic Low Back Pain Clinical Research.

BACKGROUND: Chronic low back pain (cLBP) is a complex with a heterogenous clinical presentation. A better understanding of the factors that contribute to cLBP is needed for accurate diagnosis, optimal treatment, and identification of mechanistic targets for new therapies. The Back Pain Consortium (BACPAC) Research Program provides a unique opportunity in this regard, as it will generate large clinical datasets, including a diverse set of harmonized measurements. The Theoretical Model Working Group was established to guide BACPAC research and to organize new knowledge within a mechanistic framework. This article summarizes the initial work of the Theoretical Model Working Group. It includes a three-stage integration of expert opinion and an umbrella literature review of factors that affect cLBP severity and chronicity. METHODS: During Stage 1, experts from across BACPAC established a taxonomy for risk and prognostic factors (RPFs) and preliminary graphical depictions. During Stage 2, a separate team conducted a literature review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to establish working definitions, associated data elements, and overall strength of evidence for identified RPFs. These were subsequently integrated with expert opinion during Stage 3. RESULTS: The majority (∼80%) of RPFs had little strength-of-evidence confidence, whereas seven factors had substantial confidence for either a positive association with cLBP (pain-related anxiety, serum C-reactive protein, diabetes, and anticipatory/compensatory postural adjustments) or no association with cLBP (serum interleukin 1-beta / interleukin 6, transversus muscle morphology/activity, and quantitative sensory testing). CONCLUSION: This theoretical perspective will evolve over time as BACPAC investigators link empirical results to theory, challenge current ideas of the biopsychosocial model, and use a systems approach to develop tools and algorithms that disentangle the dynamic interactions among cLBP factors.

CAPER: patient preferences to inform nonsurgical treatment of chronic low back pain: a discrete-choice experiment.

OBJECTIVE: We developed and used a discrete-choice measure to study patient preferences with regard to the risks and benefits of nonsurgical treatments when they are making treatment selections for chronic low back pain. METHODS: "CAPER TREATMENT" (Leslie Wilson) was developed with standard choice-based conjoint procedures (discrete-choice methodology that mimics an individual's decision-making process). After expert input and pilot testing, our final measure had 7 attributes (chance of pain relief, duration of relief, physical activity changes, treatment method, treatment type, treatment time burden, and risks of treatment) with 3-4 levels each. Using Sawtooth software (Sawtooth Software, Inc., Provo, UT, USA), we created a random, full-profile, balanced-overlap experimental design. Respondents (n = 211) were recruited via an emailed online link and completed 14 choice-based conjoint choice pairs; 2 fixed questions; and demographic, clinical, and quality-of-life questions. Analysis was performed with random-parameters multinomial logit with 1000 Halton draws. RESULTS: Patients cared most about the chance of pain relief, followed closely by improving physical activity, even more than duration of pain relief. There was comparatively less concern about time commitment and risks. Gender and socioeconomic status influenced preferences, especially with relation to strength of expectations for outcomes. Patients experiencing a low level of pain (Pain, Enjoyment, and General Activity Scale [PEG], question 1, numeric rating scale score<4) had a stronger desire for maximally improved physical activity, whereas those in a high level of pain (PEG, question 1, numeric rating scale score>6) preferred both maximum and more limited activity. Highly disabled patients (Oswestry Disability Index score>40) demonstrated distinctly different preferences, placing more weight on achieving pain control and less on improving physical activity. CONCLUSIONS: Individuals with chronic low back pain were willing to trade risks and inconveniences for better pain control and physical activity. Additionally, different preference phenotypes exist, which suggests a need for clinicians to target treatments to particular patients.

The Back Pain Consortium (BACPAC) Research Program Data Harmonization: Rationale for Data Elements and Standards.

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

Capnometric feedback training decreases 24-h blood pressure in hypertensive postmenopausal women.

BACKGROUND: High normal resting pCO2 is a risk factor for salt sensitivity of blood pressure (BP) in normotensive humans and has been associated with higher resting systolic BP in postmenopausal women. To date, however, no known studies have investigated the effects of regular practice of voluntary mild hypocapnic breathing on BP in hypertensive patients. The objective of the present research was to test the hypothesis that capnometric feedback training can decrease both resting pCO2 and 24-h BP in a series of mildly hypertensive postmenopausal women. METHODS: A small portable end tidal CO2 (etCO2) monitor was constructed and equipped with software that determined the difference between the momentary etCO2 and a pre-programmed criterion range. The monitor enabled auditory feedback for variations in CO2 outside the criterion range. 16 mildly hypertensive postmenopausal women were individually trained to sustain small decreases in etCO2 during six weekly sessions in the clinic and daily sessions at home. 24-h BP monitoring was conducted before and after the intervention, and in 16 prehypertensive postmenopausal women in a control group who did not engage in the capnometric training. RESULTS: Following the intervention, all 16 capnometric training participants showed decreases in resting etCO2 (- 4.3 ± 0.4 mmHg; p < .01) while 15 showed decreases in 24-h systolic BP (- 7.6 ± 2.0 mmHg; p < .01). No significant changes in either measure was observed in the control group. In addition, nighttime (- 9.5 ± 2.6; p < .01) and daytime (- 6.7 ± 0.2 mmHg) systolic BP were both decreased following capnometric training, while no significant changes in nighttime (- 2.8 ± 2.2 mmHg; p = .11) or daytime (- 0.7 ± 1.0 mmHg; p ≤ .247) systolic BP were observed in the control group. CONCLUSIONS: These findings support the hypothesis that regular practice of mild hypocapnic breathing that decreases resting etCO2 reliably decreases 24-h blood pressure in hypertensive postmenopausal women. The extent to which these effects persist beyond the training period or can be observed in other hypertensive subgroups remains to be investigated.

Exploring the Multidimensional Assessment of Interoceptive Awareness in youth aged 7-17 years.

OBJECTIVE: This study aimed to adapt the Multidimensional Assessment of Interoceptive Awareness (MAIA) questionnaire for younger respondents. METHOD: The language of the MAIA was revised and children aged 7-10 years (n = 212) and adolescents aged 11-17 years (n = 217) completed the questionnaire. RESULTS: The original eight-factor model was tested for fit using confirmatory factor analysis. The model had an acceptable fit in the total sample and younger subsample and overall fit in the older subsample was adequate following modification. Internal consistency was good, except for the Noticing, Not-Distracting and Not-Worrying scales. Results also demonstrated a negative linear relationship between the trusting scale and age, suggesting that youths may lose trust in their body as they age. CONCLUSION: The adapted MAIA can be used with a younger population and, depending on the research question, individual MAIA scales may be selected. The survey is available at https://osher.ucsf.edu/maia.

Exercise treatment effect modifiers in persistent low back pain: an individual participant data meta-analysis of 3514 participants from 27 randomised controlled trials.

BACKGROUND: Low back pain is one of the leading causes of disability worldwide. Exercise therapy is widely recommended to treat persistent non-specific low back pain. While evidence suggests exercise is, on average, moderately effective, there remains uncertainty about which individuals might benefit the most from exercise. METHODS: In parallel with a Cochrane review update, we requested individual participant data (IPD) from high-quality randomised clinical trials of adults with our two primary outcomes of interest, pain and functional limitations, and calculated global recovery. We compiled a master data set including baseline participant characteristics, exercise and comparison characteristics, and outcomes at short-term, moderate-term and long-term follow-up. We conducted descriptive analyses and one-stage IPD meta-analysis using multilevel mixed-effects regression of the overall treatment effect and prespecified potential treatment effect modifiers. RESULTS: We received IPD for 27 trials (3514 participants). For studies included in this analysis, compared with no treatment/usual care, exercise therapy on average reduced pain (mean effect/100 (95% CI) -10.7 (-14.1 to -7.4)), a result compatible with a clinically important 20% smallest worthwhile effect. Exercise therapy reduced functional limitations with a clinically important 23% improvement (mean effect/100 (95% CI) -10.2 (-13.2 to -7.3)) at short-term follow-up. Not having heavy physical demands at work and medication use for low back pain were potential treatment effect modifiers-these were associated with superior exercise outcomes relative to non-exercise comparisons. Lower body mass index was also associated with better outcomes in exercise compared with no treatment/usual care. This study was limited by inconsistent availability and measurement of participant characteristics. CONCLUSIONS: This study provides potentially useful information to help treat patients and design future studies of exercise interventions that are better matched to specific subgroups. PROTOCOL PUBLICATION: https://doi.org/10.1186/2046-4053-1-64.

An integrative group movement program for people with dementia and care partners together (Paired PLIÉ): initial process evaluation.

Objectives: To understand feedback from participants in Paired PLIÉ (Preventing Loss of Independence through Exercise), a novel, integrative group movement program for people with dementia and their care partners, in order to refine the intervention and study procedures.Method: Data sources included daily logs from the first Paired PLIÉ RCT group, final reflections from the second Paired PLIÉ RCT group, and responses to requests for feedback and letters of support from Paired PLIÉ community class participants. All data are reports from care partners. The qualitative coding process was iterative and conducted with a multidisciplinary team. The coding team began with a previously established framework that was modified and expanded to reflect emerging themes. Regular team meetings were held to confirm validity and to reach consensus around the coding system as it was developed and applied. Reliability was checked by having a second team member apply the coding system to a subset of the data.Results: Key themes that emerged included care partner-reported improvements in physical functioning, cognitive functioning, social/emotional functioning, and relationship quality that were attributed to participation in Paired PLIÉ. Opportunities to improve the intervention and reduce study burden were identified. Care partners who transitioned to the community class after participating in the Paired PLIÉ study reported ongoing benefits.Conclusion: These qualitative results show that people with dementia and their care partners can participate in and benefit from community-based programs like Paired PLIÉ that include both partners, and focus on building skills to maintain function and quality of life.

Postural awareness and its relation to pain: validation of an innovative instrument measuring awareness of body posture in patients with chronic pain.

BACKGROUND: Habitual postural patterns are associated with musculoskeletal pain, and improving a maladaptive posture requires postural awareness in order to lead to clinical improvements. This study aimed to develop and evaluate the psychometric properties of an innovative postural awareness scale. METHODS: A 12-item Postural Awareness Scale (PAS) was developed and administered to 512 chronic pain patients (50.3 ± 11.4 years, 91.6% female, 37.1% spinal/shoulder pain) to assess its factor structure and reliability. To determine convergent validity, measures of body awareness, body responsiveness, body image, and mindfulness were correlated with the PAS, as were clinical measures of pain intensity, disability, and mental health. Sensitivity to change was assessed in 202 outpatients participating in a 10-week multimodal mind-body program. RESULTS: Factor analysis revealed two factors (Ease/Familiarity with Postural Awareness and Need for Attention Regulation with Postural Awareness) that explained 50.8% of the variance. Cronbach's alpha for the complete scale was 0.80; Spearman-Brown coefficient of split-half reliability was 0.67; and intra-class correlation was ICC2,1 = 0.75 (95% confidence interval = 0.71, 0.78). Significant positive correlations were found for body awareness (r = 0.23), body responsiveness (r = 0.41), body image (r = 0.22-0.32), and mindfulness (r = 0.38); negative correlations for pain intensity (r = - 0.14), disability (r = - 0.12), depression (r = - 0.23), and stress (r = - 0.29). Postural awareness scores increased with a mind-body program (p < 0.001); changes in the PAS were negatively correlated with changes in pain intensity (r = - 0.35) in patients with spinal/shoulder pain. CONCLUSION: Self-reported postural awareness is associated with clinical symptoms in chronic pain patients; improvements in postural awareness are longitudinally associated with reduced pain in patients with spinal/shoulder pain.

A 12-week integrative exercise program improves self-reported mindfulness and interoceptive awareness in war veterans with posttraumatic stress symptoms.

OBJECTIVE: Innovative approaches to the treatment of war-related posttraumatic stress disorder (PTSD) are needed. We report on secondary psychological outcomes of a randomized controlled trial of integrative exercise (IE) using aerobic and resistance exercise with mindfulness-based principles and yoga. We expected-in parallel to observed improvements in PTSD intensity and quality of life-improvements in mindfulness, interoceptive bodily awareness, and positive states of mind. METHOD: A total of 47 war veterans with PTSD were randomized to 12-week IE versus waitlist. Changes in mindfulness, interoceptive awareness, and states of mind were assessed by self-report standard measures. RESULTS: Large effect sizes for the intervention were observed on Five-Facet Mindfulness Questionnaire Non-Reactivity (d = .85), Multidimensional Assessment of Interoceptive Awareness Body Listening (d = .80), and Self-Regulation (d = 1.05). CONCLUSION: In a randomized controlled trial of a 12-week IE program for war veterans with PTSD, we saw significant improvements in mindfulness, interoceptive bodily awareness, and positive states of mind compared to a waitlist.

Preventing Loss of Independence through Exercise (PLIÉ): qualitative analysis of a clinical trial in older adults with dementia.

OBJECTIVES: Preventing Loss of Independence through Exercise (PLIÉ) is a novel, integrative exercise program for individuals with dementia that combines elements of different conventional and complementary exercise modalities (e.g. tai-chi, yoga, Feldenkrais, and dance movement therapy) and focuses on training procedural memory for basic functional movements (e.g., sit-to-stand) while increasing mindful body awareness and facilitating social connection. This study presents analyses of qualitative data collected during a 36-week cross-over pilot clinical trial in 11 individuals. METHODS: Qualitative data included exercise instructors' written notes, which were prepared after each class and also following biweekly telephone calls with caregivers and monthly home visits; three video-recorded classes; and written summaries prepared by research assistants following pre- and post-intervention quantitative assessments. Data were extracted for each study participant and placed onto a timeline for month of observation. Data were coded and analyzed to identify themes that were confirmed and refined through an iterative, collaborative process by the entire team including a qualitative researcher (SA) and the exercise instructors. RESULTS: Three overarching themes emerged: (1) Functional changes included increasing body awareness, movement memory and functional skill. (2) Emotional changes included greater acceptance of resting, sharing of personal stories and feelings, and positive attitude toward exercise. (3) Social changes included more coherent social interactions and making friends. CONCLUSIONS: These qualitative results suggest that the PLIÉ program may be associated with beneficial functional, emotional, and social changes for individuals with mild to moderate dementia. Further study of the PLIÉ program in individuals with dementia is warranted.

Training in ChiRunning to reduce blood pressure: a randomized controlled pilot study.

BACKGROUND: People with prehypertension (120-130/80-90 mmHg) are at increased risk of progressing to hypertension. Recommendations for prehypertension include engaging in regular physical activity. We aimed to assess feasibility and acceptability and collect preliminary outcome data on ChiRunning for people with elevated blood pressure. ChiRunning is a commercially available running program based on the mindful movements of Tai Chi, which is aimed at decreasing injury by both increasing body awareness and modifying running form. METHODS: We enrolled adults with elevated systolic (130-150 mmHg) or diastolic (80-100 mmHg) blood pressure in a 12-week pilot trial. Participants were randomized 2:1:1 to 8 weeks of: 1) intervention-a trainer-led ChiRunning group (n = 10); 2) active control-a trainer-led running group (n = 6); or 3) educational control-a self-directed running group (n = 6) and followed for 4 more weeks. The active control and educational control groups were combined for analysis. RESULTS: This study was feasible, meeting recruitment, retention and adherence goals, and acceptable to participants. Systolic and diastolic blood pressure did not change significantly over the study for either the ChiRunning or control groups. Changes in BMI over time were significantly different from zero in the ChiRunning group (p = 0.04) but not in the control group (slope for ChiRunning -0.05 [-0.1 to -0.002] vs. control -0.01 [-0.06 to 0.04], between slope difference, p = 0.22). Self-reported running-related injury (i.e. discomfort leading to a decrease in running) was similar between groups (ChiRunning, 4 [1.2 to 8.4] vs. control, 3 [0.7 to 7.1] injuries per 100 h of running, p = 0.72) although self-reported running-related discomfort (i.e. discomfort that does not lead to changes in running) trended higher in the ChiRunning group (ChiRunning, 10 [5.4 to 16.8] vs. control, 4 [1.5 to 9] reports of discomfort per 100 h of running, p = 0.06). CONCLUSION: ChiRunning appears to be a feasible and acceptable exercise program for people with elevated blood pressure. We did not find that ChiRunning had a significant impact on blood pressure or self reported injury, but did see a positive change in BMI over time. ChiRunning warrants further investigation in a larger trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01587183.

Interoceptive bodily awareness in patients seeking pain relief with osteopathic manipulative treatment: an observational cohort pilot study.

CONTEXT: Interoceptive bodily awareness (IBA) is one's attentional focus on and relationship with comfortable and uncomfortable (e.g., pain) internal body sensations. Integrating IBA into research on osteopathic manipulative treatment (OMT) is growing, both as an outcome and predictor of treatment outcomes; however, it has yet to be studied in a clinical setting. OBJECTIVES: We aimed to conduct a pilot study to measure IBA, with the Multidimensional Assessment of Interoceptive Awareness (MAIA), in patients seeking OMT for pain, and to test if OMT exposure may be associated with higher IBA as measured by the MAIA. The primary outcome was the change in MAIA scores, and the secondary outcomes were reduction in pain intensity, reduction in pain interference, and increase in participants' perception of change post-OMT. METHODS: A convenience sample was recruited from individuals presenting for OMT appointments at a College of Osteopathic Medicine OMT teaching clinic. Participants were recruited into our single-arm observational cohort study (n=36), and categorized into one of two groups, OMT-naïve (n=19) or OMT-experienced (n=17), based on prior exposure to OMT. We measured MAIA scores and clinical pain-related outcomes prior to, immediately after, and at 1 and 3 weeks after a usual-care OMT session in the clinic. Covariates including experience with mind-body activities, non-OMT body work, and physical and emotional trauma were also collected to explore potential relationships. We utilized t tests to compare MAIA scores and pain outcomes between groups and across time points. Stepwise regression models were utilized to explore potential relationships with covariates. RESULTS: The OMT-experienced group scored higher on the MAIA scales "Not-worrying" (p=0.002) and "Trusting" (p=0.028) at baseline. There were no significant changes in the MAIA scores before and after the single OMT session. Analysis of secondary outcomes revealed that all pain outcomes significantly decreased post-OMT (p<0.05), with the largest relative improvements in the acute pain and OMT-naïve subgroups, with diminishing effects over time. CONCLUSIONS: Assessing IBA with MAIA in a clinical OMT setting is feasible. There were significant positive correlations between OMT exposure and two of the eight MAIA scales. Future studies are justified to further explore this relationship.

Livestream, group movement program for people living with cognitive impairment and care partners: A randomized clinical trial.

INTRODUCTION: There are few widely-available, evidence-based options to support quality of life (QOL) for people living with Alzheimer's disease and related dementias. METHODS: We performed a randomized, controlled trial with a Waitlist control group to determine whether an online, livestream, mind-body, group movement program (Moving Together, 1 hour, 2 days/week, 12 weeks) improves QOL in people with cognitive impairment (PWCI) or care partners (CPs) and explore mechanisms of action. The primary outcome for both participants was self-reported QOL. Secondary outcomes and potential mediators included mobility, isolation, well-being, cognitive function, and sleep in PWCI and burden, positive emotions, caregiver self-efficacy, stress management, and sleep in CPs. Blinded assessors collected outcome data at baseline, 12, and 24 weeks. We assessed adverse events including falls through monthly check-in surveys and collected qualitative data through evaluation surveys. Intention-to-treat analyses used linear mixed models to compare mean change over time between groups and calculated standardized effect sizes (ESs). RESULTS: Ninety-seven dyads enrolled (PWCI: age 76 ± 11 years, 43% female, 80% non-Hispanic White; CPs: age 66 ± 12 years, 78% female, 71% non-Hispanic White); 15% withdrew before 12 weeks and 22% before 24 weeks. PWCI self-reported significantly better QOL from baseline to 12 weeks in the Moving Together group compared to the Waitlist group (ES = 0.474, p = 0.048) and CPs self-reported improved ability to manage stress (ES = 0.484, p = 0.021). Improvements in participant self-reported QOL were mediated by improvements in their self-reported well-being and CP-reported ability to manage stress. Results were similar when the Waitlist group participated in the program (QOL ES = 0.663, p = 0.006; stress management ES = 0.742, p = 0.002) and were supported by qualitative data. Exploratory analyses suggested possible fall reduction in PWCI. There were no study-related serious adverse events. DISCUSSION: Online programs such as Moving Together offer a scalable strategy for supporting high QOL for PWCI and helping CPs manage stress. TRIAL REGISTRATION: ClinicalTrials.gov NCT04621448. Highlights: The approval of new medications that slow cognitive decline in people living with Alzheimer's disease and related disorders (ADRD) has raised hope and excitement. However, these medications do not appear to impact quality of life, which is often considered by patients and care partners to be the most important outcome.In this randomized clinical trial, we found that an evidence-based, online, livestream, mind-body, group movement program significantly and meaningfully improves self-rated quality of life in people with ADRD and helps care partners manage stress. Mediation analyses revealed that the key drivers of improvements in participants' quality of life were improvements in their feelings of well-being and care partners' ability to manage stress. Exploratory analyses also suggested a 30% reduction in falls.These results are important because they suggest that an online program, which is available now and can be performed by people from the comfort of home or other location of choice, could be recommended as a complement or alternative to new therapies to help maximize quality of life for people living with ADRD and their care partners.

Design of the COMEBACK and BACKHOME Studies, Longitudinal Cohorts for Comprehensive Deep Phenotyping of Adults with Chronic Low-Back Pain (cLBP): a part of the BACPAC Research Program.

Objective: The University of California, San Francisco (UCSF) Core Center for Patient-centric, Mechanistic Phenotyping in Chronic Low Back Pain (REACH) is one of the three NIH Back Pain Consortium (BACPAC) Research Programs Mechanistic Research Centers (MRCs). The goal of UCSF REACH is to define cLBP phenotypes and pain mechanisms that can lead to effective, personalized treatments for patients across the population. The primary objective of this research project is to address the critical need for new diagnostic and prognostic markers, and associated patient classification protocols for chronic low back pain (cLBP) treatment. Design: To meet this objective, REACH is conducting two large investigator-initiated translational research cohort studies called: The Longitudinal Clinical Cohort for Comprehensive Deep Phenotyping of Chronic Low-Back Pain (cLBP) Adults Study (comeBACK) and the Chronic Low-Back Pain (cLBP) in Adults Study (BACKHOME). Setting: comeBACK is a longitudinal multicenter in-person observational study of 450 adults with chronic low back pain designed to perform comprehensive deep phenotyping. While, the BACKHOME study is a site-less longitudinal observational e-cohort of approximately 3000 U.S. adults with cLBP. To our knowledge, BACKHOME is the largest prospective remote registry of nationwide adults with cLBP. Methods: Both the comeBACK and BACKHOME studies are collecting a robust and comprehensive set of risk factors, outcomes, and covariates in order to perform deep phenotyping of cLBP patients based on combined biopsychosocial variables to: define cLBP subtypes, establish phenotyping tools for routine clinical evaluation, and lead to improved cLBP outcomes in the future. The data from both studies will be used to establish techniques to develop a patient-centric definition of treatment success and to analyze cLBP patient traits to define clinically useful cLBP phenotypes, using a combination of traditional data analyses and deep learning methods. Conclusions: These 2 pivotal studies, in conjunction with the ancillary studies being performed in both comeBACK and BACKHOME, and the other BACPAC-consortium research projects, we will be able to address a number of diagnostic and therapeutic issues in this complex and diverse patient population with cLBP. These studies will help clarify biopsychosocial mechanisms of cLBP with the aim to provide a foundation to improve the evaluation of treatment effectiveness and to spur new avenues of therapeutic research, including personalized outcome measures that constitute a clinically meaningful treatment effect for individual cLBP patients.

Adaptation of an In-Person Mind-Body Movement Program for People with Cognitive Impairment or Dementia and Care Partners for Online Delivery: Feasibility, Satisfaction and Participant-Reported Outcomes.

Background: Preventing Loss of Independence through Exercise (PLIÉ) is an in-person group mind-body movement program for people across the spectrum of cognitive decline and care partners (CPs). Objective: This study developed and refined an online version called Moving Together and tested feasibility and satisfaction with an online delivery. Methods: In Phase 1, we used qualitative methods to determine which elements of the in-person program were essential to retain for the online version and adaptations that would be needed to support the user experience. In Phase 2, we created a prototype of the online program and iteratively refined it based on user feedback. In Phase 3, we assessed feasibility of online delivery based on class attendance and program completion; we assessed satisfaction and participant-reported outcomes using a post-program evaluation survey with quantitative and qualitative components. Results: Phase 1 findings from 27 participants (14 PLWD, 13 CPs) revealed three key considerations related to online delivery of PLIÉ: technology use, social connection as a primary motivator, and physical safety concerns. Phase 2 iterative testing among 25 participants (14 PLWD, 11 CPs) resulted in key refinements to program delivery and instructional elements; Phase 3 pilot testing included 39 participants (12 PLWD, 15 CPs, 12 MCI) who attended 75 ± 29% of 24 classes; 77% completed the 12-week program, of whom 96% rated it as excellent or good. Participant-reported outcomes included improvements in social connection, emotional well-being, physical function, cognitive function and present-centered body awareness. PLWD or MCI also reported improvements in self-concept, and CPs reported improvements in caregiving self-efficacy. The primary challenges were related to participant navigation of technology. Conclusion: The Moving Together online program is feasible for PLWD or MCI and CPs with participants reporting high satisfaction and positive outcomes across multiple domains. Providing individual technology support is critical for the success of livestreamed, online interventions for dementia.

Hematopoietic cell transplant and use of massage for improved symptom management: results from a pilot randomized control trial.

Background. Pediatric hematopoietic cell transplant (HCT) is a lifesaving treatment that often results in physical and psychological discomfort. An acupressure-massage intervention may improve symptom management in this setting. Methods. This randomized controlled pilot trial compared a combined massage-acupressure intervention to usual care. Children were offered three practitioner-provided sessions per week throughout hospitalization. Parents were trained to provide additional acupressure as needed. Symptoms were assessed using nurses' reports and two questionnaires, the behavioral affective and somatic experiences scale and the Peds quality of life cancer module. Results. We enrolled 23 children, ages 5 to 18. Children receiving the intervention reported fewer days of mucositis (Hedges' g effect size ES = 0.63), lower overall symptom burden (ES = 0.26), feeling less tired and run-down (ES = 0.86), having fewer moderate/severe symptoms of pain, nausea, and fatigue (ES = 0.62), and less pain (ES = 0.42). The intervention group showed trends toward increasing contentness/serenity (ES = +0.50) and decreasing depression (ES = -0.45), but not decreased anxiety (ES = +0.42). Differences were not statistically significant. Discussion. Feasibility of studying massage-acupressure was established in children undergoing HCT. Larger studies are needed to test the efficacy of such interventions in reducing HCT-associated symptoms in children.

Massage for children undergoing hematopoietic cell transplantation: a qualitative report.

Background. No in-depth qualitative research exists about the effects of therapeutic massage with children hospitalized to undergo hematopoietic cell transplantation (HCT). The objective of this study is to describe parent caregivers' experience of the effects of massage/acupressure for their children undergoing HCT. Methods. We conducted a qualitative analysis of open-ended interviews with 15 parents of children in the intervention arm of a massage/acupressure trial. Children received both practitioner and parent-provided massage/acupressure. Results. Parents reported that their child experienced relief from pain and nausea, relaxation, and greater ease falling asleep. They also reported increased caregiver competence and closeness with their child as a result of learning and performing massage/acupressure. Parents supported a semistandardized massage protocol. Conclusion. Massage/acupressure may support symptom relief and promote relaxation and sleep among pediatric HCT patients if administered with attention to individual patients' needs and hospital routines and may relieve stress among parents, improve caregiver competence, and enhance the sense of connection between parent and child.

Yoga for firefighters: Evaluation of a quality improvement program in California fire departments.

BACKGROUND: Firefighters experience high levels of physical and mental challenges. Yoga interventions have suggested benefits for firefighters. METHODS: This study reports results from a quality improvement assessment at fire departments with a 10-class yoga program. Main outcome is the total score on the Functional Movement Scale (FMS), an observer-based objective performance measure. A score of at least 14 [range 0-20] is considered as protective against injury. Secondary outcome is the score on the Multidimensional Assessment of Interoceptive Awareness (MAIA) questionnaire, a self-report measure for interoceptive bodily awareness as a parameter for a mechanism of action with yoga. We used descriptive statistics and regression analyses. RESULTS: Both total FMS and MAIA scores improved statistically significantly. The strongest performance improvement was seen in trunk stability. The mean FMS score improved from below 14 to 14 and higher indicating a decrease in the risk for injury. Changes in FMS and MAIA did not appear to be correlated. DISCUSSION: Despite the limitation of the study design, the findings support the potential benefits from a yoga program for firefighters.