Multisite musculoskeletal pain is highly prevalent and negatively impacts physical function through several potential mechanisms. However, it remains unclear how the number of affected pain regions relates to function. This study explored associations between different aspects of pain (global pain intensity, catastrophizing, kinesiophobia, pain interference) and physical function in individuals with multisite pain. This cross-sectional analysis included 101 participants aged 18–85 years. Multisite pain was assessed across eight anatomic regions, using binary questions, with scores based on total affected sites. A composite function score was derived via principal component analysis from self-reported physical function, objective gait speed, and clinician-assessed dynamic balance. Hierarchical multivariable linear regression models examined the associations between number of pain regions and composite function, adjusting for age, sex and BMI, with sequential addition of global pain intensity, catastrophizing, kinesiophobia, and pain interference. Participants (aged 40 ± 17.6; 69
BACKGROUND AND OBJECTIVES:Chronic pain in older adults affects mobility, cognition, and social isolation. Episodic medical visits often struggle to address the complexity of chronic pain. Group medical visits combine clinical care with group education and peer support, addressing limitations of one-on-one care. This systematic review and meta-analysis evaluated group medical visit's effectiveness for chronic pain management in older adults. RESEARCH DESIGN AND METHODS:A systematic literature search was conducted in June 2025 for studies evaluating group medical visits in adults aged ≥60 with chronic pain. The review included randomized controlled trials, nonrandomized trials, and single-arm studies. The primary outcome was pain intensity. Random-effects meta-analyses examined within-group (pre-post) and between-group (group medical visits vs control) effects. RESULTS:10 studies (n = 1,255 participants) were included, comprising 7 randomized controlled trials, 2 single-arm interventional studies, and 1 nonrandomized controlled trial. The meta-analysis of within-group changes for those receiving group medical visits demonstrated a significant but moderate reduction in pain from baseline to post-intervention (Hedges' g = -0.54, 95% CI: -0.82 to -0.26, p < .001). The between-group meta-analysis of randomized trials also showed a significant, although smaller, effect favoring group medical visits over control conditions (Hedges' g = -0.24, 95% CI: -0.44 to -0.05, p = .01). DISCUSSION AND IMPLICATIONS:Pain intensity improved in older adults enrolled in group medical visits. Although the magnitude of effect is modest when compared to control conditions, findings suggest that group medical visits may be a successful model of care. Future research should focus on identifying characteristics of group medical visits that contribute most to improved outcomes.
Objectives:Despite the dramatic growth in the number of clinical trials of meditation and/or mindfulness-based interventions (MMBIs), most trials focus on self-reported or psychological outcomes, less is known about the potential neuroplastic effects of MMBI practice and benefits for brain health. In this review, we aimed to map the extent and nature of existing research on this topic, identify subdomains, and determine the feasibility of conducting further systematic reviews. Methods:We conducted a bibliometric scoping review and summarized characteristics of randomized controlled trials (RCTs) with electroencephalography (EEG)-based measures for MMBIs, including publication year, country, participant characteristics, sample size, trial arms, intervention duration and components, EEG experimental design, and reported EEG-based outcomes. Results:From 3401 retrieved publications through a systematic search, we identified 142 eligible publications from 31 countries. More than half (54.6%) were published in the past five years. Ninety studies (63.4%) included healthy participants. Clinical conditions varied, but the majority included psychiatric/mental disorders, followed by pain or substance use, neurological disorders, sleep disturbances or insomnia, cancer/tumor, and age-related cognitive decline. Most studies focused on cognitive function/performance, memory/learning, executive function, attention/vigilance, sensory/perception, emotional/affective, or distress/stress. The two main types of EEG assessments were spectral analysis and measures from event-related potential. Conclusions:Despite the large number of RCTs on MMBIs with EEG outcomes, our synthesis shows significant heterogeneity in study populations, research aims, experimental designs, performed tasks, and reported outcomes. Further systematic reviews and meta-analyses will require accumulation of additional original studies to allow a meaningful focus on specific topics with sufficient amount of evidence. Future research examining neuroplastic effects of MMBI practice utilizing objective physiological EEG-based measures are warranted and encouraged to advance the mind-body field.
Background Persistent post-surgical pain, a chronic pain syndrome with few effective treatments, has spiked in recent years due to the increase in life expectancy and the number of surgical procedures performed. Studies have shown that non-pharmacological interventions, such as yoga, may help manage chronic pain, reducing pain severity and interference. Despite emerging evidence of the efficacy of yoga in managing chronic pain symptoms, rigorous studies evaluating its use in patients with persistent post-surgical pain have not been conducted. This study describes protocols used in Persistent Relief, an ongoing pilot randomized controlled trial comparing yoga to chronic pain health education. Results from a modified Delphi validation process used to adapt a yoga program for chronic low back pain to the unique needs of this patient population are also included. Methods/Design Fifty patients aged ≥18 with persistent post-surgical pain for at least 3 months and a mean pain severity of 4/10 on the Brief Pain Inventory are randomized to a 12-week yoga program (12, 75-minute sessions) or a chronic pain health education program (12, 15-30-minute sessions), followed by a 12-week follow-up period. Results of an iterative Delphi validation process led by an interdisciplinary expert panel indicated strong endorsement of the Yoga Program (across 7 experts and 9 questions; mean=6.7 [SD=0.64] on a 7-point Likert scale). Primary outcomes include pre-specified feasibility and acceptability metrics. Secondary outcomes include a battery of biopsychosocial measures, with the Brief Pain Inventory as the primary clinical outcome for a future fully powered trial. Discussion Results will provide preliminary data to inform modifications for a future fully powered study evaluating the efficacy of yoga integrated into the management of persistent post-surgical pain. Findings will also inform the design of future studies examining the biological mechanisms underlying the integrative use of yoga to prevent or resolve chronic pain syndromes. Clinicaltrials.gov identifier NCT06949007.
BACKGROUND:One potential risk after surgery is the development of chronic post-surgical pain (CPSP). Physical activity (PA) has emerged as a potential non-pharmacological approach for reducing the risk of CPSP. This systematic review synthesized and evaluated the current scientific evidence on the use of PA-based interventions for the prevention or reduction of CPSP. METHODS:We conducted a systematic review of randomized controlled trials published from inception through October 2025. Inclusion criteria were surgical patients who completed a pain assessment ≥3 months post-surgery, comparing PA interventions with a control group. We followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Synthesis Without Meta-Analysis guidelines, conducted a risk-of-bias assessment using the Cochrane risk-of-bias tool 2, and interpreted changes in CPSP relative to established minimal clinically important differences (MCIDs). RESULTS:Thirteen studies (sample size mean: 86.5; median: 67; range: 20-194) met inclusion criteria, enrolling 1155 patients (67.8% female, 32.2% male) across four main surgery types (spine, total knee/hip arthroplasty, mastectomy, lung resection). Our descriptive synthesis found that PA programs were implemented predominantly post-surgically, and varied in terms of modality, duration, frequency, and session length. Control groups also differed, with only two studies describing active controls. Low-quality evidence supports that PA interventions significantly reduce CPSP compared to control, with two studies demonstrating pain reductions exceeding MCIDs thresholds. Only three studies were considered overall low risk of bias. Findings suggest that PA interventions may offer some benefit in reducing CPSP, although the evidence remains inconclusive. CONCLUSION:Evidence from available studies is insufficient to establish the definitive efficacy of PA in preventing or reducing CPSP. Future trials should clearly define intervention parameters and employ active control groups to strengthen methodological rigor. Incorporation of more comprehensive pain assessments will allow investigation of mechanisms of efficacy, as well as differential impact among patients. PROSPERO ID:CRD42025626850.
OBJECTIVE:To explore the associations between mindfulness, psychological distress, and health-related quality of life (HRQOL), and examine whether psychological distress mediates the association between mindfulness and HRQOL in individuals with Parkinson's disease (PD). METHODS:This is a secondary analysis of baseline data from a clinical trial investigating mindfulness-based interventions in patients with mild-to-moderate PD (n = 159). Participants completed validated questionnaires assessing mindfulness, psychological distress (anxiety and depression), disease-specific HRQOL, and assessor-rated motor symptom severity. RESULTS:The sample consisted of 159 participants, including 83 female (52.2%) with a mean age of 64.8 years (SD = 7.9). Of these, 107 participants (67.3%) were classified at Hoehn and Yahr stage 3. Independent t-tests showed that psychologically distressed individuals had significantly lower mindfulness levels and poorer HRQOL than non-distressed individuals. Multiple linear regression analyses showed that higher mindfulness levels were associated with reduced anxiety and depression and improved HRQOL, particularly in the non-judging and acting with awareness facets. Mediation analyses demonstrated that anxiety and depression fully mediated the relationship between the observing and non-judging facets of mindfulness and HRQOL. In contrast, acting with awareness facet was partially mediated by both anxiety and depression, while describing facet was fully mediated by depression alone. CONCLUSION:Integrating mindfulness interventions into clinical pathways for neurodegenerative diseases could offer patients with effective tools to improve their quality of life. These interventions, focused on observing, non-judging, and acting with awareness, could enhance psychological care. Notably, for individuals at risk of comorbid depression, the 'describing' facet of mindfulness may play a particularly critical role in mitigating psychological distress.
OBJECTIVE:We examined the prevalence and patterns of complementary health approaches (CHA) use and interest in CHA research participation among COSMOS older adults. METHODS:We conducted cross-sectional analyses of the COSMOS Study 2024 survey that asked participants about their use of and research interest in six CHA categories (manual therapies, mind-body therapies, herbal products, acupuncture, spiritual practices, and cannabis/psychedelics). We compared key baseline sociodemographic, lifestyle, and clinical characteristics between CHA users and non-users overall, and for each CHA category. We used multivariable logistic regression models to estimate the odds of CHA use in the past 12 months and ever in lifetime. RESULTS:Of the 16,144 participants who responded (median age, 77.5 y), 58.8% and 76.4% indicated using CHA at least once in the past 12 months and ever in lifetime, respectively, and 50.4% reported interest in participating in CHA research. The highest prevalence of recent use was observed for spiritual practices (38.6%; 95% CI, 37.8-39.3) and lifetime use for manual therapies (51.9%; 95% CI, 51.2-52.7). A history of falls or depression was linked to higher odds of recent and lifetime CHA use. CONCLUSIONS:The high prevalence of selected CHA highlights the need to identify evidence gaps for safety, harm, and public health impact for new focused research studies. Limited generalizability to more diverse and medically underserved populations underscores the need for continued integrative health research.
Background As interest in non-pharmacologic treatments for migraine prevention increases, there is an urgent need to evaluate these treatments in well-designed randomized trials. However, designing a “control” for non-pharmacologic treatments is complex. One possible solution is to design credible educational programs to use as comparators which partially control for natural history, patient engagement, attention and positive expectancy. Objective To develop and validate through a modified Delphi process a “Headache Health Education” (HHE) program to be used as the control arm in a pilot study of multimodal chiropractic care for episodic migraine. Methods Leveraging existing patient educational materials, we drafted an initial HHE program with 14 modules, each covering a different migraine-related topic. Designed to be delivered by research personnel in a one-on-one video conference, each module provides education using a slide deck and guided conversation that is grounded in adult learning theory. Furthermore, to engage participants, the script-based sessions are informed by the psychological implications of polyvagal theory and motivational interviewing. The program was validated using a modified Delphi process. Modifications were made to the program based on the ratings and feedback, and a second round of review was then performed. Results Initial endorsement of the HHE program was generally supportive but included considerable variability. After program refinement, endorsement improved with much lower score variability. Key improvements included the addition of 2 topics, selection of new videos, and training for research assistants/associates in how to use conversational style and specific prompts to engage participants. Conclusion Initial development and validation of an HHE program to use as a comparator in trials of a non-pharmacological treatment for migraine has been completed. Future analysis will examine the fidelity and acceptability of the HHE program when used as a comparator in a randomized controlled trial of multimodal care for migraine.
BackgroundVisceral diseases often lead to referred pain, but clinical management is challenging due to poor understanding of the underlying mechanisms. Prior preclinical studies have shown that experimental induction of visceral diseases in animal models can cause cutaneous neurogenic inflammation, as assessed by Evans Blue dye extravasation. Neurogenic inflammation is associated with increased pain sensitivity. Thus, these preclinical findings may provide important mechanistic insights into the relationship between visceral diseases and referred somatic pain. ObjectiveThe objective of this systematic review is to synthesize evidence on cutaneous neurogenic inflammation and corresponding somatic pain sensitivity in preclinical animal models of visceral diseases, to lay out the current state of knowledge, and to identify any gaps or limitations to be addressed in future research on this topic. MethodsThis systematic review will be conducted, following the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol) guidelines. The literature search will be conducted in MEDLINE (Ovid), Embase, and Web of Science, using search terms related to cutaneous neurogenic inflammation and animal models of visceral diseases. Two investigators will independently screen and select studies meeting the eligibility criteria. For each included study, a predefined template will be used to extract relevant information, including the details of animal species and strains, visceral disease models, outcomes related to the distribution and extent of Evans Blue dye extravasation, and other pertinent findings and methodologies. Quality assessments will be independently performed by two investigators using the Risk of Bias tool from the Systematic Review Centre for Laboratory Animal Experimentation (SYRCLE). A qualitative summary of the findings will be provided for outcomes related to the extent and distribution of Evans Blue dye extravasation. ResultsAs of August 2025, a total of 536 records were identified from database search, and 13 studies met the eligibility criteria to be included in the review. Results from data extraction and quality assessments are expected to be published in fall 2026. ConclusionsPrior preclinical animal studies have investigated cutaneous neurogenic inflammation as a potential mechanistic outcome of referred visceral pain. The proposed review will be the first to summarize research findings and study quality on this topic. This will be an important step toward gaining insights into one of the potential mechanisms underlying referred visceral pain and informing future research in this area. International Registered Report Identifier (IRRID)DERR1-10.2196/67852
Background: The emerging paradigm of whole person health shares many core principles with traditional complementary and integrative health frameworks, including Tai Chi and Qigong (TCQ). Methods: In the fall of 2023, the Harvard Medical School Osher Center for Integrative Health hosted the inaugural international conference on The Science of Tai Chi & Qigong for Whole Person Health: Advancing the Integration of Mind-Body Practices into Contemporary Healthcare at Harvard Medical School. A two-part white paper was written to summarize key conference topics, findings, and issues. Results and Discussion: Part II presented here summarizes evidence gaps and future research opportunities, including: understudied clinical conditions and populations, impact of long-term TCQ training, understanding the impact of specific TCQ styles, training regimens, dosage, and contextual effects; implementation, cost-effectiveness, and medical utilization research; individual data meta-analysis, and teaching competencies, credentialing, and licensure. Part I of this white paper discusses the rationale for the conference, synthesizes the state of evidence for TCQ as rehabilitative and preventive tools for a range of clinical conditions, and summarizes the translational research informing therapeutic mechanisms associated with TCQ training.
PURPOSE:Many cancer survivors have high levels of distress and psychosocial symptoms. Two mind-body interventions for treating these problems are Mindfulness-Based Cancer Recovery (MBCR) and Tai Chi/Qigong (TCQ). However, while both interventions show efficacy compared with usual care, they have never been studied together. This trial was the first, to our knowledge, to incorporate innovative design features including patient choice while evaluating two interventions to treat distressed cancer survivors. METHODS:A preference-based multisite randomized comparative effectiveness trial design with broad pragmatic inclusion criteria was used. Participants with a preference for either MBCR or TCQ received their preferred intervention, while those without a preference were randomly assigned 1:1 into either intervention. Furthermore, participants were all randomly assigned 2:1 into immediate intervention or waitlist control. Total mood disturbance (TMD) on the Profile of Mood States after intervention was the primary outcome. RESULTS:Five hundred eighty-seven participants provided baseline data, 75% were female, with an average age of 60.7 years. Of 12 cancer types, the most prevalent were breast (40.7%), prostate (11.2%), and GI (9.7%) cancers. Most had stage 0-II (50.1%) diagnoses, with 17% having more advanced disease. Approximately two thirds had a preference, with 57% of those choosing TCQ and 43% choosing MBCR. The remaining 36% were equally randomly assigned. Choosing a specific program or choosing to be randomly assigned had no significant effect on outcomes. Both the combined random assignment and preference MBCR and TCQ groups improved more than their respective waitlists on TMD scores with small to medium effects. The largest improvements occurred for MBCR on subscales of tension, anger, and vigor and in TCQ on anger, depression, and vigor. CONCLUSION:This large, pragmatic trial demonstrated both mindfulness and TCQ interventions improved mood in distressed cancer survivors, whether they chose a program or chose to be randomly assigned.
Importance: Pre-pandemic physical activity (PA) levels may be associated with a lower risk of experiencing depressive symptoms in the context of psychosocial resilience during a global crisis. Objective: To investigate the association between self-reported pre-pandemic PA levels and the risk of experiencing depressive symptoms during the beginning of the COVID-19 pandemic in older U.S. adults. Design, Setting, and Participants: We combined three large ongoing prospective cohorts of US adults who provided pre-pandemic baseline self-reports of leisure-time PA and other risk factors using the most recent questionnaire completed as of December 2019. In June 2020, participants reported in a survey whether they had experienced depressive symptoms in the last 7 days. Exposure: Pre-pandemic PA data were categorized by validated criteria into three groups by metabolic equivalent hours per week (MET-hr/wk): inactive (0-3.5), insufficiently active (>3.5 to <7.5), and sufficiently active (≥7.5). Main Outcome and Measures: Our primary outcome was depressive symptoms experienced during the beginning of the COVID-19 pandemic in 2020, assessed by the PROMIS-29 depression domain. We used multivariate logistic regression to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for the association of each of the two upper pre-pandemic PA categories versus the lowest PA category with depressive symptoms during the early pandemic. Results: In total, 35,320 older U.S. adults comprised the pooled cohort (mean [standard deviation] age, 74.9[5.9] years; 66.8% female). For PA categories, 15.8% were inactive; 10.4% insufficiently active; and 73.8%, sufficiently active. A total of 1668 participants reported experiencing depressive symptoms in June 2020. After controlling for demographics, lifestyle factors, comorbidities, medications, and pre-pandemic depression at the beginning of the COVID-19 pandemic, compared with the inactive group, those sufficiently active had significantly lower odds of experiencing depressive symptoms (OR, 0.75; 95% CI, 0.66-0.86). In subgroup analyses, the association between PA and depressive symptoms differed by ethnic group. Conclusion and Relevance: In this cohort of older U.S. adults, those who achieved at least 7.5 MET-hr/wk of pre-pandemic PA had lower odds of exhibiting depressive symptoms during the early months of the pandemic. Hence, higher pre-pandemic PA levels may be associated with lower odds of experiencing depressive symptoms during exceptional global crises, such as the COVID-19 pandemic.
Background Pre-frailty is highly prevalent and multimodal lifestyle interventions are effective for preventing transition to frailty. However, little is known about the potential for medical group visits (MGV) to prevent frailty progression. Objectives To assess the feasibility and acceptability of the MGV Age Self Care-Resilience. Design Single-arm mixed methods pilot clinical trial. Setting Virtual MGV delivered in an ambulatory setting at a U.S. academic medical center. Participants Community-dwelling older adults (n = 11; age 65+) with pre- to mild frailty. Intervention Age Self Care-Resilience, an 8-week virtual MGV (90-minute sessions once per week) with sessions focused on physical activity, nutrition, social engagement, mind-body practice, and home environment modification. Measurements Primary outcomes were feasibility of recruitment, attendance, satisfaction, and feasibility of study measurements, collected via quantitative and qualitative approaches. Exploratory outcomes included frailty, psychosocial health, and physical function. Results A priori feasibility criteria were met for recruitment, with 15 (48 %) of those screened (31) meeting eligibility criteria, 11 (35 %) enrolling (mean age 74.5 yrs), and recruitment completed in less than one month. The nine participants who completed the study attended a mean of 7.2 of 8 sessions and completed 100 % of baseline and follow-up study measures; participants completed 58 % of the home practice log. Themes from participant interviews included: (1) mixed reactions to the recruitment term “pre-frailty;” (2) finding group participation as meaningful and empowering; and (3) perception that the program positively changed attitudes and lifestyle behaviors. Conclusions Age Self Care-Resilience is feasible and acceptable to pre- to mildly frail older adults. Next steps include evaluating the efficacy of Age Self Care-Resilience for preventing frailty progression with a fully powered randomized controlled trial.
Background: The emerging paradigm of whole person health shares many core principles with traditional complementary and integrative health frameworks, including Tai Chi and Qigong (TCQ). Methods: In the Fall of 2023, the Harvard Medical School Osher Center for Integrative Health hosted the inaugural international conference on The Science of Tai Chi & Qigong as Whole Person Health: Advancing the Integration of Mind-Body Practices into Contemporary Healthcare held at Harvard Medical School. A two-part white paper was written to summarize key conference topics, findings, and issues. Results and Discussion: Part I presented here summarizes the rationale for the conference and synthesizes the state of evidence for TCQ as rehabilitative and preventive tools for a range of clinical conditions, including falls and balance, cognition, mental health, sleep, cardiorespiratory health, musculoskeletal health, cancer, as well as translational evidence related to the neurophysiology, brain and immune function, and biomarkers of inflammation. The state of science of TCQ, viewed through the lens of traditional East Asian health constructs, is also discussed. Part II of this white paper outlines evidence gaps and opportunities and discusses strategies to address challenges in TCQ research, dissemination, and implementation.
BACKGROUND:Physical inactivity is highly prevalent in heart failure (HF) and chronic obstructive pulmonary disease (COPD) and is associated with poor outcomes, including worsened quality of life, increased hospitalizations, readmissions, and mortality. Accessible interventions that improve physical activity are needed. Mind-body strategies are well-suited for promoting physical activity; they show promise for targeting key health behavior change processes. OBJECTIVE:The aim of this study was to examine the feasibility and acceptability of a web-based pedometer-mediated mind-body intervention (Mindful Steps) for promoting walking among individuals with HF and COPD. METHODS:In this pilot randomized controlled trial, participants with chronic, stable HF and COPD were randomized to Mindful Steps or usual care in a 2:1 ratio. Mindful Steps is a 12-month multimodal intervention that includes a pedometer with individualized step-count goals, live mind-body exercise (MBE) classes, and a web platform with mind-body videos, motivation messages, and educational tips. Feasibility (recruitment rate, retention), intervention acceptability, and intervention adherence were the primary outcomes. Exploratory outcomes assessed at baseline, 3-, 6-, 9-, and 12-months included daily step counts, cognitive-behavioral/psychosocial measures, health-related quality of life, and self-reported physical function. Participants were enrolled in the study from April 2019 to July 2021. The study was converted to all-digital during the pandemic after March 2020. RESULTS:Forty-one participants were randomized to Mindful Steps (n=26) or usual care (n=15). The recruitment rate was 3% (43/178), and overall study retention was 76% (31/41). In the intervention group, over 12 months, 58% (15/26) met a predefined benchmark for MBE class adherence (attending >70% of classes). Participants engaged most consistently with the MBE classes, the pedometer, and mind-body videos. There was a positive signal regarding group differences in the change in daily step counts from baseline, favoring intervention at 3 months (estimate=2038.77 steps per day between groups, 95% CI 289.76-3788.77), 6 months (estimate=3031.45, 95% CI 1261.15-4801.74), and 9 months (estimate=2703.80, 95% CI 862.97-4544.62). There were also positive signals regarding group differences in the change from baseline favoring intervention in the following outcomes: emotional awareness (estimate=0.88, 95% CI 0.15-1.61) and body listening (estimate=1.16, 95% CI 0.25-2.07) at 3-months; internal motivation (estimate=1.03, 95% CI 0.01-2.04) and pressure/tension at 6-months (estimate=-1.59, 95% CI -2.55 to -0.63); and exercise self-efficacy at 12 months (estimate=1.77, 95% CI 0.20-3.33). CONCLUSIONS:Mindful Steps was largely feasible, acceptable, and had adequate intervention engagement. There were positive signals favoring the multimodal web intervention for daily step counts, interoceptive awareness, internal motivation, and exercise self-efficacy that will inform hypotheses in future studies. A pivot to fully remote conduct during the pandemic was successful. A larger trial examining the efficacy of Mindful Steps for promoting physical activity is warranted. TRIAL REGISTRATION:ClinicalTrials.gov NCT03003780; https://clinicaltrials.gov/study/NCT03003780.
Background:While mindfulness meditation (MM) apps have gained popularity as a tool for promoting sleep, research focusing on bedtime mindfulness practice and app usage is limited. Objective:As the first step toward understanding the efficacy and mechanisms of such bedtime practice and to inform future investigations, the goal of this pilot study was to explore the feasibility of app-guided bedtime MM practice with both in-lab and at-home physiological and self-report sleep remote assessments. Methods:We conducted a single-arm, prospective mixed methods pilot study that included both standard in-lab sleep studies and remote at-home assessments of individuals with insomnia disorder with self-reported difficulty falling asleep. Participants practiced MM guided by a commercially available smartphone app at bedtime for 4 weeks. Pre-post assessments included a battery of sleep-related and psychological health questionnaires, objective physiological sleep measures (polysomnography and actigraphy), and daily sleep logs. We also conducted qualitative exit interviews to further assess feasibility and acceptability. Transcripts were analyzed for dominant themes using inductive and deductive qualitative methods. Results:We recruited 13 participants with chronic insomnia (symptoms ≥3 nights weekly for ≥3 months) to complete the study protocol within 8 months (retention rate 77%). We were able to collect analyzable physiological and psychometric data with overall completion rates of more than 90%. The study was deemed feasible, meeting a priori benchmarks including recruitment, retention, completion, and adherence. The 10 participants retained in the program had excellent engagement (95% completion of in-lab studies, 100% completion of questionnaires, and 91% compliance with use of the app). Our preliminary analysis of subjective measures indicated improvement in sleep quality, insomnia severity, and presleep arousal, including Pittsburgh Sleep Quality Index change of -3.7 (95% CI -6.7 to -0.7), Insomnia Severity Index change of -4.5 (95% CI -7.7 to -1.4), Pre-Sleep Arousal Scale change of -7.7 (95% CI -13.1 to -2.3), and trend toward improvement in the Ford Insomnia Response to Stress Test indicated by a change of -2.5 (95% CI -5.9 to 0.9). From qualitative data, we identified domains that inform the feasibility and acceptability of the study, including (1) barriers to sleep prior to the study, (2) benefits and skills imparted by mindfulness, and (3) feedback on app use. Benefits and skills imparted by mindfulness included decreased catastrophizing, acceptance and nonreactivity, body awareness and relaxation, self-kindness, awareness of sleep hygiene and bedtime routine, earlier defusing of stress, increased focus and presence, and calm throughout the day. Conclusions:Bedtime app-guided MM as an intervention in patients with insomnia and the hybrid study design with in-lab and at-home assessments are feasible and acceptable. This study informs the design of future clinical and mechanistic research examining app-guided MM to impact insomnia severity and presleep arousal.
Background:Neck pain presents a personal and socioeconomic burden globally. Despite increasing prevalence, research on chronic neck pain (CNP) is limited and management relies on generalized approaches. There is growing interest in non-pharmacological interventions, however their efficacy remains uncertain due to the multifactorial etiology of CNP. Two interventions, multimodal chiropractic care (MCC) and Tai Chi, have shown promise individually in managing CNP, and when combined may offer synergistic benefits. This pilot study aims to assess the feasibility of combining these interventions for CNP.Methods/design: Forty-eight adults, aged 18-65y, with CNP defined as occurring ≥5 days a week for ≥3 consecutive months, severity of ≥3 on the numeric rating scale, and a score of ≥5 on the Neck Disability Index will be recruited. Participants will be randomized 1:1:1 to one of the three treatment groups (MCC plus Tai Chi and Enhanced Usual Care (EUC), MCC plus EUC, or EUC alone). The MCC was validated using a modified Delphi approach. Primary outcomes relate to feasibility (recruitment, retention, and adherence) and secondary outcomes include clinical measures of neck pain severity and disability, health-related quality-of-life, psychosocial well-being, and physical function. Outcomes will be assessed at baseline, 16-weeks (post-intervention), and 24-weeks. Qualitative interviews will be conducted. Discussion:Results of this study will provide preliminary evidence regarding the feasibility and clinical evaluation of pragmatically delivered MCC, alone or in combination with Tai Chi, for individuals with CNP. These data will be used to inform the design of a fully powered, factorial trial evaluating two promising non-pharmacological therapies for CNP. Trial registration:This study is registered in ClinicalTrials.gov (NCT05726331).
Tai Chi, an Asian martial art, is renowned for its health benefits, particularly in promoting healthy aging among older adults, improving balance, and reducing fall risk. However, methodological challenges hinder the objective measurement of adherence to and proficiency in performing a training protocol, critical for health outcomes. This study introduces a framework using wearable sensors and machine learning to monitor Tai Chi training adherence and proficiency. Data were collected from 32 participants with inertial measurement units (IMUs) while performing six Tai Chi movements evaluated and scored for adherence and proficiency by experts. Our framework comprises a model for identifying the specific Tai Chi movement being performed and a model to assess performance proficiency, both employing Random Forest algorithms and features from IMU signals. The movement identification model achieved a micro F1 score of 90.05%. The proficiency assessment models achieved a mean micro F1 score of 78.64%. This study shows the feasibility of using IMUs and machine learning for detailed Tai Chi movement analysis, offering a scalable method for monitoring practice. This approach has the potential to objectively enhance the evaluation of Tai Chi training protocol adherence, learnability, progression in proficiency, and safety in Tai Chi programs, and thus inform training program parameters that are key to achieving optimal clinical outcomes.