Improving multimodal physical function in adults with heterogeneous chronic pain; Protocol for a multisite feasibility RCT.

BACKGROUND: Chronic pain is associated with substantial impairment in physical function, which has been identified as a top concern among persons with pain. GetActive-Fitbit, a mind-body activity program, is feasible, acceptable, and associated with improvement in physical function among primarily White, sedentary individuals with pain. In preparation for a multisite efficacy trial, we must examine feasibility across multiple sites with diverse patient populations. Here we describe the protocol of a multisite, feasibility RCT comparing GetActive-Fitbit with a time- and attention-matched educational comparison (Healthy Living for Pain). We aim to 1) test multisite fidelity of clinician training; 2) evaluate multisite feasibility benchmarks, including recruitment of chronic pain patients taking <5000 steps/day and racial and ethnic minorities; and 3) optimize fidelity and study protocol in preparation for a future multisite efficacy trial. METHODS: Clinician training fidelity was assessed via roleplays and mock group sessions. Feasibility (i.e., recruitment, acceptability, credibility, adherence, satisfaction), multimodal physical function (e.g., self-report, 6-Minute Walk Test, step-count), and other psychosocial outcomes are assessed at baseline, posttest, and 6 months. Protocol optimization will be assessed using exit interviews and cross-site meetings. RESULTS: The trial is ongoing. Clinician training is complete. 87 participants have been recruited. 54 completed baseline assessments and randomization, 44 are mid-intervention, and 9 have completed the intervention and posttest. CONCLUSIONS: This study addresses the critical need for feasible, acceptable mind-body-activity interventions for chronic pain that follow evidence-based guidelines and improve all aspects of physical function across diverse populations. Results will inform a future fully-powered multisite efficacy trial. CLINICAL TRIAL REGISTRATION: NCT05700383.

Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults: Protocol for the Active Brains Remote Efficacy Trial.

BACKGROUND: Chronic pain and early cognitive decline, which are costly to treat and highly prevalent among older adults, commonly co-occur, exacerbate one another over time, and can accelerate the development and progression of Alzheimer disease and related dementias. We developed the first mind-body activity program (Active Brains [AB]) tailored to the needs of older adults with chronic pain and early cognitive decline. Results from our previous study strongly supported the feasibility of conducting AB remotely and provided evidence for improvements in outcomes. OBJECTIVE: We are conducting a single-blinded, National Institutes of Health stage-2, randomized clinical trial to establish the efficacy of AB versus a time-matched and dose-matched education control (Health Enhancement Program [HEP]) in improving self-reported and objective outcomes of physical, cognitive, and emotional functions in 260 participants. The methodology described in this paper was informed by the lessons learned from the first year of the trial. METHODS: Participants are identified and recruited through multidisciplinary clinician-referred individuals (eg, pain psychologists and geriatricians), the Rally Research platform, social media, and community partnerships. Interested participants complete eligibility screening and electronic informed consent. Baseline assessments include self-report, performance-based measures (eg, 6-min walk test) and objective measures (eg, Repeatable Battery for the Assessment of Neuropsychological Status). Participants are mailed a wrist-worn ActiGraph device (ActiGraph LLC) to passively monitor objective function (eg, steps) during the week between the baseline assessment and the beginning of the programs, which they continue to wear throughout the programs. After baseline assessments, participants are randomized to either AB or HEP and complete 8 weekly, remote, group sessions with a Massachusetts General Hospital psychologist. The AB group receives a Fitbit (Fitbit Inc) to help reinforce increased activity. Assessments are repeated after the intervention and at the 6-month follow-up. Coprimary outcomes include multimodal physical function (self-report, performance based, and objective). Secondary outcomes are cognitive function (self-report and objective), emotional function, and pain. RESULTS: We began recruitment in July 2022 and recruited 37 participants across 4 cohorts. Of them, all (n=37, 100%) have completed the baseline assessment, 26 (70%) have completed the posttest assessment, and 9 (24%) are actively enrolled in the intervention (total dropout: n=2, 5%). In the three cohorts (26/37, 70%) that have completed the AB or HEP, 26 (100%) participants completed all 8 group sessions (including minimal makeups), and watch adherence (1937/2072, 93.48%, average across ActiGraph and Fitbit devices) has been excellent. The fourth cohort is ongoing (9/37, 24%), and we plan to complete enrollment by March 2026. CONCLUSIONS: We aim to establish the efficacy of the AB program over a time-matched and dose-matched control in a live video-based trial and test the mechanisms through theoretically driven mediators and moderators. Findings will inform the development of a future multisite effectiveness-implementation trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05373745; https://classic.clinicaltrials.gov/ct2/show/NCT05373745. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47319.

Centers for Disease Control and Prevention Clinical Practice Guideline for Prescribing Opioids: United States, 2022: What dentists need to know.

BACKGROUND: The Centers for Disease Control and Prevention (CDC) published the Clinical Practice Guideline for Prescribing Opioids for Pain-United States, 2022 (CDCCPG) to replace the 2016 guideline. This guideline was designed to serve as a clinical tool to improve communication between clinicians and patients and empower them to make informed, person-centered decisions regarding pain management and the prescribing of opioids. It is intended for primary care and other clinicians, including dentists, who provide pain management for adults with acute, subacute, and chronic pain. TYPES OF STUDIES REVIEWED: This article summarizes the CDCCPG, with an emphasis on information of relevance to dentistry. RESULTS: For dentists, the most important recommendations for pain management are that nonsteroidal anti-inflammatory medications are first-line medications for acute dental pain, interdisciplinary care for chronic orofacial pain is indicated, and opioids should only be prescribed for acute dental pain for a maximum of 3 days after risk assessment. PRACTICAL IMPLICATIONS: The CDCCPG contains a great deal of relevant information that can help dentists and dental specialists make safe, effective, and evidence-based decisions in providing pain control for their patients.

Posttraumatic Stress Disorder and the Role of Psychosocial Comorbidities in Chronic Orofacial Pain.

This article presents the case of a patient with persistent right-sided jaw pain with a history of multiple temporomandibular joint surgeries in the setting of persistent widespread body pain, the causes of which were fibromyalgia and osteoarthritis with multiple joint replacements, as well as psychological diagnoses of PTSD and depression. Despite extensive treatment from her orofacial pain team in combination with neurology and neurosurgery, her severe pain persisted, likely due to the consequences of untreated PTSD and depression, which led to avoidance of activities that would exacerbate her pain and thus to further disability and emotional deterioration.

Pain Management for Dental Medicine in 2021: Opioids, Coronavirus and Beyond.

Over the past year our attention has inevitably been on the coronavirus pandemic, the health and welfare of our families, patients, and office staffs as well as the re-opening of our dental practices. In addition, the opioid crisis continues, is very likely to worsen as a result of the pandemic and continues to be a challenge to Dentistry. National public health issues and healthcare disparities continue and have created a global concern for providing evidence-based, adequate pain management in the dental setting. We have brought together a group of national thought leaders and experts in this field who will share their insights on the current state of opioid prescribing in Dentistry and describe some of the exciting work being done in advancing pain management. The learning objectives for this conference proceedings were: Describing the implications of current public health concerns for safe and effective pain management in dental medicine.Identifying risk factors and understanding the current guidelines for the use of opioid and non-opioid medications in dental medicine.Analyzing the interprofessional collaborations necessary for effective pain management in dental medicine.Recognizing the challenges and opportunities brought about by the COVID-19 pandemic for the dental profession.Applying evidence-based strategies for managing the complex pain patient in the dental setting.Appraising new and future modalities for the assessment and management of orofacial pain.

Sustainability of Improvements in Adaptive Coping Following Mind-Body and Activity Training for Chronic Pain.

BACKGROUND: The strategies patients use to cope with chronic pain are key determinants of pain-related treatment outcomes and are often targeted in psychosocial interventions for chronic pain. However, improvements in coping often fade after intervention completion. Here, we test whether previously reported improvements in coping following two novel mind-body and activity interventions are maintained 3 months after completion. METHODS: Eighty-two patients with heterogeneous chronic pain were randomized to two identical mind-body and activity interventions, one with the addition of a Fitbit device (GetActive-Fitbit) and one without it (GetActive; n = 41 each). Participants completed measures of pain-catastrophizing, kinesiophobia, mindfulness, adaptive coping, and pain-resilience at baseline, post-intervention, and at 3-month follow-up. RESULTS: At follow-up, participants in both groups exhibited sustained improvements in all five coping measures compared to baseline (significant in both groups for all measures except for p = .05 in kinesiophobia in GetActive and p = .07 in pain resilience in GetActive-Fitbit). CONCLUSIONS: Overall, GetActive and GetcActive-Fitbit are promising interventions to sustainably improve coping with chronic pain. TRIAL REGISTRATION: This trial is registered under ClinicalTrials.gov identifier NCT03412916.

Efficacy of a Self-Hypnotic Relaxation App on Pain and Anxiety in a Randomized Clinical Trial: Results and Considerations on the Design of Active and Control Apps.

Despite an explosion of mobile app offerings for management of pain and anxiety, the evidence for effectiveness is scarce. Placebo-controlled trials are the most desirable but designing inactive placebo apps can be challenging. For a prospective randomized clinical trial with 72 patients in a craniofacial pain center, we created an app with self-hypnotic relaxation (SHR) for use with iOS and Android systems. A placebo background audio (BA) app was built with the same look and functionality. Both iOS and Android SHR apps alone and in comparison to the BA group significantly reduced pain and anxiety during the waiting-room time. The Android BA app significantly reduced anxiety but not pain. The iOS BA app affected neither pain nor anxiety, functioning as an ideal placebo. Usage analysis revealed that different default approaches of the iOS and Android devices accounted for the difference in results.

Mind-Body Activity Program for Chronic Pain: Exploring Mechanisms of Improvement in Patient-Reported, Performance-Based and Ambulatory Physical Function.

BACKGROUND: Improving physical function among patients with chronic pain is critical for reducing disability and healthcare costs. However, mechanisms underlying improvement in patient-reported, performance-based, and ambulatory physical function in chronic pain remain poorly understood. PURPOSE: To explore psychosocial mediators of improvement in patient-reported, performance-based, and objective/accelerometer-measured physical function among participants in a mind-body activity program. METHODS: Individuals with chronic pain were randomized to one of two identical 10-week mind-body activity interventions aimed at improving physical function with (GetActive-Fitbit; N=41) or without (GetActive; N=41) a Fitbit device. They completed self-reported (WHODAS 2.0), performance-based (6-minute walk test), and objective (accelerometer-measured step-count) measures of physical function, as well as measures of kinesiophobia (Tampa Kinesiophobia Scale), mindfulness (CAMS-R), and pain resilience (Pain Resilience Scale) before and after the intervention. We conducted secondary data analyses to test mediation via mixed-effects modeline. RESULTS: Improvements in patient-reported physical function were fully and uniquely mediated by kinesiophobia (Completely Standardized Indirect Effect (CSIE)=.18; CI=0.08, 0.30; medium-large effect size), mindfulness (CSIE=-.14; CI=-25, -.05; medium effect size) and pain resilience (CSIE=-.07; CI=-.16, -.005; small-medium effect size). Improvements in performance-based physical function were mediated only by kinesiophobia (CSIE=-.11; CI=-23, -.008; medium effect size). No measures mediated improvements in objective (accelerometer measured) physical function. CONCLUSION: Interventions aiming to improve patient-reported physical function in patients with chronic pain may benefit from skills that target kinesiophobia, mindfulness, and pain resilience, while those focused on improving performance-based physical function should target primarily kinesiophobia. More research is needed to understand mechanisms of improvement in objective, accelerometer-measured physical function. TRIAL REGISTRATION: ClinicalTrials.gov NCT03412916.

Getting Active Mindfully: Rationale and Case Illustration of a Group Mind-body and Activity Program for Chronic Pain.

Chronic pain is associated with substantial decreases in physical and emotional health. Psychosocial and physical restoration interventions, although potentially helpful, typically show small-to-moderate improvements that are limited to the short term, and often exhibit problematic adherence. Here, we present GetActive-Fitbit, a novel 10-week group program that integrates mind-body skills, pain coping and gradual increases in activity reinforced by a commercially available digital monitoring device (Fitbit). We illustrate the program among a group of 4 adults with heterogeneous chronic pain. We also highlight pre to post-program improvements in physical function (objective, performance-based and self-report), emotional function (depression and anxiety) and other relevant outcomes targeted by the program (e.g., pain intensity, catastrophizing, mindfulness, coping, kinesiophobia, emotional support, social isolation, pain resilience, program satisfaction and impression of change). Group participants' experiences suggest that GetActive-Fitbit is credible, useful, and shows potential to improve physical and emotional function among this challenging population.Clinical trial number: NCT03412916.

Psychosocial Correlates of Objective, Performance-Based, and Patient-Reported Physical Function Among Patients with Heterogeneous Chronic Pain.

BACKGROUND: Improving all aspects of physical function is an important goal of chronic pain management. Few studies follow recent guidelines to comprehensively assess physical function via patient-reported, performance-based, and objective/ambulatory measures. PURPOSE: To test 1) the interrelation between the 3 types of physical function measurement and 2) the association between psychosocial factors and each type of physical function measurement. METHODS: Patients with chronic pain (N=79) completed measures of: 1) physical function (patient-reported disability; performance-based 6-minute walk-test; objective accelerometer step count); 2) pain and non-adaptive coping (pain during rest and activity, pain-catastrophizing, kinesiophobia); 3) adaptive coping (mindfulness, general coping, pain-resilience); and 4) social-emotional dysfunction (anxiety, depression, social isolation and emotional support). First, we tested the interrelation among the 3 aspects of physical function. Second, we used structural equation modeling to test associations between psychosocial factors (pain and non-adaptive coping, adaptive coping, and social-emotional dysfunction) and each measurement of physical function. RESULTS: Performance-based and objective physical function were significantly interrelated (r=0.48, p<0.001) but did not correlate with patient-reported disability. Pain and non-adaptive coping (ß=0.68, p<0.001), adaptive coping (ß=-0.65, p<0.001) and social-emotional dysfunction (ß=0.65, p<0.001) were associated with patient-reported disability but not to performance-based or objective physical function (ps>0.1). CONCLUSION: Results suggest that patient-reported physical function may provide limited information about patients' physical capacity or ambulatory activity. While pain and non-adaptive reactions to it, adaptive coping, and social-emotional dysfunction may potentially improve patient-reported physical function, additional targets may be needed to improve functional capacity and ambulatory activity. TRIAL REGISTRATION: ClinicalTrials.gov NCT03412916.

Dentistry's Role in Assessing and Managing Controlled Substance Risk: Historical Overview, Current Barriers, and Working Toward Best Practices.

Dentistry is in a unique position among the health care professions to assess and manage the patient with controlled substance risk. The concern over opioid risk is not new, and historically dentists have had to balance the critical need for adequate pain care with the importance of recognizing the consequences of using controlled substances for their patients. Barriers for providing adequate patient assessment and management may be greater in dentistry than other health care fields, although these barriers can be recognized and overcome. Collaboration with cotreating providers will improve patient outcomes and reduce patient risk.

Comorbid Conditions in Relation to Controlled Substance Abuse.

Dental patients who experience comorbid psychiatric and medical conditions present an elevated risk of medication misuse, abuse, substance use disorders, and overdose. The authors review the role of notable comorbidities in predicting the development of substance use disorder, including medical, psychiatric, and other psychosocial factors that can be assessed in general dental practice. Psychiatric disorders commonly cooccur with substance abuse, and these typically include anxiety disorders, mood disorders (major depression, bipolar), posttraumatic stress, as well as sleep and eating disorders. Medical disorders commonly found to be present with substance use disorders are also reviewed, including common cardiovascular and pulmonary disorders.

Interprofessional Collaboration in the Assessment and Management of Substance Use Risk.

Substance use disorder assessment strategies are increasingly being employed by dentistry, while adequate evaluation requires reaching out to other cotreating providers and collaborating on patient care. The field of dentistry has a range of barriers often not experienced in other professions, including limitations on e-record communication and clinical practice setting often isolated from the patient's general medical care. Barriers can be overcome if the dentist facilitates communication.

Opioid Prescribing in Dental Practice: Managing Liability Risks.

Dentistry should be proud of its history of providing responsible pain relief, as well as becoming more cautious in prescribing opioid medications when other safer pharmacologic options exist. Our training directs us to first eliminate the source of dental pain and prescribe analgesics only as adjunctive relief. Prescriptions must be written for a legitimate dental purpose and for a patient of record. Through self-regulation, the dental profession must continue to establish pain management guidelines based on scientific evidence and clinical experience to avoid further regulatory action restricting our prescribing privileges, which remain one of our most powerful therapeutic tools.

A Mind-Body Physical Activity Program for Chronic Pain With or Without a Digital Monitoring Device: Proof-of-Concept Feasibility Randomized Controlled Trial.

BACKGROUND: Chronic pain is associated with poor physical and emotional functioning. Nonpharmacological interventions can help, but improvements are small and not sustained. Previous clinical trials do not follow recommendations to comprehensively target objectively measured and performance-based physical function in addition to self-reported physical function. OBJECTIVE: This study aimed to establish feasibility benchmarks and explore improvements in physical (self-reported, performance based, and objectively measured) and emotional function, pain outcomes, and coping through a pilot randomized controlled trial of a mind-body physical activity program (GetActive) with and without a digital monitoring device (GetActive-Fitbit), which were iteratively refined through mixed methods. METHODS: Patients with chronic pain were randomized to the GetActive (n=41) or GetActive-Fitbit (n=41) programs, which combine relaxation, cognitive behavioral, and physical restoration skills and were delivered in person. They completed in-person assessments before and after the intervention. Performance-based function was assessed with the 6-min walk test, and step count was measured with an ActiGraph. RESULTS: Feasibility benchmarks (eg, recruitment, acceptability, credibility, therapist adherence, adherence to practice at home, ActiGraph wear, and client satisfaction) were good to excellent and similar in both programs. Within each program, we observed improvement in the 6-min walk test (mean increase=+41 m, SD 41.15; P<.001; effect size of 0.99 SD units for the GetActive group and mean increase=+50 m, SD 58.63; P<.001; effect size of 0.85 SD units for the GetActive-Fitbit group) and self-reported physical function (P=.001; effect size of 0.62 SD units for the GetActive group and P=.02; effect size of 0.38 SD units for the GetActive-Fitbit group). The mean step count increased only among sedentary patients (mean increase=+874 steps for the GetActive group and +867 steps for the GetActive-Fitbit group). Emotional function, pain intensity, pain coping, and mindfulness also improved in both groups. Participants rated themselves as much improved at the end of the program, and those in the GetActive-Fitbit group noted that Fitbit greatly helped with increasing their activity. CONCLUSIONS: These preliminary findings support a fully powered efficacy trial of the two programs against an education control group. We present a model for successfully using the Initiative on the Methods, Measurement, and Pain Assessment in Clinical Trials criteria for a comprehensive assessment of physical function and following evidence-based models to maximize feasibility before formal efficacy testing. TRIAL REGISTRATION: ClinicalTrial.gov NCT03412916; https://clinicaltrials.gov/ct2/show/NCT03412916.