Trends in Chiropractic Care and Physical Rehabilitation Use Among Adults with Low Back Pain in the United States, 2002 to 2018.

BACKGROUND: While nonpharmacologic treatments are increasingly endorsed as first-line therapy for low back pain (LBP) in clinical practice guidelines, it is unclear if use of these treatments is increasing or equitable. OBJECTIVE: Examine national trends in chiropractic care and physical rehabilitation (occupational/physical therapy (OT/PT)) use among adults with LBP. DESIGN/SETTING: Serial cross-sectional analysis of the National Health Interview Survey, 2002 to 2018. PARTICIPANTS: 146,087 adults reporting LBP in prior 3 months. METHODS: We evaluated the association of survey year with chiropractic care or OT/PT use in prior 12 months. Logistic regression with multilevel linear splines was used to determine if chiropractic care or OT/PT use increased after the introduction of clinical guidelines. We also examined trends in use by age, sex, race, and ethnicity. When trends were similar over time, we present differences by these demographic characteristics as unadjusted ORs using data from all respondents. RESULTS: Between 2002 and 2018, less than one-third of adults with LBP reported use of either chiropractic care or OT/PT. Rates did not change until 2016 when uptake increased with the introduction of clinical guidelines (2016-2018 vs 2002-2015, OR = 1.15; 95% CI: 1.10-1.19). Trends did not differ significantly by sex, race, or ethnicity (p for interactions > 0.05). Racial and ethnic disparities in chiropractic care or OT/PT use were identified and persisted over time. For example, compared to non-Hispanic adults, either chiropractic care or OT/PT use was lower among Hispanic adults (combined OR = 0.62, 95% CI: 0.65-0.73). By contrast, compared to White adults, Black adults had similar OT/PT use (OR = 0.98; 95% CI: 0.94-1.03) but lower for chiropractic care use (OR = 0.50; 95% CI: 0.47-0.53). CONCLUSIONS: Although use of chiropractic care or OT/PT for LBP increased after the introduction of clinical guidelines in 2016, only about a third of US adults with LBP reported using these services between 2016 and 2018 and disparities in use have not improved.

Treatment Options for Posttraumatic Headache: A Current Review of the Literature.

PURPOSE OF REVIEW: We evaluate evidence-based treatments for posttraumatic headache (PTH), a secondary headache disorder resulting from traumatic brain injury (TBI), comprising nearly 4% of all symptomatic headache disorders. Utilizing recent publications, we aim to inform clinicians of current treatment methods. RECENT FINDINGS: There is limited research on PTH treatment. A randomized controlled trial (RCT) of metoclopramide with diphenhydramine for acute PTH found that the treatment group (N = 81) experienced more significant pain improvement than placebo by 1.4 points. For persistent PTH, an open-label study of erenumab (N = 89) found that 28% of participants reported ≥ 50% reduction in moderate-to-severe headache days, but an RCT of fremanezumab showed a non-significant reduction in moderate-to-severe headache days. A randomized crossover study of 40 patients with persistent PTH found that onabotulinum toxin-A decreased cumulative number of headaches/week by 43.3% in the treatment group and increased by 35.1% among placebos. In a study of military veterans with severe posttraumatic stress disorder and persistent/delayed onset PTH (N = 193), patients who received Cognitive Behavioral Therapy reported significant improvements in headache-related disability compared to usual care (aggregate mean HIT-6, -3.4). A transcranial magnetic stimulation (N = 24) study found that 58% of participants with mild TBI-related headache experienced a 50% reduction in headache frequency. New studies indicate promise in improving clinically important outcomes of PTH. However, more research is necessary to determine the optimal treatment and whether combining pharmacologic and nonpharmacologic treatment versus a single modality is more effective.

Non-invasive vagus nerve stimulation for prevention of migraine: The multicenter, randomized, double-blind, sham-controlled PREMIUM II trial.

AIM: Evaluate the efficacy and safety of non-invasive vagus nerve stimulation for migraine prevention. METHODS: After completing a 4-week diary run-in period, adults who had migraine with or without aura were randomly assigned to receive active non-invasive vagus nerve stimulation or sham therapy during a 12-week double-blind period. RESULTS: Of 336 enrolled participants, 113 (active, n = 56; sham, n = 57) completed ≥70 days of the double-blind period and were ≥66% adherent with treatment, comprising the prespecified modified intention-to-treat population. The COVID-19 pandemic led to early trial termination, and the population was ∼60% smaller than the statistical target for full power. Mean reduction in monthly migraine days (primary endpoint) was 3.12 for the active group and 2.29 days for the sham group (difference, -0.83; p = 0.2329). Responder rate (i.e. the percentage of participants with a ≥50% reduction in migraine days) was greater in the active group (44.87%) than the sham group (26.81%; p = 0.0481). Prespecified subgroup analysis suggested that participants with aura responded preferentially. No serious device-related adverse events were reported. CONCLUSIONS: These results suggest clinical utility of non-invasive vagus nerve stimulation for migraine prevention, particularly for patients who have migraine with aura, and reinforce the well-established safety and tolerability profile of this therapy.Trial Registration: ClinicalTrials.gov (NCT03716505).

Immersive virtual reality on childbirth experience for women: a randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness of immersive virtual reality (VR) on patient satisfaction as a distractive tool and pain relief among laboring women. METHODS: This was a randomized, controlled clinical trial with 42 laboring women allocated to VR intervention and control groups. Among women in the VR group, patient satisfaction with the use of VR was assessed by a Virtual Reality Satisfaction Survey, measured by a Visual Analog Scale (VAS) score and evaluated by questioning them about whether they would choose VR in future labor. As a primary outcome, patient satisfaction scores regarding the overall childbirth experience were compared between women in the two groups. A secondary outcome was pain assessed by a visual pain rating scale in the early and active phases of labor in women in both groups. Psychometric information was also collected from participants in each group using the Beck Anxiety Inventory and Beck Depression Inventory. RESULTS: We observed a high level of patient satisfaction with the use of immersive VR during labor. The VAS revealed a mean satisfaction score of 87.7 ± 12.9 out of a maximum of 100. Twenty out of 21 (95%) women in the VR group stated that they would like to use VR again in future labor. VR improved pain scores in early labor and contributed positively to the overall childbirth experience. The mean pain score pre-VR was 2.6 ± 1.2 compared to 2.0 ± 1.3 post-VR (p < 0.01). Anxiety and depression scores were similar in participants in the intervention and control groups (p = 0.103 and p = 0.13, respectively). CONCLUSION: Immersive VR application during labor was associated with higher patient satisfaction based on our study findings. VR also improved participants' pain scores in early labor before epidural administration. Immersive VR may find a place as an adjunct in labor and delivery units to improve lengthy labor experiences for women. Studies with larger groups of participants are needed to confirm these observations. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05032456.

Co-Operative Pain Education and Self-management (COPES) Expanding Treatment for Real-World Access (ExTRA): Pragmatic Trial Protocol.

BACKGROUND: Given access barriers to cognitive behavioral therapy for chronic pain (CBT-CP), this pragmatic superiority trial will determine whether a remotely delivered CBT-CP intervention that addresses these barriers outperforms in-person and other synchronous forms of CBT-CP for veterans with musculoskeletal pain. DESIGN: This pragmatic trial compares an asynchronous form of CBT-CP that uses interactive voice response (IVR) to allow patients to participate from their home (IVR CBT-CP) with synchronous CBT-CP delivered by a Department of Veterans Affairs (VA) clinician. Veterans (n=764; 50% male) with chronic musculoskeletal pain throughout nine VA medical centers will participate. The primary outcome is pain interference after treatment (4 months). Secondary outcomes, including pain intensity, depression symptom severity, sleep, self-efficacy, and global impression of change, are also measured after treatment. Where possible, outcomes are collected via electronic health record extraction, with remaining measures collected via IVR calls to maintain blinding. Quantitative and qualitative process evaluation metrics will be collected to evaluate factors related to implementation. A budget impact analysis will be performed. SUMMARY: This pragmatic trial compares the outcomes, cost, and implementation of two forms of CBT-CP as delivered in the real-world setting. Findings from the trial can be used to guide future policy and implementation efforts related to these interventions and their use in the health system. If one of the interventions emerges as superior, resources can be directed to this modality. If both treatments are effective, patient preferences and health care system factors will take precedence when making referrals. Implications of COVID-19 on treatment provision and trial outcomes are discussed.

The international prevalence and variability of nonadherence to the nonpharmacologic treatment regimen after heart transplantation: Findings from the cross-sectional BRIGHT study.

INTRODUCTION: Heart transplant (HTx) recipients need to follow a complex therapeutic regimen. We assessed the international prevalence and variability in nonadherence to six nonpharmacologic treatment components (physical activity, sun protection, diet, alcohol use, nonsmoking, and outpatient follow-up visits). METHODS: We used self-report data of 1397 adult HTx recipients from the 36-HTx-center, 11-country, 4-continent, cross-sectional BRIGHT study (ClinicalTrials.gov ID: NCT01608477). The nonadherence definitions used were as follows: Physical activity: <3 times/wk 20 minutes' vigorous activity, <5 times/wk 30 minutes' moderate activity, or <5 times/wk a combination of either intensity; Sun protection: not "always" applying any sun protection; Diet: not "often" or "always" following recommended diet(s); Alcohol use: >1 alcoholic drink/d (women) or >2 drinks/d (men); Smoking: current smokers or stopped <1 year before; Follow-up visits: missing ≥1 of the last 5 outpatient follow-up visits. Overall prevalence figures were adjusted to avoid over- or underrepresentation of countries. Between-country variability was assessed within each treatment component via chi-square testing. RESULTS: The adjusted study-wide nonadherence prevalence figures were as follows: 47.8% for physical activity (95% CI [45.2-50.5]), 39.9% for sun protection (95% CI [37.3-42.5]), 38.2% for diet recommendations (95% CI [35.1-41.3]), 22.9% for alcohol consumption (95% CI [20.8-25.1]), 7.4% for smoking cessation (95% CI [6.1-8.7]), and 5.7% for follow-up visits (95% CI [4.6-6.9]). Significant variability was observed between countries in all treatment components except follow-up visits. CONCLUSION: Nonadherence to the post-HTx nonpharmacologic treatment regimen is prevalent and shows significant variability internationally, suggesting a need for tailored adherence-enhancing interventions.

New Developments in the Prophylactic Drug Treatment of Pediatric Migraine: What Is New in 2017 and Where Does It Leave Us?

PURPOSE OF REVIEW: Headaches in children are quite common; however, the study and characterization of headache disorders in the pediatric age group has historically been limited. Because of the lack of controlled studies on prophylactic treatment of headache disorders in this age group, the diagnosis of migraine rests on criteria similar those in adults. Likewise, data from adult studies is often inferred and applied to children. Although it appears that many preventives are safe in children, currently none are FDA or EMA approved for this age group. Consequently, many children who present to their primary care physicians with migraines do not receive any preventive therapy despite experiencing significant disability. RECENT FINDINGS: Controlled clinical trials investigating the use of preventive medications in children have suffered from high placebo response rates. The shorter duration of headaches and other characteristic features seen in children are such that designing randomized controlled trials in this age group is more problematic and limiting. Treatment practices vary widely, even among specialists, due to the absence of evidence-based guidelines from clinical trials. The Childhood and Adolescent Migraine Prevention Study (CHAMP) was developed to examine the effectiveness of two of the most widely prescribed preventive medications for pediatric migraine and help narrow this gap. To date, it has been the largest enrolling study of its kind within the pediatric migraine world; its results and implications will be discussed and considered here. The CHAMP trial was discontinued early on account of futility and exhibited that neither of two preventive medications for pediatric migraine was more effective than placebo in reducing the number of headache days over a period of 24 weeks. Subjects in the amitriptyline and topiramate groups had higher rates of adverse events than those who had received placebo.

Preliminary outcomes of a pilot physical therapy program for HIV-infected patients with chronic pain.

Chronic pain in HIV-infected individuals is common and often undertreated. Physical therapy (PT) is an evidence-based nonpharmacologic treatment for chronic pain. Our objective is to present the results of a pilot PT program in an HIV pain/palliative care clinic, which is embedded within a Ryan White-funded multidisciplinary HIV primary care clinic. Medical records of HIV-infected patients participating in a PT program between November 2012 and July 2013 were retrospectively reviewed. Pain scores on a 0-10 scale and cost data were collected and analyzed. Among 43 patients referred, 27 collectively attended 86 sessions. Median age of enrolled patients was 54 (IQR 49-58). Sixteen (59%) were African-American and 20 (77%) had an undetectable HIV viral load. Mean pain score at initial visit was 6.5 (SD = 1.1). The average session-level decrease was 2.6 (SD = 1.7) and patient-level decrease was 2.5 (SD = 1.2). The largest payors were Medicare managed care (28%), Medicaid (21%), and Ryan White grant-related funds (18%). When the first four months of the program are excluded to account for slow start-up, the program's monthly net revenue during the remaining five months was $163. We present preliminary data from a low-cost pilot PT program integrated into an HIV clinic in a primary care setting associated with clinically significant improvements in pain. Further investigation into the implementation of such programs is essential.

Therapeutical Approach to Arterial Hypertension - Current State of the Art.

Arterial hypertension (AH) is recognized as the most common illness within the group of cardiovascular diseases and the most massive chronic non-infectious disease in the world. The number of hypertensive patients worldwide has reached 1.28 billion, contributing to an increase in cardiovascular diseases and premature death globally. The high prevalence of hypertension emphasizes the importance of effectively treating this condition. Elevated blood pressure often leads to lethal complications (heart failure, stroke, renal disorders, etc.) if left untreated. Considering an increase in AH prevalence in the future, a successful therapeutical approach to this disease and its complications is essential. The goal of AH treatment is to maintain normotensive blood pressure through various approaches, including lifestyle changes, a well-balanced diet, increased physical activity, psychoeducation, and, when necessary, pharmacotherapy. The evolving pharmacotherapeutic landscape reflects the progress made in our understanding of hypertension and emphasizes the need for continuous innovation to meet the challenges posed by this prevalent global health concern. The journey toward more effective and tailored treatments for hypertension is ongoing, and the introduction of new medications plays a pivotal role in shaping the future of antihypertensive pharmacotherapy.

Proceedings of the 2022 "Lifestyle Intervention for Epilepsy (LIFE)" symposium hosted by Cleveland Clinic.

Lifestyle interventions are strategies used to self-manage medical conditions, such as epilepsy, and often complement traditional pharmacologic and surgical therapies. The need for integrating evidence-based lifestyle interventions into mainstream medicine for the treatment of epilepsy is evident given that despite the availability of a multitude of treatments with medications and surgical techniques, a significant proportion of patients have refractory seizures, and even those who are seizure-free report significant adverse effects with current treatments. Although the evidence base for complementary medicine is less robust than it is for traditional forms of medicine, the evidence to date suggests that several forms of complementary medicine including yoga, mindfulness meditation, cognitive behavioral therapy, diet and nutrition, exercise and memory rehabilitation, and music therapy may have important roles as adjuncts in the treatment armamentarium for epilepsy. These topics were discussed by a diverse group of medical providers and scientists at the "Lifestyle Intervention for Epilepsy (LIFE)" symposium hosted by Cleveland Clinic. PLAIN LANGUAGE SUMMARY: There are many people with epilepsy who continue to have seizures even though they are being treated with medication or brain surgery. Even after seizures stop, some may experience medication side effects. There is research to suggest that certain lifestyle changes, such as yoga, mindfulness, exercise, music therapy, and adjustments to diet, could help people with epilepsy, when used along with routine treatment. Experts discussed the latest research at the "Lifestyle Intervention for Epilepsy (LIFE)" symposium hosted by Cleveland Clinic.

Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial.

BACKGROUND: Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use. METHODS: As part of the National Institutes of Health Helping to End Addiction Long-term® (NIH HEAL) initiative, we designed and implemented a comparative effectiveness, 3-arm randomized control trial comparing remotely delivered telephonic/video and online CBT-CP-based services to usual care for patients with high-impact chronic pain. The RESOLVE trial is being conducted in 4 large integrated healthcare systems located in Minnesota, Georgia, Oregon, and Washington state and includes demographically diverse populations residing in urban and rural areas. The trial compares (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program; and (2) a previously developed and tested 8-session online CBT-CP-based program (painTRAINER) to (3) usual care augmented by a written guide for chronic pain management. Participants are followed for 1 year post-allocation and are assessed at baseline, and 3, 6, and 12 months post-allocation. The primary outcome is minimal clinically important difference (MCID; ≥ 30% reduction) in pain severity (composite of pain intensity and pain-related interference) assessed by a modified 11-item version of the Brief Pain Inventory-Short Form at 3 months. Secondary outcomes include pain severity, pain intensity, and pain-related interference scores, quality of life measures, and patient global impression of change at 3, 6, and 12 months. Cost-effectiveness is assessed by incremental cost per additional patient with MCID in primary outcome and by cost per quality-adjusted life year achieved. Outcome assessment is blinded to group assignment. DISCUSSION: This large-scale trial provides a unique opportunity to rigorously evaluate and compare the clinical and cost-effectiveness of 2 relatively low-cost and scalable modalities for providing CBT-CP-based treatments to persons with high-impact chronic pain, including those residing in rural and other medically underserved areas with limited access to these services. TRIAL REGISTRATION: ClinicalTrials.gov NCT04523714. This trial was registered on 24 August 2020.

STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM): Extending the CONSORT statement.

OBJECTIVES: Massage is a common therapy of nonpharmacological treatments, particularly in Tuina (Chinese massage) as its most common style, detailed guidance in reporting the intervention is warranted for its evaluation and replication. Based on the CONSORT (Consolidated Standards of Reporting Trials), we aimed to develop an Extension for Tuina/Massage, namely "The STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM)." METHODS: A group of professional clinicians, trialists, methodologists, developers of reporting guidelines, epidemiologists, statisticians, and editors has developed this STRICTOTM checklist through a standard methodology process recommended by the EQUATOR (Enhancing the QUAlity and Transparency of Health Research) Network, including prospective registration, literature review, draft of the initial items, three rounds of the Delphi survey, consensus meeting, pilot test, and finalization of the guideline. RESULTS: A checklist of seven items (namely Tuina/Massage rationale, details of Tuina/Massage, intervention regimen, other components of the intervention, Tuina/Massage provider background, control or comparator interventions, and precaution measures), and 16 subitems were developed. Explanations and examples (E&E) for each item are also provided. CONCLUSIONS: The working group hopes that the STRICTOTM, in conjunction with both the CONSORT statement and extension for nonpharmacologic treatment, can improve the reporting quality and transparency of Tuina/Massage clinical research.

Willingness to use nonpharmacologic treatments for musculoskeletal pain in the emergency department: a cross-sectional study.

Objectives: Pain is an individual experience that should incorporate patient-centered care. This study seeks to incorporate patient perspectives toward expanding nonpharmacologic treatment options for pain from the emergency department (ED). Methods: In this cross-sectional study of adult patients in ED with musculoskeletal neck, back, or extremity pain, patient-reported outcomes were collected including willingness to try and prior use of various nonpharmacologic pain treatments, sociodemographics, clinical characteristics, functional outcomes, psychological distress, and nonmusculoskeletal symptoms. Least absolute shrinkage and selection operator regression identified variables associated with (1) willingness to try and (2) having previously tried nonpharmacologic treatments. Results: Responses were analyzed from 206 adults, with a mean age of 45.4 (SD 16.4) years. The majority (90.3%) of patients in ED were willing to try at least one form of nonpharmacologic pain treatment, with 70.4%, 81.6%, and 70.9% willing to try respective subcategories of active (eg, exercise), passive (eg, heat), and psychosocial (eg, prayer) modalities. Only 56.3% of patients had previously tried any, with 35.0%, 52.4%, and 41.3% having tried active, passive, and psychosocial modalities, respectively. Patient-level factors associated with willingness included pain in upper back, more severe pain-related symptoms, and functional impairments. The factor most consistently associated with treatment use was health care provider encouragement to do so. Conclusions: Patients in ED report high willingness to try nonpharmacologic treatments for pain. Higher pain severity and interference may indicate greater willingness, while health care provider encouragement correlated with treatment use. These findings may inform future strategies to increase the introduction of nonpharmacologic treatments from the ED.

Drugs Used in Narcolepsy and Other Hypersomnias.

Lifestyle adjustment, in combination with symptomatic pharmacologic treatment, allows most patients, particularly those with an inability to stay awake during the day, to live a relatively normal life. New pharmacologic substances show encouraging results in phase 2 and 3 studies to improve the current situation. More dedicated studies in IH, particularly in those who suffer from an increased need for sleep, are needed.

The Management of Anxiety and Depression in Pediatrics.

Anxiety and depression are among the most common psychiatric conditions affecting children and adolescents, and physicians in primary care settings often represent the first point of contact for these patients. Therefore, it is critical to provide these clinicians with an overview of current, evidence-based approaches for treating these conditions in pediatric and adolescent patients. Cognitive behavioral therapy (CBT) is an appropriate and effective first-line intervention for anxiety disorders in children and adolescents. For depressive disorders, treatment guidelines recommend either CBT or interpersonal therapy (IPT) as frontline treatment approaches. Pharmacologically, selective serotonin reuptake inhibitors (SSRIs) represent the most efficacious treatment for anxiety and depressive disorders in young persons. Combination therapies consisting of a psychotherapy plus an SSRI have produced greater therapeutic effects than either treatment alone. In particular, CBT plus sertraline is most effective in those with anxiety, whereas combining CBT or IPT with fluoxetine has been identified as the most effective treatment for depression in this population. Clinically, these combination therapies are especially useful in patients showing an insufficient response to treatment with only an SSRI or psychotherapy. A physician should also recommend lifestyle alterations to aid in the management of anxiety and depression, including diet, exercise, adequate sleep, limiting screen time, and spending time in nature. When used to complement standard treatment approaches, these interventions may provide the patient with additional symptom reduction while decreasing the return of symptoms in the long term.

Clinical Guidelines to Address Low Back Pain: Using the Evidence to Guide Physical Therapist Practice.

Low back pain (LBP) is a common musculoskeletal condition, a leading cause of disability, and one of the costliest medical conditions. Due to the adverse impact of LBP and the rising costs associated with it, there is a great need to implement consistent, evidence-based practice to improve the quality of care for patients suffering from LBP. It is critical that health care practitioners take steps to reduce reliance on pharmacologic interventions, such as opioids, and promote nonpharmacologic interventions for treating and managing LBP. Synthesized and summarized new research in an update to a clinical practice guideline (CPG), published in the November 2021 issue of JOSPT, supports health care providers as they adopt and implement nonpharmacologic interventions. J Orthop Sports Phys Ther 2021;51(11):533-534. doi:10.2519/jospt.2021.0507.

Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021.

Low back pain (LBP) remains a musculoskeletal condition with an adverse societal impact. Globally, LBP is highly prevalent and a leading cause of disability. This is an update to the 2012 Academy of Orthopaedic Physical Therapy (AOPT), formerly the Orthopaedic Section of the American Physical Therapy Association (APTA), clinical practice guideline (CPG) for LBP. The overall objective of this update was to provide recommendations on interventions delivered by physical therapists or studied in care settings that included physical therapy providers. It also focused on synthesizing new evidence, with the purpose of making recommendations for specific nonpharmacologic treatments. J Orthop Sports Phys Ther 2021;51(11):CPG1-CPG60. doi:10.2519/jospt.2021.0304.