A Critical Exploration of Migraine as a Health Disparity: the Imperative of an Equity-Oriented, Intersectional Approach.

PURPOSE OF REVIEW: Despite recognition of rising prevalence and significant burden, migraine remains underestimated, underdiagnosed, and undertreated. This is especially true among groups who have been historically, socially, and economically marginalized such as communities of color, women, people experiencing poverty, people with lower levels of education, and people who hold more than one of these marginalized identities. While there is growing public and professional interest in disparities in migraine prevalence, there is a paucity of research focusing on racial/ethnic and socioeconomic disparities, and the social and structural determinants of health and equity that perpetuate these disparities. From a health equity perspective, migraine research and treatment require an examination not only of biological and behavioral factors, but of these identities and underlying, intersecting social and structural determinants of health. RECENT FINDINGS: Significant disparities in migraine incidence, prevalence, migraine-related pain and disability, access to care, and quality of care persist among marginalized and underserved groups: African Americans, Hispanics, people experiencing poverty, un- or under-employment, the un- and under-insured, people who have been exposed to stressful and traumatic events across the lifespan, and people experiencing multiple, overlapping marginalized identities. These same groups are largely underrepresented in migraine research, despite bearing disproportionate burden. Current approaches to understanding health disparities in migraine largely assume an essentializing approach, i.e., documenting differences between single identity groups-e.g., race or income or education level-rather than considering the mechanisms of disparities: the social and structural determinants of health. While disparities in migraine are becoming more widely acknowledged, we assert that migraine is more aptly understood as a health equity issue, that is, a condition in which many of the health disparities are avoidable. It is important in research and clinical practice to consider perspectives that incorporate a cultural understanding of racial, ethnic, and socioeconomic identity within and across all levels of society. Incorporating perspectives of intersectionality provides a strong foundation for understanding the role of these complex combination of factors on migraine pain and treatment. We urge the adoption of intersectional and systems perspectives in research, clinical practice, and policy to examine (1) interplay of race, gender, and social location as key factors in understanding, diagnosing, and treating migraine, and (2) the complex configurations of social and structural determinants of health that interact to produce health inequities in migraine care. An intentional research and clinical focus on these factors stands to improve how migraine is identified, documented, and treated among marginalized populations.

A Qualitative, Systems Thinking Approach to Study Self-Management in Women With Migraine.

BACKGROUND: A dearth of effective and affordable treatment options has rendered nonpharmacological self-management a crucial part of living with migraine-a debilitating neurobiological condition without cure that disproportionately disables vulnerable women. OBJECTIVE: The aim of the study was to describe the development and use of a systems thinking, problem-structuring data collection approach that was applied to the study of migraine self-management with women in diverse social locations. METHODS: Two systems mapping activities were developed for use in focus groups: one to unpack a migraine episode (system support map) and the other (connection circle [CC]) to construct a mental model of self-management. Later in the process, a strengths-based problem-solving tool was developed to replace the CC. RESULTS: The CCs-often enlightening for affluent participants-left marginalized women feeling overwhelmed and defeated, as a solution to one challenge became the cause of another. Through constant comparison analysis, we recalibrated the approach using a theory, clinical experience, and participant feedback and replaced the CC with a strengths-based problem-solving activity highlighting relationships and trade-offs in a more agential, actionable way. DISCUSSION: Bringing a critical lens and strengths-based approaches to work with vulnerable populations can replace traditional deficit thinking in healthcare, developing options for leveraging resources and understanding complex health behaviors without losing sight of systemic, distributional justice issues. These systems thinking tools can provide a way to extrapolate the complexities of actual self-management behaviors and challenges faced by vulnerable women with migraine versus what they may be instructed to do by a medical model that does not always account for the social and structural determinants of equity and health.

Role of Acupuncture in the Treatment or Prevention of Migraine, Tension-Type Headache, or Chronic Headache Disorders.

OBJECTIVE: To summarize the current evidence that evaluates the effectiveness of acupuncture for the treatment or prevention of migraine, tension-type headache, and chronic headache disorders. METHODS: Findings from selected systematic reviews and meta-analyses are summarized. RESULTS: Recently published systematic reviews and meta-analyses demonstrate that acupuncture is associated with improved clinical outcomes compared to routine care only, medical management, and sham acupuncture 2 months after randomization. The evidence in support of acupuncture's comparative effectiveness at longer follow-up periods is mixed. Cost effectiveness analyses conducted in the United Kingdom and Germany suggest that acupuncture is a cost-effective treatment option in those countries. There are few or no cost-effectiveness studies of acupuncture in the United States. DISCUSSION: This brief review of the current, published evidence does not include a discussion of potential risks or adverse events associated with acupuncture. There is also the question of the extent to which placebo effects might contribute to acupuncture's clinical effectiveness. From a purely comparative effectiveness perspective, however, the evidence from clinical trials and meta-analyses makes a compelling case in support of a potentially important role for acupuncture as part of a treatment plan for patients with migraine, tension-type headache, and several different types of chronic headache disorders.

Future Research Prioritization: Implantable Cardioverter-Defibrillator Therapy in Older Patients.

BACKGROUND: Although the implantable cardioverter-defibrillator (ICD) is highly effective therapy for preventing sudden cardiac death, there is considerable uncertainty about its benefits and harms in older patients, especially in the presence of factors, other than old age, that increase the risk of death. OBJECTIVE: To develop a prioritized research agenda for the Patient-Centered Outcomes Research Institute as informed by a diverse group of stakeholders on the use and outcomes of the ICD in older patients. DESIGN: The existing literature was reviewed to identify evidence gaps, which were then refined by engaged stakeholders. Using a forced-ranking prioritization method, the stakeholders ranked evidence gaps by importance. For the highest-ranked evidence gaps, relevant recent studies were identified using PubMed, and relevant ongoing trials were identified using ClinicalTrials.gov. PARTICIPANTS: Eighteen stakeholders, including clinical experts and researchers in the prevention of sudden cardiac death and ICD therapy, representatives from federal and non-governmental funding agencies, representatives from relevant professional societies, health care decision-makers and policymakers, and representatives from related consumer and patient advocacy groups KEY RESULTS: The top 12 evidence gaps prioritized by stakeholders were related to the safety and effectiveness of ICDs in older patient subgroups not well represented in clinical trials, predictors of SCD, the impact of the ICD on quality of life, the use of shared decision-making, disparities in ICD use, risk stratification strategies, patient preferences, and distribution of modes of death in older patients. CONCLUSIONS: In this paper, we identify evidence gaps of high priority for current and future investigations of ICD therapy. Addressing these gaps will likely resolve many of the uncertainties surrounding the use and outcomes of the ICD in older patients seen in clinical practice.

Effectiveness of Exercise Programs for Management of Shoulder Pain in Manual Wheelchair Users With Spinal Cord Injury.

BACKGROUND AND PURPOSE: Shoulder pain is prevalent in manual wheelchair users (MWUs) with spinal cord injury (SCI). Therapeutic exercise has been demonstrated to be an effective, conservative approach to treating shoulder pain in able-bodied individuals. We sought to evaluate literature on the effectiveness of exercise programs on the reduction of shoulder pain in MWUs with SCI. METHODS: We searched the literature, using search terms related to SCI, manual wheelchairs, and shoulder pain. Eligibility criteria included prospective study design, exercise intervention for MWUs with shoulder pain, and use of the Wheelchair User's Shoulder Pain Index as an outcome measure. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and assessed study quality. RESULTS: Three randomized control trials and 4 cohort studies met inclusion criteria. Two studies were rated as good quality and 5 as fair quality. Three interventions were evaluated in the included studies: arm ergometry, resistive strengthening with or without electromyographic biofeedback, and stretching that targeted the muscles of the shoulder girdle. Across the 7 studies, the exercise intervention was associated with reduction in shoulder pain that exceeded the estimated minimal detectable change of 5.10 points for the Wheelchair Users' Shoulder Pain Index. DISCUSSION AND CONCLUSION: Exercise is a feasible, conservative, therapeutic intervention for the treatment of shoulder pain among MWUs. Additional studies are needed to differentiate techniques for the reduction of shoulder pain, to determine the most effective duration of intervention, and to estimate the magnitude of effect associated with therapeutic exercise for shoulder pain among MWUs.Video Abstract available for more insights from the authors (see Supplemental Digital Content 1, http://links.lww.com/JNPT/A116).

Prioritization of research addressing management strategies for ductal carcinoma in situ.

Ductal carcinoma in situ is a common finding in women having mammography screening, and there is considerable uncertainty about the balance of harms and benefits of different management options. This article outlines the process for developing a prioritized research agenda for the Patient-Centered Outcomes Research Institute as informed by a diverse group of stakeholders on the management of ductal carcinoma in situ. Evidence gaps were identified by reviewing existing literature and engaging diverse stakeholders to refine these gaps. Stakeholders ranked evidence gaps by importance from their perspectives using a forced-ranking prioritization method. PubMed was searched for relevant recent studies, and ClinicalTrials.gov was searched for relevant ongoing trials for the 10 highest-ranked evidence gaps. Strengths and limitations of different study designs were assessed to address gaps. Stakeholders prioritized evidence gaps related to incorporation of patient-centered outcomes into future research, development of better methods to predict risk for invasive cancer, evaluation of a strategy of active surveillance, and testing of decision-making tools. The degree to which prioritized evidence gaps may have already been addressed is uncertain because a comprehensive systematic review has not been done.

Prioritization of patient-centered comparative effectiveness research for osteoarthritis.

Osteoarthritis is a leading cause of disability in the United States. This article describes a prioritized research agenda about osteoarthritis management developed for the Patient-Centered Outcomes Research Institute. Evidence gaps were identified by reviewing existing literature and engaging diverse stakeholders to expand and refine gaps. Stakeholders ranked evidence gaps by importance from their perspectives.Prioritized evidence gaps included the need to determine or evaluate key patient-centered outcomes; optimal duration, intensity, and frequency of nonsurgical interventions; whether the comparative effectiveness of nonsurgical interventions varies by socioeconomic factors; when and how to transition from nonsurgical to surgical interventions; effective ways to engage patients in self-management and promote long-term behavior change; standardized screening tools that improve early diagnosis; biomechanical strategies that improve symptoms; mechanisms for promoting and delivering coordinated, longitudinal care; and comparative effectiveness of nonsurgical therapies. Searches of PubMed and ClinicalTrials.gov showed many recent and ongoing studies addressing comparative effectiveness of nonsurgical interventions; relatively few of these evaluated treatments across categories (for example, drug therapy vs. weight management) or combined categories of treatment. Few studies addressed other high-priority evidence gaps.

Prioritization of research addressing antipsychotics for adolescents and young adults with bipolar disorder.

Despite a paucity of high-quality evidence about benefits and harms, antipsychotic medication use among adolescents and young adults with bipolar disorder is increasing. The Patient-Centered Outcomes Research Institute tasked the Duke Evidence Synthesis Group with creating a prioritized agenda for research in this area that would incorporate the perspectives of relevant stakeholders. We identified a list of potential evidence gaps by reviewing existing literature and engaged a diverse group of 9 stakeholders to expand and refine this list. Using a forced-ranking prioritization method, stakeholders prioritized 10 of 23 potential evidence gaps as the most pressing for future research. These evidence gaps relate to 3 areas: the comparative effectiveness of intervention strategies, the effect of antipsychotics on patient-centered outcomes, and the influence of various patient characteristics on antipsychotic effectiveness. In addition to presenting these findings, we suggest appropriate study designs for addressing the stakeholder-prioritized research questions.

Transitional care after hospitalization for acute stroke or myocardial infarction: a systematic review.

BACKGROUND: Transitional care is a time-limited service to prevent discontinuous care and adverse outcomes, including rehospitalization. PURPOSE: To describe transitional care interventions and evidence of benefit or harm in patients hospitalized for acute stroke or myocardial infarction (MI). DATA SOURCES: Cumulative Index to Nursing and Allied Health Literature, MEDLINE, Cochrane Database of Systematic Reviews, and EMBASE, supplemented with manual searches of reference lists of relevant studies and review articles (January 2000 to March 2012). STUDY SELECTION: 6 reviewers screened 5857 citations to identify English-language reports of trials or observational studies that compared transitional care with usual care among adults hospitalized for stroke or MI and that reported patient, caregiver, process, or systems outcomes within 1 year of hospital discharge. DATA EXTRACTION: Data on study design, quality, population, intervention characteristics, and patient- and system-level outcomes were extracted by 3 reviewers and confirmed by 1 additional reviewer. DATA SYNTHESIS: 62 articles representing 44 studies of transitional care for either acute stroke (27 studies) or MI (17 studies). Four intervention types were studied: hospital-initiated support (n = 14), patient and family education (n = 7), community-based support (n = 20), and chronic disease management (n = 3). Most studies (68%) were of fair quality. Overall, moderate-strength evidence showed that hospital-initiated support reduced length of stay for patients who had a stroke, and low-strength evidence showed that it reduced mortality for patients who had an MI. Evidence about benefits of other interventions and harms from transitional care services was insufficient. LIMITATIONS: Few studies had high-quality research designs. The usual care comparator was often poorly defined. Applicability to U.S. clinical practice was limited; only 6 studies were conducted in the United States. CONCLUSION: Available evidence shows that hospital-initiated transitional care can improve some outcomes in adults hospitalized for stroke or MI. Finding additional transitional care interventions that improve functional outcomes and prevent rehospitalizations and adverse events is a high priority for the growing population of patients who have an MI or a stroke. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Effect of clinical decision-support systems: a systematic review.

BACKGROUND: Despite increasing emphasis on the role of clinical decision-support systems (CDSSs) for improving care and reducing costs, evidence to support widespread use is lacking. PURPOSE: To evaluate the effect of CDSSs on clinical outcomes, health care processes, workload and efficiency, patient satisfaction, cost, and provider use and implementation. DATA SOURCES: MEDLINE, CINAHL, PsycINFO, and Web of Science through January 2011. STUDY SELECTION: Investigators independently screened reports to identify randomized trials published in English of electronic CDSSs that were implemented in clinical settings; used by providers to aid decision making at the point of care; and reported clinical, health care process, workload, relationship-centered, economic, or provider use outcomes. DATA EXTRACTION: Investigators extracted data about study design, participant characteristics, interventions, outcomes, and quality. DATA SYNTHESIS: 148 randomized, controlled trials were included. A total of 128 (86%) assessed health care process measures, 29 (20%) assessed clinical outcomes, and 22 (15%) measured costs. Both commercially and locally developed CDSSs improved health care process measures related to performing preventive services (n= 25; odds ratio [OR], 1.42 [95% CI, 1.27 to 1.58]), ordering clinical studies (n= 20; OR, 1.72 [CI, 1.47 to 2.00]), and prescribing therapies (n= 46; OR, 1.57 [CI, 1.35 to 1.82]). Few studies measured potential unintended consequences or adverse effects. LIMITATIONS: Studies were heterogeneous in interventions, populations, settings, and outcomes. Publication bias and selective reporting cannot be excluded. CONCLUSION: Both commercially and locally developed CDSSs are effective at improving health care process measures across diverse settings, but evidence for clinical, economic, workload, and efficiency outcomes remains sparse. This review expands knowledge in the field by demonstrating the benefits of CDSSs outside of experienced academic centers. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

ECG-based signal analysis technologies for evaluating patients with acute coronary syndrome: a systematic review.

BACKGROUND/OBJECTIVES: Timely identification of cardiac ischemia is critical in patients with acute coronary syndrome (ACS). The first test is often the standard, resting 12-lead ECG. Given its limitations, signal analysis enhancements have been proposed. We summarize the published evidence for commercially available ECG-based signal analysis technologies. METHODS: This is a systematic review of the English-language published literature. RESULTS: Published evidence meeting inclusion criteria was available for two devices: PRIME ECG and LP 3000. Meta-analysis of eight studies estimated a 68.4% sensitivity (95% CI, 35.1%-89.7%) and 91.4% specificity (CI, 83.6%-95.7%) for the PRIME ECG, compared with 40.5% sensitivity (CI, 19.6%-65.5%) and 95.0% specificity (CI, 87.9%-98.0%) for the standard 12-lead ECG. CONCLUSIONS: Existing evidence is insufficient to confidently inform the appropriate use of ECG-based signal analysis technologies for detecting ischemia or infarct in ACS. Further research is needed to determine in what circumstances, if any, these devices might precede, replace, or add to the standard ECG in test strategies for detecting ischemia or infarct in ACS.

Acupuncture for the treatment or management of chronic pain.

Evidence supports the safety and efficacy of acupuncture compared with no treatment, but it is unclear what role the placebo effect plays in acupuncture's efficacy. In determining whether acupuncture is indicated for a given individual or patient population, clinicians should consider acupuncture's effectiveness compared with no acupuncture--as well as the effectiveness, safety, and cost of alternative types of treatment.

Updated report on comparative effectiveness of ACE inhibitors, ARBs, and direct renin inhibitors for patients with essential hypertension: much more data, little new information.

OBJECTIVES: A 2007 systematic review compared angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) in patients with hypertension. Direct renin inhibitors (DRIs) have since been introduced, and significant new research has been published. We sought to update and expand the 2007 review. DATA SOURCES: We searched MEDLINE and EMBASE (through December 2010) and selected other sources for relevant English-language trials. STUDY ELIGIBILITY CRITERIA, PARTICIPANTS, AND INTERVENTIONS: We included studies that directly compared ACE inhibitors, ARBs, and/or DRIs in at least 20 total adults with essential hypertension; had at least 12 weeks of follow-up; and reported at least one outcome of interest. Ninety-seven (97) studies (36 new since 2007) directly comparing ACE inhibitors versus ARBs and three studies directly comparing DRIs to ACE inhibitor inhibitors or ARBs were included. STUDY APPRAISAL AND SYNTHESIS METHODS: A standard protocol was used to extract data on study design, interventions, population characteristics, and outcomes; evaluate study quality; and summarize the evidence. RESULTS: In spite of substantial new evidence, none of the conclusions from the 2007 review changed. The level of evidence remains high for equivalence between ACE inhibitors and ARBs for blood pressure lowering and use as single antihypertensive agents, as well as for superiority of ARBs for short-term adverse events (primarily cough). However, the new evidence was insufficient on long-term cardiovascular outcomes, quality of life, progression of renal disease, medication adherence or persistence, rates of angioedema, and differences in key patient subgroups. LIMITATIONS: Included studies were limited by follow-up duration, protocol heterogeneity, and infrequent reporting on patient subgroups. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: Evidence does not support a meaningful difference between ACE inhibitors and ARBs for any outcome except medication side effects. Few, if any, of the questions that were not answered in the 2007 report have been addressed by the 36 new studies. Future research in this area should consider areas of uncertainty and be prioritized accordingly.

Systematic review of disease-modifying antirheumatic drugs for juvenile idiopathic arthritis.

BACKGROUND: Treatment of juvenile idiopathic arthritis (JIA) with disease-modifying antirheumatic drugs (DMARDs) may improve outcomes compared to conventional therapy (e.g., non-steroidal anti-inflammatory drugs, intra-articular corticosteroids). The purpose of this systematic review was to evaluate the comparative effectiveness and safety of DMARDs versus conventional therapy and versus other DMARDs. RESULTS: A systematic evidence review of 156 reports identified in MEDLINE®, EMBASE®, and by hand searches. There is some evidence that methotrexate is superior to conventional therapy. Among children who have responded to a biologic DMARD, randomized discontinuation trials suggest that continued treatment decreases the risk of having a flare. However, these studies evaluated DMARDs with different mechanisms of action (abatacept, adalimumab, anakinra, etanercept, intravenous immunoglobulin, tocilizumab) and used varying comparators and follow-up periods. Rates of serious adverse events are similar between DMARDs and placebo in published trials. This review identified 11 incident cases of cancer among several thousand children treated with one or more DMARD. CONCLUSIONS: Few data are available to evaluate the comparative effectiveness of either specific DMARDs or general classes of DMARDs. However, based on the overall number, quality, and consistency of studies, there is moderate strength of evidence to support that DMARDs improve JIA-associated symptoms. Limited data suggest that short-term risk of cancer is low.

Percutaneous heart valve replacement for aortic stenosis: state of the evidence.

Surgical aortic valve replacement (SAVR) is the only treatment known to improve symptoms and survival in patients with severe, symptomatic aortic stenosis. Perioperative mortality, however, is high among many patients for whom SAVR may be indicated. Percutaneous heart valve replacement (PHVR) is an emerging, catheter-based technology that allows for implantation of a prosthetic valve without open heart surgery. This review describes the available literature on PHVR for aortic stenosis, which comprised 84 published reports representing 76 distinct studies and 2375 unique patients. Successful implantation was achieved in 94% of patients; 30-day survival was 89%. Differences between patients undergoing PHVR and those typically selected for SAVR make full interpretation of these results difficult. A large, multicenter, randomized, controlled trial comparing PHVR with SAVR or medical management was recently completed, with initial results expected in September 2010. Pending publication of findings from that trial, the available evidence is inadequate to determine the most appropriate clinical role of PHVR or the specific patient populations for whom it might eventually be indicated.

Acupuncture for Improving Chronic Back Pain, Osteoarthritis and Headache.

OBJECTIVE: To conduct a critical review of the literature on acupuncture for chronic back pain, osteoarthritis and headache. METHODS: Review of meta-analyses, systematic reviews and some well-conducted, recent studies. RESULTS: Overall, acupuncture appears superior to no treatment or usual care for persons with chronic back pain, osteoarthritis, or headache. However, these findings vary depending on the specific outcome and the follow-up period. The magnitude of the effect varies, but is consistent with a small to moderate effect size in most cases. Moreover, acupuncture is not clearly superior to sham acupuncture, although the latter is a controversial control group. Acupuncture has a favorable safety profile, with relatively few side effects and serious ones quite rare. Limited evidence suggests that acupuncture is a cost effective treatment. CONCLUSIONS: The evidence suggests that acupuncture is a reasonable therapeutic option, but not the clear therapy of choice for any of these conditions. Acupuncture may be especially valuable for patients who prefer it to other options or are concerned about using analgesic medications.

A pooled analysis of three studies of nonpharmacological interventions for menopausal hot flashes.

OBJECTIVE: The aim of the study was to conduct a pooled analysis of three published trials of nonpharmacological interventions for menopausal hot flashes to compare the effectiveness of interventions. METHODS: Data from three randomized controlled trials of interventions for hot flashes (two acupuncture trials, one yoga trial) were pooled. All three studies recruited perimenopausal or postmenopausal women experiencing ≥4 hot flashes/d on average. The primary outcome for all three studies was frequency of hot flashes as measured by the Daily Diary of Hot Flashes. Study 1 participants were randomly assigned to 8 weeks of acupuncture treatments (active intervention), sham acupuncture (attention control), or usual care. Study 2 participants were randomly assigned to 10 weeks of yoga classes, health and wellness education classes (attention control), or waitlist control. Study 3 randomly assigned participants to 6 months of acupuncture or waitlist control. To standardize the time frame for these analyses, only the first 8 weeks of intervention from all three studies were used. RESULTS: The three active interventions and the two attention control groups had statistically similar trends in the percentage reduction of hot flashes over 8 weeks, ranging from 35% to 40%. These five groups did not differ significantly from each other, but all showed significantly greater reduction in hot flash frequency compared with the three usual care/waitlist groups. CONCLUSION: Acupuncture, yoga, and health and wellness education classes all demonstrated statistically similar effectiveness in reduction of hot flash frequency compared with controls.

Nonpharmacological Self-Management of Migraine Across Social Locations: An Equity-Oriented, Qualitative Analysis.

BACKGROUND: Migraine is a disabling neurological disorder and the sixth biggest cause of disability worldwide. The World Health Organization has declared migraine a major public health problem due to a paucity of knowledge about cause and effective treatment options. Both in incidence and severity, migraine disproportionately affects people occupying marginalized social locations (SL). Managed pharmacologically, migraine is treated with daily preventive and as-needed abortive medications. Both come with high literal and figurative costs: intolerable side effects, medication interactions, and prohibitive prices. Cost prohibitive, ineffective, and unsustainable pharmacological treatment options have contributed to high levels of interest in complementary approaches by people with migraine, but little is known about their motivations, patterns of use or access, or how these may vary by SL. METHOD: We conducted focus groups with 30 people with migraine to explore their desires and recommendations for migraine clinicians and researchers. We used qualitative content analysis to identify themes.Outcomes: We identified 4 themes: a more holistic, collaborative, long-term treatment approach; medication as a short-term solution; high personal and economic costs of medication; and desire for more information and access to natural approaches. Across SL, participants expressed keen interest in integrative approaches and wanted better access to complementary modalities. Participants in marginalized SL described reliance on traditional/folk remedies, including engagement with family and community healers, who they described as more affordable and culturally accessible. CONCLUSIONS: Holistic and integrative approaches were preferred over medication as long-term migraine management strategies. However, people in marginalized SL, while disproportionately disabled by migraine, did not feel as comfortable accessing integrative approaches through currently available channels. Engaging with these communities and using a critical lens to explore barriers to access can develop options to make complementary modalities more approachable, while also attending to systemic blind spots that may unintentionally alienate socially marginalized groups.

Craniosacral therapy for migraine: protocol development for an exploratory controlled clinical trial.

BACKGROUND: Migraine affects approximately 20% of the population. Conventional care for migraine is suboptimal; overuse of medications for the treatment of episodic migraines is a risk factor for developing chronic daily headache. The study of non-pharmaceutical approaches for prevention of migraine headaches is therefore warranted. Craniosacral therapy (CST) is a popular non-pharmacological approach to the treatment or prevention of migraine headaches for which there is limited evidence of safety and efficacy. In this paper, we describe an ongoing feasibility study to assess the safety and efficacy of CST in the treatment of migraine, using a rigorous and innovative randomized controlled study design involving low-strength static magnets (LSSM) as an attention control intervention. METHODS: The trial is designed to test the hypothesis that, compared to those receiving usual care plus a treatment with low-strength static magnets (attention-control complementary therapy), subjects receiving usual medical care plus CST will demonstrate significant improvement in: quality-of-life as measured by the Headache Impact Test (HIT-6); reduced frequency of migraine; and a perception of clinical benefit. Criteria for inclusion are either gender, age > 11, English or Spanish speaking, meeting the International Classification of Headache Disorders (ICHD) criteria for migraine with or without aura, a headache frequency of 5 to 15 per month over at least two years. After an 8 week baseline phase, eligible subjects are randomized to either CST or an attention control intervention, low strength static magnets (LSSM). To evaluate possible therapist bias, videotaped encounters are analyzed to assess for any systematic group differences in interactions with subjects. RESULTS: 169 individuals have been screened for eligibility, of which 109 were eligible for the study. Five did not qualify during the baseline phase because of inadequate headache frequency. Nineteen have withdrawn from the study after giving consent. CONCLUSION: This report endorses the feasibility of undertaking a rigorous randomized clinical trial of CST for migraine using a standardized CST protocol and an innovative control protocol developed for the study. Subjects are able and willing to complete detailed headache diaries during an 8-week baseline period, with few dropouts during the study period, indicating the acceptability of both interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT00665236.