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The article offers the author's view on the Type 1 error rate in headache research. The author states that Type 1 error is the probability that null hypothesis is rejected when it is true. The author cites that the error sets a consistent threshold for judging the statistical inferences. The author also mentions the type of error sets which must be considered including pre-comparison, family wise, and experiment wise.

This clinical trial evaluated the independent and combined effects of a tricyclic antidepressant (desipramine) and cognitive behavioral therapy (CBT) for chronic back pain relative to an active placebo treatment. Participants (n = 142) were patients experiencing daily chronic back pain at an intensity of ≥4/10 who were randomized to a single-center, double-blind, 12-week, 4-arm, parallel groups controlled clinical trial of (1) low concentration desipramine titrated to reach a serum concentration level of 15 to 65 ng/mL; (2) CBT and active placebo medication (benztropine mesylate, 0.125 mg); (3) low concentration desipramine and CBT; and (4) active benztropine placebo medication. Participants completed the Differential Description Scale and Roland Morris Disability Questionnaires before and after treatment as validated measures of outcomes in back pain intensity and disability, respectively. Participants within each condition showed significant reductions from pre-treatment to post-treatment in pain intensity (mean changes ranged from = -2.58 to 3.87, Cohen's d's = 0.46-0.84) and improvements in pain disability (mean changes = -3.04 to 4.29, Cohen's d's = 0.54-0.88). However, intent-to-treat analyses at post-treatment showed no significant differences between any condition, with small effect sizes ranging from 0.06 to 0.27. The results from this clinical trial did not support the hypothesis that desipramine, CBT, or their combination would be statistically superior to an active medicine placebo for reducing chronic back pain intensity or disability. Key limitations included recruiting 71% of the planned sample size and use of multiple inclusion/exclusion criteria that may limit generalizability to broader populations of patients with chronic back pain. [ABSTRACT FROM AUTHOR]

Background Migraine is a neurological disease involving recurrent attacks of moderate-to-severe and disabling head pain. Worsening of pain with routine physical activity during attacks is a principal migraine symptom; however, the frequency, individual consistency, and correlates of this symptom are unknown. Given the potential of this symptom to undermine participation in daily physical activity, an effective migraine prevention strategy, further research is warranted. This study is the first to prospectively evaluate (a) frequency and individual consistency of physical activity-related pain worsening during migraine attacks, and (b) potential correlates, including other migraine symptoms, anthropometric characteristics, psychological symptoms, and daily physical activity. Methods Participants were women (n = 132) aged 18-50 years with neurologist-confirmed migraine and overweight/obesity seeking weight loss treatment in the Women's Health and Migraine trial. At baseline, participants used a smartphone diary to record migraine attack occurrence, severity, and symptoms for 28 days. Participants also completed questionnaires and 7 days of objective physical activity monitoring before and after diary completion, respectively. Patterning of the effect of physical activity on pain was summarized within-subject by calculating the proportion (%) of attacks in which physical activity worsened, improved, or had no effect on pain. Results Participants reported 5.5 ± 2.8 (mean ± standard deviation) migraine attacks over 28 days. The intraclass correlation (coefficient = 0.71) indicated high consistency in participants' reports of activity-related pain worsening or not. On average, activity worsened pain in 34.8 ± 35.6% of attacks, had no effect on pain in 61.8 ± 34.6% of attacks and improved pain in 3.4 ± 12.7% of attacks. Few participants (9.8%) reported activity-related pain worsening in all attacks. A higher percentage of attacks where physical activity worsened pain demonstrated small-sized correlations with more severe nausea, photophobia, phonophobia, and allodynia (r = 0.18 - 0.22, p < 0.05). Pain worsening due to physical activity was not related to psychological symptoms or total daily physical activity. Conclusions There is large variability in the effect of physical activity on pain during migraine attacks that can be accounted for by individual differences. For a minority of participants, physical activity consistently contributed to pain worsening. More frequent physical activity-related pain worsening was related to greater severity of other migraine symptoms and pain sensitivity, which supports the validity of this diagnostic feature. Study protocol ClinicalTrials.govIdentifier: NCT01197196. [ABSTRACT FROM AUTHOR]

The article discusses a study on whether headache triggers predict the cessation of an attack. The patients who participated in the study were asked to record headache activity and perceived stress, a headache trigger, in a diary for one month. The researchers considered the course of headache activity for either days after an attack had stopped or days after an attack had started to determine the impact of stress on eliciting a new attack or ceasing an existing attack.

Background Engagement in regular exercise routinely is recommended as an intervention for managing and preventing migraine, and yet empirical support is far from definitive. We possess at best a weak understanding of how aerobic exercise and resulting change in aerobic capacity influence migraine, let alone the optimal parameters for exercise regimens as migraine therapy (eg, who will benefit, when to prescribe, optimal types, and doses/intensities of exercise, level of anticipated benefit). These fundamental knowledge gaps critically limit our capacity to deploy exercise as an intervention for migraine. Overview Clear articulation of the markers and mechanisms through which aerobic exercise confers benefits for migraine would prove invaluable and could yield insights on migraine pathophysiology. Neurovascular and neuroinflammatory pathways, including an effect on obesity or adiposity, are obvious candidates for study given their role both in migraine as well as the changes known to accrue with regular exercise. In addition to these biological pathways, improvements in aerobic fitness and migraine alike also are mediated by changes in psychological and sociocognitive factors. Indeed a number of specific mechanisms and pathways likely are operational in the relationship between exercise and migraine improvement, and it remains to be established whether these pathways operate in parallel or synergistically. As heuristics that might conceptually benefit our research programs here forward, we: (1) provide an extensive listing of potential mechanisms and markers that could account for the effects of aerobic exercise on migraine and are worthy of empirical exploration and (2) present two exemplar conceptual models depicting pathways through which exercise may serve to reduce the burden of migraine. Conclusion Should the promise of aerobic exercise as a feasible and effective migraine therapy be realized, this line of endeavor stands to benefit migraineurs (including the many who presently remain suboptimally treated) by providing a new therapeutic avenue as an alternative or augmentative compliment to established interventions for migraine. [ABSTRACT FROM AUTHOR]

Objective To examine the potential influence of random measurement error on estimated rates of chronification and remission. Background Studies of headache chronification and remission examine the proportion of headache sufferers that move across a boundary of 15 headache days per month between 2 points in time. At least part of that apparent movement may represent measurement error or random variation in headache activity over time. Methods A mathematical simulation was conducted to examine the influence of varying degrees of measurement error on rates of chronic migraine onset and remission. Using data from the American Migraine Prevalence and Prevention Study, we estimated a starting distribution of headache days from 0 to 30 in the migraine population. Assuming various levels of measurement error, we then simulated 2 sets of data for Time 1 and Time 2. The 'individuals' in this study were assumed to have no real change in headache frequency from Time 1 to Time 2. The observed variations in headache frequency were those influenced by imputed random variance to resemble typical measurement error or natural variability. Using this simulation approach, we estimated the amount of chronification and remission rates that might be attributed simply to statistical artifacts such as unreliability or regression to the mean. Results As the degree of measurement error increased, the amounts of illusory chronification and remission increased substantially. For example, if the headache frequency of sufferers randomly varies by only 2 headache days each month due to chance alone, a substantial degree of illusory chronification (0.6% to 1.3%) and illusory remission (10.3% to 23.5%) rates are expected simply due to random variation. Conclusions Random variation, without real change, has the potential to influence estimated rates of progression and remission in longitudinal migraine studies. The magnitude of random variation needed to fully reproduce observed rates of progression and remission are implausibly large. Recommendations are offered to improve estimation of rates of progression and remission, reducing the influence of random variation. [ABSTRACT FROM AUTHOR]

Objectives To characterize the extent of measurement error arising from rounding in headache frequency reporting (days per month) in a population sample of headache sufferers. Background When reporting numerical health information, individuals tend to round their estimates. The tendency to round to the nearest 5 days when reporting headache frequency can distort distributions and engender unreliability in frequency estimates in both clinical and research contexts. Methods This secondary analysis of the 2005 American Migraine Prevalence and Prevention study survey characterized the population distribution of 30-day headache frequency among community headache sufferers and determined the extent of numerical rounding ('heaping') in self-reported data. Headache frequency distributions (days per month) were examined using a simplified version of Wang and Heitjan's approach to heaping to estimate the probability that headache sufferers round to a multiple of 5 when providing frequency reports. Multiple imputation was used to estimate a theoretical 'true' headache frequency. Results Of the 24,000 surveys, headache frequency data were available for 15,976 respondents diagnosed with migraine (68.6%), probable migraine (8.3%), or episodic tension-type headache (10.0%); the remainder had other headache types. The mean number of headaches days/month was 3.7 (standard deviation = 5.6). Examination of the distribution of headache frequency reports revealed a disproportionate number of responses centered on multiples of 5 days. The odds that headache frequency was rounded to 5 increased by 24% with each 1-day increase in headache frequency (odds ratio: 1.24, 95% confidence interval: 1.23 to 1.25), indicating that heaping occurs most commonly at higher headache frequencies. Women were more likely to round than men, and rounding decreased with increasing age and increased with symptoms of depression. Conclusions Because of the coarsening induced by rounding, caution should be used when distinguishing between episodic and chronic headache sufferers using self-reported estimates of headache frequency. Unreliability in frequency estimates is of particular concern among individuals with high-frequency (chronic) headache. Employing shorter recall intervals when assessing headache frequency, preferably using daily diaries, may improve accuracy and allow more precise estimation of chronic migraine onset and remission. [ABSTRACT FROM AUTHOR]

Objective The objective of this study was to explore the conditions necessary to assign causal status to headache triggers. Background The term 'headache trigger' is commonly used to label any stimulus that is assumed to cause headaches. However, the assumptions required for determining if a given stimulus in fact has a causal-type relationship in eliciting headaches have not been explicated. Methods A synthesis and application of Rubin's Causal Model is applied to the context of headache causes. From this application, the conditions necessary to infer that 1 event (trigger) causes another (headache) are outlined using basic assumptions and examples from relevant literature. Results Although many conditions must be satisfied for a causal attribution, 3 basic assumptions are identified for determining causality in headache triggers: (1) constancy of the sufferer, (2) constancy of the trigger effect, and (3) constancy of the trigger presentation. A valid evaluation of a potential trigger's effect can only be undertaken once these 3 basic assumptions are satisfied during formal or informal studies of headache triggers. Conclusions Evaluating these assumptions is extremely difficult or infeasible in clinical practice, and satisfying them during natural experimentation is unlikely. Researchers, practitioners, and headache sufferers are encouraged to avoid natural experimentation to determine the causal effects of headache triggers. Instead, formal experimental designs or retrospective diary studies using advanced statistical modeling techniques provide the best approaches to satisfy the required assumptions and inform causal statements about headache triggers. [ABSTRACT FROM AUTHOR]

Abstract: The objective of this study was to evaluate the time-series relationships between stress, sleep duration, and headache pain among patients with chronic headaches. Sleep and stress have long been recognized as potential triggers of episodic headache (<15 headachedays/month), though prospective evidence is inconsistent and absent in patients diagnosed with chronic headaches (⩾15days/month). We reanalyzed data from a 28-day observational study of chronic migraine (n=33) and chronic tension-type headache (n=22) sufferers. Patients completed the Daily Stress Inventory and recorded headache and sleep variables using a daily sleep/headache diary. Stress ratings, duration of previous nights’ sleep, and headache severity were modeled using a series of linear mixed models with random effects to account for individual differences in observed associations. Models were displayed using contour plots. Two consecutive days of either high stress or low sleep were strongly predictive of headache, whereas 2days of low stress or adequate sleep were protective. When patterns of stress or sleep were divergent across days, headache risk was increased only when the earlier day was characterized by high stress or poor sleep. As predicted, headache activity in the combined model was highest when high stress and low sleep occurred concurrently during the prior 2days, denoting an additive effect. Future research is needed to expand on current findings among chronic headache patients and to develop individualized models that account for multiple simultaneous influences of headache trigger factors. [Copyright &y& Elsevier]

Objective.- The present study endeavored to identify predictors of headache during pregnancy, shortly after delivery, and at 8-week follow-up. Background.- Many women suffer from headaches during pregnancy and the post-partum period. However, little is known about factors that predict headache surrounding childbirth. Methods.- Secondary analysis of longitudinal cohort study of 2434 parturients hospitalized for cesarean or vaginal delivery in 4 university hospitals in the United States and Europe. Data were gathered from interviews and review of medical records shortly after delivery; 972 of the women were contacted 8 weeks later to assess persistent headache. The primary outcome measures were experiencing headache during pregnancy, headache within 72 hours after delivery, and headache at 8 weeks after delivery. Results.- Of the parturients, 10% experienced headache during pregnancy, 3.7% within 72 hours after delivery, and 3.6% at 8 weeks postdelivery. Compared to those without a history of headache, a history of headache prior to pregnancy was the strongest predictor of headache during pregnancy (9.8% vs 23.5%; risk ratio 2.4; 95% confidence interval [CI]: 1.4 to 4.0). Experiencing headache during pregnancy (adjusted hazard ratio HR 3.8; 95% CI: 2.4 to 6.2) and receiving needle-based regional anesthesia for pain treatment (adjusted hazard ratio 2.2; 95% CI: 1.1 to 4.5) were independently associated with headache within 72 hours after delivery with event rates of 11.1% and 10.5%, respectively. Compared to those without such a history, headache before pregnancy was significantly associated with experiencing headache 8 weeks after delivery (4.0% vs 23.8%; risk ratio = 6.0; 95% CI: 2.0 to 8.0), but headache during pregnancy or shortly after delivery was not. Several other psychosocial predictors (eg, somatization, smoking before pregnancy) were statistically associated with at least 1 headache outcome. Conclusions.- A history of headache prior to pregnancy is a strong predictor of headache during and after pregnancy, the latter independent of but compounded by spinal injection. Physicians should attend to prior headache history when making decisions about pain management during and after childbirth. As the lack of formal International Classification of Headache Disorders, 2nd Edition (ICHD-II), headache diagnoses is a limitation of this study, future longitudinal studies should replicate the present design while including headache subtyping consistent with ICHD-II nosology. ( Headache 2012;52:348-362) [ABSTRACT FROM AUTHOR]

SUMMARY The focus of this review is on the efficacy of antidepressants as preventive treatments for migraine and chronic tension-type headache (TTH). Pharmacologic prophylaxis may be indicated for patients with frequent headaches, who respond insufficiently to acute therapies, or for whom medication overuse is a concern. The well-documented efficacy of the tricyclic antidepressant amitriptyline, both for migraine and chronic TTH, has been followed by widespread use of other antidepressants for headache prophylaxis. Although antidepressants in general share comparable efficacy for the treatment of depressive disorders, their efficacy as headache preventives varies widely. Evidence supporting use of the selective serotonin reuptake inhibitors as headache preventives is poor; their use should be reserved for treating comorbid depression in a patient who also has a headache disorder. Small randomized trials of venlafaxine indicate preliminary efficacy both for migraine and tension-type headache. Evidence for other antidepressants is lacking. Although antidepressants are often prescribed to headache patients under the assumption that the prescribed agent also will be effective in reducing symptoms of comorbid depression, the majority of studies have failed to find a strong relationship between depression symptoms and headache improvement. Suggestions for future research are discussed. [ABSTRACT FROM AUTHOR]

Presents information on a study which determined whether drug administration instructions informing subjects of a placebo condition affect the drug response and affect the saliva concentration of the stimulant. Methodology; Results and discussion; Conclusions.

Pharmacotherapies are the mainstays of migraine management, though it is not uncommon for them to be poorly tolerated, contraindicated, or only modestly effective. There is a clear need for nonpharmacologic migraine therapies, either employed alone or in combination with pharmacotherapies. Behavioral and psychosocial factors known to contribute to the onset, exacerbation, and persistence of primary headache disorders (e.g., stress, sleep, diet) serve as targets within a self-management model for migraine-a model that features headache pharmacotherapies, behavioral skills training, medication adherence facilitation, relevant lifestyle changes, and techniques to limit headache-related impairment. Behavioral self-management interventions for migraine with the strongest empirical validation (e.g., relaxation training, biofeedback training, cognitive-behavior therapies) presently are available in specialty headache treatment centers and routinely show promise for reducing headache pain frequency/severity and related impairment, reducing reliance on pharmacotherapies, enhancing personal control over headache activity, and reducing headache-related distress and symptoms. These approaches may be particularly well-suited among patients for whom pharmacotherapies are unwanted, poorly tolerated, or contraindicated. Though underutilized, clinical trials indicate that new and well-established behavioral therapies are similarly effective to migraine medications for migraine prevention among adults and can be successfully employed in various settings., (Copyright © 2024 Elsevier B.V. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Objective: To explore whether the association between change in headache management self-efficacy and posttraumatic headache-related disability is partially mediated by a change in anxiety symptom severity., Background: Many cognitive-behavioral therapy treatments for headache emphasize stress management, which includes anxiety management strategies; however, little is currently known about mechanisms of change in posttraumatic headache-related disability. Increasing our understanding of mechanisms could lead to improvements in treatments for these debilitating headaches., Methods: This study is a secondary analysis of veterans (N = 193) recruited to participate in a randomized clinical trial of cognitive-behavioral therapy, cognitive processing therapy, or treatment as usual for persistent posttraumatic headache. The direct relationship between headache management self-efficacy and headache-related disability, along with partial mediation through change in anxiety symptoms was tested., Results: The mediated latent change direct, mediated, and total pathways were statistically significant. The path analysis supported a significant direct pathway between headache management self-efficacy and headache-related disability (b = -0.45, p < 0.001; 95% confidence interval [CI: -0.58, -0.33]). The total effect of change of headache management self-efficacy scores on change in Headache Impact Test-6 scores was significant with a moderate-to-strong effect (b = -0.57, p = 0.001; 95% CI [-0.73, -0.41]). There was also an indirect effect through anxiety symptom severity change (b = -0.12, p = 0.003; 95% CI [-0.20, -0.04])., Conclusions: In this study, most of the improvements in headache-related disability were related to increased headache management self-efficacy with mediation occurring through change in anxiety. This indicates that headache management self-efficacy is a likely mechanism of change of posttraumatic headache-related disability with decreases in anxiety explaining part of the improvement in headache-related disability., (© 2023 American Headache Society.)

Importance: Posttraumatic headache is the most disabling complication of mild traumatic brain injury. Posttraumatic stress disorder (PTSD) symptoms are often comorbid with posttraumatic headache, and there are no established treatments for this comorbidity., Objective: To compare cognitive behavioral therapies (CBTs) for headache and PTSD with treatment per usual (TPU) for posttraumatic headache attributable to mild traumatic brain injury., Design, Setting, and Participants: This was a single-site, 3-parallel group, randomized clinical trial with outcomes at posttreatment, 3-month follow-up, and 6-month follow-up. Participants were enrolled from May 1, 2015, through May 30, 2019; data collection ended on October 10, 2019. Post-9/11 US combat veterans from multiple trauma centers were included in the study. Veterans had comorbid posttraumatic headache and PTSD symptoms. Data were analyzed from January 20, 2020, to February 2, 2022., Interventions: Patients were randomly assigned to 8 sessions of CBT for headache, 12 sessions of cognitive processing therapy for PTSD, or treatment per usual for headache., Main Outcomes and Measures: Co-primary outcomes were headache-related disability on the 6-Item Headache Impact Test (HIT-6) and PTSD symptom severity on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (PCL-5) assessed from treatment completion to 6 months posttreatment., Results: A total of 193 post-9/11 combat veterans (mean [SD] age, 39.7 [8.4] years; 167 male veterans [87%]) were included in the study and reported severe baseline headache-related disability (mean [SD] HIT-6 score, 65.8 [5.6] points) and severe PTSD symptoms (mean [SD] PCL-5 score, 48.4 [14.2] points). For the HIT-6, compared with usual care, patients receiving CBT for headache reported -3.4 (95% CI, -5.4 to -1.4; P < .01) points lower, and patients receiving cognitive processing therapy reported -1.4 (95% CI, -3.7 to 0.8; P = .21) points lower across aggregated posttreatment measurements. For the PCL-5, compared with usual care, patients receiving CBT for headache reported -6.5 (95% CI, -12.7 to -0.3; P = .04) points lower, and patients receiving cognitive processing therapy reported -8.9 (95% CI, -15.9 to -1.9; P = .01) points lower across aggregated posttreatment measurements. Adverse events were minimal and similar across treatment groups., Conclusions and Relevance: This randomized clinical trial demonstrated that CBT for headache was efficacious for disability associated with posttraumatic headache in veterans and provided clinically significant improvement in PTSD symptom severity. Cognitive processing therapy was efficacious for PTSD symptoms but not for headache disability., Trial Registration: ClinicalTrials.gov Identifier: NCT02419131.

Objective: Tinnitus and posttraumatic stress disorder (PTSD) are among the top service-connected disabilities within the Veterans Health Administration. Extant research shows that there is considerable overlap between tinnitus-related distress and PTSD, including sleep difficulty, irritability, hyperarousal, and concentration problems. However, no studies have prospectively examined the relationship between the two disorders. The purpose of this study was to examine that relationship., Method: Participants (N = 112) with posttraumatic headache completed measures of tinnitus and PTSD. Correlational analyses and analyses of variance were conducted to examine the associations with PTSD symptom clusters and factors of tinnitus-related distress., Results: Approximately, half of participants with tinnitus demonstrated severe impairment. Correlational analyses indicated that reexperiencing, avoidance, negative emotions and cognitions, and hyperarousal PTSD symptoms were significantly related to many factors of tinnitus-related distress, including intrusiveness of tinnitus, perceived loudness, awareness, and annoyance. Participants with severe tinnitus demonstrated significantly greater reexperiencing, negative mood/cognitions, hyperarousal, and PTSD total severity compared to those with mild or moderate tinnitus., Conclusions: Trauma therapists should assess for the presence of tinnitus in order to more fully conceptualize key health problems of help-seeking patients. Heightened psychological symptoms seemingly related to PTSD may be a function of tinnitus-related distress. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Importance: Migraine is the second leading cause of disability worldwide. Most patients with migraine discontinue medications due to inefficacy or adverse effects. Mindfulness-based stress reduction (MBSR) may provide benefit., Objective: To determine if MBSR improves migraine outcomes and affective/cognitive processes compared with headache education., Design, Setting, and Participants: This randomized clinical trial of MBSR vs headache education included 89 adults who experienced between 4 and 20 migraine days per month. There was blinding of participants (to active vs comparator group assignments) and principal investigators/data analysts (to group assignment)., Interventions: Participants underwent MBSR (standardized training in mindfulness/yoga) or headache education (migraine information) delivered in groups that met for 2 hours each week for 8 weeks., Main Outcomes and Measures: The primary outcome was change in migraine day frequency (baseline to 12 weeks). Secondary outcomes were changes in disability, quality of life, self-efficacy, pain catastrophizing, depression scores, and experimentally induced pain intensity and unpleasantness (baseline to 12, 24, and 36 weeks)., Results: Most participants were female (n = 82, 92%), with a mean (SD) age of 43.9 (13.0) years, and had a mean (SD) of 7.3 (2.7) migraine days per month and high disability (Headache Impact Test-6: 63.5 [5.7]), attended class (median attendance, 7 of 8 classes), and followed up through 36 weeks (33 of 45 [73%] of the MBSR group and 32 of 44 [73%] of the headache education group). Participants in both groups had fewer migraine days at 12 weeks (MBSR: -1.6 migraine days per month; 95% CI, -0.7 to -2.5; headache education: -2.0 migraine days per month; 95% CI, -1.1 to -2.9), without group differences (P = .50). Compared with those who participated in headache education, those who participated in MBSR had improvements from baseline at all follow-up time points (reported in terms of point estimates of effect differences between groups) on measures of disability (5.92; 95% CI, 2.8-9.0; P < .001), quality of life (5.1; 95% CI, 1.2-8.9; P = .01), self-efficacy (8.2; 95% CI, 0.3-16.1; P = .04), pain catastrophizing (5.8; 95% CI, 2.9-8.8; P < .001), depression scores (1.6; 95% CI, 0.4-2.7; P = .008), and decreased experimentally induced pain intensity and unpleasantness (MBSR group: 36.3% [95% CI, 12.3% to 60.3%] decrease in intensity and 30.4% [95% CI, 9.9% to 49.4%] decrease in unpleasantness; headache education group: 13.5% [95% CI, -9.9% to 36.8%] increase in intensity and an 11.2% [95% CI, -8.9% to 31.2%] increase in unpleasantness; P = .004 for intensity and .005 for unpleasantness, at 36 weeks). One reported adverse event was deemed unrelated to study protocol., Conclusions and Relevance: Mindfulness-based stress reduction did not improve migraine frequency more than headache education, as both groups had similar decreases; however, MBSR improved disability, quality of life, self-efficacy, pain catastrophizing, and depression out to 36 weeks, with decreased experimentally induced pain suggesting a potential shift in pain appraisal. In conclusion, MBSR may help treat total migraine burden, but a larger, more definitive study is needed to further investigate these results., Trial Registration: ClinicalTrials.gov Identifier: NCT02695498.

Posttraumatic headache (PTH) is a common debilitating condition arising from head injury and is highly prevalent among military service members and veterans with traumatic brain injury (TBI). Diagnosis and treatment for PTH is still evolving, and surprisingly little is known about the putative mechanisms that drive these headaches. This manuscript describes the design of a randomized clinical trial of two nonpharmacological (i.e., behavioral) interventions for posttraumatic headache. Design of this trial required careful consideration of PTH diagnosis and inclusion criteria, which was challenging due to the lack of standard clinical characteristics in PTH unique from other types of headaches. The treatments under study differed in clinical focus and dose (i.e., number of treatment sessions), but the trial was designed to balance the treatments as well as possible. Finally, while the primary endpoints for pain research can vary from assessments of pain intensity to objective and subjective functional measures, this trial of PTH interventions chose carefully to establish clinically relevant endpoints and to maximize the opportunity to detect significant differences between groups with two primary outcomes. All these issues are discussed in this manuscript., Competing Interests: None to report., (© 2021 The Authors.)

Objective: To compare the efficacy of mental health professional versus primary care nurse-delivered telehealth cognitive-behavioral therapy (CBT) and supportive care (SC) treatments for chronic low back pain, using data from 2 separate randomized controlled trials. Both trials were completed in the same hospital and used the same study design, research team, and outcome measures., Materials and Methods: Participants from Study 1 (Mental Health Professional Study) (N=66; 2007 to 2011) and Study 2 (Nursing Study) (N=61; 2012 to 2016) were patients with chronic low back pain (≥4/10 intensity) randomized to either an 8-week CBT or an SC telehealth condition matched for contact frequency, format, and time. Participants completed validated measures of improvement in back pain disability (Roland Morris Disability Questionnaire [RMDQ]), pain intensity (Numeric Rating Scale [NRS]), depressive symptoms (Beck Depression Inventory 2 [BDI-2]), pain catastrophizing (Pain Catastrophizing Scale [PCS]), and overall improvement (Global Clinical Impressions [GCI])., Results: Intent-to-treat analyses at posttreatment showed that scores on the RMDQ (Cohen d=0.33 to 0.55), NRS (d=0.45 to 0.90), PCS (d=0.21 to 0.41), and GCI (18.5% to 39.1%) improved significantly in both studies and in both treatments from pretreatment to posttreatment. Changes in BDI scores were inconsistent (d=-0.06 to 0.51). The analyses revealed no significant differences in treatment efficacy between the trained nurse versus the mental health professionals on the RMDQ, NRS, PCS, or GCI measures (P>0.20)., Discussion: Results from these clinical trials suggest that the benefits of home-based, telehealth-delivered CBT and SC treatments for chronic back pain were comparable when delivered by a primary care nurse or mental health professional.

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.

This study evaluated a nurse-delivered, telehealth intervention of cognitive-behavioral therapy (CBT) versus supportive psychotherapy for chronic back pain. Participants (N = 61) had chronic back pain (pain "daily" ≥6 months at an intensity of ≥4 of 10 scale) and were randomized to an 8-week, 12-session, CBT or to supportive care (SC) matched for frequency, format, and time, with each treatment delivered by a primary care nurse. The primary outcome was the Roland Morris Disability Questionnaire (RMDQ). Secondary outcomes included the numeric rating scale (NRS) and the Patient Global Impressions Scale (CGI). CBT participants (n = 30) showed significant improvements on the RMDQ (mean = 11.4 [SD = 5.9] vs 9.4 [SD = 6.1] at baseline and post-treatment, respectively, P < .05; d = .33), NRS (mean = 4.9 [SD = 2.1] vs 4.0 [SD = 1.9], respectively, P < .05; d = .45), and on the CGI (39.1% reporting "much improved" or "very much improved"). SC participants (n = 31) also showed significant improvements on the RMDQ (mean = 11.1 [SD = 5.4] vs 9.1 [SD = 5.2], respectively, P < .05; d = .38), the NRS, (mean = 5.0 [SD = 1.9] vs 3.8 [SD = 2.1], respectively, P < .05; d = .60), and 26.7% reporting "much improved" or "very much improved" on the CGI. Between groups comparisons of CBT and SC showed no differences on the study outcomes (Ps > .10). The results suggest that telehealth, nurse-delivered CBT, and SC treatments for chronic back pain can offer significant and relatively comparable benefits., Perspective: This article describes the benefits of training primary care nurses to deliver evidence-based behavioral therapies for low back pain. Because of the high prevalence of chronic pain and the growing emphasis on nonopioid therapies, training nurses to provide behavior therapies could be a cost-effective way to improve pain management., (Published by Elsevier Inc.)

This paper provides an overview of the well-established and empirically supported behavioral interventions for the treatment of migraine. The considerable evidence base addressing behavioral interventions amassed since 1969 has conclusively established the efficacy of therapies featuring combinations of relaxation, biofeedback, and stress management training, and demonstrated they are capable of yielding benefits on par with pharmacological therapies for migraine. Behavioral interventions also are well suited for delivery across a variety of different contexts (e.g., group vs. individual, standard clinic vs. limited therapist contact, face-to-face vs. technology-assisted). Despite the amply established efficacy and effectiveness of these self-management interventions for the treatment of migraine, the availability and implementation of these approaches remain limited for many headache sufferers. We anticipate the technological advances in delivery platforms will provide better access to behavioral self-management strategies for migraine.

Missing meals and fasting have long been reported as headache triggers. Stress also has received attention for its role in precipitating headaches. This study explored the effects of eating behaviors on new-onset headache. Analyzing only the 1070 of 1648 (64.9%) diary days that followed a non-headache day, the study included 34 migraineurs who contributed a median (25th, 75th percentile) of 28 (22, 40) days of diary entries. Multivariable survival modeling with random effects was conducted, and hazards ratios and 95% confidence intervals were calculated. Nighttime snacking was associated with a 40% reduction in the odds of experiencing a headache compared to having no food (p=0.013). Eating a late dinner was associated with a 21% reduction in the odds of headache when compared to no additional food, but this association was not statistically significant (p=0. 22). These results demonstrate the potential for eating behaviors to be targeted in headache management, as regulated eating habits may have the potential to reduce the occurrence of headache. Although no causal relationship can be established, these results indicate that further research into the mechanisms of the association between eating behaviors and headache activity is warranted., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Background: The progression and remission of migraine and the risk factors that determine the course of illness have been intensively studied for the past decade., Methods: In this fourth paper in a series of methodological articles, we summarize crucial issues that influence studies of migraine clinical course, and suggest directions and opportunities for future research., Results: Defining chronic migraine (CM) based on 15 or more headache days per month is problematic because headache frequency varies from month to month. We propose methods of defining CM as a trait and not as a state of headache frequency. Our notions of progression and remission, defined by the crossing of an arbitrary frequency boundary, are also problematic; we propose alternative approaches. Measuring headache frequency is challenging because of measurement error, temporal sampling error, and real change over time., Conclusions: We suggest alternative approaches for defining migraine subtypes, measuring change in frequency, defining progression and remission, and modeling change over time. Our suggestions are intended to encourage dialogue and need refinement and evaluation. Our long-term goal is to improve classification and measurement to facilitate the discovery of risk factors, genes, and other biological processes that determine the onset and course of migraine., (© 2013 American Headache Society.)

A growing body of literature has implicated comorbid psychopathology as a potential risk factor for the chronification of migraine. Of the psychiatric disorders, depressive and anxiety disorders have been most consistently associated with the chronification of migraine. A shared dysfunction of the serotonergic system, medication overuse, and psychological factors have been proposed to mediate this relationship, although the responsible mechanisms are still largely unclear. This article overviews literature on psychiatric comorbidities and migraine chronification, considers mechanisms underlying this relationship, and notes directions for future clinical and empirical work.

Sleep has long been recognized to both provoke and relieve headache. Epidemiologic research has associated sleep disorders with more frequent and severe headaches. Chronic daily, awakening, and morning headache patterns are particularly suggestive of sleep disorders, including sleep-related breathing disorders, insomnia, circadian rhythm disorders, and parasomnias. Snoring and other indicators of sleep-disordered breathing are the most commonly studied and are particularly salient because of the potential for headache to improve or resolve with treatment of sleep. In addition to sleep disorders, clinical research correlates specific headache diagnoses (eg, migraine, tension-type, and cluster) with chronobiologic patterns and sleep processes, implicating common anatomic structures and neurochemical processes involved in the regulation of sleep and headache. Evidence strongly supports screening for sleep disorders by headache practitioners. Headache management should identify and treat sleep disorders that may improve or resolve headache.

Interest in nonpharmacologic interventions for chronic tension-type headache has increased in recent years, with many professional organizations recommending behavioral treatments such as relaxation training, biofeedback, and cognitive-behavioral therapy alongside pharmacologic treatments. Although the efficacy of behavioral interventions is well-documented, several potential barriers in dissemination and implementation exist that have precluded more widespread adoption of behavioral treatments. This article briefly reviews the core components and efficacy of behavioral treatments for tension-type headache and outlines challenges to their broader clinical use as they occur at the levels of empirical research, treatment availability and delivery, and common clinical problems. Strategies for addressing these challenges are suggested, and directions for needed research are noted.

Migraine is recognized as a primarily neural condition. Changes in neural physiology have been consistently identified in migraineurs. Numerous studies are available that evaluate physical and functional differences between migraineurs and headache-free controls. The most prominent neuroimaging findings reported in migraine sufferers have been white matter changes. However, physical changes on neuroimaging have not been clearly correlated with functional impairment in migraineurs. The current literature addressing the neuropsychologic consequences of migraine has been far from conclusive, and reports of cognitive testing in adult migraineurs and controls has yielded inconsistent results. Neuropsychologic testing suggests that there may be some subtle but possibly significant changes in cognition that occur both during and between migraine episodes. A finding emerging with some consistency is that migraine patients with aura experience more neuropsychologic deficits than migraine patients without aura. The few studies that assess nonmigraine headache suggest that physical changes may not be unique to migraine, although neuropsychologic changes do appear to be limited to migraineurs. An examination of the unmet needs and priorities for future research addressing this important topic is provided.

Behavioral treatments (relaxation, biofeedback, cognitive-behavioral therapy) have been empirically validated for migraine and tension-type headaches, with recent meta-analyses yielding 37% to 50% reductions in tension-type headache, comparing favorably with 33% reduction from medication prophylaxis (amitriptyline). Research has moved toward increasing availability and cost effectiveness through alternative delivery formats and combining and comparing them with standard medications. Further modifications would make standard behavioral treatments available and conducive to primary care settings where most patients receive treatment. Beyond the current behavioral and drug treatments, we propose a fundamental shift in conceptualization and treatment for headache.

Headache and sleep disturbance are common health complaints. Both complaints often co-exist in the same patient, leading some to suspect a causal relationship or common underlying pathology. However, the empirical literature in this area is limited. Some attempts have been made to explore the relationship between headache and sleep disturbance, but few consistencies have emerged in the literature. There is no accepted model for understanding the link between headache and sleep disturbance. This paper reviews the available literature concerning comorbid headache and sleep disturbance and offers some preliminary suggestions based on the available literature to guide their evaluation and management. Information specific to the relationship between sleep disturbance and chronic daily headache, where available, is highlighted.

In the past three decades, behavioral interventions (chiefly relaxation, biofeedback, and stress-management) have become standard components of the armamentarium for management of migraine and tension-type headaches. Meta-analytic literature reviews of these behavioral interventions have consistently identified clinically significant reductions in recurrent headache. Across studies, behavioral interventions have yielded approximately 35-50% reduction in migraine and tension-type headache activity. Although we have only recently begun to directly compare standard drug and nondrug treatments for headache, the available evidence suggests that the level of headache improvement with behavioral interventions may rival those obtained with widely used pharmacologic therapies in representative patient samples. In recent years, some attempts have been made to increase the availability and cost effectiveness of behavioral interventions through alternative delivery formats and mass communications. Recent developments within diagnosis and classification are summarized, pointing out implications for behavioral researchers. Select future directions are discussed, which include impact of the triptans, cost and cost effectiveness, and integration of behavioral treatments into primary care settings, the place where the great majority of headache sufferers receive treatment.

Migraine is a significant women's health concern. Epidemiological research has demonstrated that migraine is one of the most common pain conditions and that women are disproportionately affected. Recent advances in pathophysiology highlight the hormonal antecedents of these sex differences in migraine and the potential influence of hormones on migraine pain pathways. Migraine spawns substantial suffering and disability and gives rise to great economic and personal burden. Despite the availability of effective pharmacological and nonpharmacological treatments, only a fraction of migraine sufferers receive state-of-the-art treatment. Access to effective treatment is limited by economic and social barriers to care, including the long-standing social stigma that trivializes headache. Although doubtless a women's health issue, migraine has been largely overlooked in the women's health initiatives. This paper argues that migraine is an important women's health concern and that greater attention to migraine promises to make a demonstrable improvement in the quality of life of many women.

BACKGROUND: Headaches account for a high percentage of office visits to primary care physicians, with migraine and tension-type headaches the most common. This article provides a summary of psychophysiologic therapies for migraine and tension-type headache and considers psychosocial factors relevant to headache. Psychophysiologic therapy of headache consists primarily of relaxation and biofeedback. METHOD: Representative controlled studies, meta-analysis, and reviews are utilized to assess the efficacy of biofeedback and relaxation for migraine and tension-type headache. RESULTS: Psychophysiologic therapy comprising biofeedback and relaxation can be provided in standard or limited therapist contact formulas to patients as sole therapy or concurrently with medical therapy. Effectiveness has been demonstrated for thermal biofeedback-and electromyograph biofeedback-assisted relaxation with minimal or no side effects. A typical treatment protocol is offered to exemplify the integration of psychophysiologic therapy into primary care practice. CONCLUSION: Psychophysiologic therapy represents an important adjunctive treatment for chronic benign headache that can be incorporated into primary care.