Migraine attack frequency, duration, and pain intensity: disease burden derived from a community-based survey in northern Tanzania

Objective.— One goal of the campaign “Lifting the burden: The global campaign against headache” is to highlight existing evidence about headache worldwide. In this context, the aim of our study was to report the migraine‐related headache burden in northern Tanzania. Methods.— From December 2003 until June 2004 a community‐based door‐to‐door survey was undertaken in northern Tanzania, using multistage cluster sampling. Based on the criteria of the International Headache Society, 7412 individuals were enrolled in this survey. Results.— Migraine patients' average annual attack frequency was 18.4 (n = 308, standard deviation [SD] ± 47.4) with a mean duration of 16.4 hours (SD ± 20.6). The average headache intensity per patient was 2.65 (SD ± 0.59) with a calculated loss of 6.59 (SD ± 26.7) working days per year. Extrapolation of data to the investigated population (n = 7412) resulted in annual migraine burden of 281.0 migraine days per 1000 inhabitants. Conclusions.— To our knowledge, this study reports for the first time the burden that arises from migraine headache in a rural population of sub‐Sahara Africa (SSA). As the presented migraine‐related burden is considerable, we hope that our data will increase the awareness among local decision makers in allocating resources for treatment and research on headache.     

The misdiagnosis of cluster headache: a nonclinic, population-based, Internet survey

OBJECTIVE: We conducted the first nonclinic, Internet-based survey of cluster headache to investigate this population with regard to diagnostic problems encountered, effective and ineffective medications, problems obtaining medications through third-party payers, and symptoms as they relate to International Headache Society criteria. BACKGROUND: Previous cluster headache surveys have been at specialty centers. These patients might be different from cluster headache sufferers in the general population. An Internet-based population of cluster headache sufferers who connected to a Web site responded to the questionnaire, and e-mailed it back to our site to be analyzed. We analyzed a total of 789 respondents, 76% men and 28% women. RESULTS: Eighty-seven percent of respondents qualified as having cluster headache according to International Headache Society criteria. However, diagnosis was delayed an average of 6.6 years from the onset of symptoms. The average number of physicians seen before the correct diagnosis was made was 4.3, and the average number of incorrect diagnoses was 3.9. Seventy-one percent of respondents had undergone unnecessary magnetic resonance or computed tomography scans, and 4% had unnecessary sinus or deviated septum surgery. We found that many inappropriate medications such as propranolol, amitriptyline, and antibiotics were prescribed and that successful medications for clusters such as sumatriptan and oxygen were often denied due to a failure to understand the nature of this disorder. Seventy-seven percent of respondents were smokers. Seventy-four percent stopped smoking in an attempt to improve their condition; however, only 3% experienced relief. CONCLUSIONS: The most alarming finding was the delay in diagnosing cluster headache in this population--an average of 6.6 years. The selection of medications demonstrated to be successful in the treatment of clusters proved effective for the majority of this population. Many respondents reported being denied some of these effective medications by their physicians or third-party payers. Using International Headache Society criteria for cluster headache, 87% of the respondents should have been correctly diagnosed by the first physician seen.     

Inhaled Oxygen for Cluster Headache: Efficacy,Mechanism of Action,Utilization, and Economics

Inhaled normobaric oxygen is an essential abortive treatment of cluster headache. Recognition of its efficacy for cluster headache goes back a half a century, but very little has actually been written on the use of inhaled oxygen for cluster headache. This article examines various issues regarding inhaled oxygen and cluster headache, including efficacy, proposed mechanism of action, utilization, and the economics of oxygen usage for cluster headache patients. Much of the data analyzed comes from the recently published United States Cluster Headache Survey. This is the largest study of cluster headache patients ever published and is the first study to focus on inhaled oxygen and cluster headache in a large, non-clinic-based population.     

Defining Refractory Migraine: Results of the RHSIS Survey of American Headache Society Members

Objectives.— To gauge consensus regarding a proposed definition for refractory migraine proposed by Refractory Headache Special Interest Section, and where its use would be most appropriate. Background.— Headache experts have long recognized that a subgroup of headache sufferers remains refractory to treatment. Although different groups have proposed criteria to define refractory migraine, the definition remains controversial. The Refractory Headache Special Interest Section of the American Headache Society developed a definition through a consensus process, assisted by a literature review and initial membership survey. Design.— A 12‐item questionnaire was distributed at the American Headache Society meeting in 2007 during a platform session and at the Refractory Headache Special Interest Section symposium. The same questionnaire was subsequently sent to all American Headache Society members via e‐mail. A total of 151 responses from AHS members form the basis of this report. The survey instrument was designed using Survey Monkey. Frequencies and percentages of the survey were used to describe survey responses. Results.— American Headache Society members agreed that a definition for refractory migraine is needed (91%) that it should be added to the International Classification of Headache Disorders‐2 (86%), and that refractory forms of non‐migraine headache disorders should be defined (87%). Responders believed a refractory migraine definition would be of greatest value in selecting patients for clinical drug trials. The current refractory migraine definition requires a diagnosis of migraine, interference with function or quality of life despite modification of lifestyle factors, and adequate trials of acute and preventive medicines with established efficacy. The proposed criteria for the refractory migraine definition require failing 2 preventive medications to meet the threshold for failure. Although 42% of respondents agreed with the working definition of refractory migraine, 43% favored increasing the number to 3 (50%) or 4 (26%) preventive treatment failures. When respondents were asked if they felt that the proposed definition was appropriate to select patients for invasive procedures (patent foramen ovale repair or stimulators) only 44% agreed. Conclusions.— There is a consensus for a need for a definition for refractory migraine and that it should be added to the International Classification of Headache Disorder‐2. There was also general agreement by the responders that refractory forms of non‐migraine headache disorders should be defined.     

Cluster Headache As the Result of Secondhand Cigarette Smoke Exposure During Childhood

(Headache 2010;50:130‐132) Unique to cluster headache (CH) compared with all other primary headache conditions is its association with a personal history of cigarette smoking. Studies have indicated that greater than 80% of CH patients have a prolonged history of tobacco usage prior to CH onset. How tobacco exposure can lead to CH has not yet been elucidated. As secondhand smoke exposure during childhood has been linked to multiple medical illnesses could CH also be the result of childhood exposure to tobacco smoke? The United States Cluster Headache survey is the largest survey ever done of CH sufferers living in the United States. The survey addressed various clinical, epidemiologic, and economic issues related to CH. Several survey questions dealt with the issue of personal and parental smoking history. Results from the survey suggest that CH can result from secondhand cigarette smoke exposure during childhood as greater than 60% of non‐smoking CH patients had parents who smoked. Strengthening the probable association between secondhand smoke exposure and the development of CH is the fact that double the number of survey responders developed CH at or before 20 years of age if during their childhood they lived with a parent who smoked cigarettes.     

Headache among patients with HIV disease: prevalence, characteristics, and associations

Background.— Headache is one of the most common medical complaints reported by individuals suffering from human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS), but limited and conflicting data exist regarding their prevalence, prototypical characteristics, and relationship to HIV disease variables in the current era of highly active antiretroviral therapy (HAART). Objectives.— The aims of the present cross‐sectional study were to characterize headache symptoms among patients with HIV/AIDS and to assess relations between headache and HIV/AIDS disease variables. Methods.— Two hundred HIV/AIDS patients (49% female; mean age = 43.22 ± 12.30 years; 74% African American) from an internal medicine clinic and an AIDS outreach clinic were administered a structured headache diagnostic interview to assess headache characteristics and features consistent with International Classification of Headache Disorders (ICHD)‐II diagnostic semiologies. They also completed 2 measures of headache‐related disability. Prescribed medications, most recent cluster of differentiation (CD4) cell count, date of HIV diagnosis, possible causes of secondary headache, and other relevant medical history were obtained via review of patient medical records. Results.— One hundred seven patients (53.5%) reported headache symptoms, the large majority of which were consistent with characteristics of primary headache disorders after excluding 4 cases attributable to secondary causes. Among those who met criteria for a primary headache disorder, 88 (85.44%) met criteria for migraine, most of which fulfilled ICHD‐II appendix diagnostic criteria for chronic migraine. Fifteen patients (14.56%) met criteria for episodic or chronic tension‐type headache. Severity of HIV (as indicated by CD4 cell counts), but not duration of HIV or number of prescribed antiretroviral medications, was strongly associated with headache severity, frequency, and disability and also distinguished migraine from TTH. Conclusions.— Problematic headache is highly prevalent among patients with HIV/AIDS, most of which conform to the semiology of chronic migraine, although with some atypical features such as bilateral location and pressing/tightening quality. A low frequency of identifiable secondary causes is likely attributable to reduced frequency of opportunistic infections in the current era of HAART. Disease severity is strongly predictive of headache, highlighting the importance of physician attention to headache symptoms and of patient adherence to treatment. (Headache 2012;52:455‐466)     

Use of cluster analysis to validate IHS diagnostic criteria for migraine and tension-type headache

Cluster analysis was used to validate headache diagnostic criteria of the International Headache Society (IHS). Structured diagnostic interviews were conducted on 443 headache sufferers from a community sample, which was randomly split to allow replication. Hierarchical cluster analysis of symptoms in both subsamples revealed two distinct ( P <.001) clusters: (1) unilateral pulsating pain, pain aggravated by activity, and photophobia and phonophobia, and (2) bilateral pressing/tightening pain, mild to moderate intensity, and absence of nausea/vomiting. These clusters were consistent with IHS migraine and tension-type classifications, respectively. Replication using a non-hierarchical clustering technique, k-means cluster analysis, revealed a migrainelike patient cluster, reflecting more frequent pulsating, unilateral pain; more severe pain; and pain aggravated by activity; nausea, vomiting, photophobia, and phonophobia. A tensionlike patient cluster was also identified, reflecting more frequent pressing/tightening pain, mild to moderate pain, bilateral location, and absence of nausea/vomiting. These patient clusters were consistent across subsamples. International Headache Society diagnoses corresponded with classification based upon statistically derived clusters ( P <.001). These results indicate that headache symptoms cluster empirically in a manner consistent with IHS criteria for migraine and tension-type headaches. Criterion overlap problems regarding pain intensity and duration were identified. Overall, these data support migraine and tension-type headache as distinct entities, and provide support for the IHS diagnostic criteria with minor modifications.     

Assessment of Chronic Refractory Headache: The Role of the MMPI-2

We investigated the utility of the newly revised version of the Minnesota Multiphasic Personality Inventory, the MMPI-2, for assessing psychopathology in three diagnostic headache groups, Post Traumatic, Status Migrainosus, and Status Migrainosus with Analgesic Rebound. We also investigated whether distinct clusters of headache sufferers could be identified using the MMPI-2 clinical scales, and whether these clusters coincide with headache diagnosis. Eighty-one patients in treatment at the Houston Headache Clinic were diagnosed and administered the MMPI-2. Significant levels of psychopathology were found in all three diagnostic groups. Furthermore, Cluster analysis identified three clusters of patients with equal proportions of patients from the three diagnostic groups. Cluster 1 patients were abnormally high on many MMPI-2 clinical scales; Cluster 2 patients showed more moderate elevations, and Cluster 3 patients had essentially normal profiles. We concluded that the MMPI-2 offers additional information not available through medical diagnosis alone. Thus, it is crucial to include psychological assessment in any comprehensive evaluation of chronic headache patients. Further implications for treatment planning and effectiveness are discussed.     

MTHFR 677C>T polymorphism and cluster headache

(Headache 2011;51:201‐207) Background.— An association between the 677C>T polymorphism (rs1801133) in the methylenetetrahydrofolate reductase gene (MTHFR) and cluster headache is plausible, but has not been investigated. Objective.— To investigate this association among Caucasians. Methods.— Case–control study among 147 cluster headache patients and 599 population‐based age‐ and gender‐matched controls. Cluster headache was diagnosed according to the criteria of the International Headache Society. Genotypes of the MTHFR 677C>T polymorphism were detected by restriction fragment length polymorphism analysis. We used logistic regression analysis to investigate the association between cluster headache and genotypes with additive, dominant, and recessive models. We considered a Bonferroni‐corrected P value <.004 as significant. Results.— Mean age at study entry among patients was 44.9 years (SD 11.4), of whom 76.2% were men. The genotype distribution among controls and patients was in Hardy–Weinberg equilibrium. The genotype and allele distribution did not differ between patients with any cluster headache and controls. We also did not find an association when assuming additive, dominant or recessive genetic models. When we looked at subgroups, the effect estimates suggested an increased risk for chronic cluster headache (dominant model: odds ratio = 2.82; 99.6% confidence interval = 0.72‐11.07; P = .03). Conclusions.— Data from our case–control study do not indicate an association between genotypes of the MTHFR 677C>T polymorphism and cluster headache overall. Subgroup analyses suggested that carriers of the MTHFR 677T allele may have an increased risk for chronic cluster headache. This may be regarded as hypothesis‐generating and should be further investigated in independent studies.     

Headache Triggers in the US Military

(Headache 2010;50:790‐794) Background.— Headaches can be triggered by a variety of factors. Military service members have a high prevalence of headache but the factors triggering headaches in military troops have not been identified. Objective.— The objective of this study is to determine headache triggers in soldiers and military beneficiaries seeking specialty care for headaches. Methods.— A total of 172 consecutive US Army soldiers and military dependents (civilians) evaluated at the headache clinics of 2 US Army Medical Centers completed a standardized questionnaire about their headache triggers. Results.— A total of 150 (87%) patients were active‐duty military members and 22 (13%) patients were civilians. In total, 77% of subjects had migraine; 89% of patients reported at least one headache trigger with a mean of 8.3 triggers per patient. A wide variety of headache triggers was seen with the most common categories being environmental factors (74%), stress (67%), consumption‐related factors (60%), and fatigue‐related factors (57%). The types of headache triggers identified in active‐duty service members were similar to those seen in civilians. Stress‐related triggers were significantly more common in soldiers. There were no significant differences in trigger types between soldiers with and without a history of head trauma. Conclusion.— Headaches in military service members are triggered mostly by the same factors as in civilians with stress being the most common trigger. Knowledge of headache triggers may be useful for developing strategies that reduce headache occurrence in the military.     

Head-HUNT: validity and reliability of a headache questionnaire in a large population-based study in Norway

We have assessed the validity and reliability of a self-administered headache questionnaire used in the 'Nord-Tr?ndelag Health Survey 1995-97 (HUNT)' in Norway, by blindly comparing questionnaire-based headache diagnoses with those made in a clinical interview of a sample of the participants. Restrictive questionnaire-based diagnostic criteria for migraine, assessed according to modified criteria of the International Headache Society, performed excellently in selecting 'definite' migraine patients (100% positive predictive value). The best agreement concerning migraine diagnoses was achieved by using a liberal set of criteria (kappa 0.59). Similar agreement was found evaluating patient status as headache sufferers, and as sufferers from frequent headaches (>6 days per month) (kappa 0.57 and 0.50, respectively). The kappa values of non-migrainous headache and chronic headache (> 14 days per month) were 0.43 and 0.44, respectively. The results suggest that our self-administered questionnaire may be suitable in identifying a population with 'definite' migraine, and the questionnaire is an acceptable instrument in determining the prevalence in Nord-Tr?ndelag of headache sufferers, migraine, non-migrainous headache, and frequent or chronic headache sufferers.     

Dental presentations of cluster headaches

Cluster headache has been defined by the International Headache Society (IHS) as one of the primary headaches. A primary headache is a headache that has no other known cause, such as infection or trauma. Cluster headache is also listed as one of the trigeminal autonomic cephalalgias. These headaches are mediated by the trigeminal nerve with accompanying autonomic symptoms that may range from conjunctival injection, lacrimation, nasal congestion, rhinorrhea, forehead and facial sweating, miosis, and ptosis to eyelid edema. The IHS has described cluster headache as "attacks of severe, strictly unilateral pain that is orbital, supraorbital, temporal or in any combination of these sites, lasting 15 to 180 minutes." In the author’s practice, as a dentist treating orofacial pain, patients with cluster headache have dental or midfacial complaints as a primary presentation. This paper introduces such presentations based on interviews with cluster headache patients, with the main purpose of having midfacial complaints considered as an important presentation to be added to the IHS diagnostic criteria for cluster headache.     

Burden of cluster headache

The aim was to analyse the socioeconomic burden of cluster headache in patients from a tertiary headache centre. One hundred consecutive patients from the Danish Headache Centre were invited to an interview about the socioeconomic impact of cluster headache. Work absence and use of medical services were compared with a Danish population-based survey. Eighty-five patients participated; 78% reported restrictions in daily living and 13% also outside of cluster periods; 25% reported a major decrease in their ability to participate in social activities, family life and housework. The disease caused lifestyle changes for 96%, most frequently in sleeping habits and avoidance of alcohol. The absence rate among patients was 30%, which was significantly higher than 12% among the general population (P < 0.001). Use of health services due to headache was also higher among the patients (P < 0.001). Cluster headache, although periodic in most cases, has considerable impact on social functions, quality of life and use of healthcare.     

Frovatriptan for prophylactic treatment of cluster headache: lessons for future trial design

(Headache 2011;51:129‐134) Objective.— The aim of this study was to determine whether frovatriptan would show efficacy in short term prophylactic treatment of episodic cluster headache (ECH) in comparison to placebo. Background.— The 5‐hydroxytryptamine_1B/d (5‐HT_1B/d )‐agonists naratriptan, eletriptan, and frovatriptan have been shown to reduce the frequency of ECH. So far, no double‐blind placebo‐controlled trials have investigated the potential prophylactic effects of 5‐HT_1B/d ‐agonists in ECH. Methods.— The trial was conducted as a multi‐center, placebo‐controlled, randomized, double‐blind, prospective phase III parallel‐group trial with two independent treatment groups (5 mg frovatriptan vs placebo). It was planned to randomize about 96 patients (48 patients per group) into the trial to obtain 80 evaluable patients (40 patients per group). Results.— The study was prematurely discontinued after 13 months and enrollment of 11, instead of the planned 80 patients, by the sponsor due to infeasibility. Recruitment was slow and each of the patients included conducted major protocol violations. The differences in the primary and secondary endpoints were not significant. Conclusion.— This study shows that particular therapeutic aims are impossible to be addressed in a double‐blind, randomized, parallel group, study design with specific inclusion and exclusion criteria according to the International Headache Society (IHS) guidelines for controlled trials of drugs in cluster headache. Further studies are required to evaluate the potential efficacy of triptans in the prophylactic treatment of ECH. The outcome of the trial suggests that the recommendations of the Guidelines for controlled Trials of Drugs in Cluster Headache from the IHS should be revised.     

An Epidemiological Study of Headaches Among Medical Students in Athens

In order to study the prevalence of frequent headaches among the medical students of Athens University, an epidemiological survey was carried out among 588 medical students (318 men and 270 women), with mean age 23.5 years. Two questionnaires were designed for the study: one general, consisting of 10 questions and a second one, specific for headache sufferers, consisting of 117 questions. All those with headache who voluntarily completed the two questionnaires also underwent a neurological examination. Thirty point eight percent of men and 50.3% of women reported various headache attacks during the previous 6 months (39.6% in both sexes). However, only the 11.9% of students (from both sexes) reported that they suffered from disturbing headaches. The 6-month prevalence of migraine was 2.4% and 9.5% for tension-type headache (in both sexes). Cluster headache was not traced. The prevalence of nonclassifiable headaches (according to the criteria of the International Headache Society) was 0.85%. Headache was correlated to sex (more frequent among women) and anxiety level (Hamilton scale for anxiety). Headache prevalence was not correlated to smoking and social class.     

Headache disorders in the millennium cohort: epidemiology and relations with combat deployment

(Headache 2011;51:1098‐1111) Objective.— Characterize migraine and other headache disorders within a large population‐based US military cohort, with an emphasis on the temporal association between military deployment and exposure to combat. Background.— Little research has been published on the prevalence of headache disorders in the US military population, especially in relation to overseas deployments and exposure to combat. A higher than expected prevalence of migraine has previously been reported among deployed US soldiers in Iraq, suggesting an association. Headache disorders, including migraine, could have important effects on the performance of service members. Methods.— A total of 77,047 US active‐duty, Reserve, and National Guard members completed a baseline questionnaire between July 2001 to June 2003 for the Millennium Cohort Study. Headache disorders were assessed using the following survey‐based measures: self‐reported history of provider‐diagnosed migraine, recurrent severe headache within the past year, and recent headaches/bothered a lot within the past 4 weeks. Follow‐up surveys were completed on average 3 years after baseline (mean = 2.7 years; range = 11.4 months to 4.5 years). Results.— The overall male and female prevalence of self‐reported headache conditions at baseline were: provider‐diagnosed migraine, 6.9% and 20.9%, respectively; recurrent severe headache, 9.4% and 22.3%, respectively; and bothered a lot by headaches, 3.4% and 10.4%, respectively. Combat deployers had significantly higher odds of any new‐onset headache disorders than non‐deployers (adjusted odds ratios = 1.72 for men, 1.84 for women; 95% confidence intervals, 1.55‐1.90 for men, 1.55‐2.18 for women), while deployers without combat exposure did not. Conclusions.— Deployed personnel with reported combat exposure appear to represent a higher risk group for new‐onset headache disorders. The identification of populations at higher risk of development of headache provides support for targeted interventions.     

Does Quality of Life Differ Among Headache Diagnoses? Analysis Using the Medical Outcomes Study Instrument

SYNOPSIS
Background: To analyze the differences in quality of life associated with headache diagnoses using the Medical Outcomes Study Short Form Health Survey (SF-20).
Methods: A patient interview survey using the SF-20 Short Form Health Survey was conducted in a headache clinic within a multi-specialty group practice. All six health components of the SF-20 were included in the study, Headache diagnoses were made using IHS criteria.
Results: 208 consecutive headache patients were studied. Patients with cluster headache had a significantly higher (worse) pain score (P<0.018) and higher percentage of patients with poor health due to pain (P<0.005) than patients with migraine headache. There were fewer cluster patients with poor health associated with physical functioning than tension-type (P<0.020) or mixed headache (P<0.022) patients. Poor health associated with social functioning was greater for cluster (P<0.011) and tension-type headache (P<0.015) than for migraine. There was a significantly higher percentage of tension-type headache patients with poor health associated with mental health (P<0.002) than patients with migraine.
Conclusions: The SF-20 is a reliable and valid measure of quality of life for patients with different headache diagnoses. Distinct headache diagnoses are marked by unique patterns of impairment and quality of life.     

Diagnostic accuracy of the ID Migraine: a systematic review and meta-analysis

(Headache 2011;51:1140‐1148) Objective.— The purpose of this systematic review with meta‐analysis is to determine the diagnostic accuracy of the identification of migraine (ID Migraine) as a decision rule for identifying patients with migraine. Background.— The ID Migraine screening tool is designed to identify patients with migraine in primary care settings. Several studies have validated the ID Migraine across various clinical settings, including primary care, neurology departments, headache clinics, dental clinics, ear, nose, and throat (ENT) and ophthalmology. Methods.— A systematic literature search was conducted to identify all studies validating the ID Migraine, with the International Headache Criteria as the reference standard. The methodological quality of selected studies was assessed using the Quality of Diagnostic Accuracy Studies tool. All selected studies were combined using a bivariate random effects model. A sensitivity analysis was also conducted, pooling only those studies using representative patient groups (primary care, neurology departments, and headache clinics) to determine the potential influence of spectrum bias on the results. Results.— Thirteen studies incorporating 5866 patients are included. The weighted prior probability of migraine across the 13 studies is 59%. The ID Migraine is shown to be useful for ruling out rather than ruling in migraine, with a greater pooled sensitivity estimate (0.84, 95% confidence interval 0.75‐0.90) than specificity (0.76, 95% confidence interval 0.69‐0.83). A negative ID Migraine score reduces the probability of migraine from 59% to 23%. The sensitivity analysis reveals similar results. Conclusions.— This systematic review quantifies the diagnostic accuracy of the ID Migraine as a brief, practical, and easy to use diagnostic tool for Migraine. Application of the ID Migraine as a diagnostic tool is likely to improve appropriate diagnosis and management of migraine sufferers.     

The headache management trial: a randomized study of coordinated care

Context.— Headache is a common, disabling disorder that is frequently not well managed in general clinical practice. Objective.— To determine if patients cared for in a coordinated headache management program would achieve reduced headache disability compared with patients in usual care. Design.— A randomized controlled trial of headache management vs usual care. Setting.— Three distinctly different practice sites: an academic internal medicine practice located in a major east coast city, a staff‐model managed care organization located in a major west coast city, and a community practice in a medium‐sized city in the southeast. Patients.— Individuals 21 years of age or older with chronic tension‐type, migraine, or mixed etiology headache and a Migraine Disability Assessment (MIDAS) score greater than 5, not receiving treatment from a neurologist or headache clinic currently or within the previous 6 months and with an intention to continue general medical care at their current location and to continue their present health insurance coverage for the next 12 months. Interventions.— Active intervention is a headache management program consisting of: (1) a class specifically designed to inform patients about headache types, triggers, and treatment options; (2) diagnosis and treatment by a professional especially trained in headache care (based on US Headache Consortium guidelines); and (3) proactive follow‐up by a case manager. Participation lasted 6 months. Control patients received usual care from their primary care providers. Main Outcome Measures.— The primary efficacy measure reported in this article is a comparison of MIDAS scores of headache disability between the intervention group and the control group at 6 months. Secondary measures were response at 12 months, general health and quality of life, and satisfaction with headache care. Results.— The intervention improved (ie, decreased) MIDAS scores by 7.0 points (95% confidence interval 2.9 to 11.1) more than the control (P = .008) at 6 months. The difference was not affected by site (P = .59 for clinic by intervention interaction), and a trend toward persistent benefit at 12 months (mean difference in improvement 6.8 points, 95% confidence interval ?.3 to 13.9, P = .06) was observed. Quality of life and satisfaction with headache treatment were similarly improved. Conclusions.— Coordinated headache management significantly improved outcomes for patients who, despite contact with the healthcare system for headache, had substantial unmet needs. The intervention in this trial can be implemented practically in a wide range of settings with the expectation that meaningful improvements will accrue.