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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
The purpose of this study is to determine how often headaches recur and to learn how to predict continued suffering from headache after emergency department discharge.
The majority of the 5 million people who arrive at Emergency Departments (ED) with a headache every year are suffering from an acute exacerbation of a chronic, recurrent headache disorder. The role of the ED in treating these patients has been ill-defined. Often emergency physicians will treat the acute exacerbation and will not attend to the natural history of the disease. However, about two thirds of primary headache patients will suffer a recurrent headache in the 24 hours after discharge from the ED. And, many patients will continue to suffer recurrent headaches for months after their ED discharge.
The purpose of this study is to learn how often headaches recur and to try to find a way to predict who will have a recurrent headache after ED discharge.
After standard ED treatment for headache, participants in the study will be asked to answer questions about prior headaches and medical history, and some census-like questions about race/ethnicity, salary, and education via a 20-minute interview with a research associate. The researchers will follow-up with 10-minute telephone calls to each participant's home in 24 hours and in 3 months with additional questions. Total length of time for study participation is approximately 40 minutes.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge | Moderate/ Severe pain after discharge from the Emergency Department (ED). Moderate and severe are study subject's description of pain | 24 hours after Emergency Department (ED) discharge |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal | Headache disability scores. On the MIDAS scale, a score > five signifies more than minimal headache related disability. MIDAS stands for MIgraine Disability Assessment Scale. More information on it can be found at http://www.migraines.org/disability/pdfs/midas.pdf. Scores of 0 are desirable. Scores greater than 20 signify a severe, functionally disabling migraine disorder. |
Inclusion Criteria:
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Convenience sample of ED patients
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Friedman, MD, MS | Department of Emergency Medicine, Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center, 111 East 210th Street | The Bronx | New York | 10467 | United States |
477 patients underwent a detailed interview in the ED. 309 of these patients were determined to have a primary headache disorder (a benign recurrent headache disease) and were entered into the post-ED follow-up portion of this cohort study.
We enrolled adult patients who presented to one urban emergency department (ED) with a chief complaint of headache.Patients were assigned a headache diagnosis based on criteria established by the International Headache Society (These are available at http://217.174.249.183/upload/CT\_Clas/ICHD-IIR1final.pdf)
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| ID | Title | Description |
|---|---|---|
| FG000 | Migraine | met International Headache Society migraine criteria |
| FG001 | Tension-type Headache | met International Headache Society tension-type headache criteria |
| FG002 | Unclassifiable | Had recurrent headache disorder but did not meet any International Headache Society criteria |
| FG003 | Other | Met other International Headache Society criteria |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Migraine | met International Headache Society migraine criteria |
| BG001 | Tension-type Headache | met International Headache Society tension-type headache criteria |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge | Moderate/ Severe pain after discharge from the Emergency Department (ED). Moderate and severe are study subject's description of pain | A small number of patients in each group were lost-to-follow-up and could not be included in this analysis. | Posted | Number | Participants | 24 hours after Emergency Department (ED) discharge |
|
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No adverse event information was gathered.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Migraine | met International Headache Society migraine criteria |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Friedman | Montefiore Medical Center | 718-920-6626 | befriedm@montefiore.org |
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| ID | Term |
|---|---|
| D006261 | Headache |
| D004630 | Emergencies |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 3 months |
| BG002 | Unclassifiable | Had recurrent headache disorder but did not meet any International Headache Society criteria |
| BG003 | Other | Met other International Headache Society criteria |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Unclassifiable | Had recurrent headache disorder but did not meet any International Headache Society criteria |
| OG003 | Other | Met other International Headache Society criteria |
|
|
| Other Pre-specified | Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal | Headache disability scores. On the MIDAS scale, a score > five signifies more than minimal headache related disability. MIDAS stands for MIgraine Disability Assessment Scale. More information on it can be found at http://www.migraines.org/disability/pdfs/midas.pdf. Scores of 0 are desirable. Scores greater than 20 signify a severe, functionally disabling migraine disorder. | A small number of patients in each group were lost-to-follow-up and could not be included in this analysis. | Posted | Number | participants | 3 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Tension-type Headache | met International Headache Society tension-type headache criteria | 0 | 0 | 0 | 0 |
| EG002 | Unclassifiable | Had recurrent headache disorder but did not meet any International Headache Society criteria | 0 | 0 | 0 | 0 |
| EG003 | Other | Met other International Headache Society criteria | 0 | 0 | 0 | 0 |
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| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |