Headache
Conditions
Keywords
headache, emergency department, migraine, recurrent headache
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Montefiore Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Emergency Department patients who present primarily for headache. * Need to consent to and be available for follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge | 24 hours after Emergency Department (ED) discharge | Moderate/ Severe pain after discharge from the Emergency Department (ED). Moderate and severe are study subject's description of pain |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal | 3 months | 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. |
Countries
United States
Participant flow
Recruitment details
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)
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Migraine met International Headache Society migraine criteria | 186 |
| Tension-type Headache met International Headache Society tension-type headache criteria | 34 |
| Unclassifiable Had recurrent headache disorder but did not meet any International Headache Society criteria | 77 |
| Other Met other International Headache Society criteria | 12 |
| Total | 309 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 2 | 5 | 12 |
Baseline characteristics
| Characteristic | Migraine | Tension-type Headache | Unclassifiable | Other | Total |
|---|---|---|---|---|---|
| Age, Continuous | 38 Years STANDARD_DEVIATION 12 | 40 Years STANDARD_DEVIATION 12 | 42 Years STANDARD_DEVIATION 12 | 40 Years STANDARD_DEVIATION 11 | 39 Years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 169 Participants | 25 Participants | 54 Participants | 8 Participants | 256 Participants |
| Sex: Female, Male Male | 17 Participants | 9 Participants | 23 Participants | 4 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: 24 hours after Emergency Department (ED) discharge
Population: A small number of patients in each group were lost-to-follow-up and could not be included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Migraine | Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge | 53 Participants |
| Tension-type Headache | Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge | 6 Participants |
| Unclassifiable | Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge | 20 Participants |
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.
Time frame: 3 months
Population: A small number of patients in each group were lost-to-follow-up and could not be included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Migraine | Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal | 65 participants |
| Tension-type Headache | Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal | 12 participants |
| Unclassifiable | Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal | 19 participants |