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OpenTrials
Completed

NCT Number: NCT00313703

Prospective ED Headache Cohort Study

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montefiore Medical Center, 111 East 210th Street

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Emergency Department patients who present primarily for headache.
  • Need to consent to and be available for follow-up

Treatment and study plan

Primary outcomes

  1. Number of Participants Who Report Moderate or Severe Pain Within 24 Hours of Emergency Department(ED) Discharge

    Time frame: 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 outcomes

  1. Number of Participants Who Reported Headache Disability Scores (MIDAS) More Than Minimal

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Predicting Poor Pain and Functional Outcomes After Discharge From the Emergency Department With a Primary Headache

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Apr 12, 2006
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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