Prospective ED Headache Cohort Study

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313703
• Other study ID #: 04-03-077E
• Status: Completed
• Start date: March 2004
• Est. completion date: November 2005

Study information

• Verified date: April 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 477
• Est. completion date: November 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Emergency Department patients who present primarily for headache.

• Need to consent to and be available for follow-up

Related Conditions & MeSH terms

• Headache

Locations

Country	Name	City	State
United States	Montefiore Medical Center, 111 East 210th Street	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	3 months
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	24 hours after Emergency Department (ED) discharge