Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department

Summary

Collectively, evidence shows that a combination of medication and behavioral therapy is most effective for migraine care. The ED is a critical point of contact with the health care system for many migraine patients; in current practice, it is a missed opportunity to initiate and establish a comprehensive migraine management paradigm. Behavioral headache treatments (e.g., progressive muscle relaxation (PMR), biofeedback, cognitive-behavioral therapy (CBT)) are effective migraine treatment options that are essentially free of side effects. PMR has also been successful as a technique that patients can do independently. Studies have shown that combination pharmacological-behavioral therapy is most effective for migraine treatment.

Several aspects of this study are innovative, including: 1. Initiation of preventive medication in a timely manner for migraineurs who present to the ED. 2. Introduction of PM+PMR in the ED at a time that can serve as a teachable moment. 3. Introduction of a smartphone application-based product (a minimal contact based behavioral therapy) in the ED setting to reduce headache disability, frequency, and intensity.

Conditions

• Migraine

Interventions

DRUG

Preventative Medication (PM)

Subjects in the PM group will be given acute migraine medication, preventive medication (topiramate), and the APP with the PMR component. The smartphone app and/or the electronic pill bottles will be used to monitor adherence.

BEHAVIORAL

Enhanced Usual Care

General Education Class consisting of basic migraine information of basic migraine information such as evidence-based ways to treat migraines: treat early, limit acute medications \< 2-3 days/week, and call the primary care physician (PCP) if abortive medications are used more frequently.

BEHAVIORAL

PMR (progressive muscle relaxation therapy)

Technique for learning to monitor and control the state of muscular tension

Sponsors & Collaborators

• NYU Langone Health

  lead OTHER

Principal Investigators

• Mia Minen, MD · New York University Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-28

Primary Completion

2019-12-31

Completion

2019-12-31

FDA Drug

Yes

Countries

• United States

Study Locations