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Trial of Comprehensive Migraine Intervention

Montefiore Medicine Academic Health System logo

Montefiore Medicine Academic Health System

Status and phase

Completed
Phase 4

Conditions

Migraine

Treatments

Drug: Sumatriptan
Behavioral: Migraine education
Drug: Naproxen
Other: Typical care
Behavioral: Reenforcement of diagnosis

Study type

Interventional

Funder types

Other

Identifiers

NCT01071317
09-08-248

Details and patient eligibility

About

Despite the fact that more than 10% of Americans suffer from migraine, this headache disorder is often not diagnosed and not appropriately treated. The goal of this proposal is to determine whether a migraine protocol designed for use in an emergency room can be used to deliver the headache care that many migraine patients never receive. This is a randomized trial. Consecutive inadequately treated migraine patients will be randomized to TYPICAL care or to COMPREHENSIVE care. Those patients in the comprehensive care arm will receive the following intervention: 1) reinforcement of diagnosis, 2) an adaptable online educational intervention, reading material, and headache diaries, 3) two migraine specific medications and 4) expedited referral to a headache specialist, if needed. Patients in the typical care arm will receive whatever intervention the emergency physician feels is most appropriate. Headache surveys will be used toll if the protocol improves migraine-related pain and functional disability one month after the ER visit.

Enrollment

50 patients

Sex

All

Ages

21 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Migraine,
  • Baseline migraine related disability of mild or worse,
  • No current or past triptan use,
  • Not satisfied with current headache care.

Exclusion criteria

  • Allergy or contraindication to study medications,
  • Daily or near daily analgesic medication use.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Comprehensive care
Experimental group
Description:
Reinforcement of diagnosis, education, medications, and referral
Treatment:
Behavioral: Migraine education
Drug: Sumatriptan
Behavioral: Reenforcement of diagnosis
Drug: Naproxen
Typical care
Active Comparator group
Description:
Usual care
Treatment:
Other: Typical care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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