Use of MigraineBoxTM Head and Neck Cooling Bath for Treatment of Primary Headache in the Emergency Department

NCT ID: NCT01977001

Last Updated: 2014-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-06-30

Brief Summary

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MigraineBoxTM is a simple, contoured cooling bath for the head and neck. Effectiveness of MigraineBoxTM will be studied in primary headaches in the emergency department. The user simply reclines his/her head and neck into this device that has contours that support the head and neck. Luke warm water is filled into the MigraineBoxTM before use and then a frozen insert is placed inside. This will gradually cool the water surrounding the patient's head and theoretically provide headache relief.

Detailed Description

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Conditions

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Primary Headache

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary Headache

Treatment with MigraineBoxTM

MigraineBoxTM

Intervention Type DEVICE

Interventions

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MigraineBoxTM

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18-85 years old
* Benign headache
* Physician intends to treat headache pain in the ED with either droperidol, prochlorperazine, or a parenteral narcotic

Exclusion Criteria

* Unable to provide informed consent
* Headache due to trauma, subarachnoid hemorrhage, meningitis, intracerebral bleed, cranial tumor, sinusitis, dental pathology, temporomandibular joint dysfunction, glaucoma, or systemic infection
* Known renal impairment
* Known hepatic impairment
* A history of coronary artery disease, peripheral vascular disease, or cerebrovascular disease
* Perforated ear drum
* Pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hennepin Healthcare Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James R Miner, MD

Role: PRINCIPAL_INVESTIGATOR

Hennepin Healthcare Research Institute

Locations

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Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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12-3542

Identifier Type: -

Identifier Source: org_study_id

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