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

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.

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Key information

Conditions

Primary Headache Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

MigraineBoxTM

Device

Primary outcomes

Change from Baseline in Pain Level

Time frame: Baseline, 30 minutes, 60 minutes

Patients will be asked to complete a 100 mm visual analog scale and a four point Likert scale concerning their pain.

Secondary outcomes

Change from Baseline in Nausea

Time frame: Baseline, 30 minutes, 60 minutes

Patients will be asked to complete a 100 mm visual analog scale concerning their level of nausea.

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Nov 6, 2013
Registry last updated: Oct 24, 2014

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.

Published trials that share one or more normalized conditions with this study.

Completed