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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01977001
Enrollment
29
Registered
2013-11-06
Start date
2012-11-30
Completion date
2014-06-30
Last updated
2014-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Headache

Keywords

Primary headache, Headache, MigraineBox

Brief summary

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.

Interventions

DEVICEMigraineBoxTM

Sponsors

Hennepin Healthcare Research Institute
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in Pain LevelBaseline, 30 minutes, 60 minutesPatients will be asked to complete a 100 mm visual analog scale and a four point Likert scale concerning their pain.

Secondary

MeasureTime frameDescription
Change from Baseline in NauseaBaseline, 30 minutes, 60 minutesPatients will be asked to complete a 100 mm visual analog scale concerning their level of nausea.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026