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

Completed

• Conditions: Primary Headache
• Interventions: Device: MigraineBoxTM

• Registration Number: NCT01977001
• Lead Sponsor: Hennepin Healthcare Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-23
• Last Update Posted: 2014-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary Headache	MigraineBoxTM	Treatment with MigraineBoxTM

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Pain Level	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 Outcome Measures

Name	Time	Method
Change from Baseline in Nausea	Baseline, 30 minutes, 60 minutes	Patients will be asked to complete a 100 mm visual analog scale concerning their level of nausea.

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States