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

• Sponsor: Hennepin Healthcare Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01977001
• Collaborator: (none)
• Enrollment: 29
• Location: 1
• Duration (Months): 19
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Headache	Device: MigraineBoxTM

Study Design

• Study Type: Observational
• Actual Enrollment: 29 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Use of MigraineBoxTM Head and Neck Cooling Bath for Treatment of Primary Headache in the Emergency Department
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Primary Headache Treatment with MigraineBoxTM	Device: MigraineBoxTM

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415

Sponsors and Collaborators

• Hennepin Healthcare Research Institute

Investigators

• Principal Investigator: James R Miner, MD, Hennepin Healthcare Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hennepin Healthcare Research Institute
• ClinicalTrials.gov Identifier: NCT01977001
• Other Study ID Numbers: 12-3542
• First Posted: Nov 6, 2013
• Last Update Posted: Oct 24, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Hennepin Healthcare Research Institute: Primary headache; Headache; MigraineBox
• Additional relevant MeSH terms: Emergencies; Headache

Study Results

No Results Posted as of Oct 24, 2014