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

Primary Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977001
• Other study ID #: 12-3542
• Status: Completed
• Phase: N/A
• First received: October 24, 2013
• Last updated: October 23, 2014
• Start date: November 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2014
• Source: Minneapolis Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Headache
• Primary Headache

Intervention

Device:
• MigraineBoxTM

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Pain Level	Patients will be asked to complete a 100 mm visual analog scale and a four point Likert scale concerning their pain.	Baseline, 30 minutes, 60 minutes	No
Secondary	Change from Baseline in Nausea	Patients will be asked to complete a 100 mm visual analog scale concerning their level of nausea.	Baseline, 30 minutes, 60 minutes	No