NCT01977001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

1.6 years

First QC Date

October 24, 2013

Last Update Submit

October 23, 2014

Conditions

Primary Headache

Keywords

Primary headacheHeadacheMigraineBox

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change from Baseline in Nausea

    Baseline, 30 minutes, 60 minutes

Study Arms (1)

Primary Headache

Treatment with MigraineBoxTM

Device: MigraineBoxTM

Interventions

MigraineBoxTMDEVICE
Primary Headache

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to the emergency department at an urban county hospital.

You may qualify if:

  • years old
  • Benign headache
  • Physician intends to treat headache pain in the ED with either droperidol, prochlorperazine, or a parenteral narcotic

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • James R Miner, MD

    Hennepin Healthcare Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2013

First Posted

November 6, 2013

Study Start

November 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 24, 2014

Record last verified: 2014-10

Locations

US(1)