Use of MigraineBoxTM Head and Neck Cooling Bath for Treat... | NCT01977001

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

NCT01977001

Sponsor

Hennepin Healthcare Research Institute

Status

Completed

Last Update Posted

Oct 24, 2014Estimated

Enrollment

29Actual

Phase

Not provided

Conditions

Primary Headache

Interventions

MigraineBoxTM

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Oct 24, 2013

First Submission Date that Met QC Criteria

Oct 30, 2013

First Posted Date

Nov 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2014

Last Update Posted Date

Oct 24, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Primary Headache		Treatment with MigraineBoxTM	Device: MigraineBoxTM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MigraineBoxTM	Device		Primary Headache

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James R Miner, MD	Hennepin Healthcare Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hennepin County Medical Center		Minneapolis	Minnesota	55415	United States

Condition Browse Module

MeSH Terms

ID	Term
D006261	Headache

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided