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Abortive Effect of an Ear Insufflator on Migraine

NCT ID: NCT02614378

Last Updated: 2016-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-12-31

Brief Summary

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Evaluate the effectiveness of air insufflation in aborting (stopping) an acute episode of migraine and compare it with a placebo effect of using the same procedure but without active insufflation. The insufflation will be used when the subject is experiencing an acute episode of migraine to determine its ability to reduce, if not to completely eliminate the migraine symptoms. Subjects receiving the placebo treatment will be offered the active treatment during the subsequent episode of migraine.

Detailed Description

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Each patient will be asked (using a questionnaire) to describe the nature of their presenting symptoms including distribution pattern, symmetry, laterality, severity and associated symptoms. Severity of migraine/headache will be recorded. The patient's description of their symptoms will be used to guide the treatment process in terms of treatment time and side (i.e. left or right ear). A tubular soft silicone ear-plug will be inserted into the patient's ear on the side of greatest reported severity. In the absence of clear laterality with respect to severity, the side associated with the greatest surface area of involvement will be selected (e.g., the patient has a bilateral headache but on the left, it is perceived as retro-orbital whereas on the right it is retro-orbital and temporal, therefore the right side will be selected), In the absence of lateralizing features, the initial treatment side will be randomly selected. Then the air insufflation will start. The patient will be encouraged to relax during the process and the extent of the insufflation will be maintained a level that is comfortable for the patient. The patient will be asked to report any sense of aggravation of their symptoms, which would prompt the examiner to suspend the treatment. The patient will not know if the treatment received is the active or the placebo one.

Following insufflation, the ear plug will be removed and the patient will be asked to rate the severity of their symptoms and describe any changes in characteristics. A significant reduction in pain level will be considered an indication that the treatment is appropriate for that patient and the treatment will then continue on the ipsilateral side. If the patients will describe resolution of their symptoms in a hemi-distribution of the head ("the symptoms are gone from this side of my head but they're still left on the other side"), the treatment process will be repeated on the contralateral side until resolution (or maximal reduction in symptoms) will be achieved. Treatment session in this study will last 20 minutes.

There will be a followup at 2h and 24h post treatment to monitor the status of the patient and they will all be invited back for a second treatmentduring the subsequent episode of migraine.

Vitals (blood pressure, heart rate, pulse oxygenation and temperature) will also be monitored to see if there are any changes before and immediately after treatment.

Conditions

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Migraine

Keywords

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abortive effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Subject receiving treatment

participant receiving air insufflation

Group Type ACTIVE_COMPARATOR

air insufflation

Intervention Type PROCEDURE

modulated air insufflation of the ear canal

Subject receiving placebo

participant not receiving air insufflation

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type PROCEDURE

no air will be introduced in the ear canal

Interventions

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air insufflation

modulated air insufflation of the ear canal

Intervention Type PROCEDURE

placebo

no air will be introduced in the ear canal

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult subjects suffering from acute migraine episodes
* Possibly located in the Phoenix, AZ area

Exclusion Criteria

* Pregnant/nursing women
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carrick Institute for Graduate Studies

OTHER

Sponsor Role lead

Responsible Party

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Frederick Carrick, PhD, FACCN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frederick R Carrick, PhD

Role: PRINCIPAL_INVESTIGATOR

Carrick Institute for Graduate Studies

Locations

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Buckler Chiropractic

Phoenix, Arizona, United States

Site Status

Doctor's office

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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CI-IRB-20151104001

Identifier Type: -

Identifier Source: org_study_id