Abortive Effect of an Ear Insufflator on Migraine
Primary Purpose
Migraine
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
air insufflation
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring abortive effect
Eligibility Criteria
Inclusion Criteria:
- Adult subjects suffering from acute migraine episodes
- Possibly located in the Phoenix, AZ area
Exclusion Criteria:
- Pregnant/nursing women
Sites / Locations
- Buckler Chiropractic
- Doctor's office
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Subject receiving treatment
Subject receiving placebo
Arm Description
participant receiving air insufflation
participant not receiving air insufflation
Outcomes
Primary Outcome Measures
Changes in Symptoms severity scale
Subjects will grade the severity of their symptoms on a scale from 0 to 10. Changes in the symptoms severity scale will be assessed between pre and immediately post treatment
Secondary Outcome Measures
Changes in Symptoms severity scale at 2h
Subjects will grade the severity of their symptoms on a scale from 0 to 10. Changes in the symptoms severity scale will be assessed between pre and 2h post treatment
Changes in Symptoms severity scale at 24h
Subjects will grade the severity of their symptoms on a scale from 0 to 10. Changes in the symptoms severity scale will be assessed between pre and 24h post treatment
Changes in blood pressure
Blood pressure will be measured. Changes in blood pressure will be assessed between pre and immediately post treatment
Full Information
NCT ID
NCT02614378
First Posted
November 21, 2015
Last Updated
December 13, 2016
Sponsor
Carrick Institute for Graduate Studies
1. Study Identification
Unique Protocol Identification Number
NCT02614378
Brief Title
Abortive Effect of an Ear Insufflator on Migraine
Official Title
Abortive Effect of an Ear Insufflator on Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carrick Institute for Graduate Studies
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
abortive effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subject receiving treatment
Arm Type
Active Comparator
Arm Description
participant receiving air insufflation
Arm Title
Subject receiving placebo
Arm Type
Placebo Comparator
Arm Description
participant not receiving air insufflation
Intervention Type
Procedure
Intervention Name(s)
air insufflation
Intervention Description
modulated air insufflation of the ear canal
Intervention Type
Procedure
Intervention Name(s)
placebo
Intervention Description
no air will be introduced in the ear canal
Primary Outcome Measure Information:
Title
Changes in Symptoms severity scale
Description
Subjects will grade the severity of their symptoms on a scale from 0 to 10. Changes in the symptoms severity scale will be assessed between pre and immediately post treatment
Time Frame
pre-treatment, immediately post-treatment
Secondary Outcome Measure Information:
Title
Changes in Symptoms severity scale at 2h
Description
Subjects will grade the severity of their symptoms on a scale from 0 to 10. Changes in the symptoms severity scale will be assessed between pre and 2h post treatment
Time Frame
pre-treatment, 2h post-treatment
Title
Changes in Symptoms severity scale at 24h
Description
Subjects will grade the severity of their symptoms on a scale from 0 to 10. Changes in the symptoms severity scale will be assessed between pre and 24h post treatment
Time Frame
pre-treatment, 24h post-treatment
Title
Changes in blood pressure
Description
Blood pressure will be measured. Changes in blood pressure will be assessed between pre and immediately post treatment
Time Frame
pre-treatment, immediately post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult subjects suffering from acute migraine episodes
Possibly located in the Phoenix, AZ area
Exclusion Criteria:
Pregnant/nursing women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick R Carrick, PhD
Organizational Affiliation
Carrick Institute for Graduate Studies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buckler Chiropractic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85044
Country
United States
Facility Name
Doctor's office
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Abortive Effect of an Ear Insufflator on Migraine
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