- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02614378
Abortive Effect of an Ear Insufflator on Migraine
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85044
- Buckler Chiropractic
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Scottsdale, Arizona, United States, 85254
- Doctor'S Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult subjects suffering from acute migraine episodes
- Possibly located in the Phoenix, AZ area
Exclusion Criteria:
- Pregnant/nursing women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Subject receiving treatment
participant receiving air insufflation
|
modulated air insufflation of the ear canal
|
Placebo Comparator: Subject receiving placebo
participant not receiving air insufflation
|
no air will be introduced in the ear canal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Symptoms severity scale
Time Frame: pre-treatment, immediately post-treatment
|
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
|
pre-treatment, immediately post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Symptoms severity scale at 2h
Time Frame: pre-treatment, 2h post-treatment
|
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
|
pre-treatment, 2h post-treatment
|
Changes in Symptoms severity scale at 24h
Time Frame: pre-treatment, 24h post-treatment
|
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
|
pre-treatment, 24h post-treatment
|
Changes in blood pressure
Time Frame: pre-treatment, immediately post-treatment
|
Blood pressure will be measured.
Changes in blood pressure will be assessed between pre and immediately post treatment
|
pre-treatment, immediately post-treatment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CI-IRB-20151104001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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