Abortive Effect of an Ear Insufflator on Migraine
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|ClinicalTrials.gov Identifier: NCT02614378|
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : December 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Procedure: air insufflation Procedure: placebo||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Abortive Effect of an Ear Insufflator on Migraine|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Active Comparator: Subject receiving treatment
participant receiving air insufflation
Procedure: 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
- 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
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614378
|United States, Arizona|
|Phoenix, Arizona, United States, 85044|
|Scottsdale, Arizona, United States, 85254|
|Principal Investigator:||Frederick R Carrick, PhD||Carrick Institute for Graduate Studies|