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Abortive Effect of an Ear Insufflator on Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02614378
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies

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.

Condition or disease Intervention/treatment Phase
Migraine Procedure: air insufflation Procedure: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
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
Procedure: placebo
no air will be introduced in the ear canal




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant/nursing women

Information from the National Library of Medicine

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


Locations
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United States, Arizona
Buckler Chiropractic
Phoenix, Arizona, United States, 85044
Doctor's office
Scottsdale, Arizona, United States, 85254
Sponsors and Collaborators
Carrick Institute for Graduate Studies
Investigators
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Principal Investigator: Frederick R Carrick, PhD Carrick Institute for Graduate Studies
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Responsible Party: Frederick Carrick, PhD, FACCN, Principal Investigator, Carrick Institute for Graduate Studies
ClinicalTrials.gov Identifier: NCT02614378    
Other Study ID Numbers: CI-IRB-20151104001
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies:
abortive effect
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases