Abortive Effect of an Ear Insufflator on Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

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.
    

Intervention name(s): air insufflation; placebo
Intervention type(s): Procedure; Procedure
Intervention description(s): modulated air insufflation of the ear canal; no air will be introduced in the ear canal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: abortive effect