Abortive Effect of an Ear Insufflator on Migraine
1 other identifier
interventional
58
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 21, 2015
CompletedFirst Posted
Study publicly available on registry
November 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedDecember 14, 2016
December 1, 2016
1.1 years
November 21, 2015
December 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
pre-treatment, immediately post-treatment
Secondary Outcomes (3)
Changes in Symptoms severity scale at 2h
pre-treatment, 2h post-treatment
Changes in Symptoms severity scale at 24h
pre-treatment, 24h post-treatment
Changes in blood pressure
pre-treatment, immediately post-treatment
Study Arms (2)
Subject receiving treatment
ACTIVE COMPARATORparticipant receiving air insufflation
Subject receiving placebo
PLACEBO COMPARATORparticipant not receiving air insufflation
Interventions
Eligibility Criteria
You may qualify if:
- Adult subjects suffering from acute migraine episodes
- Possibly located in the Phoenix, AZ area
You may not qualify if:
- Pregnant/nursing women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Buckler Chiropractic
Phoenix, Arizona, 85044, United States
Doctor's office
Scottsdale, Arizona, 85254, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederick R Carrick, PhD
Carrick Institute for Graduate Studies
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 21, 2015
First Posted
November 25, 2015
Study Start
November 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
December 14, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share