This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in acute migraine headache.
A total of 40 adult subjects will be enrolled, male and female. Subjects will be consented to inhale either Normobaric Oxygen (NBO) or Room air for 30 minutes at the start of their migraine attacks. Outcomes will be assessed during and after gas treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
22
Massachusetts General Hospital
Boston, Massachusetts, United States
Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS)
The mean change in VAS pain scores from 0 minutes to 30 minutes was selected as the primary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
Time frame: From baseline (0 minutes) to 30 mins
Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS)
The mean change in VAS pain scores from 0 minutes to 15 minutes was selected as a secondary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
Time frame: Baseline (0 minutes) to 15 minutes
Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS)
The mean change in VAS pain scores from 0 minutes to 60 minutes was selected as a secondary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
Time frame: Baseline (0 minutes) to 60 minutes
Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS)
The percentage of migraine attacks with the final (60 minute) VAS pain score 0-1 was selected as a secondary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
Time frame: 60 minutes
Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS)
The percentage of migraine attacks with the final (60 minute) VAS pain score either 0-1, or a 3-point improvement from baseline, was selected as a secondary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
Time frame: 60 minutes
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Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS)
The percentage of migraine attacks with the final (60 minute) VAS visual symptom score 0-1 was selected as a secondary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
Time frame: 60 minutes
Final Nausea Score 0-1 on the Visual Analog Scale (VAS)
The percentage of migraine attacks with the final (60 minute) VAS nausea score 0-1 was selected as a secondary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
Time frame: 60 minutes