This study will evaluate the clinical performance and safety of a self-administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (Neurolief device, Relievion™).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation
1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation
Meir General Hospital
Kfar Saba, Israel
Pain Visual Analogue Scale (VAS) Change from basline to 1 hour
Mean change of pain score (measured on a visual analog scale) at 1 hour compared to baseline (if rescue therapy was not used)
Time frame: 1 Hour
Pain VAS change from baseline to 30 minutes
Mean change of pain score (measured on a visual analog scale) at 30 minutes compared to baseline (if rescue therapy was not used).
Time frame: 30 minutes
Pain VAS change from baseline to 2 hours
Mean change of pain score (measured on a visual analog scale) at 2 hours compared to baseline (if rescue therapy was not used).
Time frame: 2 Hours
Pain VAS change from baseline to 24 hours
Mean change of pain score (measured on a visual analog scale) at 24 hours compared to baseline (if rescue therapy was not used).
Time frame: 24 Hours
Pain VAS change from baseline to 48 hours
Mean change of pain score (measured on a visual analog scale) at 48 hours compared to baseline (if rescue therapy was not used).
Time frame: 48 Hours
Rescue medication at 2 hours
Proportion of patients not having required rescue medication at 2 hours
Time frame: 2 hours
Rescue medication within 24 hours
Proportion of patients not having required rescue medication within 24 hours
Time frame: 24 hours
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Rescue medication within 48 hours
Proportion of patients not having required rescue medication within 48 hours
Time frame: 48 hours