This clinical trial will enroll participants to evaluate the effects of SPG block on post-traumatic headache. The study hypothesizes that patients that receive a SPG block with lidocaine vs. placebo (saline) will have a lower number of headache days in the week following the procedure, and will also report lower symptom scores. Eligible participants will receive one treatment (SPG block) as well as complete surveys prior to and after receiving treatment (for a total of approximately 2 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2
Participants will receive 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares.The portion of the procedure involving this device lasts approximately 30-60 seconds.
Participants will receive saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasts approximately 30-60 seconds.
University of Michigan
Ann Arbor, Michigan, United States
Mean Change in Headache Severity Score
Patients will rate their headache on a scale of 0 to 6, with 0 corresponding to "absent" and 6 corresponding to "severe."
Time frame: 48 hours pre-SPG to 48 hours after SPG block
Patient Global Impression of Change (PGIC)
A rating scale of global improvement which participants use a seven-point scale ("1" = very much improved, "4" = no change, "7" very much worse). Participants will rate their change at two hours and 24 hours following the SPG block procedure.
Time frame: 2, 24 hours after SPG block
Mean Change in the Number of Headache Occurrences
The number of headache episodes over the one week prior to the SPG block compared to one week after the procedure.
Time frame: 1 week before SPG block, up to 1 week post SPG block
Mean Headache Occurrences Within 48 Hours pre-and 48 Hours Post-SPG Block
The number of headache episodes prior to the SPG block to after the procedure.
Time frame: 48 hours pre SPG to 48 hours post block
Mean Headache Occurrences Within 1 Week Pre- and 1 Week Post-SPG Block
The number of headache episodes over the one week prior to the SPG block to one week after the procedure.
Time frame: 1 week before SPG block up to 1 week post SPG block
Mean Change in Headache Hours Per Day
The number hours with headache 1 week prior to the SPG block and for up to 1 week after the procedure.
Time frame: 1 week before SPG block, up to 1 week post SPG block
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Mean Headache Hours Per Day Within 48 Hours Pre- and 48 Hours Post-SPG Block
Time frame: 48 hours pre SPG up to 48 hours post SPG
Mean Headache Hours Per Day Within 1 Week Pre and 1 Week Post Block
Time frame: 1 week before SPG block to 1 week post SPG block
Mean Change in the Number of Days With Headache
Time frame: 1 week before SPG block, up to 1 week post SPG
Mean Number of Days With Headache in the1 Week Post-SPG Block Compared to 1 Week Pre-SPG Block.
Time frame: 1 week before SPG block up to 1 week post SPG
Mean Change in As-needed Headache Treatment Uses
Patients will be asked to report the number of uses of as-needed headache medications used in the one week prior to the SPG block and after SPG block for up to one week after the procedure.
Time frame: 1 week before SPG block to 1 week post SPG block
Mean As-needed Headache Treatment Uses Within 48 Hours Pre- and 48 Hours Post-SPG
Patients will be asked to report the number of uses of as-needed headache medications used in the one week prior to the SPG block and after SPG block for up to one week after the procedure.
Time frame: 48 hours before SPG block to 48 hours post SPG block
Mean As-needed Headache Treatment Uses Within 1 Week Pre and 1 Week Post Block
Patients will be asked to report the number of uses of as-needed headache medications used in the one week prior to the SPG block and after SPG block for up to one week after the procedure.
Time frame: 1 week before SPG block up to 1 week post SPG block