Concussion, Headache
Conditions
Keywords
Concussions, headaches, sphenopalatine ganglion block
Brief summary
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).
Interventions
COMBINATION_PRODUCTLidocaine in SphenoCath device
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.
COMBINATION_PRODUCTSaline Solution in SphenoCath device
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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with a concussion and are greater than 14 days from the date of their injury. * Experiencing greater or equal than 4 occurrences of headache per week lasting at least 1 hour per occurrence with a headache severity score greater or equal to 2 out of 6.
Exclusion criteria
* Allergy to local anesthetics of the amide type (for example (i.e.) lidocaine) * Frequent epistaxis (i.e. more than one nose bleed per month), * Bleeding disorders * History of any of the following: nasal or facial fracture, nasal septal defect, any other craniofacial abnormality, hepatic disease, Adam-Stokes syndrome, Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or intraventricular heart block * Pregnant * Are at increased risk for methemoglobinemia (including patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, and concurrent exposure to oxidizing agents or their metabolites and drugs associated with methemoglobinemia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Headache Severity Score | 48 hours pre-SPG to 48 hours after SPG block | Patients will rate their headache on a scale of 0 to 6, with 0 corresponding to absent and 6 corresponding to severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Change (PGIC) | 2, 24 hours after SPG block | 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. |
| Mean Change in the Number of Headache Occurrences | 1 week before SPG block, up to 1 week post SPG block | The number of headache episodes over the one week prior to the SPG block compared to one week after the procedure. |
| Mean Headache Occurrences Within 48 Hours pre-and 48 Hours Post-SPG Block | 48 hours pre SPG to 48 hours post block | The number of headache episodes prior to the SPG block to after the procedure. |
| Mean Headache Occurrences Within 1 Week Pre- and 1 Week Post-SPG Block | 1 week before SPG block up to 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. |
| Mean Change in Headache Hours Per Day | 1 week before SPG block, up to 1 week post SPG block | The number hours with headache 1 week prior to the SPG block and for up to 1 week after the procedure. |
| Mean Headache Hours Per Day Within 1 Week Pre and 1 Week Post Block | 1 week before SPG block to 1 week post SPG block | — |
| Mean Change in the Number of Days With Headache | 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. | 1 week before SPG block up to 1 week post SPG | — |
| Mean Change in As-needed Headache Treatment Uses | 1 week before SPG block to 1 week post SPG 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. |
| Mean As-needed Headache Treatment Uses Within 48 Hours Pre- and 48 Hours Post-SPG | 48 hours before SPG block to 48 hours post SPG 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. |
| Mean As-needed Headache Treatment Uses Within 1 Week Pre and 1 Week Post Block | 1 week before SPG block up to 1 week post SPG 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. |
| Mean Headache Hours Per Day Within 48 Hours Pre- and 48 Hours Post-SPG Block | 48 hours pre SPG up to 48 hours post SPG | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine in SphenoCath Device One treatment was given.
Lidocaine in SphenoCath device: Participants received 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds. | 1 |
| Saline Solution in SphenoCath Device One treatment was given.
Saline Solution in SphenoCath device: Participants received saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds. | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Lidocaine in SphenoCath Device | Total | Saline Solution in SphenoCath Device |
|---|---|---|---|
| Age, Customized 20 to 45 years of age | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 1 Participants |
| Region of Enrollment United States | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
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
Population: Because only one participant was involved in each arm, showing data could violate privacy interests.
Secondary
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
Population: Because only one participant was involved in each arm, showing data could violate privacy interests.
Secondary
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
Population: Because only one participant was involved in each arm, showing data could violate privacy interests.
Secondary
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
Population: Because only one participant was involved in each arm, showing data could violate privacy interests.
Secondary
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
Population: Because only one participant was involved in each arm, showing data could violate privacy interests.
Secondary
Mean Change in the Number of Days With Headache
Time frame: 1 week before SPG block, up to 1 week post SPG
Population: Because only one participant was involved in each arm, showing data could violate privacy interests.
Secondary
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
Population: Because only one participant was involved in each arm, showing data could violate privacy interests.
Secondary
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
Population: Because only one participant was involved in each arm, showing data could violate privacy interests.
Secondary
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
Population: Because only one participant was involved in each arm, showing data could violate privacy interests.
Secondary
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
Population: Because only one participant was involved in each arm, showing data could violate privacy interests.
Secondary
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
Population: Because only one participant was involved in each arm, showing data could violate privacy interests.
Secondary
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
Population: Because only one participant was involved in each arm, showing data could violate privacy interests.
Secondary
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
Population: Because only one participant was involved in each arm, showing data could violate privacy interests.