Sphenopalatine Ganglion Block for Headache After Concussion

Study Overview
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Brief Summary
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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).

Official Title
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A Phase II Randomized Controlled Double-Blind Clinical Trial of Sphenopalatine Ganglion (SPG) Block for Headache After Concussion

Conditions
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Concussion, Headache

Intervention / Treatment
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* Combination Product: Lidocaine in SphenoCath device
* Combination Product: Saline Solution in SphenoCath device


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine in SphenoCath device<br>One treatment will be given. | Combination Product: Lidocaine in SphenoCath device<br>* 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.<br>|
| Placebo Comparator: Saline Solution in SphenoCath device<br>One treatment will be given. | Combination Product: Saline Solution in SphenoCath device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 48 hours pre-SPG to 48 hours after SPG block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 1 week before SPG block, up to 1 week post SPG block | 
| 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 | 
| 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 | 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. | 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. | 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. | 1 week before SPG block up to 1 week post SPG block | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Concussions, headaches, sphenopalatine ganglion block