Clinical trial NCT04650282: Sphenopalatine Ganglion Block for Headache After Concussion
Official title: A Phase II Randomized Controlled Double-Blind Clinical Trial of Sphenopalatine Ganglion (SPG) Block for Headache After Concussion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Concussion
Headache
Keywords: Concussions
headaches
sphenopalatine ganglion block
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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)

Primary outcomes:
measure: Mean Change in Headache Severity Score
timeFrame: 48 hours pre-SPG to 48 hours after SPG block
Secondary outcomes:
measure: Patient Global Impression of Change (PGIC)
timeFrame: 2, 24 hours after SPG block
measure: Mean Change in the Number of Headache Occurrences
timeFrame: 1 week before SPG block, up to 1 week post SPG block
measure: Mean Headache Occurrences Within 48 Hours pre-and 48 Hours Post-SPG Block
timeFrame: 48 hours pre SPG to 48 hours post block
measure: Mean Headache Occurrences Within 1 Week Pre- and 1 Week Post-SPG Block
timeFrame: 1 week before SPG block up to 1 week post SPG block
measure: Mean Change in Headache Hours Per Day
timeFrame: 1 week before SPG block, up to 1 week post SPG block
measure: Mean Headache Hours Per Day Within 48 Hours Pre- and 48 Hours Post-SPG Block
timeFrame: 48 hours pre SPG up to 48 hours post SPG
measure: Mean Headache Hours Per Day Within 1 Week Pre and 1 Week Post Block
timeFrame: 1 week before SPG block to 1 week post SPG block
measure: Mean Change in the Number of Days With Headache
timeFrame: 1 week before SPG block, up to 1 week post SPG
measure: Mean Number of Days With Headache in the1 Week Post-SPG Block Compared to 1 Week Pre-SPG Block.
timeFrame: 1 week before SPG block up to 1 week post SPG
measure: Mean Change in As-needed Headache Treatment Uses
timeFrame: 1 week before SPG block to 1 week post SPG block
measure: Mean As-needed Headache Treatment Uses Within 48 Hours Pre- and 48 Hours Post-SPG
timeFrame: 48 hours before SPG block to 48 hours post SPG block
measure: Mean As-needed Headache Treatment Uses Within 1 Week Pre and 1 Week Post Block
timeFrame: 1 week before SPG block up to 1 week post SPG block
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Michael Popovich, MD
role: PRINCIPAL_INVESTIGATOR
References: