Sphenopalatine Ganglion Block for Headache After Concussion

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04650282
• Other study ID #: HUM00185200
• Status: Terminated
• Phase: Phase 2
• Start date: March 18, 2021
• Est. completion date: April 6, 2021

Study information

• Verified date: August 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 6, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Concussion
• Ganglion Cysts
• Headache

Intervention

Combination Product:
• Lidocaine 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.
• Saline 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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."	48 hours pre-SPG to 48 hours after SPG block
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.	2, 24 hours after SPG block
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.	1 week before SPG block, up to 1 week post SPG block
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.	48 hours pre SPG to 48 hours post block
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.	1 week before SPG block up to 1 week post SPG block
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.	1 week before SPG block, up to 1 week post SPG block
Secondary	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
Secondary	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
Secondary	Mean Change in the Number of Days With Headache		1 week before SPG block, up to 1 week post SPG
Secondary	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
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.	1 week before SPG block to 1 week post SPG block
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.	48 hours before SPG block to 48 hours post SPG block
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.	1 week before SPG block up to 1 week post SPG block