Sphenopalatine Ganglion Block for Headache After Concussion

Phase 2

Terminated

• Conditions: Headache; Concussion
• Interventions: Combination Product: Lidocaine in SphenoCath device; Combination Product: Saline Solution in SphenoCath device

• Registration Number: NCT04650282
• Lead Sponsor: University of Michigan

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-12-02
• Study Start: 2021-03-18
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-06
• Results First Submitted: 2022-04-22
• Results First Submitted QC: 2022-04-22
• Results First Posted: 2022-05-18
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine in SphenoCath device	Lidocaine in SphenoCath device	One treatment will be given.
Saline Solution in SphenoCath device	Saline Solution in SphenoCath device	One treatment will be given.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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 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 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 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 Change in the Number of Days With Headache	1 week before SPG block, up to 1 week post SPG
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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States