Visual Instillation of Sphenopalatine-block Intervention for ONgoing Migraine

A vizsgálat adatai

Ki végzi

Association of Migraine Disorders

Azonosító

NCT07764783

A regiszteradat frissítve

2026. november 9.

Eredeti leírás

The goal of this double-blinded, randomized placebo controlled clinical trial is to to see if using a numbing medicine (lidocaine) on certain areas inside the nose can help with headaches, neck pain, facial pain and pressure, and other symptoms. It also aims to understand the pathophysiology that causes these symptoms.A teljes eredeti leírásKevesebb

The goal of this double-blinded, randomized placebo controlled clinical trial is to to see if using a numbing medicine (lidocaine) on certain areas inside the nose can help with headaches, neck pain, facial pain and pressure, and other symptoms. It also aims to understand the pathophysiology that causes these symptoms.

The main questions it aims to answer are:

1. Is applying numbing medication directly to the sphenopalatine ganglion (SPG) area, while watching through the scope to make sure it's in the right place, a workable and effective way to treat migraine headaches immediately and 24 hours? 2. Is applying numbing medication directly to the sphenopalatine ganglion (SPG) area, while watching through the scope to make sure it's in the right place, a workable and effective way to improve patient-reported outcomes? 3. Does daily lidocaine nasal spray improve patient-reported outcomes?

The 3-month study requires:

* One virtual visit (on the computer) * One visit to the office for placement of the numbing medicine under direct vision * One week of daily nasal spray treatment * Daily headache diary entries that take less than two minutes to complete

Bevonási feltételek: Aged 18 years or older; Any race; Any gender; At least 2 of 3 positives (a, b, c) below on the ID Migraine Screener from the American Headache Society:; Photophobia; Inability to function; Nausea; At least 3 months of patient-reported episodic or persistent discomfort, pain, or pressure in the anatomic distribution of the paranasal sinuses, orbits, or nasal cavities; The patient experiences at least 10 days of headaches and/or FPP within a 30-day period, during the run-in phase; No evidence of abnormal sinus findings on imaging [paranasal sinus CT, including cone beam imaging, or MRI (MRI images must include all paranasal sinuses) obtained when symptomatic in the last 12 months prior to presentation. Normal imaging findings included isolated mucus retention cysts 2 cm or less in size and minimal non-circumferential (isolated areas) mucosal thickening (3mm or less); Normal endoscopy if performed prior to enrollment, defined as the absence of purulent (opaque - white or other discolored - secretions) at the middle meatus or sphenoethmoid recess or nasal polyp disease; Daily access to a cell phone that can function with the study mobile application; For women of child bearing potential: not pregnant and using a method of contraception during the duration of the study; The patient can be taking interventional and preventive medications and other treatments before and during the study period, including new medications which will be tracked. The clinical coordinator will ask the patient to refrain from taking any abortive medication, cannabis, and psilocybin 24 hours prior to the procedure visit.

Kizáró feltételek: Prior endoscopic sinus surgery within the 3 months prior to enrollment; Nasal endoscopy if performed prior to enrollment shows severe signs of mucosal infection, (mucopurulent drainage) or nasal polyposis; Nasal endoscopy if performed prior to enrollment does not allow visualization of the middle turbinate on endoscopy bilaterally after application of a topical decongestant; Is currently using a schedule II narcotic for migraine pain; Has received any investigational agent within 30 days of enrollment; Plans to participate in a concurrent clinical trial; A history of anterior skull base neoplasia; Allergy to lidocaine or other local anesthetics (tertiary amine class 1b); History or evidence of any other unstable or clinically significant medical condition that in the opinion of the sponsor-investigator/ Principal Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion; Signs of active or chronic sinusitis on CT (>3mm mucosal thickening or air fluid level in any paranasal sinus.); The patient cannot tolerate the use of topical anesthetics or intranasal endoscopy without sedation or general anesthesia; Unable to see the middle meatus with either a nasal speculum or an endoscope; Current cocaine use or cocaine use within the last 30 days; Currently immunocompromised.

ClinicalTrials.gov NCT07764783