Visual Instillation of Sphenopalatine-block Intervention for ONgoing Migraine
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssociation of Migraine Disorders
About this trial
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?
The 2-month study requires:
* One virtual visit (on the computer) * One visit to the office for placement of the numbing medicine under direct vision * Daily headache diary entries that take less than two minutes to complete
Eligibility criteria
Qualifiers
Aged 18 years or older
Any race
Any gender
Photophobia
Disqualifiers
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.
A history of anterior skull base neoplasia.
Nasal endoscopy if performed prior to enrollment does not allow visualization of the middle turbinate on endoscopy bilaterally after application of a topical decongestant.
Trial design
Treatments tested in this trial
- Topical solution of 4% lidocaine
- Saline 0.9%
Treatment groups
74 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov