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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Topical solution of 4% lidocaine
DrugA rigid endoscopic technique utilizing a cotton pledget as a delivery vehicle of the topical lidocaine allows direct visualization of the target.
Saline 0.9%
DrugA rigid endoscopic technique utilizing cotton pledget as a delivery vehicle of the topical saline allows direct visualization of the target.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Topical lidocaine endoscopically-guided intranasal nerve blockExperimental treatment 1 intervention
Group B: Placebo (saline) endoscopically-guided intranasal nerve blockPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Acute headache pain
Acute headache pain will be measured using a 0 to 10 Likert scale (0 representing No Pain, and 10 representing the worst pain possible), before (pre-treatment) and after the endoscopy procedure (post-treatment) at 15, 30, 60 min and 24 hours.
Time frame
Immediately before (pre-treatment) and after the endoscopy procedure at Visit 2, approximately 1 month after enrollment.2
Acute facial pain or pressure
Acute facial pain or pressure will be measured using a 0 to 10 Likert scale (0 representing No Pain, and 10 representing the worst pain possible), before (pre-treatment) and after the endoscopy procedure (post-treatment) at 15, 30, 60 min and 24 hours.
Time frame
Immediately before (pre-treatment) and after the endoscopy procedure at Visit 2, approximately 1 month after enrollment.3
Acute neck pain
Acute neck pain will be measured using a 0 to 10 Likert scale (0 representing No Pain, and 10 representing the worst pain possible), before (pre-treatment) and after the endoscopy procedure (post-treatment) at 15, 30, 60 min and 24 hours.
Time frame
Immediately before (pre-treatment) and after the endoscopy procedure at Visit 2, approximately 1 month after enrollment.Secondary outcomes
1
Headache days per month
Daily headache pain recorded in a mobile application. Recorded as binary (Yes/No) and rated using a 0 to 10 Likert scale (0 representing No Pain, and 10 representing the worst pain possible).
Time frame
Daily, following enrollment to right before the treatment at 1 month and again from right after the treatment to 1 month after treatment.2
Facial pain or pressure days per month
Daily facial pain or pressure recorded in a mobile application. Recorded as binary (Yes/No) and rated using a 0 to 10 Likert scale (0 representing No Pain or pressure, and 10 representing the worst pain or pressure possible).
Time frame
Daily, following enrollment to right before the treatment at 1 month and again from right after the treatment to 1 month after treatment.3
Neck pain days per month
Daily neck pain recorded in a mobile application. Recorded as binary (Yes/No) and rated using a 0 to 10 Likert scale (0 representing No Pain, and 10 representing the worst pain possible).
Time frame
Daily, following enrollment to right before the treatment at 1 month and again from right after the treatment to 1 month after treatment.4
Sinonasal Outcome Test- 22 (SNOT-22)
SNOT-22 is A validated 22-item questionnaire that measures the health-related quality of life (HRQoL) of patients with chronic rhinosinusitis (CRS). The SNOT-22 is scored by adding the individual values of 22 symptom and quality-of-life items. Each item is graded on a scale from 0 to 5, yielding a total cumulative score between 0 and 110, where higher numbers reflect more severe symptoms and a greater impact on health.
Time frame
Immediately before the treatment at 1 month and again 1 month after treatment.Other outcomes
1
Additional headache symptoms
Additional headache symptoms recorded in a mobile application. Recorded as binary (Yes/No) and rated using a 0 to 10 Likert scale (0 representing No Pain, and 10 representing the worst pain possible).
Time frame
Daily, following enrollment to right before the treatment at 1 month and again from right after the treatment to 1 month after treatment.2
Rescue medications
Rescue medication needed, recorded in a mobile application. Recorded as binary (Yes/No).
Time frame
Daily, following enrollment to right before the treatment at 1 month and again from right after the treatment to 1 month after treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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