Facial Pain or Pressure, Headache, Migraine
Conditions
Brief summary
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
Interventions
DRUGTopical solution of 4% lidocaine
A rigid endoscopic technique utilizing a cotton pledget as a delivery vehicle of the topical lidocaine allows direct visualization of the target.
DRUGSaline 0.9%
A rigid endoscopic technique utilizing cotton pledget as a delivery vehicle of the topical saline allows direct visualization of the target.
Sponsors
Association of Migraine Disorders
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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: 1. Photophobia 2. Inability to function 3. 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.
Exclusion criteria
* 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. * 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 * Allergy to lidocaine or other local anesthetics (tertiary amine class 1b). * Is currently using a schedule II narcotic for migraine pain. * Current cocaine use or cocaine use within the last 30 days. * Currently immunocompromised * 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. * Has received any investigational agent within 30 days of enrollment. * Plans to participate in a concurrent clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute neck pain | Immediately before (pre-treatment) and after the endoscopy procedure at Visit 2, approximately 1 month after enrollment. | 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. |
| Acute headache pain | Immediately before (pre-treatment) and after the endoscopy procedure at Visit 2, approximately 1 month after enrollment. | 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. |
| Acute facial pain or pressure | Immediately before (pre-treatment) and after the endoscopy procedure at Visit 2, approximately 1 month after enrollment. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neck pain days per month | Daily, following enrollment to right before the treatment at 1 month and again from right after the treatment to 1 month after treatment. | 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). |
| Sinonasal Outcome Test- 22 (SNOT-22) | Immediately before the treatment at 1 month and again 1 month after treatment. | 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. |
| Migraine Disability Assessment (MIDAS) | Immediately before the treatment at 1 month and again 1 month after treatment. | MIDAS is a valid and reliable short questionnaire for assessment of headache related disability. Respondents will enter the total number of days affected in the last one month for: Work or school: Days missed. Work or school productivity: Days where productivity was reduced by half or more. Household work: Days missed. Household work productivity: Days where productivity was reduced by half or more. Family, social, or leisure activities: Days missed. |
| Headache days per month | Daily, following enrollment to right before the treatment at 1 month and again from right after the treatment to 1 month after treatment. | 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). |
| Facial pain or pressure days per month | Daily, following enrollment to right before the treatment at 1 month and again from right after the treatment to 1 month after treatment. | 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). |
Countries
United States
Contacts
CONTACTStudy Coorinator
PRINCIPAL_INVESTIGATORJerry Schreibstein, MD
Ear, Nose, & Throat Surgeons of Western New England
Outcome results
None listed