Visual Instillation of Sphenopalatine-block Intervention for ONgoing Migraine
Part of paid clinical trials in Springfield, Massachusetts.
- Sponsor
- Association of Migraine Disorders
- Study ID
- NCT07764783
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Facial Pain or Pressure
- Headache
- Migraine
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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.
Study Details
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
Key Dates
- First listed
- Aug 14, 2026
- Start date
- Sep 30, 2026
- Status verified
- Aug 2026
- Primary completion
- Sep 30, 2028
- Completion
- Sep 30, 2028
Study Design
- Enrollment
- 74 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Topical lidocaine endoscopically-guided intranasal nerve blockTopical solution of 4% lidocaine on small cotton pledgets with be placed endoscopically at the posterior root of the middle turbinate and in the anterior ethmoid nerve region bilaterally for Sphenopalatine Ganglion Block (SPG) block with anterior ethmoid (AE) block.
- Placebo Comparator: Placebo (saline) endoscopically-guided intranasal nerve blockTopical solution of saline on small cotton pledgets with be placed endoscopically at the posterior root of the middle turbinate and in the anterior ethmoid nerve region bilaterally for Sphenopalatine Ganglion Block (SPG) block with anterior ethmoid (AE) block.
Primary Outcome Measure
Acute headache pain [ Time Frame: Immediately before (pre-treatment) and after the endoscopy procedure at Visit 2, approximately 1 month after enrollment. ]
Central Contacts
- Study Coorinator413-200-8634
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ear, Nose, & Throat Surgeons of Western New England | Springfield | Massachusetts | 01107 |
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