Visual Instillation of Sphenopalatine-block Intervention for ONgoing Migraine
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Acute headache pain
研究概览
简要总结
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:
- 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?
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
Topical lidocaine endoscopically-guided intranasal nerve block
Topical 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.
干预措施: Topical solution of 4% lidocaine (Drug)
Placebo (saline) endoscopically-guided intranasal nerve block
Topical 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.
干预措施: Saline 0.9% (Drug)
结局指标
主要结局
Acute headache pain
时间窗: 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
时间窗: 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.
Acute neck pain
时间窗: 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.
次要结局
- 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.)
- 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.)
- 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.)
- Sinonasal Outcome Test- 22 (SNOT-22)(Immediately before the treatment at 1 month and again 1 month after treatment.)
- Migraine Disability Assessment (MIDAS)(Immediately before the treatment at 1 month and again 1 month after treatment.)