Capsaicin in Treatment of Rhinogenic Headache
关键词
抽象
描述
1. Title: The role of capsaicin in treatment of rhinogenic headache
2. Description: Capsaicin (8- methyl-N-vanillyl-6-nonenamide) has been demonstrated to have a therapeutic effect in idiopathic rhinitis, migraines and cluster headaches. We hypothesize that capsaicin has a therapeutic effect on rhinogenic headaches as well. This study aims to evaluate capsaicin impact on headaches attributed to the nose and paranasal sinus distribution.
3. Interventions, evaluations, and follow-up: Subjects are recruited from an Otolaryngology clinic, where a formal headache questionnaire is administered in-office, and standard endoscopy is performed in office to rule out confounding causes of headache and sinonasal disease. Written instructions are provided and consent obtained. A symptom journal is provided. Subjects are randomly selected to receive two bottles of either eucalyptol spray (placebo) or sinus buster (capsaicin) spray and are blinded to the content of the spray bottle. They are instructed to use the nasal spray one to two times daily. Subjects are permitted to continue to take headache medication as needed, but it must be recorded in their symptom journal. The journal is completed daily, and includes medication use, a headache pain score, and side effect log. Additionally, subjects fill out SinoNasal Outcome test (SNOT)22 at 2 weeks, 4 weeks, and 8 weeks. Weekly emails are sent to remind subject to fill out their journal. A phone call is made to the subject to survey them on progress at 2 and 6 weeks. Follow up visits are scheduled at 4 weeks and 8 weeks, or sooner if problems arise. A standard nasal endoscopy is performed at the first and last visit.
4. Additional data that would be tracked: Quality of life score as measured by SNOT-22 scores, treatment failure and drop-outs, and objective changes in sinus endoscopy.
日期
| 最后验证: | 04/30/2020 |
| 首次提交: | 07/26/2017 |
| 提交的预估入学人数: | 10/29/2017 |
| 首次发布: | 11/05/2017 |
| 上次提交的更新: | 05/06/2020 |
| 最近更新发布: | 05/07/2020 |
| 实际学习开始日期: | 06/30/2020 |
| 预计主要完成日期: | 04/30/2022 |
| 预计完成日期: | 11/30/2023 |
状况或疾病
干预/治疗
Other: Experimental Group
Other: Placebo Group
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Experimental Group This group will receive the capsaicin. The Study Drug ICX72 or sinus buster which is a homeopathic blend of capsicum annum and eucalyptol, that is readily available over the counter. | Other: Experimental Group Capsaicin is a homeopathic medication and there for this drug is not subject to the requirements of the FDA. |
| Placebo Comparator: Placebo Group This group will receive saline. The Placebo formulation contained saline and eucalyptol in a concentration that matched the control. | Other: Placebo Group This group will receive the saline placebo solution. |
资格标准
| 有资格学习的年龄 | 19 Years 至 19 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Consenting Adults aged 19-100 presenting to the Otolaryngology DepartmentofUniversityof Nebraska Medical center complaining of headaches/ facial pain and pressure Diagnosis of a primary rhinogenic headache disorder by the senior authors. Exclusion Criteria: - Exclusion criteria include: pregnancy, age less than 19, active history of smoking, presence of confirmed sinonasal disease, fibromyalgia, poorly controlled chronic health problems, allergies to chili peppers or any ingredient in the nasal spray, or confirmed Temporal Mandibular Joint (TMJ) arthralgia as the etiology of primary headache. |
结果
主要结果指标
1. headache medication use [1 year]
次要成果指标
1. number of patients with treatment related adverse events [1 year]
2. headache frequency and severity [1 year]
