Surgical Correction of Contact Point Headaches - Randomized Controlled Trial. [Rhinogenic Headache Improvement After Nasal Operation] Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Between-group difference in patient-rated headache improvement at 10 days, 6 weeks, 6 months and 12 months post-intervention, as measured by a validated questionnaire, the Headache Impact Test - 6 (HIT-6™).
研究概览
简要总结
Objective: To determine the efficacy of surgical correction of intranasal mucosal contact points in improving quality of life and decreasing medication use in patients with rhinogenic headaches.
详细描述
Significance: Chronic, debilitating headaches that resist maximal medical treatment by various headache specialists are sometimes linked to structural anomalies within the nose that exert pressure on apposing mucosal surfaces. A number of otolaryngologists have reported success in alleviating rhinogenic headaches with contact point correction surgery. This practice is supported by anecdotal reports along with retrospective and observational studies; however, a prospective study with an appropriate surgical control group has not been conducted. Because the specific effect of contact point correction has not yet been differentiated from the placebo effect of surgery itself, many headache specialists are reluctant to recommend surgical evaluation for their patients. To demonstrate the efficacy of contact point correction surgery to both the headache and otolaryngology communities - and thus, to make this treatment option more widely available to rhinogenic headache sufferers - a randomized controlled trial is needed.
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
- Double (Participant, Outcomes Assessor)
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
- •Chronic (> 2 months) pain or pressure over nasal bridge, glabella, or forehead
- •Unilateral or bilateral nasal septal deviation that is chronically symptomatic (e.g. nasal airway obstruction)
- •Failure of standard medical therapy for headache
- •Symptomatic contact points as demonstrated by physical examination, sinus CT and nasal endoscopy
- •Relief of headache after application of topical anesthetic to contact points
- •Contact points that remain after mucosal decongestion
- •Absence of any other obvious cause of headaches after a thorough evaluation by a neurologist, ophthalmologist, dentist, internist, or other related specialist
排除标准
- •Previous sinonasal surgery
- •Active acute sinonasal disease:
- •Seasonal allergic exacerbations with mucosal swelling
- •Acute infectious rhino-sinusitis
- •Chronic sinonasal problems:
- •Severe nasal polyps mimicking contact points
- •Mucoceles protruding from sinuses into nasal cavity
- •Nasal and sinus tumors
- •General medical condition that precludes elective surgery (including pregnancy)
结局指标
主要结局
Between-group difference in patient-rated headache improvement at 10 days, 6 weeks, 6 months and 12 months post-intervention, as measured by a validated questionnaire, the Headache Impact Test - 6 (HIT-6™).
时间窗: 12 months
次要结局
- Between-group differences in subject responses to a non-validated questionnaire so as to permit comparison with previous studies. Additionally, headache medication use will be examined as a secondary end-point.(12 months)