Headache
Conditions
Keywords
Headache, Rhinogenic, Nose, Nasal septum, Deviated septum, Surgery, Septoplasty, Turbinoplasty, Contact point, HIT-6
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURESeptoplasty
Surgical straightening of nasal septum
PROCEDURESeptoplasty and endoscopic contact point correction
Septoplasty (as previously described). Contact point correction: structures of the lateral nasal wall that impinge on the nasal septum are mobilized to a more lateral position under endoscopic guidance.
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Previous sinonasal surgery * Active acute sinonasal disease: 1. Seasonal allergic exacerbations with mucosal swelling 2. Acute infectious rhino-sinusitis * Chronic sinonasal problems: 1. Severe nasal polyps mimicking contact points 2. Mucoceles protruding from sinuses into nasal cavity 3. Nasal and sinus tumors * General medical condition that precludes elective surgery (including pregnancy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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™). | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed