Rhinogenic Headache Improvement After Nasal Operation

Study Overview
=================
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.

Official Title
-----------------
Surgical Correction of Contact Point Headaches - Randomized Controlled Trial. [Rhinogenic Headache Improvement After Nasal Operation] Trial

Conditions
-----------------
Headache

Intervention / Treatment
-----------------
* Procedure: Septoplasty
* Procedure: Septoplasty and endoscopic contact point correction


Participation Criteria
=================
Eligibility Criteria
-----------------
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: 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Septoplasty<br>Septoplasty only | Procedure: Septoplasty<br>* Surgical straightening of nasal septum<br>|
| Experimental: Septoplasty and correction<br>Septoplasty and endoscopic contact point correction | Procedure: Septoplasty and endoscopic contact point correction<br>* 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.<br>* Other names: Turbinoplasty;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Headache, Rhinogenic, Nose, Nasal septum, Deviated septum, Surgery, Septoplasty, Turbinoplasty, Contact point, HIT-6