Rhinogenic Headache Improvement After Nasal Operation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Septoplasty

Septoplasty only

Group Type PLACEBO_COMPARATOR

Septoplasty

Intervention Type PROCEDURE

Surgical straightening of nasal septum

Septoplasty and correction

Septoplasty and endoscopic contact point correction

Group Type EXPERIMENTAL

Septoplasty and endoscopic contact point correction

Intervention Type PROCEDURE

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.

Interventions

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Septoplasty

Surgical straightening of nasal septum

Intervention Type PROCEDURE

Septoplasty 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.

Intervention Type PROCEDURE

Other Intervention Names

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Turbinoplasty

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No