Clinical trial NCT00580307: Rhinogenic Headache Improvement After Nasal Operation
Official title: Surgical Correction of Contact Point Headaches - Randomized Controlled Trial. [Rhinogenic Headache Improvement After Nasal Operation] Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Headache
Keywords: Headache
Rhinogenic
Nose
Nasal septum
Deviated septum
Surgery
Septoplasty
Turbinoplasty
Contact point
HIT-6
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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)

Primary outcomes:
measure: 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™).
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 12 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: Dept. OtoHNS, U. Missouri - Columbia
name: Matthew P Page, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. OtoHNS, U. Missouri- Columbia
name: Alvis L Barrier, MD
role: STUDY_DIRECTOR
affiliation: Dept. OtoHNS, U. Missouri - Columbia
name: Karen H Calhoun, MD, FACS
role: STUDY_CHAIR
References: