Rhinogenic Headache Improvement After Nasal Operation

Condition(s) targeted: Rhinogenic Headache; Contact Point Headache

Intervention: Septoplasty (Procedure); Septoplasty and endoscopic contact point correction (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: University of Missouri-Columbia

Official(s) and/or principal investigator(s):
Matthew P Page, MD, Principal Investigator, Affiliation: Dept. OtoHNS, U. Missouri - Columbia
Alvis L Barrier, MD, Study Director, Affiliation: Dept. OtoHNS, U. Missouri- Columbia
Karen H Calhoun, MD, FACS, Study Chair, Affiliation: Dept. OtoHNS, U. Missouri - Columbia

Overall contact:
Matthew P Page, MD, Phone: 573-882-8173, Email: pagemp@health.missouri.edu

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: 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™).

Secondary outcome: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Matthew P Page, MD, Phone: 573-882-8173, Email: pagemp@health.missouri.edu

University of Missouri, Columbia, Missouri 65212, United States; Recruiting

Starting date: December 2007
Ending date: June 2010
Last updated: February 24, 2009