Rhinogenic Headache Improvement After Nasal Operation - Full Text View

Sponsor:	University of Missouri-Columbia
Information provided by:	University of Missouri-Columbia
ClinicalTrials.gov Identifier:	NCT00580307

Purpose

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.

Condition	Intervention
Rhinogenic Headache Contact Point Headache	Procedure: Septoplasty Procedure: Septoplasty and endoscopic contact point correction

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Surgical Correction of Contact Point Headaches - Randomized Controlled Trial. [Rhinogenic Headache Improvement After Nasal Operation] Trial

Resource links provided by NLM:

MedlinePlus related topics: Headache Surgery

Drug Information available for: Statrol Neocidin Neosporin

U.S. FDA Resources

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:

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™). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	December 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Septoplasty only	Procedure: Septoplasty Surgical straightening of nasal septum
2: Experimental Septoplasty and endoscopic contact point correction	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580307

Contacts

Contact: Matthew P Page, MD	573-882-8173	pagemp@health.missouri.edu
Contact: Alvis L Barrier, MD	573-882-7129	barriera@health.missouri.edu

Locations

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

Sponsors and Collaborators

University of Missouri-Columbia

Investigators

Principal Investigator:	Matthew P Page, MD	Dept. OtoHNS, U. Missouri - Columbia
Study Director:	Alvis L Barrier, MD	Dept. OtoHNS, U. Missouri- Columbia
Study Chair:	Karen H Calhoun, MD, FACS	Dept. OtoHNS, U. Missouri - Columbia

More Information

No publications provided

Responsible Party:	Dept. of OtoHNS, University of Missouri - Columbia ( Matthew P. Page, M.D. (Principal investigator) )
Study ID Numbers:	1089377
Study First Received:	December 12, 2007
Last Updated:	February 24, 2009
ClinicalTrials.gov Identifier:	NCT00580307 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:

Headache
Rhinogenic
Nose
Nasal septum
Deviated septum

Surgery
Septoplasty
Turbinoplasty
Contact point
HIT-6

Additional relevant MeSH terms:

Signs and Symptoms
Nervous System Diseases
Headache
Neurologic Manifestations
Pain

ClinicalTrials.gov processed this record on February 08, 2010