Rhinogenic Headache Improvement After Nasal Operation - Tabular View

Tracking Information

First Received Date ^ICMJE

December 12, 2007

Last Updated Date

February 24, 2009

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00580307 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Rhinogenic Headache Improvement After Nasal Operation

Official Title ^ICMJE

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

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.

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Rhinogenic Headache
Contact Point Headache

Intervention ^ICMJE

Procedure: Septoplasty
Procedure: Septoplasty and endoscopic contact point correction

Study Arms / Comparison Groups

Placebo Comparator: Septoplasty only
Experimental: Septoplasty and endoscopic contact point correction

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2010

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00580307

Responsible Party

Matthew P. Page, M.D. (Principal investigator), Dept. of OtoHNS, University of Missouri - Columbia

Study ID Numbers ^ICMJE

1089377

Study Sponsor ^ICMJE

University of Missouri-Columbia

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

University of Missouri-Columbia

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP