Rhinogenic Headache Improvement After Nasal Operation (RHINO)

This study has been withdrawn prior to enrollment.
(slow accrual)
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00580307
First received: December 12, 2007
Last updated: February 24, 2011
Last verified: February 2011
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Surgical Correction of Contact Point Headaches - Randomized Controlled Trial. [Rhinogenic Headache Improvement After Nasal Operation] Trial

Resource links provided by NLM:


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
Placebo Comparator: 1
Septoplasty only
Procedure: Septoplasty
Surgical straightening of nasal septum
Experimental: 2
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.
Other Name: Turbinoplasty

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Missouri
University of Missouri
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: Matthew P. Page, M.D. (Principal investigator), Dept. of OtoHNS, University of Missouri - Columbia
ClinicalTrials.gov Identifier: NCT00580307     History of Changes
Other Study ID Numbers: 1089377
Study First Received: December 12, 2007
Last Updated: February 24, 2011
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:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014