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Rhinogenic Headache Improvement After Nasal Operation (RHINO)

This study has been terminated.
(slow accrual)
Information provided by (Responsible Party):
University of Missouri-Columbia Identifier:
First received: December 12, 2007
Last updated: September 29, 2016
Last verified: September 2016
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.

Condition Intervention
Procedure: Septoplasty
Procedure: Septoplasty and endoscopic contact point correction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]

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 ]

Enrollment: 6
Study Start Date: December 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Septoplasty
Septoplasty only
Procedure: Septoplasty
Surgical straightening of nasal septum
Experimental: Septoplasty and correction
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00580307

United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
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

Responsible Party: University of Missouri-Columbia Identifier: NCT00580307     History of Changes
Other Study ID Numbers: 1089377
Study First Received: December 12, 2007
Last Updated: September 29, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University of Missouri-Columbia:
Nasal septum
Deviated septum
Contact point

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on April 28, 2017