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Rhinogenic Headache Improvement After Nasal Operation (RHINO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00580307
Recruitment Status : Terminated (slow accrual)
First Posted : December 24, 2007
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Headache Procedure: Septoplasty Procedure: Septoplasty and endoscopic contact point correction Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Surgical Correction of Contact Point Headaches - Randomized Controlled Trial. [Rhinogenic Headache Improvement After Nasal Operation] Trial
Study Start Date : December 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580307


Locations
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United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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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
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Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00580307    
Other Study ID Numbers: 1089377
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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:
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Headache
Pain
Neurologic Manifestations