Rhinogenic Headache Improvement After Nasal Operation (RHINO)

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

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.

Study Overview

• Status: Terminated
• Conditions: Headache
• Intervention / Treatment: Procedure: Septoplasty; Procedure: Septoplasty and endoscopic contact point correction

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Turbinoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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™).	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (ACTUAL): January 1, 2010
• Study Completion (ACTUAL): January 1, 2010

Study Registration Dates

• First Submitted: December 12, 2007
• First Submitted That Met QC Criteria: December 18, 2007
• First Posted (ESTIMATE): December 24, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): September 30, 2016
• Last Update Submitted That Met QC Criteria: September 29, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Surgery; Headache; Nasal septum; Septoplasty; HIT-6; Nose; Rhinogenic; Deviated septum; Turbinoplasty; Contact point
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: 1089377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED