Rhinogenic Headache Improvement After Nasal Operation

NCT00580307 | Terminated

• 1 other identifier: 1089377
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache

Keywords

Headache; Rhinogenic; Nose; Nasal septum; Deviated septum; Surgery; Septoplasty; Turbinoplasty; Contact point; HIT-6

Outcome Measures

Primary Outcomes (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™).

  12 months

Secondary Outcomes (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.

  12 months

Study Arms (2)

Septoplasty

PLACEBO COMPARATOR

Septoplasty only

Procedure: Septoplasty

Septoplasty and correction

EXPERIMENTAL

Septoplasty and endoscopic contact point correction

Procedure: Septoplasty and endoscopic contact point correction

Interventions

Septoplasty PROCEDURE

Surgical straightening of nasal septum

Septoplasty

Septoplasty and endoscopic contact point correction PROCEDURE

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.

Also known as: Turbinoplasty

Septoplasty and correction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous sinonasal surgery
• Active acute sinonasal disease:
• Seasonal allergic exacerbations with mucosal swelling
• Acute infectious rhino-sinusitis
• Chronic sinonasal problems:
• Severe nasal polyps mimicking contact points
• Mucoceles protruding from sinuses into nasal cavity
• Nasal and sinus tumors
• General medical condition that precludes elective surgery (including pregnancy)

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew P Page, MD

  Dept. OtoHNS, U. Missouri - Columbia

  PRINCIPAL INVESTIGATOR

• Alvis L Barrier, MD

  Dept. OtoHNS, U. Missouri- Columbia

  STUDY DIRECTOR

• Karen H Calhoun, MD, FACS

  Dept. OtoHNS, U. Missouri - Columbia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 24, 2007
• Study Start: December 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: September 30, 2016

Record last verified: 2016-09

Locations

US (1)