Rhinogenic Headache Improvement After Nasal Operation

Headache Clinical Trial

— RHINO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00580307
• Other study ID #: 1089377
• Status: Terminated
• Phase: N/A
• First received: December 12, 2007
• Last updated: September 29, 2016
• Start date: December 2007
• Est. completion date: January 2010

Study information

• Verified date: September 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache

Intervention

Procedure:
• Septoplasty
Surgical straightening of nasal septum
• 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.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No