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Rhinogenic Headache Improvement After Nasal Operation (RHINO)

Primary Purpose

Headache

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Septoplasty

Septoplasty and endoscopic contact point correction

About this trial

This is an interventional treatment trial for Headache focused on measuring Headache, Rhinogenic, Nose, Nasal septum, Deviated septum, Surgery, Septoplasty, Turbinoplasty, Contact point, HIT-6

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Septoplasty

Septoplasty and correction

Arm Description

Septoplasty only

Septoplasty and endoscopic contact point correction

Outcomes

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™).

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.

Full Information

NCT ID

NCT00580307

First Posted

December 12, 2007

Last Updated

September 29, 2016

Sponsor

University of Missouri-Columbia

1. Study Identification

Unique Protocol Identification Number

NCT00580307

Brief Title

Rhinogenic Headache Improvement After Nasal Operation

Acronym

RHINO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Terminated

Why Stopped

slow accrual

Study Start Date

December 2007 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Missouri-Columbia

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Headache

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Septoplasty

Arm Type

Placebo Comparator

Arm Description

Septoplasty only

Arm Title

Septoplasty and correction

Arm Type

Experimental

Arm Description

Septoplasty and endoscopic contact point correction

Intervention Type

Procedure

Intervention Name(s)

Septoplasty

Intervention Description

Surgical straightening of nasal septum

Intervention Type

Procedure

Intervention Name(s)

Septoplasty and endoscopic contact point correction

Other Intervention Name(s)

Turbinoplasty

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew P Page, MD

Organizational Affiliation

Dept. OtoHNS, U. Missouri - Columbia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alvis L Barrier, MD

Organizational Affiliation

Dept. OtoHNS, U. Missouri- Columbia

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Karen H Calhoun, MD, FACS

Organizational Affiliation

Dept. OtoHNS, U. Missouri - Columbia

Official's Role

Study Chair

Facility Information:

Facility Name

University of Missouri

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65212

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Rhinogenic Headache Improvement After Nasal Operation

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