Clinical Trials Directory

Trials / Terminated

TerminatedNCT00580307

Rhinogenic Headache Improvement After Nasal Operation

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
6 (actual)
Sponsor
University of Missouri-Columbia · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESeptoplastySurgical straightening of nasal septum
PROCEDURESeptoplasty and endoscopic contact point correctionSeptoplasty (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.

Timeline

Start date
2007-12-01
Primary completion
2010-01-01
Completion
2010-01-01
First posted
2007-12-24
Last updated
2016-09-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00580307. Inclusion in this directory is not an endorsement.