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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Septoplasty | Surgical straightening of nasal septum |
| 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. |
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.