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slow accrual
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Septoplasty | Placebo Comparator | Septoplasty only |
|
| Septoplasty and correction | Experimental | Septoplasty and endoscopic contact point correction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Septoplasty | Procedure | Surgical straightening of nasal septum |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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-6â„¢). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Previous sinonasal surgery
Active acute sinonasal disease:
Chronic sinonasal problems:
General medical condition that precludes elective surgery (including pregnancy)
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Columbia | Missouri | 65212 | United States |
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| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. |
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