Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome Syndrome
Nyckelord
Abstrakt
Beskrivning
Background:
Empty Nose Syndrome (ENS) is the term used to describe the condition resulting from over resection of nasal turbinate. Symptoms include depression, dysosmia, bleeding, discharge, crusting, dryness, dysosmia, and pain.
Treatment modalities include adjunctive comfort measures (primarily irrigation), mechanical measures (Silicon cones, cotton wads) and surgical treatment (alloderm implants, plastipore cartilage grafts etc.) We will investigate a new method of treatment for ENS. This will involve injection of botulinum toxin type A into the dilator nasalis muscle thus collapsing the internal nasal valve to provide added resistance to air flow.
Objective:
To evaluate effectiveness of botulinum toxin type A in improving overall quality of life in ENS patients.
Methods:
ENS patients in this study will receive botulinum toxin type A along with adjunctive treatment which will include several measures. First of all, patients will be given a nasal rinse bottle and will be instructed to irrigate their noses twice a day as follows:
- Irrigate the nose 250cc (about 125cc each side) to clear the mucus.
- Stop and gently clear the nose.
- Irrigate the nose 250cc (about 125cc each side) once again.
- Sit quietly for 10 minutes. No blowing.
- Do not blow the nose for 2 hours.
Patients will be asked to use sesame oil once a day to prevent drying of the nasal mucosa with further administration as needed. In addition they will advised to make certain lifestyle modifications that will include sleeping with a cool mist humidifier, drinking plenty of fluids and engaging in regular physical activity.
Before and after treatment data will be obtained in the form of a breathing test and patient questionnaires that will measure changes in physical and mental health.
Datum
| Senast verifierad: | 02/29/2016 |
| Först skickat: | 08/07/2008 |
| Beräknad anmälan inlämnad: | 08/10/2008 |
| Först publicerad: | 08/11/2008 |
| Senaste uppdatering skickad: | 03/17/2016 |
| Senaste uppdatering publicerad: | 04/17/2016 |
| Datum för första inlämnade resultat: | 11/12/2013 |
| Datum för första inlämnade QC-resultat: | 12/29/2013 |
| Datum för först publicerade resultat: | 02/12/2014 |
| Faktiskt startdatum för studien: | 11/30/2008 |
| Uppskattat primärt slutdatum: | 10/31/2009 |
| Beräknat slutfört datum: | 10/31/2009 |
Tillstånd eller sjukdom
Intervention / behandling
Drug: Botulinum Toxin Type A
Fas
Armgrupper
| Ärm | Intervention / behandling |
|---|---|
| Experimental: Botulinum Toxin Type A Treatment will be in the form of 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose. | Drug: Botulinum Toxin Type A 10 Units of Botulinum Toxin Type A injected into the dilator nasalis muscle on each side of the nose. |
Urvalskriterier
| Åldrar berättigade till studier | 18 Years Till 18 Years |
| Kön som är berättigade till studier | All |
| Accepterar friska volontärer | Ja |
| Kriterier | Inclusion Criteria: - Any patient aged 18-65 years of age presenting with a known diagnosis of ENS who has no known allergies to Botox. Exclusion Criteria: - Patients younger than 18 years or older than 65 years of age. - Patients with neuromuscular disorders or neuropathic diseases. - Patients with infection and or swelling at the site where Botox is to be injected. - Patients with known hypersensitivity to any ingredient in the drug formulation (botulinum toxin, human albumin) - Patients who are or plan to become pregnant within the time period in which the study will be conducted. - Patients who are nursing |
Resultat
Primära resultatåtgärder
1. Mean Score of Sino Nasal Outcome Test 22 (SNOT 22) [2 weeks after intervention, 2 months]
