Clinical Trial: Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome Syndrome

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Prospective Case Series Evaluating Short and Long Term Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome

Brief Summary:

Empty Nose Syndrome patients suffer from disabling physical symptoms and considerable distress. To date there is no definitive cure for these symptoms. Established treatment modalities include saline irrigation, surgical implantation of materials or simply use of cotton wads/ silicon cones to simulate the resistive action to airflow of the resected turbinates.

This study will research the effectiveness of a new treatment modality in the treatment of Empty Nose Syndrome. This novel treatment method involves the use of botulinum toxin type A (Botox).


Detailed Summary:

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
Sponsor: Mayo Clinic

Current Primary Outcome: Mean Score of Sino Nasal Outcome Test 22 (SNOT 22) [ Time Frame: 2 weeks after intervention, 2 months ]

The SNOT 22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0-110 and lower scores represent better health related quality of life.


Original Primary Outcome: The endpoints will include the patient questionnaire scores 2 months post-intervention (Snot 22 score, BDI-2 score) and rhinomanometry measurements. [ Time Frame: 4 months ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mayo Clinic

Dates:
Date Received: August 8, 2008
Date Started: December 2008
Date Completion:
Last Updated: March 18, 2016
Last Verified: March 2016