Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome Syndrome
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
With this study, we will determine the effectiveness of a new treatment modality in the treatment of Empty Nose Syndrome. This novel treatment method involves the use of Botox.
| Condition | Intervention |
|---|---|
|
Empty Nose Syndrome Atrophic Rhinitis |
Drug: Botox |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective Case Series Evaluating Short and Long Term Benefits of the Use of Botox in the Treatment of Empty Nose Syndrome |
- The endpoints will include the patient questionnaire scores 2 months post-intervention (Snot 22 score, SF36, and IES R scores) and rhinomanometry measurements. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
| Enrollment: | 9 |
| Study Start Date: | December 2008 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Botox
Treatment will be in the form of 10 Units of Botox type A injected into the dilator nasalis muscle on each side of the nose along with adjunctive measures used in the control phase.
|
Drug: Botox
Treatment will be in the form of 10 Units of Botox type A injected into the dilator nasalis muscle on each side of the nose along with adjunctive measures used in the control phase.
|
Detailed Description:
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, plasti-pore cartilage grafts etc.) We will investigate a new method of treatment for ENS. This will involve injection of Botox 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 Botox in improving overall QoL in patients.
Methods:
42 subjects will undergo treatment with Botox and adjunctive measures that will involve the use of saline irrigation alongwith sesame oil amongst other measures.
Before and after treatment data will be obtained in the form of a breathing test and patient questionnaires that will help us measure changes in physical and mental health (using the sinonasal outcome test questionnaire or SNOT 22, the short form health survey 36 item questionnaire, and the Impact of events revised scale).
Conclusion:
We anticipate that Botox application in ENS patients improve overall QoL in these subjects.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Oren Friedman M.D., Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00732680 History of Changes |
| Other Study ID Numbers: | 08-005015 |
| Study First Received: | August 8, 2008 |
| Last Updated: | December 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
Empty nose syndrome Over resection of turbinate Atrophic rhinitis |
Additional relevant MeSH terms:
|
Rhinitis Rhinitis, Atrophic Atrophy Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
Pathological Conditions, Anatomical Botulinum Toxins, Type A Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013