The Use of Botox and Relaxation Techniques in the Treatment of Empty Nose Syndrome - Full Text View

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00732680

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 two new treatment modalities in the treatment of Empty Nose Syndrome. These two novel treatment methods are Botox injection and relaxation techniques.

Condition	Intervention
Empty Nose Syndrome Atrophic Rhinitis	Behavioral: Relaxation techniques Drug: Botox Drug: Normal Saline

MedlinePlus related topics: Botox

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	The Use of Botox and Relaxation Techniques in the Treatment of Empty Nose Syndrome: A Randomized Trial Evaluating Short and Long Term Benefits

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	21
Study Start Date:	December 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Control group: No Intervention ENS will be treated in this group of patients with adjunctive measures which will include several measures including saline irrigation, use of rose geranium oil to maintain moisture in nasal mucosa, and lifestyle modification techniques.
Group 1: Experimental Treatment will be in the form of relaxation techniques self taught to the patient (following a session with an instructor) with the aid of audiovisual media. Participants will undergo a one-hour instruction session in meditation and basic skills in mindfulness, acceptance, forgiveness and finding meaning in their life. This will be a part of a stress management visit incorporated in patient care. Participants will then receive a DVD to practice the intervention at home . In addition subjects in this group will also follow the adjunctive measures used in the control phase.	Behavioral: Relaxation techniques Treatment will be in the form of relaxation techniques self taught to the patient (following a session with an instructor) with the aid of audiovisual media. Participants will undergo a one-hour instruction session in meditation and basic skills in mindfulness, acceptance, forgiveness and finding meaning in their life. Participants will the continue practicing these techniques with the aid of a DVD by themselves.
Group 2: Experimental 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.
Group 3: Experimental Treatment will be in the form of a sham injection filled with normal saline which will be injected into the dilator nasalis muscle on each side of the nose along with adjunctive measures used in the control phase.	Drug: Normal Saline Treatment will be in the form of a sham injection filled with normal saline which will be 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 two new methods of treatment for ENS. One 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. The other is relaxation techniques involving meditation, even breathing and stress management.

Objective:

To evaluate effectiveness of Botox and relaxation techniques in improving overall QoL in patients.

Methods:

21 subjects will undergo initial treatment with adjunctive measures only, followed by random enrollment into three treatment arms

Relaxation techniques.
Chemical (Botox).
Sham injection of normal saline. Pre and post intervention data will be obtained in the form of rhinomanometry measurements and questionnaires (Sino Nasal Outcome Test 22-SNOT 22, Beck Depression Inventory 2 - BDI 2).

Conclusion:

We anticipate that Botox application and relaxation techniques 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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732680

Contacts

Contact: Rizwan Siwani, MD		siwani.rizwan@mayo.edu
Contact: Nicole Tombers	507-538-1392	tombers.nicole@mayo.edu

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55904
Sub-Investigator: Nicole Tombers
Sub-Investigator: Rizwan Siwani, MBBS
Sub-Investigator: Amit Sood, M.D.

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Oren Friedman, M.D.

Mayo Clinic

More Information

Additional Information:

Online listing of the study with study details and contact information. This link exits the ClinicalTrials.gov site

FDA website. Great website for information on Botox. This link exits the ClinicalTrials.gov site

Information on Botox from the US Food and Drug Administration. This link exits the ClinicalTrials.gov site

online blog of people with empty nose syndrome. This link exits the ClinicalTrials.gov site

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

Publications:

Moore EJ, Kern EB. Atrophic rhinitis: a review of 242 cases. Am J Rhinol. 2001 Nov-Dec;15(6):355-61. Review.

Responsible Party:	Mayo Clinic ( Oren Friedman M.D. )
Study ID Numbers:	08-005015
Study First Received:	August 8, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00732680 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Empty nose syndrome
Over resection of turbinate
Atrophic rhinitis

Study placed in the following topic categories:

Rhinitis, Atrophic
Botulinum Toxins
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

Atrophy
Rhinitis
Peripheral Nervous System Agents
Botulinum Toxin Type A

Additional relevant MeSH terms:

Rhinitis, Atrophic
Otorhinolaryngologic Diseases
Disease
Physiological Effects of Drugs
Rhinitis
Neuromuscular Agents
Pharmacologic Actions

Nose Diseases
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Syndrome
Peripheral Nervous System Agents
Botulinum Toxin Type A

ClinicalTrials.gov processed this record on May 07, 2009