Benefits Of The Use Of Botox In The Treatment Of Empty Nose Syndrome

Benefits Of The Use Of Botox In The Treatment Of Empty Nose Syndrome

Empty Nose Syndrome patients endure disabling physical symptoms and considerable distress. To date, there’s no definitive cure for these symptoms. Established treatment modalities include saline irrigation, surgical implantation of materials or just use of cotton wads/ silicon cones to simulate the resistive action to airflow from the resected turbinates.
This study will investigate the effectiveness of the new treatment modality inside the treatment of Empty Nose Syndrome. This novel procedure involves using botulinum toxin type A (Botox).

Condition or disease

Phase 1 Phase 2

Background:

Empty Nose Syndrome (ENS) will be the term used to spell out the condition caused by over resection of the 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 medical procedures (alloderm implants, blastopore cartilage grafts, etc.) We will investigate a whole new method of treatment for ENS. This will involve the injection of botulinum toxin type A in the dilator nasalis muscle thus collapsing the inner nasal valve to supply added capacity airflow.
Objective:

To evaluate the effectiveness of botulinum toxin type A in improving overall well being in ENS patients.

Methods:

ENS patients in this particular study will get botulinum toxin type A in addition to adjunctive treatment that could include several measures. First of all, patients will be provided a nasal rinse bottle and you will be instructed to irrigate their noses two times a day as follows:

Irrigate the nose 250cc (about 125cc either side) in order to the mucus.
Stop and gently pay off the nose.
Irrigate the nose 250cc (about 125cc both sides) yet again.
Sit quietly for ten mins. No blowing.
Do not blow the nose for two main hours.

Patients are going to be asked to use sesame oil once per day to prevent drying from the nasal mucosa with further administration when necessary. In addition, they will be advised ensuring that lifestyle modification that could include sleeping which has a cool-mist humidifier, drinking a lot of fluids and engaging in regular exercising.
Before and after treatment data will probably be obtained from the form of any breathing ensure that your patient questionnaires that can measure alterations in physical and mental health.

Study Type :
Official Title:
Prospective Case Series Evaluating Short and Long Term Benefits from the Use of Botox from the Treatment of Empty Nose Syndrome
Study Start Date :
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Experimental: Botulinum Toxin Type A
Treatment will be inside the form of 10 Units of Botulinum Toxin Type A injected to the dilator nasalis muscle on each side in the nose.
Drug: Botulinum Toxin Type A
10 Units of Botulinum Toxin Type A injected into your dilator nasalis muscle on each side on the nose.
Other Name: Botox
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Primary Outcome Measures :
Mean Score of Sino Nasal Outcome Test 22 (SNOT 22) Time Frame: 2 weeks after the intervention, 2 months
The SNOT 22 can be a validated measure of health-related quality lifestyle in sinonasal disease. It can be a 22 item questionnaire with each item assigned a score between 0-5. The total score may cover anything from 0-110 and minimize scores represent a better health-related quality lifestyle.
Eligibility Criteria
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Information in the National Library of Medicine
Choosing to participate in a study is a personal decision. Talk with your doctor and close relatives or friends about settling on join a report. To learn more about these studies, you or your doctor may contact case study research staff utilizing the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
Sexes Eligible for Study:
Inclusion Criteria:
Any patient aged 18-65 years presenting which has a known diagnosing ENS who’s no known allergies to Botox.
Exclusion Criteria:
Patients younger than 18 years or over 65 years old.
Patients with neuromuscular disorders or neuropathic diseases.
Patients with infection and swelling at the website where Botox is to get injected.
Patients with known hypersensitivity to your ingredient inside the drug formulation (botulinum toxin, human albumin)
Patients who will be or prefer to become pregnant from the time period where the study is going to be conducted.

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