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The present work aims to assess the effectiveness and safety of topical application of BTX - A compared with its intra turbinate injection in controlling the symptoms in non infectious chronic rhinosinusitis patients
A prospective comparative study will be carried out on 30 participant of both sex at Otorhinolaryngology Department, Benha University Hospital, it will include patients suffering from non infectious chronic rhinosinustitis symptoms in the form of nasal blockage, rhinorrhea, itching and/or sneezing.
The patients will be divided randomly into two groups:
All patients will be subjected to:
Full clinical evaluation:
A) Full history taking B) Clinical examination by
C) Investigations:CT nose and paranasal sinuses coronal cuts to exclude fungal sinusitis, nasal polyps or other structural abnormalities e.g; posterior septal deviation, conchae bullosa or any other nasal pathology .
Intervention :
Follow Up Follow up visits will be at 1,2,4,6,8 weeks, patients will be assessed and questionnaired about severity of the symptoms and possible adverse effects including epistaxis and nasal dryness .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical group | Experimental | Topical application in the form of merocel soaked with 20 units of BTX_A (2ml) will be placed at each side of the nasal cavity for 30 minutes. |
|
| Injection group | Experimental | 20 units of BTX_A (2ml) will be injected submucosally in each inferior turbinate using insulin syringe needle after local anesthesia using 10% xylocaine spray . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTX A Topical | Drug | In group A (topical group) ,topical application in the form of merocel soaked with 20 units of BTX_A (2ml) will be placed at each side of the nasal cavity for 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| the rhinitis symptom severity | the rhinitis symptom severity questionnaire, this is questionnaire consists of 4 items (nasal obstruction, rhinorrhea , sneezing and or nasal itching) . each symptom given score from 0 to 3 ( 0 = none, 1 = mild, 2 = moderate and 3 = severe) | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| possible adverse effects | epistaxis and nasal dryness (yes/no) | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abdelrahman A Abdelalim, MD | Benha University | Principal Investigator |
| Mohamed A Elsayed, MD | Benha University | Study Chair |
| Naslshah G Kazeem, MD | Benha University | Study Chair |
| Aya L Hassan, Resident | Benha University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha University Hospital, Faculty of Medicine | Banhā | Qalyubia Governorate | 13512 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28681969 | Background | Zhang EZ, Tan S, Loh I. Botolinum toxin in rhinitis: Literature review and posterior nasal injection in allergic rhinitis. Laryngoscope. 2017 Nov;127(11):2447-2454. doi: 10.1002/lary.26616. Epub 2017 Jul 6. | |
| 16935174 | Background | Ozcan C, Vayisoglu Y, Dogu O, Gorur K. The effect of intranasal injection of botulinum toxin A on the symptoms of vasomotor rhinitis. Am J Otolaryngol. 2006 Sep-Oct;27(5):314-8. doi: 10.1016/j.amjoto.2006.01.008. |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| BTX A Injection | Drug | In group B (injected group), 20 units of BTX_A(2ml) will be injected submucosally in each inferior turbinate using insulin syringe needle after local anesthesia using 10% xylocaine spray . |
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