Voice Therapy in Reactive Benign Vocal Fold Polyp and Injection of Steroid
Comparative Study Between Voice Therapy in Reactive Benign Vocal Fold Polyp and Injection of Steroid
The aim of this study is to compare the efficacy between Voice Therapy and Injection of Steroid in Reactive Benign Vocal Fold polyp.
Przegląd badań
Status
Szczegółowy opis
Benign lesions of the vocal fold are common. Standard clinical classification has included nodules, polyps, Reinke's edema, and cysts. More recently, fibrous masses and reactive lesions have been added. However, there is still no consensus on terminology, and this is especially true of benign traumatic bilateral vocal fold lesions . At times, definitive diagnosis can only be established intraoperatively, as Poels et al showed that bilateral lesions were found in 53% of patients preoperatively and in 82% of these patients when explored intraoperatively. It is essential to understand that accurate definition of benign bilateral vocal fold lesions guides prognosis and therapeutic planning.
Reactive lesions represent a difficult entity within bilateral vocal fold lesions . They are not well defined, their behavior is not well understood, and there is no consensus on the best treatment; therefore, proposing a standard nomenclature for the reactive lesion.
Different groups have attempted to characterize the entity. Some authors describe a contralateral reactive callus with epithelial hyperplasia caused by shearing forces of a unilateral vocal fold lesion.
Vocal polyps and cysts are generally unilateral, whereas reactive lesions are often found on the contralateral vocal fold directly opposite the primary lesion. A reactive vocal fold lesion must be paired with a contralateral vocal fold lesion. It may have a cup-and-saucer appearance, with the primary lesion indenting the reactive vocal fold lesion at the point of maximum contact. Reactive lesions may be more responsive to nonsurgical therapy because some clinical and video stroboscopic findings have indicated that the lesion is anatomically superficial. However, there is little support for this hypothesis.
Such lesions are common, especially among professional voice users, and can affect their quality of life. These lesions cause dysphonia, narrowed vocal range, and deteriorated voice quality, so selecting proper and effective treatment is important.
Conservative measures including voice rest and regular attendance of voice therapy sessions remain the first lines of treatment. However, compliance with voice therapy is usually poor, impairing treatment outcomes in the majority of cases .
The aim of this study is to compare the efficacy between Voice Therapy and Injection of Steroid in Reactive Benign Vocal Fold polyp.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Tanta, Egipt
- Tanta University
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Adult patients over age 18 years of age.
- Patients with benign primary lesion as ( polyps, nodules, cysts, singer's nodule and papilloma). And the reactive benign vocal lesion are polyps
- Reactive lesions showing small caliber (less than 50% width of true vocal fold in maximum dimension
Exclusion Criteria:
- Patients with recurrent vocal fold lesions
- Present or recurrent laryngeal carcinoma.
- Pregnancy.
- History of Allergy to corticosteroid preparations.
- Patients with cervical spondylosis, osteoarthritis, caries spine and those in whom direct laryngoscopy will be contraindicated.
- Patients with reactive vocal fold lesions as (nodules, cysts, and papilloma).
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Group 1: Patients with reactive benign vocal fold polyp will be treated by Voice Therapy
Group 1: Patients with reactive benign vocal fold polyp will be treated by Voice Therapy |
Urządzenie: Group 1: Patients with reactive benign vocal fold polyp will be treated by Voice Therapy
Group 1: Patients with reactive benign vocal fold polyp will be treated by Voice Therapy |
|
Eksperymentalny: Group 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroid
Group 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroid |
Lek: Group 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroid
Group 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroid |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Laryngeal Clinical Examination by Grade, Roughness, Breathiness, Asthenia, Strain scales
Ramy czasowe: after 1 month, 3 months, and 6 months
|
The GRBAS scale consisted of five parameters, each rated on a four-point Likert scale (0 = no deviation, 1 = mild, 2 = moderate, 3 = severe). |
after 1 month, 3 months, and 6 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Voice evaluation by Modified GARBS SCALE
Ramy czasowe: After 1 month, 3 months and 6 months from intervention
|
Modified GRBAS scale is a 4-degree scale, as follows: Overall grade of dysphonia: "(0) Normal, (1) slight, (2) moderate, (3) severe" Character (quality): "strained- leaky- breathy- rough (irregular)" Pitch: "overall increase decrease- diplophonia" Loudness: "excessively loud- excessively soft fluctuating- average". |
After 1 month, 3 months and 6 months from intervention
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 35866/9/22
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
It will be available if it needed
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- ICF
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .