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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Tanta, Egipto
- Tanta University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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 |
Group 1: Patients with reactive benign vocal fold polyp will be treated by Voice Therapy |
|
Experimental: 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 |
Group 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroid |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Laryngeal Clinical Examination by Grade, Roughness, Breathiness, Asthenia, Strain scales
Periodo de tiempo: after 1 month, 3 months, and 6 months
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Voice evaluation by Modified GARBS SCALE
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 35866/9/22
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
It will be available if it needed
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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