- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07904988
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Tanta, Egypt
- Tanta University
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Laryngeal Clinical Examination by Grade, Roughness, Breathiness, Asthenia, Strain scales
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Voice evaluation by Modified GARBS SCALE
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 35866/9/22
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
It will be available if it needed
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
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