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Voice Therapy in Reactive Benign Vocal Fold Polyp and Injection of Steroid

2026年10月30日 更新者:Amany Abd Al-Gayed Fathy、Tanta University

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Tanta、埃及
        • Tanta University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Adult patients over age 18 years of age.
  2. Patients with benign primary lesion as ( polyps, nodules, cysts, singer's nodule and papilloma). And the reactive benign vocal lesion are polyps
  3. Reactive lesions showing small caliber (less than 50% width of true vocal fold in maximum dimension

Exclusion Criteria:

  1. Patients with recurrent vocal fold lesions
  2. Present or recurrent laryngeal carcinoma.
  3. Pregnancy.
  4. History of Allergy to corticosteroid preparations.
  5. Patients with cervical spondylosis, osteoarthritis, caries spine and those in whom direct laryngoscopy will be contraindicated.
  6. Patients with reactive vocal fold lesions as (nodules, cysts, and papilloma).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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

实验性的: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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Laryngeal Clinical Examination by Grade, Roughness, Breathiness, Asthenia, Strain scales
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Voice evaluation by Modified GARBS SCALE
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年11月30日

初级完成 (实际的)

2023年11月30日

研究完成 (实际的)

2023年11月30日

研究注册日期

首次提交

2026年10月24日

首先提交符合 QC 标准的

2026年10月24日

首次发布 (实际的)

2026年10月29日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月30日

最后验证

2022年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • 35866/9/22

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

It will be available if it needed

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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