Comparing steroid injections and voice therapy for vocal nodules
Intralesional Steroid Injection Versus Accent Method of Voice Therapy in Management of Vocal Nodules: A Randomized Controlled Trial
This study is testing whether steroid injections or voice therapy works better for adult women with vocal nodules to help improve their voice.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Assiut) |
| Trial ID | NCT03914092 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of intralesional steroid injections versus voice therapy in treating vocal nodules in adult females. Vocal nodules, often caused by chronic voice misuse, can lead to significant dysphonia and related issues. The study aims to compare the outcomes of steroid injections, which have shown high rates of improvement in similar conditions, against the Accent method of voice therapy, which focuses on holistic voice behavior adjustments. By assessing these two treatment modalities, the study seeks to determine the most effective approach for managing vocal nodules.
Who should consider this trial
Good fit: Ideal candidates for this study are adult females aged 18-55 with diagnosed bilateral vocal fold soft edematous nodules.
Not a fit: Patients who have previously undergone voice therapy or micro-phono-surgery, or those with certain medical conditions affecting vocal function, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from vocal nodules, potentially improving their voice quality and quality of life.
How similar studies have performed: While many studies have shown success with steroid injections for benign lesions, this specific comparison of steroid injections versus voice therapy is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - 1- Female patients diagnosed with bilateral vocal fold soft edematous nodules with preserved stroboscopic waves , don't exceed base 2.5 mm and apex .5mm. 2- age: 18-55 years. 3- Normal articulation, resonance and language ability. 4- Normal hearing. Exclusion Criteria: * 1- Previous voice therapy or micro-phono-surgery. 2- Use of drugs (which may cause changes in laryngeal function, mucosa, or muscle activity). 3- History of allergies, lung disease, gastroesophageal reflux disease, or other concomitant vocal pathology (e.g., vocal polyp and vocal cyst). 4- Current psychiatric, neurological conditions.
Where this trial is running
Assiut
- Assiut university hospitals — Assiut, Egypt (Recruiting)
Study contacts
- Principal investigator: Nada A Kamel, M.Sc. — Assiut University
- Study coordinator: Eman S Hassan, MD
- Email: eshh2003@aun.edu.eg
- Phone: 00201004082014
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.