Intralesional Steroid Injection Versus Voice Therapy in Management of Vocal Nodules

Study Overview
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Brief Summary
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Vocal nodules represent 16 % of benign vocal fold lesions.They are caused by chronic voice abuse or misuse and often occur in children and adult females. The resultant dysphonia leads to personal, social and occupational problems. The first line of treatment is voice rest and voice therapy. The Accent method is a holistic technique for behavior readjustment voice therapy which targets various voice parameters as loudness, pitch and timbre. However, voice rest and voice therapy are sometimes difficult to be carried out in patients with voice-related occupations. So, complete resolution may not be possible in all patients. When voice therapy is inefficient, resection is performed by laryngeal microsurgery under general anesthesia. However, the role of surgery is much restricted.

Detailed Description
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An intralesional steroid injection to vocal nodules has come to the forefront as another treatment choice. Steroids decrease the synthesis and maturation of collagen, suppress fibroblast function, and inhibit the antibacterial phagocytic action of some defense cells and vasoactive substances release.These actions are considered to be functional for treating vocal nodules. Many studies, investigated steroid injection in benign lesions including nodules, reported that 93-100% of the nodules either disappeared or improved. The reported nodules recurrence rate after 2 years was 26.7- 31%. However, to our knowledge, no previous study has compared vocal nodule steroid injection with a group receiving voice therapy to accurately assess the clinical role of vocal fold steroid injection.

Official Title
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Intralesional Steroid Injection Versus Accent Method of Voice Therapy in Management of Vocal Nodules: A Randomized Controlled Trial

Conditions
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Vocal Nodules in Adults

Intervention / Treatment
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* Drug: triamcinolone acetonide injection
* Behavioral: Smith Accent method of voice therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>female patients with vocal fold nodules undergoing intralesional steroid injection | Drug: triamcinolone acetonide injection<br>* ,1 mm percutaneous intralesional injection<br>* Other names: kenacort;|
| Active Comparator: control group<br>female patients with vocal fold nodules undergoing Smith Accent voice therapy | Behavioral: Smith Accent method of voice therapy<br>* regular sessions of smith accent voice therapy (about 24 sessions, twice session / week) for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective measurements of severity of dysphonia | Measurements of Grade of Dysphonia, strain, leakiness, Breathiness and irregularity by auditory perceptual assessment using modified (GRBAS) scale. Grades ranging from 0 (normal) up to 3 ( severe) | Before intervention | 
| Subjective measurements of patient's assessment of voice severity | Measurements of scores of Arabic Voice Handicap Index | Before intervention | 
| Objective measurements of vocal nodules size | Measurements of base and rise of nodules using videostroboscopic examination | before intervention | 
| Objective measurements of vocal pitch | Measurements of acoustic analysis: fundamental frequency (Hz) | Before intervention | 
| Objective measurements of vocal waveform frequency aperiodicity | Measurements of acoustic analysis: jitter (%) | Before intervention | 
| Objective measurements of vocal waveform amplitude aperiodicity | Measurements of acoustic analysis: shimmer (dB) | Before intervention | 
| Objective measurements of vocal waveform periodicity to aperiodicity ratio | Measurements of acoustic analysis : harmonic to noise ratio(dB) | Before intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Subjective measurements of severity dysphonia | Measurements of change of Grade of Dysphonia, strain, leakiness, Breathiness and irregularity by auditory perceptual assessment using modified (GRBAS) scale. Grades ranging from 0 (normal) up to 3 ( severe) | 1, 2 and 3 months after intervention | 
| Change in subjective measurements of patient's assessment of voice severity | Measurements of change in scores of Arabic Voice Handicap Index | 1, 2 and 3 months after intervention | 
| Change in objective measurements of vocal nodules size | Measurements of change in base and rise of nodules using videostroboscopic examination | 1, 2 and 3 months after intervention | 
| Change in objective measurements of vocal pitch | Measurements of change in acoustic analysis including fundamental frequency (Hz) | 1, 2 and 3 months after intervention | 
| Change in objective measurements of vocal waveform frequency aperiodicity | Measurements of change in acoustic analysis : jitter (%) | 1,2 and 3 months after intervention | 
| Change in objective measurements of vocal waveform amplitude aperiodicity | Measurements of change in acoustic analysis : shimmer (dB) | 1,2 and 3 months after intervention | 
| Change in objective measurements of vocal waveform periodicity to aperiodicity ratio | Change in measurements of acoustic analysis : harmonic to noise ratio (dB) | 1,2 and 3 after intervention |