Vocal Nodules in Adults
Conditions
Brief summary
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
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.
Interventions
0.1- 0.3 mm percutaneous intralesional injection
BEHAVIORALSmith Accent method of voice therapy
regular sessions of smith accent voice therapy (about 24 sessions, twice session / week) for 3 months
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
\- 1- Female patients diagnosed with bilateral vocal fold soft edematous nodules with preserved or minimally impacted 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective measurements of glottal efficiency | Before intervention | Measurements of aerodynamic parameter : Maximum phonation time (seconds) |
| Subjective measurements of severity of dysphonia | Before intervention | Measurements of change of Grade of Dysphonia, Roughness, Breathiness, Asthenia, and Straining by auditory perceptual assessment using the GRBAS scale. Grades ranging from 0 (normal) up to 3 (severe) |
| Subjective measurements of patient's assessment of voice severity | Before intervention | Measurements of scores of Arabic Voice Handicap Index |
| Objective measurements of vocal nodules size | before intervention | Measurements of base and rise of nodules using videostroboscopic examination |
| Objective measurements of vocal pitch | Before intervention | Measurements of acoustic analysis: fundamental frequency (Hz) |
| Objective measurements of vocal waveform frequency aperiodicity | Before intervention | Measurements of acoustic analysis: jitter (%) |
| Objective measurements of vocal waveform amplitude aperiodicity | Before intervention | Measurements of acoustic analysis: shimmer (dB) |
| Objective measurements of vocal waveform periodicity to aperiodicity ratio | Before intervention | Measurements of acoustic analysis : harmonic to noise ratio(dB) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Subjective measurements of severity dysphonia | 1 week and 1, 2, 3, and 6 months after intervention | Measurements of change of Grade of Dysphonia, Roughness, Breathiness, Asthenia, and Straining by auditory perceptual assessment using the GRBAS scale. Grades ranging from 0 (normal) up to 3 (severe) |
| Change in subjective measurements of patient's assessment of voice severity | 1 week and 1, 2, 3 and 6 months after intervention | Measurements of change in scores of Arabic Voice Handicap Index |
| Change in objective measurements of vocal nodules size | 1 week and 1, 2, 3 and 6 months after intervention | Measurements of change in base and rise of nodules using videostroboscopic examination |
| Change in objective measurements of vocal pitch | 1 week and 1, 2, 3 and 6 months after intervention | Measurements of change in acoustic analysis including fundamental frequency (Hz) |
| Change in objective measurements of vocal waveform frequency aperiodicity | 1 week and 1, 2, 3 and 6 months after intervention | Measurements of change in acoustic analysis : jitter (%) |
| Change in objective measurements of vocal waveform amplitude aperiodicity | 1 week and 1, 2, 3 and 6 months after intervention | Measurements of change in acoustic analysis : shimmer (dB) |
| Change in objective measurements of vocal waveform periodicity to aperiodicity ratio | 1 week and 1, 2, 3 and 6 months after intervention | Change in measurements of acoustic analysis : harmonic to noise ratio (dB) |
| Change in objective measurements of glottal efficiency | 1 week and 1, 2, 3 and 6 months after intervention | Measurements of change in aerodynamic parameter: Maximum phonation time (seconds) |
Countries
Egypt
Outcome results
None listed