Intralesional Steroid Injection Versus Voice Therapy in Management of Vocal Nodules
- Conditions
- Vocal Nodules in Adults
- Interventions
- Behavioral: Smith Accent method of voice therapy
- Registration Number
- NCT03914092
- Lead Sponsor
- Assiut University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 40
- 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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group Smith Accent method of voice therapy female patients with vocal fold nodules undergoing Smith Accent voice therapy study group triamcinolone acetonide injection female patients with vocal fold nodules undergoing intralesional steroid injection
- Primary Outcome Measures
Name Time Method Subjective measurements of severity of dysphonia Before intervention 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)
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 Outcome Measures
Name Time Method Change in Subjective measurements of severity dysphonia 1, 2 and 3 months after intervention 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)
Change in subjective measurements of patient's assessment of voice severity 1, 2 and 3 months after intervention Measurements of change in scores of Arabic Voice Handicap Index
Change in objective measurements of vocal nodules size 1, 2 and 3 months after intervention Measurements of change in base and rise of nodules using videostroboscopic examination
Change in objective measurements of vocal pitch 1, 2 and 3 months after intervention Measurements of change in acoustic analysis including fundamental frequency (Hz)
Change in objective measurements of vocal waveform frequency aperiodicity 1,2 and 3 months after intervention Measurements of change in acoustic analysis : jitter (%)
Change in objective measurements of vocal waveform amplitude aperiodicity 1,2 and 3 months after intervention Measurements of change in acoustic analysis : shimmer (dB)
Change in objective measurements of vocal waveform periodicity to aperiodicity ratio 1,2 and 3 after intervention Change in measurements of acoustic analysis : harmonic to noise ratio (dB)
Trial Locations
- Locations (1)
Assiut university hospitals
🇪🇬Assiut, Egypt