Intralesional Steroid Injection Versus Accent Method of Voice Therapy in Management of Vocal Nodules: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Subjective measurements of patient's assessment of voice severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- 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.
排除标准
- •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.
研究组 & 干预措施
study group
female patients with vocal fold nodules undergoing intralesional steroid injection
干预措施: triamcinolone acetonide injection (Drug)
control group
female patients with vocal fold nodules undergoing Smith Accent voice therapy
干预措施: Smith Accent method of voice therapy (Behavioral)
结局指标
主要结局
Subjective measurements of patient's assessment of voice severity
时间窗: Before intervention
Measurements of scores of Arabic Voice Handicap Index
Objective measurements of vocal nodules size
时间窗: before intervention
Measurements of base and rise of nodules using videostroboscopic examination
Objective measurements of vocal pitch
时间窗: Before intervention
Measurements of acoustic analysis: fundamental frequency (Hz)
Objective measurements of vocal waveform frequency aperiodicity
时间窗: Before intervention
Measurements of acoustic analysis: jitter (%)
Objective measurements of vocal waveform amplitude aperiodicity
时间窗: Before intervention
Measurements of acoustic analysis: shimmer (dB)
Objective measurements of vocal waveform periodicity to aperiodicity ratio
时间窗: Before intervention
Measurements of acoustic analysis : harmonic to noise ratio(dB)
Objective measurements of glottal efficiency
时间窗: Before intervention
Measurements of aerodynamic parameter : Maximum phonation time (seconds)
Subjective measurements of severity of dysphonia
时间窗: 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)
次要结局
- Change in Subjective measurements of severity dysphonia(1 week and 1, 2, 3, and 6 months after intervention)
- Change in subjective measurements of patient's assessment of voice severity(1 week and 1, 2, 3 and 6 months after intervention)
- Change in objective measurements of vocal nodules size(1 week and 1, 2, 3 and 6 months after intervention)
- Change in objective measurements of vocal pitch(1 week and 1, 2, 3 and 6 months after intervention)
- Change in objective measurements of vocal waveform frequency aperiodicity(1 week and 1, 2, 3 and 6 months after intervention)
- Change in objective measurements of vocal waveform amplitude aperiodicity(1 week and 1, 2, 3 and 6 months after intervention)
- Change in objective measurements of vocal waveform periodicity to aperiodicity ratio(1 week and 1, 2, 3 and 6 months after intervention)
- Change in objective measurements of glottal efficiency(1 week and 1, 2, 3 and 6 months after intervention)
研究者
Nada Ali Kamel
principle investigator
Assiut University