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Completed

NCT Number: NCT03914092

Intralesional Steroid Injection Versus Voice Therapy in Management of Vocal Nodules

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.

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Key information

Conditions

Vocal Nodules in Adults

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Assiut university hospitals

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triamcinolone acetonide injection

Drug

0.1- 0.3 mm percutaneous intralesional injection

Other names: Epirelefan

Smith Accent method of voice therapy

Behavioral

regular sessions of smith accent voice therapy (about 24 sessions, twice session / week) for 3 months

Primary outcomes

  1. Subjective measurements of severity of dysphonia

    Time frame: 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)

  2. Subjective measurements of patient's assessment of voice severity

    Time frame: Before intervention

    Measurements of scores of Arabic Voice Handicap Index

  3. Objective measurements of vocal nodules size

    Time frame: before intervention

    Measurements of base and rise of nodules using videostroboscopic examination

  4. Objective measurements of vocal pitch

    Time frame: Before intervention

    Measurements of acoustic analysis: fundamental frequency (Hz)

  5. Objective measurements of vocal waveform frequency aperiodicity

    Time frame: Before intervention

    Measurements of acoustic analysis: jitter (%)

  6. Objective measurements of vocal waveform amplitude aperiodicity

    Time frame: Before intervention

    Measurements of acoustic analysis: shimmer (dB)

  7. Objective measurements of vocal waveform periodicity to aperiodicity ratio

    Time frame: Before intervention

    Measurements of acoustic analysis : harmonic to noise ratio(dB)

  8. Objective measurements of glottal efficiency

    Time frame: Before intervention

    Measurements of aerodynamic parameter : Maximum phonation time (seconds)

Secondary outcomes

  1. Change in Subjective measurements of severity dysphonia

    Time frame: 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)

  2. Change in subjective measurements of patient's assessment of voice severity

    Time frame: 1 week and 1, 2, 3 and 6 months after intervention

    Measurements of change in scores of Arabic Voice Handicap Index

  3. Change in objective measurements of vocal nodules size

    Time frame: 1 week and 1, 2, 3 and 6 months after intervention

    Measurements of change in base and rise of nodules using videostroboscopic examination

  4. Change in objective measurements of vocal pitch

    Time frame: 1 week and 1, 2, 3 and 6 months after intervention

    Measurements of change in acoustic analysis including fundamental frequency (Hz)

  5. Change in objective measurements of vocal waveform frequency aperiodicity

    Time frame: 1 week and 1, 2, 3 and 6 months after intervention

    Measurements of change in acoustic analysis : jitter (%)

  6. Change in objective measurements of vocal waveform amplitude aperiodicity

    Time frame: 1 week and 1, 2, 3 and 6 months after intervention

    Measurements of change in acoustic analysis : shimmer (dB)

  7. Change in objective measurements of vocal waveform periodicity to aperiodicity ratio

    Time frame: 1 week and 1, 2, 3 and 6 months after intervention

    Change in measurements of acoustic analysis : harmonic to noise ratio (dB)

  8. Change in objective measurements of glottal efficiency

    Time frame: 1 week and 1, 2, 3 and 6 months after intervention

    Measurements of change in aerodynamic parameter: Maximum phonation time (seconds)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Apr 16, 2019
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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