Intralesional Steroid Injection Versus Voice Therapy in Management of Vocal Nodules

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

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.

Study Overview

• Status: Completed
• Conditions: Vocal Nodules in Adults
• Intervention / Treatment: Behavioral: Smith Accent method of voice therapy; Drug: triamcinolone acetonide injection

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Asyut, Egypt
    • Assiut University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; female patients with vocal fold nodules undergoing intralesional steroid injection	Drug: triamcinolone acetonide injection; 0.1- 0.3 mm percutaneous intralesional injection; Other Names: Epirelefan
Active Comparator: control group; female patients with vocal fold nodules undergoing Smith Accent voice therapy	Behavioral: Smith Accent method of voice therapy; regular sessions of smith accent voice therapy (about 24 sessions, twice session / week) for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Objective measurements of glottal efficiency	Measurements of aerodynamic parameter : Maximum phonation time (seconds)	Before intervention
Subjective measurements of severity of dysphonia	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)	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, Roughness, Breathiness, Asthenia, and Straining by auditory perceptual assessment using the GRBAS scale. Grades ranging from 0 (normal) up to 3 (severe)	1 week and 1, 2, 3, and 6 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 week and 1, 2, 3 and 6 months after intervention
Change in objective measurements of vocal nodules size	Measurements of change in base and rise of nodules using videostroboscopic examination	1 week and 1, 2, 3 and 6 months after intervention
Change in objective measurements of vocal pitch	Measurements of change in acoustic analysis including fundamental frequency (Hz)	1 week and 1, 2, 3 and 6 months after intervention
Change in objective measurements of vocal waveform frequency aperiodicity	Measurements of change in acoustic analysis : jitter (%)	1 week and 1, 2, 3 and 6 months after intervention
Change in objective measurements of vocal waveform amplitude aperiodicity	Measurements of change in acoustic analysis : shimmer (dB)	1 week and 1, 2, 3 and 6 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 week and 1, 2, 3 and 6 months after intervention
Change in objective measurements of glottal efficiency	Measurements of change in aerodynamic parameter: Maximum phonation time (seconds)	1 week and 1, 2, 3 and 6 months after intervention

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Nada A Kamel, M.Sc., Assiut University

Publications and helpful links

General Publications

• Bassiouny S. Efficacy of the accent method of voice therapy. Folia Phoniatr Logop. 1998;50(3):146-64. doi: 10.1159/000021458.
• Tateya I. Laryngeal steroid injection. Curr Opin Otolaryngol Head Neck Surg. 2009 Dec;17(6):424-6. doi: 10.1097/MOO.0b013e3283327d4c.
• Campagnolo AM, Tsuji DH, Sennes LU, Imamura R, Saldiva PH. Histologic study of acute vocal fold wound healing after corticosteroid injection in a rabbit model. Ann Otol Rhinol Laryngol. 2010 Feb;119(2):133-9. doi: 10.1177/000348941011900211.
• Lee SH, Yeo JO, Choi JI, Jin HJ, Kim JP, Woo SH, Jin SM. Local steroid injection via the cricothyroid membrane in patients with a vocal nodule. Arch Otolaryngol Head Neck Surg. 2011 Oct;137(10):1011-6. doi: 10.1001/archoto.2011.168.
• Woo JH, Kim DY, Kim JW, Oh EA, Lee SW. Efficacy of percutaneous vocal fold injections for benign laryngeal lesions: Prospective multicenter study. Acta Otolaryngol. 2011 Dec;131(12):1326-32. doi: 10.3109/00016489.2011.620620.
• Wang CT, Lai MS, Hsiao TY. Comprehensive Outcome Researches of Intralesional Steroid Injection on Benign Vocal Fold Lesions. J Voice. 2015 Sep;29(5):578-87. doi: 10.1016/j.jvoice.2014.11.002. Epub 2015 May 2.
• Wang CT, Lai MS, Cheng PW. Long-term Surveillance Following Intralesional Steroid Injection for Benign Vocal Fold Lesions. JAMA Otolaryngol Head Neck Surg. 2017 Jun 1;143(6):589-594. doi: 10.1001/jamaoto.2016.4418.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2019
• Primary Completion (Actual): August 15, 2022
• Study Completion (Actual): August 28, 2023

Study Registration Dates

• First Submitted: April 6, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Polycyclic Compounds; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Triamcinolone Acetonide
• Other Study ID Numbers: QWE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No