Intralesional Steroid Injection Versus Voice Therapy in Management of Vocal Nodules

NCT03914092 | Completed Phase 4

• 1 other identifier: QWE
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Vocal Nodules in Adults

Outcome Measures

Primary Outcomes (8)

• 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

• 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

Secondary Outcomes (8)

• 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

Study Arms (2)

study group

EXPERIMENTAL

female patients with vocal fold nodules undergoing intralesional steroid injection

Drug: triamcinolone acetonide injection

control group

ACTIVE COMPARATOR

female patients with vocal fold nodules undergoing Smith Accent voice therapy

Behavioral: Smith Accent method of voice therapy

Interventions

triamcinolone acetonide injection DRUG

0.1- 0.3 mm percutaneous intralesional injection

Also known as: Epirelefan

study group

Smith Accent method of voice therapy BEHAVIORAL

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

control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.
• age: 18-55 years. 3- Normal articulation, resonance and language ability. 4- Normal hearing.

You may not qualify if:

• Previous voice therapy or micro-phono-surgery. 2- Use of drugs (which may cause changes in laryngeal function, mucosa, or muscle activity).
• History of allergies, lung disease, gastroesophageal reflux disease, or other concomitant vocal pathology (e.g., vocal polyp and vocal cyst).
• Current psychiatric, neurological conditions.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospitals

Asyut, Egypt

Location

Related Publications (7)

• Bassiouny S. Efficacy of the accent method of voice therapy. Folia Phoniatr Logop. 1998;50(3):146-64. doi: 10.1159/000021458.

  PMID: 9691529 BACKGROUND

• Tateya I. Laryngeal steroid injection. Curr Opin Otolaryngol Head Neck Surg. 2009 Dec;17(6):424-6. doi: 10.1097/MOO.0b013e3283327d4c.

  PMID: 19779349 BACKGROUND

• 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.

  PMID: 20336925 BACKGROUND

• 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.

  PMID: 22006779 BACKGROUND

• 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.

  PMID: 22074107 BACKGROUND

• 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.

  PMID: 25944294 BACKGROUND

• 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.

  PMID: 28334309 BACKGROUND

MeSH Terms

Interventions

Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Nada A Kamel, M.Sc.

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: April 6, 2019
• First Posted: April 16, 2019
• Study Start: June 29, 2019
• Primary Completion: August 15, 2022
• Study Completion: August 28, 2023
• Last Updated: January 16, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)