Intralesional Steroid Injection Versus Voice Therapy in Management of Vocal Nodules

Vocal Nodules in Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03914092
• Other study ID #: QWE
• Status: Recruiting
• Phase: Phase 4
• Start date: September 29, 2019
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: Assiut University
• Contact: Eman S Hassan, MD
• Phone: 00201004082014
• Email: eshh2003[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

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.

Related Conditions & MeSH terms

• Vocal Nodules in Adults

Intervention

Drug:
• triamcinolone acetonide injection
,1 mm percutaneous intralesional injection

Behavioral:
• Smith Accent method of voice therapy
regular sessions of smith accent voice therapy (about 24 sessions, twice session / week) for 3 months

Locations

Country	Name	City	State
Egypt	Assiut university hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective measurements of severity of dysphonia	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)	Before intervention
Primary	Subjective measurements of patient's assessment of voice severity	Measurements of scores of Arabic Voice Handicap Index	Before intervention
Primary	Objective measurements of vocal nodules size	Measurements of base and rise of nodules using videostroboscopic examination	before intervention
Primary	Objective measurements of vocal pitch	Measurements of acoustic analysis: fundamental frequency (Hz)	Before intervention
Primary	Objective measurements of vocal waveform frequency aperiodicity	Measurements of acoustic analysis: jitter (%)	Before intervention
Primary	Objective measurements of vocal waveform amplitude aperiodicity	Measurements of acoustic analysis: shimmer (dB)	Before intervention
Primary	Objective measurements of vocal waveform periodicity to aperiodicity ratio	Measurements of acoustic analysis : harmonic to noise ratio(dB)	Before intervention
Secondary	Change in Subjective measurements of severity dysphonia	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)	1, 2 and 3 months after intervention
Secondary	Change in subjective measurements of patient's assessment of voice severity	Measurements of change in scores of Arabic Voice Handicap Index	1, 2 and 3 months after intervention
Secondary	Change in objective measurements of vocal nodules size	Measurements of change in base and rise of nodules using videostroboscopic examination	1, 2 and 3 months after intervention
Secondary	Change in objective measurements of vocal pitch	Measurements of change in acoustic analysis including fundamental frequency (Hz)	1, 2 and 3 months after intervention
Secondary	Change in objective measurements of vocal waveform frequency aperiodicity	Measurements of change in acoustic analysis : jitter (%)	1,2 and 3 months after intervention
Secondary	Change in objective measurements of vocal waveform amplitude aperiodicity	Measurements of change in acoustic analysis : shimmer (dB)	1,2 and 3 months after intervention
Secondary	Change in objective measurements of vocal waveform periodicity to aperiodicity ratio	Change in measurements of acoustic analysis : harmonic to noise ratio (dB)	1,2 and 3 after intervention