Clinical Trials Directory

Trials / Completed

CompletedNCT03914092

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Assiut University · Academic / Other
Sex
Female
Age
18 Years – 55 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DRUGtriamcinolone acetonide injection0.1- 0.3 mm percutaneous intralesional injection
BEHAVIORALSmith Accent method of voice therapyregular sessions of smith accent voice therapy (about 24 sessions, twice session / week) for 3 months

Timeline

Start date
2019-06-29
Primary completion
2022-08-15
Completion
2023-08-28
First posted
2019-04-16
Last updated
2026-01-16

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03914092. Inclusion in this directory is not an endorsement.