Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-01 @ 8:30 AM
Study NCT ID:
NCT03914092
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2019-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intralesional Steroid Injection Versus Voice Therapy in Management of Vocal Nodules
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Intralesional Steroid Injection Versus Accent Method of Voice Therapy in Management of Vocal Nodules: A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: