Intralesional Steroid Injection Versus Voice Therapy in Management of Vocal Nodules

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-29

Study Completion Date

2023-08-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes

NCT02286960

Dysphonia

COMPLETED PHASE4

Comparing Topical Tetracaine Drops to Topical Focal Phenol for Local Anesthesia During Intratympanic Steroid Injection

NCT04794842

Intratympanic Steroid Injection Idiopathic Sudden Sensorineural Hearing Loss Meniere Disease

UNKNOWN EARLY_PHASE1

Prevention of Noise-induced Hearing Loss

NCT02049073

Noise-induced Hearing Loss

WITHDRAWN PHASE1/PHASE2

Intracochlear Injection of Glucocorticoid

NCT07134075

Sudden Sensorineural Hearing Loss (SSNHL)

NOT_YET_RECRUITING PHASE2

The Efficacy of Steroid Therapy in Vestibular Neuritis

NCT02098330

Vestibular Neuritis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Vocal Nodules in Adults

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

study group

female patients with vocal fold nodules undergoing intralesional steroid injection

Group Type EXPERIMENTAL

triamcinolone acetonide injection

Intervention Type DRUG

0.1- 0.3 mm percutaneous intralesional injection

control group

female patients with vocal fold nodules undergoing Smith Accent voice therapy

Group Type ACTIVE_COMPARATOR

Smith Accent method of voice therapy

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

triamcinolone acetonide injection

0.1- 0.3 mm percutaneous intralesional injection

Intervention Type DRUG

Smith Accent method of voice therapy

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Epirelefan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No