Intralesional Steroid Injection Versus Voice Therapy in Management of Vocal Nodules

Assiut University

Status and phase: Completed; Phase 4

Conditions: Vocal Nodules in Adults

Treatments: Drug: triamcinolone acetonide injection; Behavioral: Smith Accent method of voice therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03914092

QWE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

study group

Experimental group

Description:

female patients with vocal fold nodules undergoing intralesional steroid injection

Treatment:

Drug: triamcinolone acetonide injection

control group

Active Comparator group

Description:

female patients with vocal fold nodules undergoing Smith Accent voice therapy

Treatment:

Behavioral: Smith Accent method of voice therapy