Clinical trial NCT03914092: Intralesional Steroid Injection Versus Voice Therapy in Management of Vocal Nodules
Official title: Intralesional Steroid Injection Versus Accent Method of Voice Therapy in Management of Vocal Nodules: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Vocal Nodules in Adults
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Subjective measurements of severity of dysphonia
timeFrame: Before intervention
measure: Subjective measurements of patient's assessment of voice severity
timeFrame: Before intervention
measure: Objective measurements of vocal nodules size
timeFrame: before intervention
measure: Objective measurements of vocal pitch
timeFrame: Before intervention
measure: Objective measurements of vocal waveform frequency aperiodicity
timeFrame: Before intervention
measure: Objective measurements of vocal waveform amplitude aperiodicity
timeFrame: Before intervention
measure: Objective measurements of vocal waveform periodicity to aperiodicity ratio
timeFrame: Before intervention
Secondary outcomes:
measure: Change in Subjective measurements of severity dysphonia
timeFrame: 1, 2 and 3 months after intervention
measure: Change in subjective measurements of patient's assessment of voice severity
timeFrame: 1, 2 and 3 months after intervention
measure: Change in objective measurements of vocal nodules size
timeFrame: 1, 2 and 3 months after intervention
measure: Change in objective measurements of vocal pitch
timeFrame: 1, 2 and 3 months after intervention
measure: Change in objective measurements of vocal waveform frequency aperiodicity
timeFrame: 1,2 and 3 months after intervention
measure: Change in objective measurements of vocal waveform amplitude aperiodicity
timeFrame: 1,2 and 3 months after intervention
measure: Change in objective measurements of vocal waveform periodicity to aperiodicity ratio
timeFrame: 1,2 and 3 after intervention
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
Study officials:
affiliation: Assiut University
name: Nada A Kamel, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bassiouny S. Efficacy of the accent method of voice therapy. Folia Phoniatr Logop. 1998;50(3):146-64. doi: 10.1159/000021458.
citation: Tateya I. Laryngeal steroid injection. Curr Opin Otolaryngol Head Neck Surg. 2009 Dec;17(6):424-6. doi: 10.1097/MOO.0b013e3283327d4c.
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.
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.
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.
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.
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.