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Intralesional Steroid Injection Versus Voice Therapy in Management of Vocal Nodules

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914092
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Nada Ali Kamel, Assiut University

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.


Condition or disease Intervention/treatment Phase
Vocal Nodules in Adults Drug: triamcinolone acetonide injection Behavioral: Smith Accent method of voice therapy Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intralesional Steroid Injection Versus Accent Method of Voice Therapy in Management of Vocal Nodules: A Randomized Controlled Trial
Actual Study Start Date : September 29, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: study group
female patients with vocal fold nodules undergoing intralesional steroid injection
Drug: triamcinolone acetonide injection
,1 mm percutaneous intralesional injection
Other Name: kenacort

Active Comparator: control group
female patients with vocal fold nodules undergoing Smith Accent voice therapy
Behavioral: Smith Accent method of voice therapy
regular sessions of smith accent voice therapy (about 24 sessions, twice session / week) for 3 months




Primary Outcome Measures :
  1. Subjective measurements of severity of dysphonia [ Time Frame: Before intervention ]
    Measurements of Grade of Dysphonia, strain, leakiness, Breathiness and irregularity by auditory perceptual assessment using modified (GRBAS) scale. Grades ranging from 0 (normal) up to 3 ( severe)

  2. Subjective measurements of patient's assessment of voice severity [ Time Frame: Before intervention ]
    Measurements of scores of Arabic Voice Handicap Index

  3. Objective measurements of vocal nodules size [ Time Frame: before intervention ]
    Measurements of base and rise of nodules using videostroboscopic examination

  4. Objective measurements of vocal pitch [ Time Frame: Before intervention ]
    Measurements of acoustic analysis: fundamental frequency (Hz)

  5. Objective measurements of vocal waveform frequency aperiodicity [ Time Frame: Before intervention ]
    Measurements of acoustic analysis: jitter (%)

  6. Objective measurements of vocal waveform amplitude aperiodicity [ Time Frame: Before intervention ]
    Measurements of acoustic analysis: shimmer (dB)

  7. Objective measurements of vocal waveform periodicity to aperiodicity ratio [ Time Frame: Before intervention ]
    Measurements of acoustic analysis : harmonic to noise ratio(dB)


Secondary Outcome Measures :
  1. Change in Subjective measurements of severity dysphonia [ Time Frame: 1, 2 and 3 months after intervention ]
    Measurements of change of Grade of Dysphonia, strain, leakiness, Breathiness and irregularity by auditory perceptual assessment using modified (GRBAS) scale. Grades ranging from 0 (normal) up to 3 ( severe)

  2. Change in subjective measurements of patient's assessment of voice severity [ Time Frame: 1, 2 and 3 months after intervention ]
    Measurements of change in scores of Arabic Voice Handicap Index

  3. Change in objective measurements of vocal nodules size [ Time Frame: 1, 2 and 3 months after intervention ]
    Measurements of change in base and rise of nodules using videostroboscopic examination

  4. Change in objective measurements of vocal pitch [ Time Frame: 1, 2 and 3 months after intervention ]
    Measurements of change in acoustic analysis including fundamental frequency (Hz)

  5. Change in objective measurements of vocal waveform frequency aperiodicity [ Time Frame: 1,2 and 3 months after intervention ]
    Measurements of change in acoustic analysis : jitter (%)

  6. Change in objective measurements of vocal waveform amplitude aperiodicity [ Time Frame: 1,2 and 3 months after intervention ]
    Measurements of change in acoustic analysis : shimmer (dB)

  7. Change in objective measurements of vocal waveform periodicity to aperiodicity ratio [ Time Frame: 1,2 and 3 after intervention ]
    Change in measurements of acoustic analysis : harmonic to noise ratio (dB)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914092


Contacts
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Contact: Eman S Hassan, MD 00201004082014 eshh2003@aun.edu.eg
Contact: Hanan A Mohamed, MD 00201007954155 hanan.abdelrashed2007@yahoo.com

Locations
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Egypt
Assiut university hospitals Recruiting
Assiut, Egypt
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Nada A Kamel, M.Sc. Assiut University
Publications:
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Responsible Party: Nada Ali Kamel, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03914092    
Other Study ID Numbers: QWE
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action