Clinical trial NCT04582292: Laryngeal Manifestations of Connective Tissue Diseases
Official title: Laryngeal Manifestations of Connective Tissue Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Connective Tissue Diseases
Keywords: Laryngeal manifestation in connective tissue diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cross_sectional study

Brief summary: Connective tissue diseases represent a rather heterogeneous spectrum of overlapping pathologies, which have as a common feature the involvement of multiple organ systems. Though generally uncommon, they represent lifelong conditions, which are often coupled with various immunologic disorders, thus significantly affecting the overall health and quality of life of the affected individual. The classic connective tissue disorders include rheumatoid arthritis ,Juvenile idiopathic arthritis, systemic lupus erythematosus , scleroderma, Sjogren's syndrome, and the mixed connective tissue disease several studies have reported that up to fifty percent of connective tissue diseases' patients are having laryngeal involvement as the sole manifestation of this disease In acute phases, patients may complain of burning, foreign body sensation in the throat, and difficulty in swallowing. In chronic cases the cricoarytenoid joint is usually affected with resultant fixation. The laryngoscopic findings include mucosal edema, myositis of the intrinsic laryngeal muscles, hyperemia, inflammation and swelling of the arytenoids, interarytenoid mucosa, aryepiglottic folds and epiglottis, and impaired mobility or fixation of the cricoarytenoid joint. In the early stage of the disease, the laryngeal examination may be normal

Detailed description: In acute involvement of the cricoarytenoid joints, signs of inflammation such as edema and redness may be present with or without impaired mobility chronic cases where ankylosis of the connective tissue disease cricoarytenoid joint is present, one or both vocal folds may be fixed in the median, paramedian, or lateral positions. Other laryngoscopic findings include the presence of inflammatory masses or rheumatoid nodules in the larynx and pharynx. In 1987, the American Rheumatism Association has included submucosal nodules in the laryngeal tissue in her revised criteria for the classification of Rheumatoid arthritis there was a description of small submucous rheumatoid nodule in the larynx, were later confirmed by multiple studies . Rheumatoid deposits in the form of bamboo nodes which are white- yellow bands in the middle of the membranous portion of the vocal folds had been described Cricoarytenoiditis has been reported to occur in Juvenile rheumatoid arthritis, and sometimes, it may be the first presentation of the disease ,Vocal cord lesions that have been reported in connective tissue diseases diseases include cricoarytenoid arthritis, rheumatoid nodules, and bamboo nodes .

Eligibility criteria: Inclusion Criteria:

1. Age: any age group may be included in this study.
2. Gender: both sexes will be included in the study.
3. 'previously established diagnosis of connective tissue diseases:

Exclusion Criteria:

1. history of neurological diseases .
2. previous history of neck radiation
3. presence of any other systemic diseases
4. professional voice users
5. chronic nonspecific laryngitis like laryngeal scleroma,Tuberculous laryngitis
6. presence of laryngeal masses
7. history of neurological diseases .
8. previous history of neck surgery,intubation.

Primary outcomes:
measure: Subjective measurement of severity of dysphonia connective tissue disease.
timeFrame: Baseline
measure: Subjective measurements of patient's assessment of voice severity
timeFrame: Baseline
measure: Objective measurement of vocal pitch
timeFrame: Baseline
measure: Objective measurement of vocal waveform frequency aperiodicity
timeFrame: Baseline
measure: Objective measurement of vocal waveform amplitude aperiodicity
timeFrame: Baseline
measure: Objective measurement of vocal waveform periodicity to aperiodicity ratio
timeFrame: Baseline
Secondary outcomes:
measure: Objective measurements of changes of vocal folds
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Hebatullah Badry, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
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