None listed
Conditions
Brief summary
The purpose of this study is to trial a combination treatment of speech pathology and amitriptyline for vocal cord dysfunction and compare this to speech pathology alone. The aim is to reduce the symptoms of vocal cord dysfunction.
Interventions
Arm 1 - Amitriptyline 25mg per day for one week, then increased to 50mg per day for one week then increased to maximal dose of 75mg per day for 8 weeks, oral route - oral capsules, combined with speech pathology behavioural intervention. Speech pathology intervention includes education on vocal cord dysfunction and related conditions such as chronic refractory cough, provision of lifestyle strategies, vocal hygiene and behavioural breathing and voice exercises, provided on an individual basis fo
Arm 1 - Amitriptyline 25mg per day for one week, then increased to 50mg per day for one week then increased to maximal dose of 75mg per day for 8 weeks, oral route - oral capsules, combined with speech pathology behavioural intervention. Speech pathology intervention includes education on vocal cord dysfunction and related conditions such as chronic refractory cough, provision of lifestyle strategies, vocal hygiene and behavioural breathing and voice exercises, provided on an individual basis for 6 sessions over 10 weeks, provided by an experienced speech pathologist. Arm 2 - Placebo medication and identical speech pathology behavioural intervention. Adherence to medication and speech pathology intervention will be monitored by unused product return (medication) and participant diary and participant explanation and modelling of exercises (speech pathology intervention).
Sponsors
LaTrobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Adults with vocal cord dysfunction diagnosed using laryngoscopy. Diagnosis defined as abnormal adduction of the vocal folds during inspiration or > 50% adduction during expiration.
Exclusion criteria
previous speech pathology treatment for vocal cord dysfunction contraindications for the use of amitriptyline including pregnancy and breast feeding Lung pathology excluding asthma progressive neurological condition structural vocal fold pathology inability to attend study visits
Outcome results
None listed