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Onabotulinum Toxin A (Botox) in the Treatment of Pharyngo-esophageal Dysphagia
Sponsor: All India Institute of Medical Sciences
Summary
Dysphagia in patients with stroke, multiple sclerosis, parkinsonism or dystonia can occur due to relative hypertonia of the cricopharyngeus muscle. In the resting state, muscle is contracted and relaxes only during deglutition. Treatment of dysphagia by injecting botulinum toxin in the cricopharyngeus was described by Schneider et al. in 1994. More than 100 cases have been described after that, however there are no randomized controlled trials. A meta-analysis from Cochrane has also concluded that there is no sufficient evidence to conclude regarding the efficacy and safety of Botulinum toxin injection in cricopharyngeal dysfunction. So this study is necessary to fill this void in knowledge
Official title: Efficacy and Safety of Onabotulinum Toxin A (Botox) Injections in the Upper Esophageal Sphincter for the Treatment of Pharyngo-esophageal Dysphagia Due to Cricopharyngeal Dysfunction- A Randomized Double Blinded Placebo Controlled Trial
Key Details
Gender
All
Age Range
14 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-08-11
Completion Date
2027-09-01
Last Updated
2026-07-07
Healthy Volunteers
No
Interventions
Botulinum Toxin Type A Injection [Botox]
50 units of Botulinum toxin A (Botox, Allergan, CA) under endoscopic guidance will be injected in the cricopharyngeus muscle
Locations (1)
All India Institute of Medical Sciences, New Delhi
New Delhi, National Capital Territory of Delhi, India