Abstract
BackgroundCricopharyngeal dysfunction (CPD) occurs in various neurological disorders, especially stroke. The treatment approaches of CPD include swallowing training, cricopharyngeal dilation, botulinum toxin (BTX) injection, and cricopharyngeal myotomy. BTX injection into the cricopharyngeal muscle is effective and safe for some patients with dysphagia, with a success rate between 43 and 100% (mean = 76%). However, well-designed randomized controlled clinical trials are needed to verify its efficacy and safety for the treatment of CPD. The objective of this study is to explore the efficacy and safety of BTX for neurogenic cricopharyngeal achalasia, when administering an injection into the cricopharyngeal muscle guided by a novel precise positioning method, that combines ultrasound, catheter balloon, and electromyography (BECURE).MethodsBECURE is a single-center randomized, placebo controlled, double-blinded, superiority clinical trial. To detect a significant difference between the 2 groups, a sample size of 44 patients is estimated. The intervention is BTX versus placebo, with 1:1 randomization. The randomization sequence from 1 to 44 was generated using the Statistical Package for Social Sciences. The study is divided into two phases. In the first phase, patients will be injected with BTX or the placebo. In the second phase, patients who received a placebo injection and those who did not respond to the first BTX injection will receive an injection of BTX. The primary outcome is the score of the Functional Oral Intake Scale (FOIS). The secondary outcomes are as follows: upper esophageal sphincter (UES) residual pressure, UES resting pressure, duration of UES relaxation, velopharyngeal and laryngopharyngeal peak pressure, UES opening, pharyngeal construction ratio, residue of bolus in the epiglottis valley or piriform sinus, and penetration and aspiration.DiscussionDysphagia is a common complication of stroke. There is lack of high-quality evidence for the efficacy of BTX in treating neurogenic CPD. This study will clarify whether BTX injection into the cricopharyngeal muscle can be effective and safe for patients with stroke and CPD.Trial registrationChinese Clinical Trial Register (ChiCTR1900025562). Registered on September 1, 2019.
Highlights
Cricopharyngeal dysfunction (CPD) occurs in various neurological disorders, especially stroke
This study will clarify whether botulinum toxin (BTX) injection into the cricopharyngeal muscle can be effective and safe for patients with stroke and CPD
The injection of BTX into the cricopharyngeal muscle can be effective for neurogenic dysphagia [7, 16,17,18]
Summary
Cricopharyngeal dysfunction (CPD) occurs in various neurological disorders, especially stroke. Dysphagia occurs due to neurological disorders that impair the transport of food from the oral cavity to the stomach efficiently and/or safely [2] and is associated with an increased risk of pulmonary complications, dehydration, malnutrition, and mortality [1, 3]. The cricopharyngeal muscle is main muscle responsible for UES function [5] This muscle remains in a contracted position during respiration, preventing air from entering into the esophagus and relaxes and opens during swallowing or vomiting [2]. Cricopharyngeal dysfunction (CPD), characterized by difficulty of food bolus entering the esophagus, occurs often due to 3 main factors: cricopharyngeal muscle spasm, incomplete laryngeal movement, and insufficient descending pressure of the bolus [2]
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