Behavioural Balloon Dilatation in Upper Esophageal Sphincter (UES) Dysfunction

Each participant will undergo 6 assessments and 10 treatment sessions over a period of 4 months at the Rose Centre for Stroke Recovery and Research, University of Canterbury (see attachment “Study procedures” for a diagram detailing procedures that will occur at each session). Each session is expected to last approximately one hour. Some of the assessment and treatment sessions have been combined – these sessions will last approximately 1.5 hours. Each session will be an individual face-to-face session. They will be delivered by a speech language therapist with a minimum of 5 years’ experience. Each participant will undergo two baseline assessments with the Timed Water Swallow Test (TWST), the Test of Mastication and Swallowing Solids (TOMASS). These are screening tests where the participant will be observed while drinking a fixed amount of water and when eating a cracker. The participant will then undergo High-Resolution Manometry (HRM) and Videofluoroscopic Swallowing Study (VFSS) to document UES function prior to therapy. At the second baseline assessment session, if measures on HRM and the screening tests remain similar, VFSS will be omitted to limit radiation exposure. After the two baseline assessment sessions, a two-week behavioural dilatation treatment program will then commence. The intervention under investigation is behavioural balloon dilatation. It involves oral insertion of a urethral balloon catheter without sedation to the upper esophageal sphincter (UES). Two balloon dilatation methods will be carried out for each participant: a. the retrograde method – the balloon catheter is inserted to under the UES before the balloon is inflated with air and pulled through the UES in synchrony with swallowing (20 repetitions) b. the anterograde method –the balloon portion of the catheter is inflated with air before the participant swallows it down past the UES with the aid of a guidewire (10 repetitions). The retrograde method will be implemented from the first week of treatment. The anterograde method will be added on only in the second week. Each time a new method of dilatation is taught, the first dilatation will be done with visualisation by VFSS to mark how far the balloon catheter needs to be inserted. This will hence occur twice: once in the first retrograde dilatation attempt in the first week; the other in the first anterograde dilatation attempt in the second week. In subsequent dilatation attempts without VFSS, insertions will follow the markings made and the participant will be instructed to phonate after swallowing the catheter to ensure the catheter has not been inserted into the trachea. The regimen will hence consist of a total of twenty repetitions of balloon dilatation at each session, two sessions per day, five times per week for the first week. At the end of the first week, HRM will be carried out to chart progress before commencing the second week of treatment. It potentially may yield data that indicates which patients may or may not tolerate anterograde dilatation. The regimen then increases to thirty repetitions of balloon dilatation at each session, two sessions per day, five times per week for the second week. Patients are encouraged to perform self-dilatation of the UES. To rate the tolerability of the treatment program, participants will be asked to rate their comfort level on a visual analogue scale at one week into the treatment phase and again at immediately after treatment has ended. Initial balloon sizes will be determined by VFSS opening diameters measured from the baseline VFSS sessions. Balloon size will then gradually be increased based on patient comfort levels and intra-balloon pressures generated when the balloon passes the UES. Intra-balloon pressures will be measured throughout the whole dilatation session with a manometer connected to a laptop which will display pressures within the balloon on screen. Dou and colleagues (2012) reported that small increments in balloon size will lead to fewer side effects like bleeding from mucosal trauma. Typically intra-balloon pressures will be monitored to remain less than 20% above baseline pressures. If pressures stay within 20% of baseline pressures, balloon size will be increased by 0.5mm. The maximum balloon diameter will correspond to normative data of maximum UES diameter during swallowing (normative data is available in Leonard and Kendall, 2013). Once this maximum diameter is achieved, therapy will continue at this balloon size until the end. This is to minimise the risk of bleeding from over-expansion. At the end of the two-week of treatment, the TWST, TOMASS, HRM and VFSS will be repeated to document change in UES opening and manometric pressures from treatment. At two weeks and at three months after treatment has terminated, the TWST, TOMASS and HRM will be repeated to assess short and long-term effects of treatment. Once again, VFSS will be omitted if HRM measures remain stable to minimise radiation exposure. Functional change in swallowing function will be monitored via scoring on the Functional Oral Intake Scale (FOIS), a 7-point scale based on details of a participant’s feeding status and amount of intake. The Eating Assessment Tool (EAT-10), a short questionnaire that assesses change in patient-reported dysphagia symptoms and severity, and quality of life, will also be administered at each session. Based on previous research indicating that reflux symptoms may increase after oesophageal dilatation, it would be of interest to investigate if laryngopharyngeal reflux, in particular, will be affected after behavioural dilatation. Change in symptoms will be tracked using the Reflux Symptom Index (RSI).