Novel use of Electrical Muscle Stimulation in patients with bothersome chronic Bloating or Abdominal Distention: A Randomised Placebo-Controlled Trial.

Population: Patients with symptoms of chronic abdominal bloating and/or distension secondary to a Disorders of Gut-Brain Interaction (DGBI) as per Rome IV criteria. Setting: The study will be conducted at Western Sydney University (WSU) MacArthur Clinical School. Duration: Two-week at home treatment period with two sessions at the MacArthur Clinical School (pre- and post-treatment assessment sessions). Electrical Muscle Stimulation (EMS) Group (intervention): Participants will receive EMS treatment using the Slendertone Abs 8 muscle stimulation belt, applied to the abdominal region as per the manufacturer's guidelines. The researcher will Educate participants on proper device use, including the following: Gel pad placement, securing the belt, turning on the device, setting a 5-minute beginner session (20 Hz), and adjusting intensity. Conduct a 5-minute session (beginner mode) followed by a 10-minute session at higher intensity (35 Hz). The Belt will then be used at home on this same intensity. The intensity will be pre-set on the belt and therefore cannot then be changed after the training session. This study will be conducted at MacArthur Clinical School, Parkside Crescent, Campbelltown NSW 2560. The study involves two sessions conducted at the MacArthur Clinical School in Campbelltown. Each of these sessions will take approximately 120 minutes. Between the first and the last session, you will be loaned an abdominal belt to be used at home for two weeks. Prior to the first session, you will be asked to complete a 7-day symptom questionnaire about your abdominal bloating/distension. For the first session you will be asked to bring with you a meal that is known to trigger your bloating/abdominal distension (probe meal). Kitchen facilities including a fridge and microwave will be available for use. You will be taken into a private clinic room with an ergonomic chair and an examination bed. Prior to consuming your probe meal, a researcher will take three baseline measurements. One will be of your abdominal circumference using a measuring tape. The next will be measurements of your abdominal muscle activity using gel pads connected to an electromyography machine (like an ECG of your muscles). The final measurement will be your own rating of your abdominal distension on a symptom scale like the one used in the week prior to the session. You will then be given time to consume your probe meal. 20 minutes after you have finished your meal, the research team will repeat the same three measurements outlined above. We will then randomised you into either the placebo or treatment arms. Only the researchers will know the outcome of your randomisation until the completion of the study. However, participants who receive placebo will be invited to join the intervention arm of the study immediately after completing the placebo period (2 weeks). You will then be introduced to the abdominal belt you will be using for the remainder of the trial. This is a commercially available professional device that is designed to be used within the home. The belt has been shown to be safe, pain-free and well tolerated by people with similar symptoms to you. The research team will explain its function and how to use the device safely. You will then wear the abdominal belt for approximately 20 minutes and the researcher will conduct the same three measurements outlined above. After this first session, you will be loaned the same abdominal belt used at the baseline session to take home. This belt is to be used at least three times a day (ideally with each meal) for 10 minutes before and 10 minutes after meals for a period of two weeks. The belt is portable and undetectable under clothing. You will be provided with an instruction manual. During the second week of using the belt, you will be asked to complete the same 7-day symptom questionnaire about your abdominal bloating/distension. At the conclusion of your two-week treatment period, you will be asked to attend a post-treatment session at MacArthur Clinical School in Campbelltown (this session will take approximately 120 minutes). For this post-treatment session, you will again be asked to bring with you a meal that is known to trigger your bloating/abdominal distension (probe meal). Kitchen facilities including a fridge and microwave will be available for use. Prior to consuming your probe meal, the research team will take three baseline measurements. One will be of your abdominal circumference using a measuring tape. The next will be measurements of your abdominal muscle activity using gel pads connected to an electromyography machine (like an ECG of your muscles). The final measurement will be your rating of your abdominal distension on a symptom scale like the one used in the prior session. Adherence to belt use will be monitored only by a physical diary given to participants at randomisation on day 1,. The investigator will be sending text messages from a dedicated phone to the participants to periodically remind patients to fill in the diary and ensure that everything is going well with the belt use.