Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000822482
Ethics application status
Approved
Date submitted
15/07/2025
Date registered
31/07/2025
Date last updated
31/07/2025
Date data sharing statement initially provided
31/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Novel use of Electrical Muscle Stimulation in patients with bothersome chronic Bloating or Abdominal Distention: A Randomised Placebo-Controlled Trial.
Scientific title
Novel use of Electrical Muscle Stimulation in patients with bothersome chronic Bloating or Abdominal Distention: A Randomised Placebo-Controlled Trial.
Secondary ID [1] 314914 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal bloating 338234 0
Abdominal distension 338289 0
Condition category
Condition code
Oral and Gastrointestinal 334510 334510 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 331520 0
Treatment: Devices
Comparator / control treatment
Population: Patients with symptoms of chronic abdominal bloating and/or distension secondary to a 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).

Placebo Group: Participants will use a non-active device designed to mimic the EMS device in appearance and user experience but without electrical stimulation (Slendertone Abs 8 muscle stimulation belt with the electrical controller component removed).
Control group
Placebo

Outcomes
Primary outcome [1] 342192 0
To evaluate the effect of EMS on symptoms of gastrointestinal bloating compared to a placebo treatment.
Timepoint [1] 342192 0
Baseline and two weeks after treatment. The Placebo group will then be invited to participate in the interventional arm immediately. Therefore this will extend the second time point for this group by another 2 weeks.
Secondary outcome [1] 449882 0
Change in abdominal muscle activity (specifically internal oblique) on Electromyography in the context of a symptom triggering meal after two weeks of EMS treatment compared to baseline vs placebo.
Timepoint [1] 449882 0
Baseline and two weeks after treatment. The Placebo group will then be invited to participate in the interventional arm immediately. Therefore this will extend the second time point for this group by another 2 weeks.

Eligibility
Key inclusion criteria
Inclusion Criteria:
- greater or equal to 18 years old
- Bothersome chronic bloating and/or abdominal distension thought to be secondary to a DGBI as per Rome IV criteria.
- Can give informed consent
- Can understand risks/benefits of study
- BMI under 40
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
o Organic structural diseases detected by clinical work up, including: Gastroscopy, colonoscopy and other relevant investigations as deemed appropriate by the referring gastroenterologist.
o Constipation not controlled by steady laxative treatment
o Treatment with neuromodulators in the previous 3 months
o Currently Pregnant and within 6 weeks of vaginal delivery (3 months if caesarean delivery).
o Abdominal implants
o Cardiac pacemakers, defibrillators, or other implanted metallic or electronic devices.
o Major abdominal surgery within last 6 weeks
o History of severe skin allergies or sensitivity to adhesives, cosmetics or lotions
o Chronically damaged or vulnerable abdominal skin (fragile skin, wounds, inflammation, skin lesions)
o Unable to remain in a seated position for the test duration
o Acute illness to account for bloating symptoms including acute gastroenteritis, acute bowel ischaemia, abdominal ascites, gastrointestinal malignancy, acute gastric outlet obstruction, acute bowel obstruction.
o Prior recruitment in any clinical trial in which Electrical muscle stimulation was used on the abdomen.
o For patients with constipation, patients must have regular bowel motions prior to participating in and during the two-week trial period. If patients are on laxatives, they must remain on a stable and regular regime during the two-week trial period.
o Any changes to medications related to intestinal function and perception during the three-week study period (includes one week prior to trial intervention and the two weeks during the intervention). This includes pro-kinetic medications (eg. Domperidone, prucalopride, linaclotide) and neuromodulating medications (eg. amitriptyline)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
The placebo group will be invited to complete the 2 week intervention arm of the study following their 2 weeks of placebo. The participants in the intervention arm will not need to complete the placebo arm of the study.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/09/2025
Actual
Date of last participant enrolment
Anticipated
15/04/2026
Actual
Date of last data collection
Anticipated
24/07/2026
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319479 0
University
Name [1] 319479 0
Western Sydney University
Country [1] 319479 0
Australia
Primary sponsor type
Individual
Name
Ryan Abraham. Western Sydney University and NSW health.
Address
Country
Australia
Secondary sponsor category [1] 321967 0
None
Name [1] 321967 0
Address [1] 321967 0
Country [1] 321967 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318049 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 318049 0
Ethics committee country [1] 318049 0
Australia
Date submitted for ethics approval [1] 318049 0
23/09/2024
Approval date [1] 318049 0
25/10/2024
Ethics approval number [1] 318049 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142962 0
A/Prof Vincent Ho
Address 142962 0
Campbelltown Private Hospital. Suite 211, 4 Hyde Parade, Campbelltown NSW 2560
Country 142962 0
Australia
Phone 142962 0
+61 404204841
Fax 142962 0
Email 142962 0
[email protected]
Contact person for public queries
Name 142963 0
Ryan Abraham
Address 142963 0
Campbelltown Private Hospital Suite 211, 4 Hyde Parade, Campbelltown NSW 2560
Country 142963 0
Australia
Phone 142963 0
+61 0449981171
Fax 142963 0
Email 142963 0
[email protected]
Contact person for scientific queries
Name 142964 0
Ryan Abraham
Address 142964 0
Campbelltown Private Hospital Suite 211, 4 Hyde Parade, Campbelltown NSW 2560
Country 142964 0
Australia
Phone 142964 0
+61 0449981171
Fax 142964 0
Email 142964 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.