Treatment of Functional Abdominal Distension
Primary Purpose
Irritable Bowel Syndrome, Dyspepsia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Biofeedback
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome
Eligibility Criteria
Inclusion Criteria:
- episodes of visible abdominal distension triggered by meal ingestion
- patients are able to identify the offending foodstuff
Exclusion Criteria:
- organic cause detected by clinical work-up
- constipation
- abdominal distension not confirmed by the 7-day clinical questionnaires of after the probe meal in the pre-intervention evaluation
Sites / Locations
- University Hospital Vall d'Hebron
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Biofeedback
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Effect of the probe meal on thoraco-abdominal activity of the muscular walls.
Activity of thoraco-abdominal muscles (intercostals, external oblique, internal oblique, upper rectus, lower rectus) will be measured by electromyography before and after the probe meal. The response to the meal will be measured before and after treatment.
Secondary Outcome Measures
Effect of the probe meal on sensation of abdominal distension
Sensation score measured by 0-6 scales after the probe meal.The response to the meal will be measured before and after treatment.
Changes in girth produced by the probe meal
Abdominal girth will be measured using a non-stretch belt that is placed over the umbilicus before and after the probe meal.The response to the meal will be measured before and after treatment.
Sensation of abdominal distension
Sensation score measured by 0-6 scales after each meal (breakfast, lunch, dinner) over a 7-day clinical evaluation period before and during the 4th week of the intervention.
Follow-up after biofeedback
Sensation of abdominal distension measured by 0-6 scales after each meal (breakfast, lunch, dinner) over a 7-day clinical evaluation period at 1, 3 and 6 months after biofeedback treatment.
Full Information
NCT ID
NCT04043208
First Posted
July 31, 2019
Last Updated
February 21, 2022
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04043208
Brief Title
Treatment of Functional Abdominal Distension
Official Title
Tratamiento de la Distension Abdominal Funcional
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 25, 2019 (Actual)
Primary Completion Date
January 19, 2021 (Actual)
Study Completion Date
January 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Background. Abdominal distention is produced by an abnormal somatic postural tone. We developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. In a randomized, placebo-controlled trial we demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical.
Aim. To prove the efficacy of a simplified biofeedback technique for the treatment of abdominal distension.
Selection criteria. Visible abdominal distension after meal ingestion; patients are able to identify the offending meal.
Intervention. Patients will be randomized into biofeedback in placebo groups.Three sessions of either biofeedback or placebo intervention will be performed 30 min after ingestion of the offending meal during the first 3 weeks of the intervention period.
Biofeedback: patients will be taught to control abdominal and thoracic muscular activity by providing a visual display of the abdominal and thoracic perimeter; specifically, they will be instructed to reduce the abdominal perimeter (girth); patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.
Placebo: abdominal and thoracic perimeter will be recorded but not shown to the patient and a pill of placebo containing 0.5 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.
Primary Outcome Measure:
Effect of the probe meal on the activity of thoraco-abdominal muscles (intercostals, external oblique, internal oblique, upper rectus, lower rectus) measured by electromyography before and after the probe meal. The response to the probe meal will be measured before and after treatment.
Secondary Outcome Measures:
Effect of the probe meal on sensation of abdominal distension measured by 0-6 scales after the probe meal.
Changes in girth produced by the probe meal measured using a non-stretch belt placed over the umbilicus before and after the probe meal.
Sensation of abdominal distension measured by 0-6 scales after each meal (breakfast, lunch, dinner) over a 7-day clinical evaluation period before and during the 4th week of the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Dyspepsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biofeedback
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback
Intervention Description
Three sessions of biofeedback will be performed during the first 3 weeks of the intervention period. Biofeedback sessions will be performed 30 min after ingestion of the offending meal: patients will be taught to control abdominal and thoracic muscular activity by providing a visual display of the abdominal and thoracic perimeter; specifically, they will be instructed to reduce the abdominal perimeter (girth). Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Three sessions will be performed during the first 3 weeks of the intervention period. Each session will be performed 30 min after ingestion of the offending meal: abdominal and thoracic perimeter will be recorded but not shown to the patient; patients will take a pill of placebo containing 0.5 g glucose and no specific instructions will be provided. Patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.
Primary Outcome Measure Information:
Title
Effect of the probe meal on thoraco-abdominal activity of the muscular walls.
Description
Activity of thoraco-abdominal muscles (intercostals, external oblique, internal oblique, upper rectus, lower rectus) will be measured by electromyography before and after the probe meal. The response to the meal will be measured before and after treatment.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Effect of the probe meal on sensation of abdominal distension
Description
Sensation score measured by 0-6 scales after the probe meal.The response to the meal will be measured before and after treatment.
Time Frame
4 weeks
Title
Changes in girth produced by the probe meal
Description
Abdominal girth will be measured using a non-stretch belt that is placed over the umbilicus before and after the probe meal.The response to the meal will be measured before and after treatment.
Time Frame
4 weeks
Title
Sensation of abdominal distension
Description
Sensation score measured by 0-6 scales after each meal (breakfast, lunch, dinner) over a 7-day clinical evaluation period before and during the 4th week of the intervention.
Time Frame
4 weeks
Title
Follow-up after biofeedback
Description
Sensation of abdominal distension measured by 0-6 scales after each meal (breakfast, lunch, dinner) over a 7-day clinical evaluation period at 1, 3 and 6 months after biofeedback treatment.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
episodes of visible abdominal distension triggered by meal ingestion
patients are able to identify the offending foodstuff
Exclusion Criteria:
organic cause detected by clinical work-up
constipation
abdominal distension not confirmed by the 7-day clinical questionnaires of after the probe meal in the pre-intervention evaluation
Facility Information:
Facility Name
University Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
28705783
Citation
Barba E, Accarino A, Azpiroz F. Correction of Abdominal Distention by Biofeedback-Guided Control of Abdominothoracic Muscular Activity in a Randomized, Placebo-Controlled Trial. Clin Gastroenterol Hepatol. 2017 Dec;15(12):1922-1929. doi: 10.1016/j.cgh.2017.06.052. Epub 2017 Jul 11.
Results Reference
result
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Treatment of Functional Abdominal Distension
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