Treatment of Functional Abdominal Distension by Non-instrumental Biofeedback

NCT06150638 | Completed

• 1 other identifier: PR(AG)459-2023
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. In a randomized, placebo-controlled trial the authors 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 non-instrumental 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 during the first 3 weeks of the intervention period. Biofeedback: patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period. Placebo: sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 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.

Conditions

Irritable Bowel Syndrome; Dyspepsia; Functional Bloating

Outcome Measures

Primary Outcomes (1)

• Sensation of abdominal distension

  Sensation score measured by scales graded from 0 (not at all) to 10 (very much) at the end of each day over a 7-day clinical evaluation period before and during the 4th week of the intervention.

  4 weeks

Secondary Outcomes (2)

• Changes in girth produced by the probe meal

  4 weeks

• Effect of probe meal on sensation of abdominal distension

  4 weeks

Other Outcomes (1)

• Follow-up after biofeedback

  6 months

Study Arms (2)

Biofeedback

EXPERIMENTAL

Behavioral: Biofeedback

Placebo

PLACEBO COMPARATOR

Behavioral: Placebo

Interventions

Biofeedback BEHAVIORAL

Three sessions of biofeedback intervention will be performed during the first 3 weeks of the intervention period. Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.

Biofeedback

Placebo BEHAVIORAL

Three sessions of placebo intervention will be performed during the first 3 weeks of the intervention period. Sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• episodes of visible abdominal distension triggered by meal ingestion
• patients are able to identify the offending foodstuff

You may not qualify if:

• organic cause detected by clinical work-up
• constipation
• abdominal distension not confirmed by the 7-day clinical questionnaires or after the probe meal in the pre-intervention evaluation

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (1)

• 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.

  PMID: 28705783 RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome; Dyspepsia

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Fernando Azpiroz, MD

  University Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 29, 2023
• Study Start: April 29, 2024
• Primary Completion: December 8, 2024
• Study Completion: July 14, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-03

Locations

ES (1)