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Completed

NCT Number: NCT06150638

Treatment of Functional Abdominal Distension by Non-instrumental Biofeedback

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Dyspepsia Functional Bloating Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 or after the probe meal in the pre-intervention evaluation

Treatment and study plan

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.

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.

Primary outcomes

  1. Sensation of abdominal distension

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. Changes in girth produced by the probe meal

    Time frame: 4 weeks

    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.

  2. Effect of probe meal on sensation of abdominal distension

    Time frame: 4 weeks

    Sensation score measured by scales graded from 0 (not at all) to 10 (very much) after the probe meal. The response to the meal will be measured before and after the intervention.

Other outcomes

  1. Follow-up after biofeedback

    Time frame: 6 months

    Sensation of abdominal distension 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 at 1, 3 and 6 months after biofeedback treatment

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Tratamiento de la distensión Abdominal Funcional Mediante Biofeedback no Instrumental

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 29, 2023
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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