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OpenTrials
Completed

NCT Number: NCT04043208

Treatment of Functional Abdominal Distension

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

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 of after the probe meal in the pre-intervention evaluation

Treatment and study plan

Biofeedback

Behavioral

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.

Placebo

Dietary Supplement

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 outcomes

  1. Effect of the probe meal on thoraco-abdominal activity of the muscular walls.

    Time frame: 4 weeks

    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 outcomes

  1. Effect of the probe meal on sensation of abdominal distension

    Time frame: 4 weeks

    Sensation score measured by 0-6 scales after the probe meal.The response to the meal will be measured before and after treatment.

  2. 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.

  3. Sensation of abdominal distension

    Time frame: 4 weeks

    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.

  4. Follow-up after biofeedback

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Tratamiento de la Distension Abdominal Funcional

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 2, 2019
Registry last updated
Feb 22, 2022

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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