Treatment of Functional Abdominal Distension
Condition: Irritable Bowel Syndrome; Dyspepsia
MeSH terms: Irritable Bowel Syndrome; Dyspepsia
Study type: Interventional

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.
    


Intervention name(s): Biofeedback; Placebo
Intervention type(s): Behavioral; Dietary Supplement
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment