Visible Abdominal Distension
Start Date
7/30/2025
Completion Date
10/1/2026
Summary
Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique. 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 noninstrumental biofeedback technique, transmitted by a standard training program, for the treatment of abdominal distension in different centers. Selection criteria. Episodes of visible abdominal distension. Intervention. Patients will be randomized into biofeedback and 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. In each center one operator will receive a standard training on how to deliver the noninstrumental biofeedback treatment. 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.
Eligibility Criteria
Age Range: 18 years to 80 years
Interventions
Biofeedback
Placebo
Conditions
Locations
G. Oppenheimer Center for Neurobiology of Stress and Resilience
Los Angeles, California 90095
United States
McMaster University
Hamilton, Ontario ON L8S 4L8
Canada
Bordeaux University Hospital
Bordeaux, 33000
France
Santa Orsola Hospital
Bologna, 40138
Italy
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Sahlgrenska Hospital, Gothenburg
Gothenburg, 413 45
Sweden
Manchester University
Manchester, M14 9PR
United Kingdom