Clinical Research Directory
Browse clinical research sites, groups, and studies.
Visible Abdominal Distension
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
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.
Official title: Tratamiento de la distensión Abdominal Funcional
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-07-30
Completion Date
2026-10
Last Updated
2025-10-31
Healthy Volunteers
Yes
Interventions
Biofeedback
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
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.
Locations (7)
G. Oppenheimer Center for Neurobiology of Stress and Resilience
Los Angeles, California, United States
McMaster University
Hamilton, Ontario, Canada
Bordeaux University Hospital
Bordeaux, France
Santa Orsola Hospital
Bologna, Italy
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Sahlgrenska Hospital, Gothenburg
Gothenburg, Sweden
Manchester University
Manchester, United Kingdom