Condition: Irritable Bowel Syndrome · Dyspepsia · Functional Bloating · Sponsor: Hospital Universitari Vall d'Hebron Research Institute
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…
This description comes directly from the study's public registry record.
Fernando Azpiroz, MD · 34 932746259 · azpiroz.fernando@gmail.com
Jordi Serra, MD · 34 932746259 · jordi.serra@vallhebron.cat
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| G. Oppenheimer Center for Neurobiology of Stress and Resilience | Los Angeles, California, United States | Recruiting |
| McMaster University | Hamilton, Ontario, Canada | Recruiting |
| Bordeaux University Hospital | Bordeaux, France | Active Not Recruiting |
| Santa Orsola Hospital | Bologna, Italy | Active Not Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona, Spain | Not Yet Recruiting |
| Sahlgrenska Hospital, Gothenburg | Gothenburg, Sweden | Active Not Recruiting |
| Manchester University | Manchester, United Kingdom | Active Not Recruiting |
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Source record: clinicaltrials.gov/study/NCT06369753