Tratamiento de la distensión Abdominal Funcional

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• episodes of visible abdominal distension triggered by meal ingestion

Locations
United States
California
G. Oppenheimer Center for Neurobiology of Stress and Resilience
RECRUITING
Los Angeles
Other Locations
Canada
McMaster University
RECRUITING
Hamilton
France
Bordeaux University Hospital
ACTIVE_NOT_RECRUITING
Bordeaux
Italy
Santa Orsola Hospital
ACTIVE_NOT_RECRUITING
Bologna
Spain
Hospital Universitari Vall d'Hebron
NOT_YET_RECRUITING
Barcelona
Sweden
Sahlgrenska Hospital, Gothenburg
ACTIVE_NOT_RECRUITING
Gothenburg
United Kingdom
Manchester University
ACTIVE_NOT_RECRUITING
Manchester
Contact Information
Primary
Fernando Azpiroz, MD
azpiroz.fernando@gmail.com
34 932746259
Backup
Jordi Serra, MD
jordi.serra@vallhebron.cat
34 932746259
Time Frame
Start Date: 2025-07-30
Estimated Completion Date: 2026-10
Participants
Target number of participants: 100
Treatments
Experimental: Biofeedback
Placebo_comparator: Placebo
Sponsors
Leads: Hospital Universitari Vall d'Hebron Research Institute

This content was sourced from clinicaltrials.gov