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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06369753
Other study ID # PR(AG)459/2023B
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2024
Est. completion date July 2025

Study information

Verified date April 2024
Source Hospital Universitari Vall d'Hebron Research Institute
Contact Fernando Azpiroz, MD
Phone 34 932746259
Email azpiroz.fernando@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date July 2025
Est. primary completion date May 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - episodes of visible abdominal distension triggered by meal ingestion Exclusion Criteria: - organic cause detected by clinical work-up - constipation - abdominal distension not confirmed by the 7-day clinical questionnaires in the pre- intervention evaluation

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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

Country Name City State
Spain Hospital Universitari Vall d'Hebron Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Barba E, Accarino A, Azpiroz F. Correction of Abdominal Distention by Biofeedback-Guided Control of Abdominothoracic Muscular Activity in a Randomized, Placebo-Controlled Trial. Clin Gastroenterol Hepatol. 2017 Dec;15(12):1922-1929. doi: 10.1016/j.cgh.201 — View Citation

Barba E, Livovsky DM, Accarino A, Azpiroz F. THORACOABDOMINAL WALL MOTION-GUIDED BIOFEEDBACK TREATMENT OF ABDOMINAL DISTENSION: A RANDOMIZED PLACEBO-CONTROLLED TRIAL. Gastroenterology. 2024 Mar 9:S0016-5085(24)00285-3. doi: 10.1053/j.gastro.2024.03.005. Online ahead of print. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Follow-up after biofeedback Sensation of abdominal distension measured by scales graded from 0 (not at all) to 10 (very much) at the end of each day over a 7-day clinical evaluation period at 1, 3 and 6 months after biofeedback treatment 6 months
Primary Visible abdominal distension Distension score measured by scales graded from 0 (not at all) to 10 (very much) at the end of each day over a 7-day clinical evaluation period before and during the 4th week of the intervention. 4 weeks
Secondary Sensation of abdominal pressure/fullness Sensation score measured by scales graded from 0 (not at all) to 10 (very much) at the end of each day over a 7-day clinical evaluation period before and during the 4th week of the intervention. 4 weeks
Secondary Sensation of abdominal discomfort/pain Sensation score measured by scales graded from 0 (not at all) to 10 (very much) at the end of each day over a 7-day clinical evaluation period before and during the 4th week of the intervention 4 weeks
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