Treatment of Abdominal Distension by Biofeedback - a Randomized Controlled Trial
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
Background: Abdominal bloating is a frequent and bothersome complaint in patients with
functional gut disorders without satisfactory treatment to date. Recent data from our
laboratory indicate that abdominal distention in these patients is produced by
abdomino-phrenic dyssynergia: diaphragmatic contraction associated with abdominal wall
relaxation (particularly the internal oblique). In analogy to other clinical situations (e.g.
functional outlet obstruction, rumination or aerophagia) behavioral treatment by means of
biofeedback might be equally effective in these patients. The investigators hypothesized that
abdomino-phrenic coordination and abdominal distention can be controlled by biofeedback
techniques.
Aim: to prove the efficacy of behavioural treatment using biofeedback techniques for
abdominal distension.
Randomization: Patients will be randomized into biofeedback and placebo groups.
Intervention. Biofeedback: patients will be taught to control abdominothoracic muscular
activity by bio-feedback using online electromyography information. Placebo: patients will be
given a pill containing placebo medication. Interventions will be delivered in 3 sessions (20
min each) over 10-day period
. Measurements: Sensation of abdominal distension will be assessed by means of graphic rating
scales graded from 0 (no perception) to 6 (very intense sensation). The activity of the
abdomino-thoracic muscles will be recorded. Abdominal distension will be measured by a metric
tape fixed to a non-stretch belt placed over the umbilicus.
Outcomes: Primary outcome: Change in sensation of abdominal sensation. Secondary outcomes: a)
changes in thoraco-abdominal activity of the muscular walls; activity of thoraco-abdominal
muscles (intercostals, diaphragm, external oblique, internal oblique, upper rectus, lower
rectus) will be measured by electromyography; b) changes in girth; abdominal girth will be
measured using a nonstretch belt (48mm wide) that is placed over the umbilicus. The
overlapping ends of the belt will be adjusted carefully with two elastic bands to adapt
constantly to the abdominal wall.
Phase:
N/A
Details
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute