Irritable Bowel Syndrome Clinical Trial
Official title:
Feedback-assisted Treatment of Abdominal Distension - a Randomized Controlled Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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