Treatment of Abdominal Distension by Biofeedback

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Biofeedback

Patients will be taught to control abdominal and diaphragmatic muscles by bio-feedback using EMG recordings.

Group Type ACTIVE_COMPARATOR

Bio-feedback

Intervention Type BEHAVIORAL

By providing on-line electromyography information of muscle activity, patients will be able to control and actively correct their muscle activity during the 15 min treatment session. Each patients will attend 3 treatment sessions.

Placebo medication

Electromyography will be recorded but not shown to the patients. Patients will take a pill of placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Bio-feedback

By providing on-line electromyography information of muscle activity, patients will be able to control and actively correct their muscle activity during the 15 min treatment session. Each patients will attend 3 treatment sessions.

Intervention Type BEHAVIORAL

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: episodes of visible abdominal distension triggered by meal ingestion

Exclusion Criteria: organic cause detected by clinical work-up

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No