Treatment of Abdominal Distension by Biofeedback - 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.
Aims: Based on the investigators hypothesis, the investigators plan the following milestones: a) to prove the efficacy of behavioural treatment using biofeedback techniques for abdominal distension, and b) identify biological markers that may predict the response to treatment.
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. The training session will last 15 min. Placebo: Patients will be given a pill containing placebo medication.
Measurements: In the erect position, electromyographic activity of the diaphragm, the anterior abdominal wall, and the intercostal muscles will be continuously recorded. Abdominal distension will be measured by a metric tape fixed to a non-stretch belt placed over the umbilicus. Conscious perception will be assessed by means of graphic rating scales graded from 0 (no perception) to 6 (very intense sensation).
Outcomes: Primary outcome: Reduction of electromyographic muscle activity of the diaphragm and the internal oblique Secondary outcome: Reduction of bloating sensation.
Follow-up: Patients will be followed for 3 months after the initial treatment session.
Irritable Bowel Syndrome
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Feedback-assisted Treatment of Abdominal Distension - a Randomized Controlled Trial|
- Reduction of diaphragmatic: electromyography activity [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]Electromyographic activity of the diaphragm will be continuously measured using a esophageal probe (6 ring electrodes over a nasogastric tube) placed at the hiatus. The outcome measurement takes place after 30 minutes of treatment session.
- Bloating sensation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Bloating sensation will be assessed by means of a graphic rating scale graded from 0 (no perception) to 6 (very intense perception).
- Reduction of internal oblique electromyography activity [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]Electromyographic activity of the abdominal wall (external oblique, internal oblique, upper rectus, lower rectus) will be continuously measured using 4 pairs of surface electrodes. The outcome measurement takes place after 30 minutes of treatment session.
- Decrease of abdominal girth [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]Abdominal girth will be continuously measured using a nonstretch belt (48mm wide) that is placed over the umbilicus and ﬁxed to the skin on the back to prevent slipping. The overlapping ends of the belt will be adjusted carefully with two elastic bands to adapt constantly to the abdominal wall. The outcome measurement takes place after 30 minutes of treatment session.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Biofeedback
Patients will be taught to control abdominal and diaphragmatic muscles by bio-feedback using EMG recordings.
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 Comparator: Placebo medication
Electromyography will be recorded but not shown to the patients. Patients will take a pill of placebo.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205100
|Contact: Fernando Azpiroz, M.D.||+34 93 274 firstname.lastname@example.org|
|Contact: Anna Accarino, M.D.||+34 93 274 email@example.com|
|University Hospital Vall d'Hebron||Recruiting|
|Barcelona, Catalunya, Spain, 08035|
|Contact: Fernando Azpiroz, M.D. PhD +34 93 274 6222 firstname.lastname@example.org|
|Principal Investigator: Fernando Azpiroz, M.D. PhD|
|Sub-Investigator: Anna Accarino, M.D.|
|Sub-Investigator: Elizabeth Barba, MD|
|Principal Investigator:||Fernando Azpiroz, M.D.||University Hospital Vall d'Hebron|