Treatment of Abdominal Distension by Biofeedback - a Randomized Controlled Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT01205100
First received: September 6, 2010
Last updated: September 26, 2012
Last verified: June 2011
  Purpose

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 by a 2:1 (Feedback : Placebo) randomization, stratified by gender.

Intervention: Feedback: Patients will be taught thoracic inspiration with bio-feedback using online electromyography information. The training session will last 15 min. Placebo: Patients will be given a pill containing Dimeticon-Siliciumdioxid (Simethicon).

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.


Condition Intervention
Abdominal Distention
Irritable Bowel Syndrome
Functional Bloating
Behavioral: Bio-feedback assisted respiratory maneuvers
Drug: Placebo medication

Study Type: Interventional
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

Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 70
Study Start Date: November 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Feedback
Patients will be taught to control abdominal and diaphragmatic muscles by bio-feedback.
Behavioral: Bio-feedback assisted respiratory maneuvers
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
Patients will be given a pill containing Dimeticon-Siliciumdioxid (Simethicon).
Drug: Placebo medication
Patients will take a pill that contains Dimetico-Siliciumdioxid (Simethicon). Dimetico-Siliciumdioxid is an anti-foaming agent that decreases surface tension of gas bubbles and is used as a gold-standard in the treatment of patients with abdominal bloating and distension. However, recent studies have shown that the amount of intestinal gas does not change during spontaneous bloating in patients with irritable bowel syndrome and functional bloating. Therefore, we do not expect the drug to have any effect. Respiratory maneuvers will not be performed and no electromyography information will be provided.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Abdominal distension in irritable bowel syndrome or functional bloating (according to Rome III criteria)

Exclusion Criteria:

  • Age 18 over younger
  • Gastrointestinal motility disorder
  • Not meeting Rome III criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205100

Locations
Spain
University Hospital Vall d'Hebron
Barcelona, Catalunya, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
Principal Investigator: Fernando Azpiroz, M.D. University Hospital Vall d'Hebron
  More Information

Publications:
Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01205100     History of Changes
Other Study ID Numbers: PR(AG)60/2009
Study First Received: September 6, 2010
Last Updated: September 26, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Gastrointestinal Diseases
Irritable Bowel Syndrome
Behavioral Research
Biofeedback

Additional relevant MeSH terms:
Dilatation, Pathologic
Irritable Bowel Syndrome
Pathological Conditions, Anatomical
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 21, 2014