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Treatment of Abdominal Distension by Biofeedback - a Randomized Controlled Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT01205100
First received: September 6, 2010
Last updated: July 26, 2016
Last verified: July 2016
  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.

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.


Condition Intervention
Irritable Bowel Syndrome
Dyspepsia
Behavioral: Bio-feedback
Drug: Placebo

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:
  • Sensation of abdominal distension [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Sensation score measured by 0-6 scales after each meal (breakfast, lunch, dinner) over a 10-day clinical evaluation period before and after intervention.


Secondary Outcome Measures:
  • Changes in thoraco-abdominal activity of the muscular walls. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Activity of thoraco-abdominal muscles (intercostals, diaphragm, external oblique, internal oblique, upper rectus, lower rectus) will be continuously measured by electromyography.

  • Changes in girth [ Time Frame: 10 days ] [ 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. Measurements will be taken before and at the beginning at the end of each intervention session.


Enrollment: 48
Study Start Date: January 2013
Study Completion Date: June 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Biofeedback
Patients will be taught to control abdominal and diaphragmatic muscles by bio-feedback using EMG recordings.
Behavioral: 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.
Placebo Comparator: Placebo medication
Electromyography will be recorded but not shown to the patients. Patients will take a pill of placebo.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria: organic cause detected by clinical work-up

  Contacts and Locations
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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: July 26, 2016
Health Authority: Spain: Comité Ético de Investigación Clínica
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Publication in scientific journal.

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

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Dyspepsia
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2016