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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

September 6, 2010
July 26, 2016
January 2013
January 2016   (final data collection date for primary outcome measure)
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.
Reduction of diaphragmatic: EMG acticity [ 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 mintues of treatment session.
Complete list of historical versions of study NCT01205100 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 EMG 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 mintues 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 mintues of treatment session.
Not Provided
Not Provided
 
Treatment of Abdominal Distension by Biofeedback - a Randomized Controlled Trial
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Irritable Bowel Syndrome
  • Dyspepsia
  • 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.
  • Drug: Placebo
  • Active Comparator: Biofeedback
    Patients will be taught to control abdominal and diaphragmatic muscles by bio-feedback using EMG recordings.
    Intervention: Behavioral: Bio-feedback
  • Placebo Comparator: Placebo medication
    Electromyography will be recorded but not shown to the patients. Patients will take a pill of placebo.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
June 2016
January 2016   (final data collection date for primary outcome measure)

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

Exclusion Criteria: organic cause detected by clinical work-up

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01205100
PR(AG)60/2009
No
Yes
Publication in scientific journal.
Hospital Universitari Vall d'Hebron Research Institute
Hospital Universitari Vall d'Hebron Research Institute
Not Provided
Principal Investigator: Fernando Azpiroz, M.D. University Hospital Vall d'Hebron
Hospital Universitari Vall d'Hebron Research Institute
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP