Treatment of Abdominal Distension by Biofeedback - a Randomized Controlled Trial
Summary
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.
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Conditions
Abdominal Distention
Intervention
Bio-feedback assisted respiratory maneuvers, Placebo medication
Location
University Hospital Vall d'Hebron
Barcelona
Catalunya
Spain
08035
Status
Active, not recruiting
Source
Hospital Universitari Vall d'Hebron Research Institute
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01205100
- Information obtained from ClinicalTrials.gov on October 24, 2012
Medical and Biotech [MESH] Definitions
Feedback, Physiological
A mechanism of communication with a physiological system for homeostasis, adaptation, etc. Physiological feedback is mediated through extensive feedback mechanisms that use physiological cues as feedback loop signals to control other systems.
Hernia, Abdominal
A protrusion of abdominal structures through the retaining ABDOMINAL WALL. It involves two parts: an opening in the abdominal wall, and a hernia sac consisting of PERITONEUM and abdominal contents. Abdominal hernias include groin hernia (HERNIA, FEMORAL; HERNIA, INGUINAL) and VENTRAL HERNIA.
Hernia, Umbilical
A HERNIA due to an imperfect closure or weakness of the umbilical ring. It appears as a skin-covered protrusion at the UMBILICUS during crying, coughing, or straining. The hernia generally consists of OMENTUM or SMALL INTESTINE. The vast majority of umbilical hernias are congenital but can be acquired due to severe abdominal distention.
Hand-assisted Laparoscopy
Placement of one of the surgeon's gloved hands into the ABDOMINAL CAVITY to perform manual manipulations that facilitate the laparoscopic procedures.
Injections, Intraperitoneal
Forceful administration into the peritoneal cavity of liquid medication, nutrient, or other fluid through a hollow needle piercing the abdominal wall.
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