Treatment of Abdominal Distension by Biofeedback - a Randomized Controlled Trial

Irritable Bowel Syndrome Clinical Trial

Official title:

Feedback-assisted Treatment of Abdominal Distension - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01205100
• Other study ID #: PR(AG)60/2009
• Status: Completed
• Phase: N/A
• First received: September 6, 2010
• Last updated: July 26, 2016
• Start date: January 2013
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria: organic cause detected by clinical work-up

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Irritable Bowel Syndrome

Intervention

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

Locations

Country	Name	City	State
Spain	University Hospital Vall d'Hebron	Barcelona	Catalunya

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Tremolaterra F, Villoria A, Azpiroz F, Serra J, Aguadé S, Malagelada JR. Impaired viscerosomatic reflexes and abdominal-wall dystony associated with bloating. Gastroenterology. 2006 Apr;130(4):1062-8. — View Citation

Villoria A, Azpiroz F, Soldevilla A, Perez F, Malagelada JR. Abdominal accommodation: a coordinated adaptation of the abdominal wall to its content. Am J Gastroenterol. 2008 Nov;103(11):2807-15. doi: 10.1111/j.1572-0241.2008.02141.x. Epub 2008 Sep 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensation of abdominal distension	Sensation score measured by 0-6 scales after each meal (breakfast, lunch, dinner) over a 10-day clinical evaluation period before and after intervention.	10 days	No
Secondary	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 continuously measured by electromyography.	10 days	No
Secondary	Changes in girth	Abdominal girth will be continuously measured using a nonstretch belt (48mm wide) that is placed over the umbilicus and ?xed 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.	10 days	No